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## Protocol Section ### Identification Module **NCT ID:** NCT06413719 **Acronym:** SPD **Brief Title:** Assessing the Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder **Official Title:** Assessing the Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder: a Feasibility Study #### Organization Study ID Info **ID:** I-0030 #### Organization **Class:** OTHER **Full Name:** Life University ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Life University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial's main aims are to investigate the feasibility of implementing our novel assessment battery in tandem with normal and customary chiropractic care in a practice-based setting using a pediatric population with parent-reported SPD. More specifically, our primary endpoints are 1) recruitment rate, 2) tolerability, 3) adherence, 4) retention, 5) efficiency, and 6) data quality. **Detailed Description:** The total estimated time requirement for this study is \~60 minutes. Up to 20 children (ages 5-12) will be recruited in a maximum 3-month enrollment period. The total estimated time requirement for the parent and child is \~1 hour excluding the normal and customary chiropractic care. Per the clinic's normal and customary procedures, a welcome email is sent to each parent who schedules their child for a chiropractic exam at Premier Wellness Care (PWC) chiropractic (Crystal Lake, IL). An addendum will be added to this email briefly introducing the study along with a HIPAA compliant Jotform link to an online screening survey which incorporates the 38-item short sensory profile v1 (SSP-1). Those who complete the online screen and meet the eligibility criteria described below will be notified when they arrive at PWC for their initial exam \& offered the opportunity to participate in the study. Informed consent (IC) and assent (IA) will be collected in a private room within PWC. A PWC staff member (TM) will sit down with each parent \& child to review the IC \& IA forms and answer any queries. To be enrolled, the parent must sign the IC and the child must acknowledge their willingness to participate verbally (e.g., "yes I would like to do the study") and/or physically (e.g., nod their head \& give a 'thumbs up'). It will be made clear to all parents \& children that they may decline participation without penalty and declining participation will in no way impact the child's access to normal and customary chiropractic care. Children will be asked to stand up straight on a scale so we can measure their heights and weights. They will then be asked to sit in a comfortable chair, shown a visual analog scale (VAS), and asked to rate their pain level on a scale from 0 ("no pain") to 10 ("worst pain possible"). To track autonomic nervous system (ANS) activity, children will be asked to place their hand on the class II FDA registered neuroPULSE scanner (CLA Inc., Toronto, ON, Canada) and put their index, middle, \& ring fingers onto the sensors. To track sweat gland (i.e., electrodermal, EDA) activity, a safe and unrecognizable low-voltage, high-amplitude current is passed between sensors located at the palmar-surfaces of the index and ring fingers. The pulse rate is measured via photoplethysmography (PPG) whereby blood flow-dependent changes in the quantity of emitted light passing though the fingertip are tracked via a sensor located on the palmar-surface of the middle finger. All signals will be transmitted to an iPad for viewing by the assessor via a secure Wi-Fi connection. With their hand in the neuroPULSE, children will undergo a sensory challenge protocol (SCP). For the SCP, the kids will be fitted with noise cancelling headphones and be shown a series of pictures. Prior to initiating the SCP, the assessor will instruct the child how to perform the test. The headphones will then be paired via Bluetooth to an iPhone/iPad device \& switched on. Upon presentation of the "sitting" picture, the child will be asked to sit still and quietly for \~2 minutes. Upon presentation of the "standing" picture, they will be asked to quickly stand and remain still and quiet for \~2 minutes. Upon re-presentation of the "sitting" picture, the child will be asked to quickly return to a seated position \& remain still and quiet for \~2 minutes. Finally, upon presentation of the "noise" picture, the child will be asked to sit still and quietly while an auditory stimulus (1000 Hz, sine wave, 50% system volume, \~75 dB) generated via a free tone generator app (f Generator, v7.4.1) is presented to both ears through the headphones for \~2 minutes. The sound is like what you would hear on your mobile device during an "AMBER Alert". This prolonged auditory stimulus is well below acceptable noise exposure limits and is in line with a protocol used in prior studies to test pediatric SPD populations. To help keep the children occupied during the SCP, a researcher will place an iPad directly in front of the subject \& play a relaxing video (e.g., fish swimming in the ocean). When the SCP is finished, the video will be stopped, the headphones will be removed, and the child will be asked to remove his/her hand from the neuroPULSE scanner. During the child's assessment, parents will then be given an iPad \& asked to complete the 38-item SSP-1. All assessments will be repeated following 12 sessions of PWC's normal and customary chiropractic care. ### Conditions Module **Conditions:** - Sensation Disorders **Keywords:** - Pediatrics - sensation disorders - autonomic nervous system - HRV - heart rate variability ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children with probable or definite sensory processing challenges per the SSP-1 **Label:** No Intervention ### Outcomes Module #### Primary Outcomes **Description:** Average number of subjects enrolled per month **Measure:** Recruitment rate **Time Frame:** 3 months (recruitment period) **Description:** % of participants unable/unwilling to complete a given assessment **Measure:** Tolerability **Time Frame:** 4 months (data collection period) **Description:** % of participants attending \<80% of their chiropractic sessions within the recommended time frame **Measure:** Adherence **Time Frame:** 4 months (data collection period) **Description:** % of participants completing the trial **Measure:** Retention **Time Frame:** 4 months (data collection period) **Description:** Average time to completion of each assessment section **Measure:** Efficiency **Time Frame:** 4 months (data collection period) **Description:** % of acquisitions unsuitable for analysis for a given assessment **Measure:** Data quality **Time Frame:** 6 months (study period) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 5-12 years of age * SSP-1 total score no greater than 154 Exclusion Criteria: * Unable to perform assessments due to vision, hearing, or movement impairment (e.g., blind, deaf, confined to wheelchair) * Unable to perform the assessments due to a preexisting condition whereby quick postural changes are contraindicated (e.g., postural orthostatic tachycardia syndrome (POTS), postural hypotension) * Pacemaker or known heart condition that influences the electrical or mechanical function of the heart **Maximum Age:** 12 Years **Minimum Age:** 5 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Children with probable or definite sensory processing challenges per the SSP-1 ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** research.studies@life.edu **Name:** Dusty Baker, BS **Phone:** 7704262639 **Role:** CONTACT #### Locations **Location 1:** **City:** Crystal Lake **Contacts:** ***Contact 1:*** - **Email:** traci@pwcchiropractic.com - **Name:** Traci Miller - **Phone:** 815-455-8213 - **Role:** CONTACT **Country:** United States **Facility:** Premier Wellness Care (PWC) Chiropractic **State:** Illinois **Zip:** 60012 #### Overall Officials **Official 1:** **Affiliation:** Life University **Name:** Tyson Perez, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15490 - Name: Sensation Disorders - Relevance: HIGH - As Found: Sensation Disorders - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012678 - Term: Sensation Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413706 **Brief Title:** A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy **Official Title:** A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy #### Organization Study ID Info **ID:** 18646 #### Organization **Class:** INDUSTRY **Full Name:** Eli Lilly and Company #### Secondary ID Infos **Domain:** Eli Lilly and Company **ID:** I3Y-MC-JPEH **Type:** OTHER **ID:** 2022-502269-13-00 **Type:** CTIS **Domain:** UTN **ID:** U1111-1289-0405 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Eli Lilly and Company #### 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 measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond. ### Conditions Module **Conditions:** - Glioma **Keywords:** - Brain tumor - Central nervous system (CNS) tumor - Spinal cord tumor - Cyclin-dependent kinase (CDK) 4/6 inhibitor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV). **Intervention Names:** - Drug: Abemaciclib - Drug: Temozolomide **Label:** Abemaciclib + Temozolomide - Arm A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive temozolomide administered orally or IV. **Intervention Names:** - Drug: Temozolomide **Label:** Temozolomide - Arm B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Abemaciclib + Temozolomide - Arm A **Description:** Administered orally **Name:** Abemaciclib **Other Names:** - LY2835219 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Abemaciclib + Temozolomide - Arm A - Temozolomide - Arm B **Description:** Administered orally or IV **Name:** Temozolomide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Event free survival as determined by blinded independent review committee. **Measure:** Event Free Survival as Determined by Blinded Independent Review Committee **Time Frame:** Baseline up to approximately 11 months #### Secondary Outcomes **Description:** Event free survival as determined by investigator assessment **Measure:** Event Free Survival as Determined by Investigator Assessment **Time Frame:** Baseline up to approximately 11 months **Description:** Overall survival **Measure:** Overall Survival (OS) **Time Frame:** Baseline to date of death due to any cause (up to approximately 18 months) **Description:** Overall response rate **Measure:** Overall Response Rate (ORR) **Time Frame:** Baseline up to approximately 3 months **Description:** Disease control rate **Measure:** Disease Control Rate (DCR) **Time Frame:** Baseline through to disease progression (up to approximately 3 months ) **Description:** Duration of response **Measure:** Duration of Response (DoR) **Time Frame:** Date of Complete Response (CR) or Partial Response (PR) or Minor Response (MR) to date of disease progression or death (up to approximately 3 months ) **Description:** PK Abemaciclib Plasma Concentrations **Measure:** Pharmacokinetic (PK): Abemaciclib Plasma Concentration **Time Frame:** Cycle 1 through Cycle 4 (21 Day cycle) **Description:** Questionnaire **Measure:** Abemaciclib Acceptability and Palatability Questionnaire **Time Frame:** Day 1 of Cycles 1 through 3 (21 Day Cycles)] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including: * Anaplastic astrocytoma * Anaplastic ganglioglioma * Anaplastic oligodendroglioma. * Anaplastic pleomorphic xanthoastrocytoma, * Glioblastoma OR as defined by the 2021 WHO Classification Criteria as molecularly characterized: * Non-pontine diffuse midline glioma, H3 K27-altered, * Diffuse hemispheric glioma, H3 G34-mutant * Diffuse pediatric HGG, H3/IDH-wildtype * Isocitrate dehydrogenase-mutant (IDH-mutant) Infant-type hemispheric glioma * High-grade astrocytoma with piloid features * High-grade pleomorphic xanthoastrocytoma * IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion, * IDH-mutant and 1p/19q co-deleted oligodendroglioma * IDH-mutant astrocytoma with homozygous CDKN2A/B deletion * Contraceptive use should be consistent with local regulations foe participants in clinical studies. * Radiotherapy initiated within 6 weeks (±1 week) of diagnosis and administered over 6 weeks (±1 week). Participants \<3 years of age, considered not suitable for radiotherapy may be eligible. * Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1). * Maximum of 8 weeks between completion of radiation and C1D1. Exceptional circumstances can be discussed with the medical monitor. * Acute effects of prior therapies must be Grade ≤1 unless deemed clinically insignificant by the investigator. * Adequate hematologic and organ function ≤7 days prior to C1D1 * Life expectancy of ≥8 weeks and deemed likely to complete at least 1 cycle of treatment. * A performance score of ≥60 using: 1. Lansky scale for participants \<16 years 2. Karnofsky scale for participants ≥16 years * Able to swallow and/or have a gastric/nasogastric tube. * Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D1. * Able and willing to adhere to study procedures, including frequent blood draws and MRI. * At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury. Exclusion Criteria: Participants are excluded if any of the following apply: * Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons. * Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy. * Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy. * Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator. * Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide). * Current enrollment in another trial deemed incompatible with this study. * Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer). * Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results. * A preexisting medical condition(s) that, per the investigator, would preclude study participation. * Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1. * Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome, to temozolomide, its excipients, or dacarbazine. * Received a live virus vaccine within 28 days of C1D1. * Pregnant, breastfeeding, or intend to become pregnant during the study. **Maximum Age:** 20 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ClinicalTrials.gov@lilly.com **Name:** There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or **Phone:** 317-615-4559 **Role:** CONTACT **Contact 2:** **Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) **Role:** CONTACT #### Locations **Location 1:** **City:** Phoenix **Contacts:** ***Contact 1:*** - **Name:** Lindsey M Hoffman - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Phoenix Childrens Hospital (PCH) **State:** Arizona **Zip:** 97557 #### Overall Officials **Official 1:** **Affiliation:** Eli Lilly and Company **Name:** Contact Lilly at 1-800-LillyRx (1-800-545-5979) **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. **Description:** Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. **URL:** http://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - 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: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: M5209 - Name: Brain Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15917 - Name: Spinal Cord Neoplasms - 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: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma ### 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: 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 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413693 **Brief Title:** A STUDY TO LEARN HOW THE STUDY MEDICINE CALLED PF-07293893 AFFECTS MUSCLE BIOMARKERS OF HEALTHY ADULTS **Official Title:** A PHASE 1, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN) PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECT OF PF-07293893 ON SKELETAL MUSCLE BIOMARKERS IN HEALTHY ADULT PARTICIPANTS #### Organization Study ID Info **ID:** C5171004 #### Organization **Class:** INDUSTRY **Full Name:** Pfizer ### Status Module #### Completion Date **Date:** 2024-10-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pfizer #### 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 understand how the study medicine (PF-07293893) affects muscle biomarkers. Biomarkers are like clues or signs in our body that can help doctors understand our health. PF-07293893 is being studied as a possible treatment for people with heart disease who have reduced ability to exercise. This study aims to see how the study medicine affects muscle biomarkers related to the ability to exercise. This study is seeking participants who: 1. Are males 18 to 65 years of age and females who are not able to become pregnant; 2. Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds); 3. Over prior 4 weeks have an average of less than: -150 minutes of moderate-intensity aerobic physical activity throughout each week. Moderate-intensity physical activity feels somewhat hard. Your breathing becomes faster, but you are not out of breath. You can hold a conversation, but you cannot sing. AND -75 minutes of vigorous-intensity aerobic physical activity throughout each week. Vigorous-intensity physical activity feels challenging. You are breathing fast and deep. You cannot say more than a few words without pausing. OR -An equivalent combination of moderate-and vigorous-intensity activity. Participants will stay at the study clinic for about four days. On the third day, participants will take the study medicine or placebo (dummy pill) by mouth once at the study clinic and then stay at the study clinic for another day. During this time, the study team will check the treatment and take some blood and muscle tissue samples from the leg. This will help to understand if the study medicine affects muscle biomarkers. Participants will return to the study clinic for a follow-up visit or receive a follow-up telephone call about a month later. ### Conditions Module **Conditions:** - Healthy Participants ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy adult participants will receive a single dose of PF-07293893 or placebo **Intervention Names:** - Drug: PF-07293893 - Drug: Placebo **Label:** Cohort 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Healthy adult participants will receive a single dose of PF-07293893 or placebo **Intervention Names:** - Drug: PF-07293893 - Drug: Placebo **Label:** Optional Cohort 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 - Optional Cohort 2 **Description:** A single dose of PF-07293893 administered orally as tablets **Name:** PF-07293893 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort 1 - Optional Cohort 2 **Description:** A single dose of Placebo administered orally as tablets that look the same as PF-07293893 **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from baseline of skeletal muscle pACC/tACC ratio **Time Frame:** Day 1 Pre-dose and 2 & 4 hours Post-dose #### Secondary Outcomes **Measure:** Number of Participants with Treatment Related Adverse Events (AEs) **Time Frame:** Baseline through Day 36 **Measure:** Number of Participants with change from Baseline in Laboratory Test Results **Time Frame:** Baseline through Day 36 **Measure:** Number of Participants with Clinically Significant Change From Baseline in Vital Signs **Time Frame:** Baseline through Day 36 **Measure:** Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) **Time Frame:** Baseline and Day 1 Pre-dose and 6 hours Post-dose **Measure:** Number of Participants With Change From Baseline in Physical Examinations **Time Frame:** Baseline through Day 36 **Measure:** Maximum Observed Plasma Concentration (Cmax) **Time Frame:** Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2 **Measure:** Time to Reach Maximum Observed Plasma Concentration (Tmax) **Time Frame:** Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2 **Measure:** Area under the serum concentration vs. time curve for 0-24 hours (AUC24) **Time Frame:** Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males 18 to 65 years of age and females of non-childbearing potential; 2. Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb); 3. Over prior 4 weeks an average of less than 150 minutes of moderate-intensity aerobic physical activity throughout each week, and less than 75 minutes of vigorous-intensity aerobic physical activity throughout each week, or an equivalent combination of moderate- and vigorous-intensity activity. Exclusion Criteria: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease; 2. History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C; 3. Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m²; 4. A positive urine drug test; 5. Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ClinicalTrials.gov_Inquiries@pfizer.com **Name:** Pfizer CT.gov Call Center **Phone:** 1-800-718-1021 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Pfizer **Name:** Pfizer CT.gov Call Center **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** To obtain contact information for a study center near you, click here. **URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C5171004 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413680 **Brief Title:** A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies **Official Title:** A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) in Patients With Advanced Solid Organ Malignancies #### Organization Study ID Info **ID:** R10597-ONC-22114 #### Organization **Class:** INDUSTRY **Full Name:** Regeneron Pharmaceuticals ### Status Module #### Completion Date **Date:** 2030-03-21 **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:** 2030-03-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Regeneron Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) **Detailed Description:** Phase 1: Conducted in the United States Phase 2: Conducted globally ### Conditions Module **Conditions:** - Melanoma - Clear-Cell Renal-Cell Carcinoma (ccRCC) - Advanced Solid Tumors **Keywords:** - Advanced solid organ malignancies - Locally advanced - Metastatic - Non-uveal - Unresectable - Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Multiple dose level (DL) Cohorts to identify the recommended Phase 2 dose (RP2D) **Intervention Names:** - Drug: REGN10597 **Label:** Phase 1: Dose Escalation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Cohort 1: Melanoma Participants Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants **Intervention Names:** - Drug: REGN10597 **Label:** Phase 2: Dose Expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1: Dose Escalation - Phase 2: Dose Expansion **Description:** Administered as an intravenous (IV) infusion **Name:** REGN10597 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of dose-limiting toxicities (DLTs) **Time Frame:** Up to Day 28 **Measure:** Incidence of treatment-emergent adverse event (TEAEs) **Time Frame:** Approximately 6 Years **Measure:** Incidence of serious adverse events (SAEs) **Time Frame:** Approximately 6 Years **Measure:** Incidence of TEAEs leading to treatment discontinuation **Time Frame:** Approximately 6 Years **Measure:** Incidence of TEAEs leading to death **Time Frame:** Approximately 6 Years **Description:** Grade 3 or higher per Common terminology criteria for adverse events (CTCAE) version 5.0 **Measure:** Number of participants with Grade ≥3 laboratory abnormalities **Time Frame:** Approximately 6 Years **Description:** Dose-expansion **Measure:** Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST 1.1) criteria by investigator assessment **Time Frame:** Approximately 6 Years #### Secondary Outcomes **Description:** Dose-escalation **Measure:** ORR based on RECIST 1.1 criteria by investigator assessment **Time Frame:** Approximately 6 Years **Measure:** Best overall response (BOR) based on RECIST 1.1 criteria **Time Frame:** Approximately 6 Years **Measure:** Duration of response (DOR) based on RECIST 1.1 criteria **Time Frame:** Approximately 6 Years **Measure:** Disease control rate based on RECIST 1.1 **Time Frame:** Approximately 6 Years **Measure:** Time to response based on RECIST 1.1 **Time Frame:** Approximately 6 Years **Measure:** Progression free survival (PFS) based on RECIST 1.1 **Time Frame:** Approximately 6 Years **Measure:** Concentrations of REGN10597 in serum **Time Frame:** Approximately 6 Years **Measure:** Incidence of anti-drug antibody (ADA) to REGN10597 over time **Time Frame:** Approximately 6 Years **Measure:** Titer of ADA to REGN10597 over time **Time Frame:** Approximately 6 Years ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: Dose-escalation cohorts: 1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy 2. Participants are required to submit archival tissue with optional fresh biopsy Dose-expansion cohorts: 1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol 2. Participants are required to submit fresh pretreatment biopsy during screening Key Exclusion Criteria: 1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7 2. Prior treatment with anti PD-1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol 3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs 4. Has had prior anti-cancer immunotherapy within 2 months prior to study therapy 5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol 6. Has known allergy or hypersensitivity to components of the study drug 7. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study drug 8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments NOTE: 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:** clinicaltrials@regeneron.com **Name:** Clinical Trials Administrator **Phone:** 844-734-6643 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Regeneron Pharmaceuticals **Name:** Clinical Trial Management **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf **Description:** All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009371 - Term: Neoplasms by Site - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11528 - Name: Melanoma - Relevance: LOW - As Found: Unknown - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Clear Cell Renal Cell Carcinoma - ID: M6845 - Name: Death - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: HIGH - As Found: Clear Cell Renal Cell Carcinoma ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000002292 - Term: Carcinoma, Renal Cell ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413667 **Acronym:** MRAtlas **Brief Title:** Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder **Official Title:** Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder #### Organization Study ID Info **ID:** 2023.0628 #### Organization **Class:** OTHER **Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) #### Responsible Party **Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Investigator Full Name:** Aart Nederveen **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:** Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2). The aim of this study is to evaluate the position and alignment of the Atlas in chronic whiplash-associated disorder (grades 1 or 2) and compare it to patients with tension headache and healthy controls. Additionally, it will explore how these factors relate to pain intensity, neck movement limitations, daily activities, overall improvement, and quality of life. **Detailed Description:** Treating some neurological conditions, like chronic whiplash-associated disorder (WAD), is highly challenging for medical practitioners. Patients with chronic WAD frequently visit their general practitioner because it's hard to pinpoint the cause of their symptoms. This makes finding the right treatment very difficult. The number of chronic WAD cases is rising worldwide, costing Europe an estimated 10 billion euros annually. Half of all whiplash injuries develop into chronic conditions, leading to significant disability and societal costs. These patients face major limitations in daily activities, greatly affecting their quality of life. Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2). The aim of this study is to apply advanced imaging technologies to assess the position and alignment of the Atlas (C1) and the surrounding tissues. The study has three main goals: i. Study the feasibility and repeatability of state-of-the-art MRI measurements in 30 healthy controls across an age range of 18 to 75 years. ii. Assess the position and alignment of the Atlas and surrounding tissues using MRI in patients with WAD, compared to patients with tension headaches and healthy control participants; iii. Relate these MRI parameters to neurological examinations and questionnaires (patient- reported outcome measures) in patients with WAD and tension headaches. ### Conditions Module **Conditions:** - Chronic Whiplash Associated Disorder **Keywords:** - Atlas - MRI ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy control participants without intervention **Label:** Control participants #### Arm Group 2 **Description:** Chronic Whiplash Associated Disorder without intervention **Label:** Chronic Whiplash Associated Disorder #### Arm Group 3 **Description:** Tension headache without intervention **Label:** Tension headache ### Outcomes Module #### Primary Outcomes **Description:** MRI images will be used to measure the angles between the Atlas and adjacent vertebrae at two different time points in the same healthy participants. **Measure:** Repeatability measurement **Time Frame:** 12 months **Description:** MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups. **Measure:** Alignment of the Atlas **Time Frame:** 12 months **Description:** A neurological examination will be performed and scored during the participants' visit **Measure:** Neurological examination scores **Time Frame:** 18 months **Description:** The scores will be obtained by using quality of life questionnaire **Measure:** Quality of life scores **Time Frame:** 18 months #### Secondary Outcomes **Description:** Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups. **Measure:** Muscle volume **Time Frame:** 24 months **Description:** Fat fraction (in %) will be measured from MRI and compared across the groups. **Measure:** Fat fraction **Time Frame:** 24 months **Description:** Blood flow (in cm/s) in the brain feeding arteries will be obtained from the quantitative MRI scans and compared across the groups. **Measure:** Blood flow **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Participants fulfilling the criteria mentioned below: Control participants In order to be eligible to participate in this study, a participant must meet the following criteria: * Healthy individuals * Ability to follow test instructions * Aged between 18 - 75 years Chronic Whiplash Associated Disorder In order to be eligible to participate in this study, a participant must meet the following criteria: * Healthy individuals * Ability to follow test instructions * WAD 1 or 2 Diagnosis * Aged between 18 - 75 years Tension headache In order to be eligible to participate in this study, a participant must meet the following criteria: * Healthy individuals * Ability to follow test instructions * Diagnosis Tension headache * Aged between 18 -75 years Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Inability to provide informed consent * Have a history of claustrophobia * Patient/ participant is not eligible to follow instructions * Contra-indication for MRI (e.g., pacemaker, claustrophobia) * Being under investigation for non-diagnosed disease at the time of investigation **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The aim of this study is to evaluate high resolution MR techniques to measure position and alignment of the Atlas and its surrounding structures in healthy participants, individuals with tension headache and individuals with chronic whiplash disorder. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.j.nederveen@amsterdamumc.nl **Name:** Nederveen **Phone:** +31 20 5629338 **Role:** CONTACT **Contact 2:** **Email:** l.afzali-hashemi@amsterdamumc.nl **Name:** Afzali-Hashemi **Role:** CONTACT #### Locations **Location 1:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Email:** a.j.nederveen@amsterdamumc.nl - **Name:** Nederveen - **Role:** CONTACT **Country:** Netherlands **Facility:** Amsterdam UMC **Status:** RECRUITING **Zip:** 1105 AZ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019838 - Term: Neck Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17651 - Name: Whiplash Injuries - Relevance: HIGH - As Found: Whiplash - ID: M21725 - Name: Neck Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014911 - Term: Whiplash Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413654 **Brief Title:** A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) **Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder #### Organization Study ID Info **ID:** SPH-B001-301 #### Organization **Class:** INDUSTRY **Full Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd ### Status Module #### Completion Date **Date:** 2029-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Shanghai Pharmaceuticals Holding Co., Ltd #### Lead Sponsor **Class:** INDUSTRY **Name:** Shanghai Jiaolian Drug Research and Development 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:** To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder. ### Conditions Module **Conditions:** - Neuromyelitis Optica Spectrum Disorders ### 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:** 132 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: B001 **Label:** B001 injection **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - B001 injection **Description:** The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP **Name:** B001 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD. **Measure:** Time to first NMOSD Attack During RCP **Time Frame:** Approximately 48 weeks #### Secondary Outcomes **Description:** EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). **Measure:** Change in Expanded Disability Status Scale (EDSS) Score **Time Frame:** Approximately 48 weeks **Description:** Change in VA/LCVA **Measure:** Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA) **Time Frame:** Approximately 48 weeks **Description:** Annualized attack rate is defined as total number of attacks divided by total person years. **Measure:** Annualized relapse rate (ARR) **Time Frame:** Approximately 3 years **Description:** Change in OSIS **Measure:** Change in Opticospinal Impairment Scale (OSIS) **Time Frame:** Approximately 48 weeks **Description:** An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. **Measure:** Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) **Time Frame:** Approximately 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Confirmed NMOSD patients; 2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening; 3. The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation; 4. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures. Exclusion Criteria: 1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study; 2. Subjects with chronic active immune system diseases undergoing systematic treatment; 3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose; 4. Received the prescribed drug treatment at the prescribed time before first dose; 5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose; 6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose; 7. Pregnant or lactating women; Subjects with birth plans during the trial; 8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial; 9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study; 10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening; 11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period; 12. Subjects with severe or persistent infection currently or within the 3 months prior to screening; 13. Subjects with positive gamma interferon release test; 14. Subjects who currently have active hepatitis or have a history of severe liver disease; 15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion; 16. Abnormal laboratory test results; 17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing; 18. Subjects with symptoms of severe mental illness who are clinically uncooperative; 19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ttyyirb@163.com **Name:** FuDong Shi **Phone:** 0086-010-59978555 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Guangzhi Liu - **Role:** CONTACT **Country:** China **Facility:** Beijing Anzhen Hospital，Capital Medical University **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Fudong Shi - **Role:** CONTACT **Country:** China **Facility:** Beijing Tiantan Hospital，Capital Medical University **Location 3:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Feng Gao - **Role:** CONTACT **Country:** China **Facility:** Peking University First Hospital **Location 4:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Xiaomei Wu - **Role:** CONTACT **Country:** China **Facility:** The Second Xiangya Hospital of Central South University **Location 5:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Name:** Aiyu Lin - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Fujian Medical University **Location 6:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** Honghao Wang - **Role:** CONTACT **Country:** China **Facility:** Guangzhou First People's Hospital **Location 7:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** Jinsheng Zeng - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital, Sun Yat-sen University **Location 8:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Zhiying Wu - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of Zhejiang University School of Medicine **Location 9:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Name:** Ruisheng Duan - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Shandong First Medical University **Location 10:** **City:** Kunming **Contacts:** ***Contact 1:*** - **Name:** Qiang Meng - **Role:** CONTACT **Country:** China **Facility:** First People's Hospital of Yunnan Province **Location 11:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Name:** Zhe Wu - **Role:** CONTACT **Country:** China **Facility:** The First Hospital of China Medical University **Location 12:** **City:** Shijiazhuang **Contacts:** ***Contact 1:*** - **Name:** Bin Li - **Role:** CONTACT **Country:** China **Facility:** The Second Hospital of Hebei Medical University **Location 13:** **City:** Taiyuan **Contacts:** ***Contact 1:*** - **Name:** Meini Zhang - **Role:** CONTACT **Country:** China **Facility:** First Hospital of Shanxi Medical University **Location 14:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Name:** Li Yang - **Role:** CONTACT **Country:** China **Facility:** Tianjin Medical University General Hospital **Location 15:** **City:** Wenzhou **Contacts:** ***Contact 1:*** - **Name:** Xu Zhang - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Wenzhou Medical University **Location 16:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Name:** Ting Chen - **Role:** CONTACT **Country:** China **Facility:** Renmin Hospital of Wuhan University **Location 17:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Name:** Daishi Tian - **Role:** CONTACT **Country:** China **Facility:** Tongji Hospital **Location 18:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Name:** Jun Guo - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University **Location 19:** **City:** Yantai **Contacts:** ***Contact 1:*** - **Name:** Jianhua Tang - **Role:** CONTACT **Country:** China **Facility:** Yantai Mountain Hospital in Yantai City **Location 20:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Name:** Yue Huang - **Role:** CONTACT **Country:** China **Facility:** Henan Provincial People's Hospital **Location 21:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Name:** Yuming Xu - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Zhengzhou University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009188 - Term: Myelitis, Transverse - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000009902 - Term: Optic Neuritis - ID: D000009901 - Term: Optic Nerve Diseases - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12414 - Name: Neuromyelitis Optica - Relevance: HIGH - As Found: Neuromyelitis Optica - ID: M12142 - Name: Myelitis - Relevance: LOW - As Found: Unknown - ID: M12143 - Name: Myelitis, Transverse - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M12387 - Name: Neuritis - Relevance: LOW - As Found: Unknown - ID: M12833 - Name: Optic Neuritis - Relevance: LOW - As Found: Unknown - ID: M12832 - Name: Optic Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T4103 - Name: Neuromyelitis Optica Spectrum Disorder - Relevance: HIGH - As Found: Neuromyelitis Optica Spectrum Disorder - ID: T3988 - Name: Myelitis - Relevance: LOW - As Found: Unknown - ID: T4263 - Name: Optic Neuritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009471 - Term: Neuromyelitis Optica ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413641 **Acronym:** VICAD-RISK **Brief Title:** VIsualization of Coronary Artery Disease for Modification of RISK Factors **Official Title:** VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis. #### Organization Study ID Info **ID:** NNF21OC0068200 #### Organization **Class:** OTHER **Full Name:** Aarhus University Hospital #### Secondary ID Infos **Domain:** VMK NVK **ID:** 1-10-72-213-22 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-12 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital of South West Jutland **Class:** OTHER **Name:** Vejle Hospital **Class:** OTHER **Name:** Gødstrup Hospital **Class:** OTHER **Name:** Aalborg University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Aarhus University Hospital #### Responsible Party **Investigator Affiliation:** Aarhus University Hospital **Investigator Full Name:** Bjarne Linde Nørgaard **Investigator Title:** MD, Professor, DMSCi, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The VICAD-RISK study assesses if visualization of coronary CT angiography images in participants with non-obstructive coronary artery disease will improve LDL lowering, reduce reporting of side effects by cholesterol lowering medications, and modify the coronary artery disease phenotype over 12 months. **Detailed Description:** In Denmark non-obstructive coronary artery disease is found in 35-40% of patients undergoing coronary CT angiography for suspected coronary artery disease. Modification of risk factors is essential in patients with coronary artery disease to prevent major cardiovascular events. However, in non-obstructive coronary artery disease, initiation and adherence to treatment with lipid lowering therapy is poor. The study will include 390 patients from 5 different sites; patients will be randomized into 3 groups; standard follow up by general practice, structured disease education or the combination of the latter with visualization of coronary CT angiography images. A follow-up CT angiography will be performed at 12 months. ### Conditions Module **Conditions:** - Coronary Artery Disease - Non-Obstructive Coronary Atherosclerosis **Keywords:** - Coronary computed tomography - Hypercholesterolemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients will be randomized 1:1:1 to post-CTA usual care follow up in general practice or one of two intervention strategies ("low" or "high" intensity intervention). Patients randomized to the intervention groups will be invited to an individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 390 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care follow up in general practice **Intervention Names:** - Other: Follow up at GP **Label:** Usual care **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test **Intervention Names:** - Other: Consultation **Label:** Low intensity intervention **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test combined with visualization of the individual CTA images with focus on the atherosclerotic findings and the effect of statin treatment on the disease **Intervention Names:** - Other: Consultation - Other: Visualization of CTA images **Label:** High intensity intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Usual care **Description:** As described before **Name:** Follow up at GP **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - High intensity intervention - Low intensity intervention **Description:** As described before **Name:** Consultation **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - High intensity intervention **Description:** As described before **Name:** Visualization of CTA images **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up **Measure:** Change in LDL cholesterol **Time Frame:** 12 months #### Secondary Outcomes **Description:** Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up **Measure:** Side effects of statin therapy **Time Frame:** 12 months **Description:** Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary CTA exam **Measure:** Changes in high risk coronary plaque volumes **Time Frame:** 12 months **Description:** Assessed with questionnaire at 12 months follow-up **Measure:** Proportion of patients adherent to statin (%) **Time Frame:** 12 months **Description:** Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up **Measure:** Change in high-sensitive CRP **Time Frame:** 12 months **Description:** Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up **Measure:** Change in HbA1c **Time Frame:** 12 months **Description:** Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up **Measure:** Change in total-cholesterol levels **Time Frame:** 12 months **Description:** Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months **Measure:** Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level) **Time Frame:** 12 months **Description:** Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up **Measure:** Change in dietary, exercise, and smoking habits **Time Frame:** 12 months **Description:** Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up **Measure:** Change in Angina and QoL scores **Time Frame:** 12 months **Description:** Assessed by electronic patient records **Measure:** Adverse clinical events (%) **Time Frame:** 12 months **Description:** Unit of measure: mmHg. Assessed at 12 months follow-up **Measure:** Change in blood pressure **Time Frame:** 12 months **Description:** Assessed at 12 months follow-up. Unit of measure kg/m2 **Measure:** Change in BMI **Time Frame:** 12 months **Description:** Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up **Measure:** Use of cardiovascular medication **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Symptoms suggestive of chronic coronary syndrome * No known CAD (no previous coronary revascularization) * CAD-Rads score 1-3 * Sinus rhythm * LDL cholesterol \> 2.0 mM * Life expectancy \>3 years * Signed informed consent Exclusion Criteria: * Post CTA test indication for invasive coronary angiography * Nonevaluable CTA exam * Obstructive coronary disease (One or more coronary stenosis ≥70%, left main \>40%) * Ongoing lipid lowering medical treatment (Patients already on lipid lowering medical therapy can be included if the treatment was initiated \<3 months before the time of the CTA test) * BMI \>40 * Renal insufficiency (eGFR \<40 ml/min) * Allergy to iodinated contrast media * Contraindications to statins (Active liver disease Child-Pugh A, B and C, excessive alcohol consumption) * Participation in a cardiac rehabilitation or lifestyle modification programme * Pregnancy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** bjarnoer@rm.dk **Name:** Bjarne L Nørgaard **Phone:** 004540136570 **Role:** CONTACT **Contact 2:** **Email:** arckul@uni.au.dk **Name:** Archana Kulasingam **Phone:** 004529296612 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus **Contacts:** ***Contact 1:*** - **Email:** bjarnoer@rm.dk - **Name:** Bjarne L Nørgaard - **Role:** CONTACT ***Contact 2:*** - **Name:** Archana Kulasingam, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Bjarne L Nørgaard **Status:** RECRUITING **Location 2:** **City:** Esbjerg **Contacts:** ***Contact 1:*** - **Name:** Niels PR Sand - **Role:** CONTACT ***Contact 2:*** - **Name:** Niels PR Sand, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Hospital of South West Jutland **Status:** NOT_YET_RECRUITING **Location 3:** **City:** Vejle **Contacts:** ***Contact 1:*** - **Name:** Martin Busk - **Role:** CONTACT ***Contact 2:*** - **Name:** Martin Busk, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Vejle Hospital **Status:** NOT_YET_RECRUITING **Zip:** 7100 #### Overall Officials **Official 1:** **Affiliation:** Aarhus University Hospital **Name:** Bjarne L Nørgaard **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: BC18 - Name: Nutritional and Metabolic 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: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerosis - ID: M9988 - Name: Hypercholesterolemia - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - 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 - ID: D000050197 - Term: Atherosclerosis ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21155 - Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413628 **Brief Title:** Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients **Official Title:** Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Cases #### Organization Study ID Info **ID:** A02011023RP #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2023-12-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-08-13 **Type:** ACTUAL #### Start Date **Date:** 2022-04-11 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Aim: to compare different treatment modalities for radiation induced trismus for maxillofacial patients methods:45 participants (20 females and 25 males) with trismus and pain following head and neck cancer and underwent radiation therapy were enrolled in this study . patients were divided into three groups : group1 received threaded tapered screw appliance therapy, patients in group II received low-level laser therapy and patients in group III received low-level laser therapy in addition to threaded tapered screw appliance therapy. **Detailed Description:** All patients received treatment according to their group: For group I, received threaded tapered screw appliance therapy . The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printer was loaded with material of 3D-printed denture base. The appliance was printed. For group II received low-level laser therapy, the laser type was of diode laser.The laser apparatus consisted of a hand piece with two attachments: either a plastic tip was attached to the same hand piece to transfer laser energy intro-orally when it was used to irradiate the lateral pterygoid muscle, or a specially designed optic prism was attached to the tip of the prism for extraoral application on extra oral muscles. All patients in this group received low level laser therapy twice times a week for 6 weeks totaling 12 sessions. In each session, the laser beam was applied in a three phases treatment protocol as follows: (a) The insertion of the lateral pterygoid muscle into the condylar neck and disc was treated in the first phase by applying a laser beam 1 cm anterior to the condyle below the zygomatic arch. (b) Tender spots in the masseter and temporalis muscles that were found during the initial assessment were exposed to radiation during the second phase. (c) The lateral pterygoid muscle origin was exposed to radiation in the third phase, which was performed with the mouth slightly open and intro-orally posterior to the final molar. During each phase, the laser was operated for two minutes per area at a wavelength of 810 nm and a peak output of 500 mW. It was applied continuously, a little distance away from the tissues. The laser probe was positioned perpendicular to the target area. Prior to usage, the laser was calibrated. Protective glasses were worn by the clinician and the patients. For group III, received low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II. Concurrent with the initial low level laser therapy session, screw tapered appliance was used for the first time. Throughout the trial, no medication was administered to any of the groups. The patients were not allowed to use any painkillers or analgesics. ### Conditions Module **Conditions:** - Trismus - Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** group I received threaded tapered screw appliance therapy , patients in group II received low-level laser therapy, and patients in group III received low-level laser therapy in addition to threaded tapered screw appliance therapy. ##### Masking Info **Masking:** SINGLE **Masking Description:** The randomization and assignment of patients to treatment groups was carried out by dental experts who were not informed about the treatment groups. **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printer was loaded with material of 3D-printed denture base. The appliance was printed. **Intervention Names:** - Other: screw tapered appliance **Label:** threaded tapered screw appliance therapy **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The laser apparatus consisted of a handpiece with two attachments: either a plastic tip was attached to the same handpiece to transfer laser energy intra-orally when it was used to irradiate the lateral pterygoid muscle, or a specially designed optic prism was attached to the tip of the prism for extraoral application on extraoral muscles. **Intervention Names:** - Other: screw tapered appliance **Label:** low-level laser therapy **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II **Intervention Names:** - Other: screw tapered appliance **Label:** low level laser therapy combined with appliance **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - low level laser therapy combined with appliance - low-level laser therapy - threaded tapered screw appliance therapy **Description:** The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printerwas loaded with material of 3D-printed denture base. The appliance was printed. **Name:** screw tapered appliance **Other Names:** - low level laser therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** was assessed using Gothenburg trismus questionnaire witha scale ranging between 0-100, where a higher score indicates greater perceived dysfunction due to trismus. It contains three main domains 1-Jaw related problems 2- Eating limitations 3-Muscular tension **Measure:** patient satisfaction(Quality of life) assessed by the Gothenburg Trismus Questionnaire (GTQ) which is a trismus-specific self-administered questionnaire **Time Frame:** six months **Description:** the patients filled out a self-assessment 0 to 10 visual analogue scale (VAS) for Pain (where 0 equals no pain and 10 is the most severe pain) **Measure:** Satisfaction assessed by the (VAS)visual analogue scale of pain **Time Frame:** six months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (a) Clinical diagnosis of trismus in head and neck cancer patients who received radiation therapy * (b) unable to chew, swallow and muscles stiffness Exclusion Criteria: * (a) patients with Bell's palsy * (b) patients still receiving radiation. **Maximum Age:** 70 Years **Minimum Age:** 55 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Marwa Aboelez #### Overall Officials **Official 1:** **Affiliation:** Mansoura University **Name:** marwa aboelez, PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 Apr;35(4):337-42. doi: 10.1016/j.ijom.2005.08.001. Epub 2005 Nov 8. **PMID:** 16280237 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013035 - Term: Spasm - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M17065 - Name: Trismus - Relevance: HIGH - As Found: Trismus - ID: M12077 - Name: Muscle Cramp - Relevance: LOW - As Found: Unknown - ID: M15837 - Name: Spasm - 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: D000014313 - Term: Trismus ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413615 **Brief Title:** A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors **Official Title:** A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients With Advanced/Metastatic Solid Tumors #### Organization Study ID Info **ID:** F0034-201 #### Organization **Class:** INDUSTRY **Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shanghai Fudan-Zhangjiang Bio-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 is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W **Intervention Names:** - Drug: FDA022-BB05 **Label:** HER2 Low Metastatic/Recurrent Breast Cancer **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W **Intervention Names:** - Drug: FDA022-BB05 **Label:** HER2 Expressing Metastatic/Recurrent Endometrial Cancer **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W **Intervention Names:** - Drug: FDA022-BB05 **Label:** HER2 Overxpressing/Mutant Metastatic/Recurrent Solid tumor **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HER2 Expressing Metastatic/Recurrent Endometrial Cancer - HER2 Low Metastatic/Recurrent Breast Cancer - HER2 Overxpressing/Mutant Metastatic/Recurrent Solid tumor **Description:** Monoclonal antibody-drug conjugate for injection **Name:** FDA022-BB05 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1 **Measure:** Objective Response Rate (ORR) **Time Frame:** up to 24 month **Description:** Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0. **Measure:** Occurrence of adverse events (AEs) and serious adverse events (SAEs) **Time Frame:** up to 24 month #### Secondary Outcomes **Description:** DOR is defined as the time from the date of first documented response until the date of documented progression or death. **Measure:** Duration of response (DoR) **Time Frame:** up to 24 month **Description:** DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD). **Measure:** Disease control rate (DCR) **Time Frame:** up to 24 month **Description:** PFS is the time from date of first dose of study treatment until the date of objective disease progression or death. **Measure:** Progression free survival (PFS) **Time Frame:** up to 24 month **Description:** OS is the time from date of first dose of study treatment until death due to any cause. **Measure:** Overall survival (OS) **Time Frame:** up to 24 month **Description:** The serum PK parameters of FDA022-BB05 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods. **Measure:** Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum FDA022-BB05 Following First Dose **Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. ) **Description:** The serum PK parameters Maximum (peak) Observed serum concentration of FDA022-BB05 and its analytes were estimated using standard non-compartmental method. **Measure:** Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum FDA022-BB05 Following First Dose **Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. ) **Description:** The serum PK parameters of Time of maximum plasma concentration (Tmax) for FDA022-BB05 and its analytes were estimated using standard non-compartmental methods. **Measure:** Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum FDA022-BB05 Following First Dose **Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. ) **Description:** The serum PK parameters of Terminal elimination half-life for FDA022-BB05 and its analytes was estimated using standard non-compartmental methods. **Measure:** Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum FDA022-BB05 Following First Dose **Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. ) **Description:** Individual participant data and descriptive statistics will be provided for data at each time point. **Measure:** Number of participants who developed measurable anti-drug antibodies **Time Frame:** up to 24 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects fully understand and voluntarily participate in this study and sign informed consent. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose. Eastern Cooperative Oncology Group performance status( PS) of 0 or 1. Life expectancy ≥ 3 months. Histopathologically or cytologically confirmed advanced/unresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available: Cohort A: Pathologically documented breast cancer that: * Is unresectable or metastatic. * Has a history of low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested). * For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy. * Was never previously HER2-positive(IHC 3+ or IHC 2+/ISH+) on prior pathology testing or was historically HER2 IHC 0 only. Cohort B: Pathologically documented endometrial cancer that: * Is unresectable or metastatic. * Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC). * Have had at least one prior line of platinum-based therapy (in any setting). * Was never previously received other ADC anti-tumor treatment. Cohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer). Exclusion Criteria: * A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors. Subjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months. Subjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment). Subjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy. Adverse reactions from the previous anti-tumor treatment have not yet recovered (\>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator). Subjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to: a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia. a medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females. Subjects with a medical history of interstitial lung disease (ILD)/pneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening. Subjects with any uncontrolled active infection within 1 week prior to first dose. Subjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB05. Subjects with a History of alcohol abuse or psychotropic/narcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** syner2000@163.com **Name:** Jian Zhang, MD **Phone:** 021-64175590 **Phone Ext:** 85000 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** syner2000@163.com - **Name:** Jian Zhang, MD - **Phone:** 021-64175590 - **Phone Ext:** 85000 - **Role:** CONTACT **Country:** China **Facility:** Fudan University Shanghai Cancer Center #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Jian Zhang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413602 **Brief Title:** The Synergistic Effects of AIH and FES in Persons With MS **Official Title:** Exploring the Synergistic Effects of AIH and FES in Persons With MS #### Organization Study ID Info **ID:** STU00221027 #### Organization **Class:** OTHER **Full Name:** Shirley Ryan AbilityLab ### Status Module #### Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Northwestern University #### Lead Sponsor **Class:** OTHER **Name:** Shirley Ryan AbilityLab #### Responsible Party **Investigator Affiliation:** Shirley Ryan AbilityLab **Investigator Full Name:** Milap Sandhu **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to examine how neuromuscular electrical stimulation (NMES), may synergistically enhance corticospinal excitability in people with relapsing form multiple sclerosis (MS). This is an important intermediate step to evaluate the potential of AIH + NMES as a plasticity-priming strategy for more efficacious interventions for persons with MS. This study will measure ankle torque generation and amplitude of motor evoked potentials (MEPs) using a repeated measures study design in order to better understand the effects of AIH combined with NMES, as compared to only receiving NMES, and only receiving AIH. **Detailed Description:** NMES: NMES refers to the application of mild electrical stimulation and is often used as an assistive technology for foot drop in MS and other neurologic conditions. The NMES-induced improvement in motor performance appears to be mediated primarily by an increase in corticomotoneuronal excitability. A single session of NMES applied over a peripheral nerve, has been shown to transiently increase net corticospinal excitability (increased MEP amplitude) in both able-bodied individuals and in people with neurological conditions. AIH: AIH involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. While AIH has shown potential in enhancing neuroplasticity in people with spinal cord injury (SCI), it has yet to be studied extensively in MS. Preliminary research in the MS population demonstrates that a single session of AIH enhances motor output, increasing voluntary muscle strength by as much as 15-20% within 60 minutes. Over the past decade, studies have found AIH can rapidly enhance neural plasticity in persons with incomplete SCI. AIH activates the serotonergic pathway, leading to increased activity of serotonin receptors and the synthesis of plasticity-related proteins. This plasticity is manifested by a rapid increase in voluntary muscle strength, emerging within 60-90 minutes. In this study, we will examine how NMES, which has been shown to affect cortical excitability, and AIH, which has been shown to affect corticospinal plasticity, may synergistically enhance corticospinal excitability in people with relapsing form of MS. Foot drop is a common symptom in the diagnosis of MS where the inability to maintain active dorsiflexion during the swing phase of the gait cycle affects walking efficiency, instability, and falls. Seminal studies show that individuals with MS retain the ability to express plasticity even at higher levels of disease burden. This indicates that strategies targeting neuroplasticity can be used to enhance functional recovery and limit the impact of MS disability. We will conduct a randomized, blinded, placebo-controlled, cross-over study in 20 MS patients with established motor deficits and controlled relapse activity. ### Conditions Module **Conditions:** - Multiple Sclerosis - Multiple Sclerosis, Relapsing-Remitting - Multiple Sclerosis, Secondary Progressive **Keywords:** - multiple sclerosis - plasticity - electrical stimulation - NMES - modalities - neuroplasticity - motoneuron - aih - hypoxia - acute intermittent hypoxia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** randomized, blinded, cross-over study ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will undergo 30 minutes of AIH. **Intervention Names:** - Other: Acute Intermittent Hypoxia **Label:** AIH alone **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will undergo repetitive common peroneal nerve stimulation for up to 30 minutes. **Intervention Names:** - Other: Neuromuscular Electrical Stimulation **Label:** NMES alone **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will undergo 30 minutes of AIH. Immediately following, participants will undergo NMES for up to 30 minutes. **Intervention Names:** - Other: Acute Intermittent Hypoxia - Other: Neuromuscular Electrical Stimulation **Label:** Combined AIH and NMES **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AIH alone - Combined AIH and NMES **Description:** During AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles. One cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout. **Name:** Acute Intermittent Hypoxia **Other Names:** - AIH **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Combined AIH and NMES - NMES alone **Description:** During NMES, participants will receive electrical stimulation to the common peroneal nerve. Stimulation will be done with a 50% duty cycle, duration of 0.5-1ms for each pulse and a frequency 25-40 Hz. The stimulus intensity will be adjusted to produce approximately 50% of the maximum M-wave (compound muscle action potential) for each participant. **Name:** Neuromuscular Electrical Stimulation **Other Names:** - NMES **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The MEPs will be elicited by Transcranial Magnetic Stimulation (TMS), a procedure that uses magnetic fields to stimulate nerve cells in the brain. **Measure:** Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors **Time Frame:** Immediately prior to and within 60 minutes after the intervention. #### Secondary Outcomes **Description:** Maximal volitional ankle dorsiflexion flexion torque will be measured using a strength testing dynamometer (Biodex System 4). **Measure:** Ankle Dorsiflexion Torque **Time Frame:** Immediately prior to and within 60 minutes after the intervention. **Description:** While measuring ankle dorsiflexion torque, we will also record surface electromyography (EMG) from the tibialis anterior muscle during each contraction. **Measure:** Ankle Dorsiflexion EMG **Time Frame:** Immediately prior to and within 60 minutes after the intervention. **Description:** A neurocognitive test that requires individuals to pair specific numbers with given geometric figures within 90 seconds. Both written and oral format will be administered, and scores will be calculated by totaling the number of correct answers for each section. **Measure:** Symbol Digit Modalities Test **Time Frame:** Immediately prior to and within 60 minutes after the intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of relapsing form of MS * Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5 * Motor Functional Systems Score (FSS) between 2-4 * Relapse free for at least 1 year * Age ≥18 years and ≤75 years * Safe to participate in MRI (as indicated via the SRALab MRI questionnaire) * No change in Dalfampridine dose at least 2 months prior to enrollment Exclusion Criteria: * Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg) * History of epilepsy or seizures * Uncontrolled medical problems affecting the lungs (pulmonary diseases including chronic obstructive pulmonary disease), the heart (cardiovascular diseases) or the musculoskeletal system (orthopedic diseases) * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of stroke * Metal in head (e.g., surgical clips, shrapnel) * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants * Surgery to the head * Any non-MS related neurological diseases * Illnesses that may have caused brain injury * Unexplained frequent or severe headaches * Pregnancy in females * Implanted devices (e.g., pacemakers, medical pumps, brain stimulators) **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rkravitt@sralab.org **Name:** Rachel A Kravitt, OTD, OTR/L **Phone:** (312)238-3947 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Shirley Ryan AbilityLab **State:** Illinois **Zip:** 60611 ### IPD Sharing Statement Module **Description:** We do not currently have a plan to share IPD. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4185 - Name: Hypoxia - Relevance: LOW - As Found: Unknown - ID: M22314 - Name: Multiple Sclerosis, Relapsing-Remitting - Relevance: HIGH - As Found: Multiple Sclerosis, Relapsing-Remitting - ID: M22313 - Name: Multiple Sclerosis, Chronic Progressive - Relevance: HIGH - As Found: Multiple Sclerosis, Secondary Progressive - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000020529 - Term: Multiple Sclerosis, Relapsing-Remitting - ID: D000020528 - Term: Multiple Sclerosis, Chronic Progressive - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413589 **Brief Title:** Efficacy of SMOF Lipid in the Management of Acute Poisoning With Clozapine **Official Title:** Efficacy of SMOF Lipid in the Management of Acute Poisoning With Clozapine Secondary IDs: #### Organization Study ID Info **ID:** SMOF in clozapine toxicity #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2023-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-01 **Type:** ACTUAL #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-18 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute, moderate-to-severe clozapine poisoning. **Detailed Description:** Antipsychotics, a class of drugs primarily used to treat schizophrenia and various mood disorders, including bipolar disorder, encompass a medication like clozapine. Clozapine stands out among antipsychotics due to its lower incidence of extrapyramidal symptoms, such as tardive dyskinesia, and its effectiveness in addressing negative symptoms of schizophrenia. Recent data from the American Association of Poison Control Centers (AAPCC) highlight sedatives/hypnotics/antipsychotics as among the top five frequently encountered xenobiotics in human exposure cases. This class of drugs has seen a notable uptick in incidence over the past 18 years. In Egypt, studies from institutions like Tanta University Poison Control Centre (TUPCC) and the National Poisoning Center in Cairo have identified acute clozapine poisoning as a common occurrence within cases of pharmaceutical drug poisonings affecting the central nervous system. Clozapine toxicity manifests across multiple organ systems, with the central nervous system (CNS) and cardiovascular system (CVS) being most significantly impacted. Common symptoms include pronounced sedation, confusion, delirium, tachycardia, and mild hypotension. Because there is no definitive antidote for clozapine poisoning, poison control centres recommend supportive therapy based on the patient's clinical condition and multiple-dose activated charcoal (MDAC) as a specific intervention for enhanced elimination. Nevertheless, the elimination of the drug from the body can be prolonged. The scarcity of physiological antidotes for acute poisonings encourages toxicologists to supplement standard supportive treatment protocols with promising agents that tend to improve morbidity and mortality. In this context, intravenous lipid emulsions (ILE) are mainly used as a source of energy and essential fatty acids in patients requiring parenteral nutrition. Apart from their nutritional value, lipid emulsion therapy is becoming increasingly popular in critical care settings as a treatment for toxicity with lipophilic agents, particularly when the standard remedies are ineffective. Following the encouraging outcomes of using ILEs for the treatment of local anaesthetic systemic toxicity, subsequent studies reported the therapeutic effect of ILEs in acute poisonings with other xenobiotics. However, the evidence for the potential effectiveness of ILE in clinical toxicology consists mainly of case reports and experimental studies. ILE may be suitable for the treatment of clozapine toxicity due to its lipid solubility. SMOF 20%, a blend of soybean oil, medium-chain triglycerides, olive oil, and fish oil, is a new lipid emulsion product that has shown better therapeutic results regarding parentral nutrition when compared with traditional ones such as Intralipid® 20%. It has been associated with decreased oxidative injury, improved liver function, and increased antioxidant activity ### Conditions Module **Conditions:** - Acute Poisoning **Keywords:** - clozapine poisoning - SMOF lipid - lipophilic agents ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group constitutes the control group that was administered the standard treatment protocol for clozapine toxicity. **Intervention Names:** - Other: standard treatment for clozapine toxicity **Label:** control group **Type:** OTHER #### Arm Group 2 **Description:** The second group received the SMOF lipid infusion in addition to the standard protocol.Drug: SMOF lipid 20% SMOF 20%; a blend of soybean oil, medium-chain triglycerides, olive oil, and fish oil, is a new lipid emulsion product that was provided as a bolus dose of 1.5ml/kg for one hour, followed by a maintenance dose of 6 ml/kg for a period of four hours to the active comparator group **Intervention Names:** - Other: SMOF lipid 20% **Label:** SMOF lipid treated group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SMOF lipid treated group **Description:** Drug: SMOF lipid 20% SMOF 20%, a blend of soybean oil, medium-chain triglycerides, olive oil, and fish oil, is a new lipid emulsion product that was provided as a bolus dose of 1.5ml/kg for one hour, followed by a maintenance dose of 6 ml/kg for a period of four hours to the active comparator group **Name:** SMOF lipid 20% **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - control group **Description:** Hypotension was initially treated with isotonic crystalloid; vasopressors were utilised if intravenous fluids failed to restore the hypotension. This was in the form of norepinephrine with a dose of 0.05 μg/kg/min and titrated till reaching the goal mean arterial pressure (\>65 mmHg) \[29\]. Those experiencing seizures due to CBZ overdose were treated with benzodiazepines (diazepam) at a dose of 10-20 mg. Benzodiazepines are considered allosteric modulators of the gamma-aminobutyric acid channel. MDAC (50 grammes every six hours) was given to all patients in the current study. Those with severe poisoning were given the MDAC after securing the airway with a cuffed endotracheal tube **Name:** standard treatment for clozapine toxicity **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This study evaluates the efficacy of SMOF lipid 20% in improving conscious levels among participants with acute clozapine poisoning within 24 hours. Conscious level improvement is assessed using the Glasgow Coma Scale (GCS), a widely recognised tool for neurological assessment. The GCS measures eye opening, verbal response, and motor response. The minimum value is 3 and the maximum value is 15, with higher scores indicating better conscious levels. The study aims to determine the extent of improvement in GCS scores following SMOF lipid administration, providing valuable insights into its effectiveness in enhancing neurological function. **Measure:** Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS) **Time Frame:** participants were monitored within 24 hours from admission to the hospital **Description:** This study investigates the requirement for intubation and mechanical ventilation among participants with acute clozapine poisoning using multiple clinical assessment tools, including the Glasgow Coma Scale (GCS) and Acute Physiology and Chronic Health Evaluation (APACHE). The GCS evaluates the level of consciousness based on eye opening, verbal response, and motor response, with lower scores indicating a higher likelihood of intubation and mechanical ventilation. The APACHE score assesses the severity of illness and predicts the need for respiratory support, with higher scores indicating an increased risk of respiratory failure and the requirement for intervention. **Measure:** Assessment of Intubation Requirement Using APACHE **Time Frame:** participants were assessed within 24 hours from admission to the hospital **Description:** This study evaluates the length of stay in the Intensive Care Unit (ICU) among participants with acute clozapine poisoning. The length of the ICU stay is defined as the duration from the time of admission to the ICU to discharge from the ICU in days. Participants will be monitored throughout their hospitalisation period, and the length of their ICU stay will be recorded. The study aims to assess the impact of SMOF lipid administration on the duration of ICU stays, providing insights into its effectiveness in optimising resource utilisation and patient management. Understanding the factors influencing the length of the ICU stay may contribute to improved healthcare delivery and patient outcomes in acute clozapine poisoning. **Measure:** Length of Intensive Care Unit (ICU) Stay **Time Frame:** up to one month **Description:** This study evaluates the length of stay in the hospital among participants with acute clozapine poisoning. The length of stay is defined as the duration from the time of admission to the hospital to discharge from the hospital in days. Participants will be monitored throughout their hospitalisation period, and the length of their hospital stay will be recorded. The study aims to assess the impact of SMOF lipid administration on the duration of hospital stays, providing insights into its effectiveness in optimising resource utilisation and patient management. Understanding the factors influencing length of stay may contribute to improved healthcare delivery and patient outcomes in acute clozapine poisoning. **Measure:** length of hospital stay **Time Frame:** up to one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patients were enrolled in the study in accordance with the following: Gender and age: adult symptomatic males and females. Patients were admitted within 12 hours of exposure to the poison. Patients received no prior treatment before admission. Patients with moderate-to-severe carbamazepine poisoning according to the Poisoning Severity Score (PSS) Patients classified as high-risk (HR) with anti-depressant overdose risk assessment (ADORA) criteria. Exclusion Criteria: Patients were excluded if they had any of the following conditions: pregnant and lactating women. Patients with major medical conditions (e.g. diabetes mellitus), cardiovascular disease, renal, or hepatic failure). Patients suffering from hyperlipidemia. Malignancy. Co-ingestion. **Maximum Age:** 66 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Country:** Egypt **Facility:** Faculty of Medicine #### Overall Officials **Official 1:** **Affiliation:** Alexandria University **Name:** Abeer Sheta, professor **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Jaffal K, Chevillard L, Megarbane B. Lipid Emulsion to Treat Acute Poisonings: Mechanisms of Action, Indications, and Controversies. Pharmaceutics. 2023 May 3;15(5):1396. doi: 10.3390/pharmaceutics15051396. **PMID:** 37242638 **Citation:** Elgazzar FM, Elgohary MS, Basiouny SM, Lashin HI. Intravenous lipid emulsion as an adjuvant therapy of acute clozapine poisoning. Hum Exp Toxicol. 2021 Jul;40(7):1053-1063. doi: 10.1177/0960327120983873. Epub 2021 Jan 5. **PMID:** 33401984 **Citation:** Taftachi F, Sanaei-Zadeh H, Sepehrian B, Zamani N. Lipid emulsion improves Glasgow coma scale and decreases blood glucose level in the setting of acute non-local anesthetic drug poisoning--a randomized controlled trial. Eur Rev Med Pharmacol Sci. 2012 Mar;16 Suppl 1:38-42. **PMID:** 22582483 **Citation:** Ok SH, Sohn JT. Effect of lipid emulsion on acute clozapine poisoning-induced QT prolongation. Hum Exp Toxicol. 2021 Dec;40(12):2237-2239. doi: 10.1177/09603271211025598. Epub 2021 Jun 17. No abstract available. **PMID:** 34137281 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M13931 - Name: Poisoning - Relevance: HIGH - As Found: Poisoning - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011041 - Term: Poisoning ### Intervention Browse Module - Ancestors - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018756 - Term: GABA Antagonists - ID: D000018682 - Term: GABA Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: AnEm - Name: Antiemetics - Abbrev: MuRelCen - Name: Muscle Relaxants, Central - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M6254 - Name: Clozapine - Relevance: HIGH - As Found: Capsaicin - ID: M7167 - Name: Diazepam - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M8799 - Name: gamma-Aminobutyric Acid - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: T294 - Name: Soy Bean - Relevance: LOW - As Found: Unknown - ID: T242 - Name: Olive - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003024 - Term: Clozapine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413576 **Brief Title:** Homocysteine in Critically Ill Preeclampsia **Official Title:** The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients #### Organization Study ID Info **ID:** FMASU R09/2024 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-19 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-06 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams 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:** Preeclampsia is a disorder characterized by the new onset of hypertension and proteinuria typically presenting after 20 weeks of gestation. Elevated circulating homocysteine is a risk factor for endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Our study is to investigate the association between elevated blood homocysteine levels and complications in pregnant women in order to conclude the clinical utility of homocysteine as a marker of severity in the cases of pre-eclampsia. **Detailed Description:** Hypertensive disorders of pregnancy are an important cause of morbidity and mortality among mothers and infants. Preeclampsia is a pregnancy-related hypertensive disorder occurring usually after 20 weeks of gestation. It is associated with fetal growth restriction, low birth weight, preterm birth, respiratory distress syndrome, and admission to a neonatal intensive care unit. According to a systemic review and meta-analysis published in 2013, preeclampsia has a noticeable relationship with an increased risk of developing hypertension, ischemic heart disease, and cerebrovascular accident in later life. There is already abundant evidence indicating that elevated serum homocysteine levels may be related to the risk of coronary, cerebral, and peripheral arterial diseases. Elevated circulating homocysteine is a risk factor of endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Normally, homocysteine levels decline throughout pregnancy and since the vascular alterations brought on by homocysteine are comparable to those brought on by hypertensive disorders of pregnancy, it can be assumed that high levels of homocysteine are linked to the hypertensive disorder spectrum. Homocysteine has been shown to produce oxidative stress and endothelial dysfunction, endothelial cell injury and thrombus formation and thereby producing pre-eclampsia. Estimation of homocysteine may help to predict and prevent pre-eclampsia and eclampsia, thus reducing the undesired outcome of pregnancy. Among various studies, there is a lack of consistency in the reported results that support the link between maternal homocysteine concentrations assessed throughout each of the three trimesters of pregnancy and difficulties caused by the placenta. our study investigate the relation between the level of homocysteine and severity of preeclampsia. ### Conditions Module **Conditions:** - Pre-Eclampsia - Critical Illness ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Normotensive age- matched pregnant controls **Intervention Names:** - Diagnostic Test: homocysteine measurement **Label:** normal pregnancy #### Arm Group 2 **Description:** pre-eclampsia patients who are managed in ward (not critical) **Intervention Names:** - Diagnostic Test: homocysteine measurement **Label:** preeclampsia #### Arm Group 3 **Description:** pre-eclampsia patients who are admitted to intensive care unit due to severity or complications **Intervention Names:** - Diagnostic Test: homocysteine measurement **Label:** critically ill preeclampsia ### Interventions #### Intervention 1 **Arm Group Labels:** - critically ill preeclampsia - normal pregnancy - preeclampsia **Description:** measuring the serum level of homocysteine **Name:** homocysteine measurement **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Quantitative measurement of the serum level of homocysteine. The measurement will be done using a commercially available sandwich enzyme linked immunosorbent assay (ELIZA) kit supplied by ( Bioassay technology laboratory) according to the manufacturer's instructions.nthe results will be expressed in ng/ml. Absorbance of standards and samples were measured at 450 nm using a microtiter plate ELISA reader . **Measure:** homocysteine level **Time Frame:** within 24 hours postoperative(post delivery) #### Secondary Outcomes **Description:** the co relation between levels of homocysteine and degree of severity of preeclampsia using spearman rank correlation co efficient **Measure:** Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia **Time Frame:** within 24 hours postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients diagnosed by preeclampsia will be included in light of the following diagnostic criteria (blood pressure more than 140\\90 mm\\Hg on 2 occasions at least 4 hours apart after 20 weeks' gestation in a previously normotensive patient accompanied by Protein/creatinine ratio ≥0.3 . Exclusion Criteria: * Essential hypertension suggested by history or documentation of hypertension in pre pregnant state or hypertension before 20 weeks of gestation. * Cardiovascular or renal failure * Liver failure * Diabetes mellitus * Inflammatory or infective disorders * History or documentation of epilepsy in prepregnant state * Space occupying lesion in brain like tuberculoma or brain tumor * Trauma to brain * Hyperpyrexia * On treatment with antifolate drugs such as methotrexate **Gender Based:** True **Gender Description:** pregnant females **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** pregnant females with pre-eclampsia and within 24 hours of delivery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** w.z.selima@gmail.com **Name:** wessam selima, MD **Phone:** +201001958858 **Role:** CONTACT **Contact 2:** **Name:** Amera ahmed, MD **Phone:** +201000358439 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** REC-FAMSU@med.asu.edu.eg - **Name:** fathy tash, MD - **Phone:** 2022685 - **Phone Ext:** 7539 - **Role:** CONTACT ***Contact 2:*** - **Name:** rania gamal, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Amera ahmed, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Rasha ahmed, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Ain shams University **Status:** RECRUITING **Zip:** 11591 **Location 2:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** anesth_office@med.asu.edu.eg - **Name:** Anesthesia department - **Phone:** 01009499962 - **Role:** CONTACT ***Contact 2:*** - **Email:** w.z.selima@med.asu.edu.eg - **Phone Ext:** selima - **Role:** CONTACT ***Contact 3:*** - **Name:** wessam selima, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Amera Ahmed, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Rania Gamal, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Rasha Ahmed, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Ain shams university **State:** القاهرة **Status:** RECRUITING ### References Module #### References **Citation:** Salam RA, Das JK, Ali A, Bhaumik S, Lassi ZS. Diagnosis and management of preeclampsia in community settings in low and middle-income countries. J Family Med Prim Care. 2015 Oct-Dec;4(4):501-6. doi: 10.4103/2249-4863.174265. **PMID:** 26985406 **Citation:** Thakur P, Bhalerao A. High Homocysteine Levels During Pregnancy and Its Association With Placenta-Mediated Complications: A Scoping Review. Cureus. 2023 Feb 20;15(2):e35244. doi: 10.7759/cureus.35244. eCollection 2023 Feb. **PMID:** 36968916 **Citation:** Chaudhry SH, Taljaard M, MacFarlane AJ, Gaudet LM, Smith GN, Rodger M, Rennicks White R, Walker MC, Wen SW. The determinants of maternal homocysteine in pregnancy: findings from the Ottawa and Kingston Birth Cohort. Public Health Nutr. 2020 Dec;23(17):3170-3180. doi: 10.1017/S1368980019004002. Epub 2020 Mar 19. **PMID:** 32188521 **Citation:** Aubard Y, Darodes N, Cantaloube M. Hyperhomocysteinemia and pregnancy--review of our present understanding and therapeutic implications. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):157-65. doi: 10.1016/s0301-2115(00)00282-7. **PMID:** 11074137 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M7633 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Pre-Eclampsia - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia ### Condition Browse Module - Meshes - ID: D000011225 - Term: Pre-Eclampsia - ID: D000004461 - Term: Eclampsia - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413563 **Brief Title:** Analysis of Peripheral Blood Lymphocytes in Patients With Juvenile Idiopathic Arthritis With Respect to Disease Subtypes and Therapy **Official Title:** Analysis of Peripheral Blood Lymphocytes in Patients With Juvenile Idiopathic Arthritis With Respect to Disease Subtypes and Therapy #### Organization Study ID Info **ID:** soh-Med-24-04-03MD #### Organization **Class:** OTHER **Full Name:** Sohag University ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sohag University #### Responsible Party **Investigator Affiliation:** Sohag University **Investigator Full Name:** Hager Ibrahim Abdelaal **Investigator Title:** assisstant lecturer in physical medicine,rheumatology and erhabilitation- sohag university **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children. JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years, persisting for more than six weeks and with an unknown cause. Based on the current International League of Associations in Rheumatology classification criteria (ILAR 2003) , different subtypes of JIA can be distinguished, essentially by a very limited set of clinical features (number of affected joints in the first six months of disease, extra-articular manifestations like fever or features of psoriasis) and serology (presence or absence of rheumatoid factor, RF). The most frequently diagnosed JIA subtypes are oligoarticular JIA (oJIA), polyarticular JIA (pJIA), and systemic JIA (sJIA). Less frequently occurring subtypes are enthesitis-related JIA, psoriatic arthritis, and undefined arthritis. The pathophysiology mechanisms associated to JIA development are related to an abnormal activation of immune system cells such as B cells, T cells, natural killer (NK) cells, dendritic cells (DCs), monocytes, neutrophils, plasma cells, and to the production and release of pro-inflammatory mediators that ultimately lead to cartilage and bone destruction and systemic manifestations. JIA has been classically considered a T-cell driven autoimmune disease, except for sJIA subtype, in which innate immune cells have a central role in disease pathogenesis. However, the detection of autoantibodies reacting with different target antigens in JIA patients suggests a central role of B cells in JIA pathophysiology. Therapeutic intervention of jia begins at diagnosis with non-steroidal anti-inflammatory drugs (NSAIDs) followed by disease-modifying anti-rheumatic drugs (DMARDs, most often methotrexate) and/or corticosteroid intra-articular injection. NSAIDs obtain both analgesic and anti-inflammatory effects. Local corticosteroid joint injections are effective in synovitis and may be a first-line treatment for oligoarthritis alone or in addition to DMARDs. Systemic administration of high dose corticosteroids provides good short-term effect, especially in sJIA patients. The American College of Rheumatology (ACR) recommends early use of DMARDs, specifically MTX, leflunomide and/or sulfasalazine. MTX is considered to be the first choice DMARD for oligo- and pJIA when NSAIDs and intraarticular steroids are insufficient. MTX is also considered to be effective in children with PsJIA, though the axial manifestations limits prescription of MTX and so TNF inhibitors are typically required in these cases. Leflunomide may be used as an alternative DMARD for pJIA in cases of MTX intolerance. Sulfasalazine is recommended for patients with moderate activity of ERA with active peripheral arthritis, but is inefficient in case of sacroiliitis. The emergence of biologic treatments has changed the prognosis for many JIA patients, whose condition did not improve adequately on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), mainly methotrexate, or experienced side effects because of them. TNF-α inhibitors, such as etanercept, adalimumab , infliximab are widely used in JIA. In fact, etanercept is one of the most frequently prescribed biologics for JIA in many countries, including the United Kingdom. (19) Other biologics include tocilizumab , anakinra and canakinumab , abatacept and rituximab . The efficacy of biologics varies depending on the disease subtype. Most healthy children have episodes of mild infections during the first years of life. In most cases, these episodes are respiratory or gastrointestinal viral infections. Children with juvenile idiopathic arthritis (JIA) have an allegedly higher risk of infection compared with healthy children because of their underlying condition. Treatments used in JIA include corticosteroids, disease-modifying antirheumatic drugs (DMARDs), and biologic agents, all of which can increase the frequency of common mild infections and the risk of severe and opportunistic infections. Disease-modifying anti-rheumatic drugs (DMARDs) help manage JIA by reducing inflammation and preventing joint damage, slowing the progression of the disease. These therapies work by suppressing the immune system, which can lead to infection, despite growing evidence regarding the efficacy and safety of these drugs for children with JIA, it is unclear whether these agents increase the risk of infections - or whether the risk is increased to all or to only specific infections. Moreover, there is a proportional relationship between the severity of the disease and the intensity of the treatment administered, and this association might constitute a confounding factor when assessing susceptibility to infections. Besides novel findings, there is still little data available regarding the alteration of immune cells which control infection. ### Conditions Module **Conditions:** - Juvenile Idiopathic Arthritis ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years, persisting for more than six weeks and with an unknown cause. Based on the current International League of Associations in Rheumatology classification criteria (ILAR 2003) , different subtypes of JIA can be distinguished, essentially by a very limited set of clinical features (number of affected joints in the first six months of disease, extra-articular manifestations like fever or features of psoriasis) and serology (presence or absence of rheumatoid factor, RF). The most frequently diagnosed JIA subtypes are oligoarticular JIA (oJIA), polyarticular JIA (pJIA), and systemic JIA (sJIA). Less frequently occurring subtypes are enthesitis-related JIA, psoriatic arthritis, and undefined arthritis. complete blood count will be done for all patients **Intervention Names:** - Diagnostic Test: Complete blood count **Label:** juvenile idiopathic arthritis #### Arm Group 2 **Description:** control **Intervention Names:** - Diagnostic Test: Complete blood count **Label:** control group ### Interventions #### Intervention 1 **Arm Group Labels:** - control group - juvenile idiopathic arthritis **Description:** Complete blood count will be done for all patients and then will search about CD4, CD8 T lymphocyte cells surface markers * CD56 Natural killer cells surface marker * CD19 Lymphocyte cells surface marker **Name:** Complete blood count **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** lymphopenia in JIA patients receiving MTX and biological therapy **Measure:** lymphopenia **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Patient age is above 16 years old 2. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria received DMARDS therapy and in inactive state of disease Exclusion Criteria: * 1. Patients with active JIA 2. Any patient with any autoimmune disease other than JIA 3. Acquired and congenital lymphopenia **Healthy Volunteers:** True **Maximum Age:** 16 Years **Minimum Age:** 6 Months **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** -1. Patient age is above 16 years old 2. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria received DMARDS therapy and in inactive state of disease ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Hageribrahim018@gmail.com **Name:** Hager I I Abdelaal, assistant lecutrer **Phone:** 01023686688 **Role:** CONTACT **Contact 2:** **Name:** Abdellah M Radwan, professor **Phone:** 01092914019 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Oliveira-Ramos F, Eusebio M, M Martins F, Mourao AF, Furtado C, Campanilho-Marques R, Cordeiro I, Ferreira J, Cerqueira M, Figueira R, Brito I, Canhao H, Santos MJ, Melo-Gomes JA, Fonseca JE. Juvenile idiopathic arthritis in adulthood: fulfilment of classification criteria for adult rheumatic diseases, long-term outcomes and predictors of inactive disease, functional status and damage. RMD Open. 2016 Sep 22;2(2):e000304. doi: 10.1136/rmdopen-2016-000304. eCollection 2016. **PMID:** 27752356 **Citation:** Oliveira Ramos F, Rodrigues A, Magalhaes Martins F, Melo AT, Aguiar F, Brites L, Azevedo S, Duarte AC, Furtado C, Mourao AF, Sequeira G, Cunha I, Figueira R, Melo Gomes JA, Santos MJ, Fonseca JE. Health-related quality of life and disability in adults with juvenile idiopathic arthritis: comparison with adult-onset rheumatic diseases. RMD Open. 2021 Nov;7(3):e001766. doi: 10.1136/rmdopen-2021-001766. **PMID:** 34819385 **Citation:** Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2. No abstract available. **PMID:** 14760812 **Citation:** Zaripova LN, Midgley A, Christmas SE, Beresford MW, Baildam EM, Oldershaw RA. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021 Aug 23;19(1):135. doi: 10.1186/s12969-021-00629-8. **PMID:** 34425842 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4479 - Name: Arthritis, Juvenile - Relevance: HIGH - As Found: Juvenile Idiopathic Arthritis - 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: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001171 - Term: Arthritis, Juvenile ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M15046 - Name: Rheumatoid Factor - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413550 **Brief Title:** The Efficacy of Hibiscus Sabdariffa in Xerostomia **Official Title:** The Efficacy of Hibiscus Sabdariffa L. Mouth Rinse in Head and Neck Cancer Patients With Xerostomia: A Randomized, Placebo-Controlled Clinical Trial #### Organization Study ID Info **ID:** Xerostomia & Hibiscus #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Hibiscus Sabdariffa L. mouth rinse using the subjective dry mouth score as a primary objective and to assess the effect of that mix on the salivary flow rate and objective dry mouth score as a secondary objective. **Detailed Description:** Xerostomia, defined as the subjective complaint of dry mouth, is one of the most prevalent and challenging adverse effects for head and neck cancer (HNC) patients treated with radiotherapy (RT) in definitive or adjuvant setting with or without concomitant chemotherapy (CHT). It represents a toxicity that can resolve over time, but often translates into a permanent condition that seriously affects swallowing, speaking and oral health, impairing several domains of patients' quality of life (QoL). Symptomatically, xerostomia may range from mild discomfort to severe oral disease accompanied by signs and symptoms affecting the oral cavity, including mucous membranes, lips, tongue, salivary glands and teeth. In the most severe cases it can cause severe depression. Although radiation-induced xerostomia (RIX) is multifactorial, it is primarily the consequence of damage to the major and minor salivary glands that are usually included in the radiation fields or are in their close proximity. Thus, the severity of glandular injury and potential for recovery depends on the irradiated gland volume, the cumulative radiation dose and the capability of surviving cells to repopulate. Such injury causes diminution in function of the salivary glands and the consequences are reduction in saliva volume, consistency, pH, immunoglobulins and antimicrobial proteins. The efficacy of Aqualief in treating xerostomia, or dry mouth, in patients contacting a randomized, placebo-controlled, double-blind trial was evaluated by a previous study. Aqualief contains two key ingredients, carnosine and karkadé (Hibiscus sabdariffa), which were selected and mixed with normalizing saliva pH and increasing saliva buffering activity. These parameters are often impaired in xerostomia patients, leading to acid-induced enamel and dental erosion and promoting the growth of aciduric bacteria. Aqualief was found to normalize saliva pH to a neutral value and significantly increase the saliva flow rate in xerostomic patients. After six days of treatment, saliva pH was increased toward a neutral value, and the saliva flow rate was increased by almost 60%, compared to the basal value. This improvement was more than three times greater than that achieved with a placebo, which only increased resting salivation by 19%. ### Conditions Module **Conditions:** - Radiation-induced Xerostomia **Keywords:** - xerostomia - Hibiscus Sabdariffa - Radiation ### 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:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients in test group will topically apply 20 mL of Hibiscus Sabdariffa L. to the oral mucosa as oral rinse 3 times per day. Patients were advised to rinse 20 mL of Hibiscus Sabdariffa L. from the fourth week of radiotherapy to three months after radiotherapy. **Intervention Names:** - Biological: Hibiscus Sabdariffa **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control arm will topically apply 20 mL of 0.9% of normal saline rinses 3 times per day. Patients were advised to rinse with 20 mL normal saline from the fourth week of radiotherapy to three months after radiotherapy. **Intervention Names:** - Biological: Hibiscus Sabdariffa **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Intervention group **Description:** The fresh red Roselle plant was obtained; the red calyxes of Hibiscus Sabdariffa were separated from the plant and dried for a week at 25°C. The dried calyxes were ground to powder, kept in a sealed container, and stored in a refrigerator (4°C) until used. Aqueous Roselle calyx extract was prepared by adding 10 gm of the previously prepared powder to 100 ml of boiling water and then heated on a hot stirrer plate for 30 min. To remove the remnants, the mixture was filtered via Whatman No 1 filter paper (Whatman products, Springfield Paper Mill, Maidstone, UK). The water content of the filtered solution was evaporated using an air recirculation oven and then kept at 4°C in the dark until used to determine antibacterial effectiveness \[20\]. **Name:** Hibiscus Sabdariffa **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** • Using a questionnaire will be recorded according to the following: Q1. Does your mouth feel dry? Q2. Do you sip liquids to aid in swallowing dry food? Q3. Does your mouth feel dry when eating a meal? Q4. Does the amount of saliva in your mouth seem to be too little? Subject who answered affirmatively to at least one of the questions related to oral dryness will be considered as positive for subjective complaints of oral dryness and take score from 1-4 according to the number of positive answers. **Measure:** Subjective symptoms of oral dryness **Time Frame:** Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy. **Description:** * The patients will be examined for their signs of dry mouth including: 1. loss of pooled saliva 2. Mouth mirror stickiness 3. Stringy or foamy appearance 4. Labial dehydration 5. Irresponsiveness to parotid stimulation * Objective dry mouth scores will be calculated as the number of observed dry mouth signs (0-5), and patients with a score less than 2 will be excluded. **Measure:** Objective dry mouth score **Time Frame:** Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy. #### Secondary Outcomes **Description:** • Eating and talking were prohibited during the time of collection. Unstimulated whole saliva will be collected for 5 min by spitting method. The collection will be timed, so that flow rate (mL/min) could be measured. **Measure:** Salivary flow rate **Time Frame:** Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both genders, aged above 20 years. * All patients must have complaint of xerostomia. * Objective dry mouth score from ( 2-5). * Subjective dry mouth score from (1-4). * Patients must be able to make reliable decision or communications. Exclusion Criteria: * - Smoking, Alcohol. * Patient with history of any serious illness as malignancy. * Patients with any autoimmune disease. * Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation. **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fatmahassanein@dent.asu.edu.eg **Name:** Fatma E.Sayed A Hassanein, PHD **Phone:** +201000093885 **Role:** CONTACT **Contact 2:** **Email:** Asmaa.Aboubakr@bue.edu.eg **Name:** Asma A. Abou Bakr **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** fatmahassanein@dent.asu.edu.eg - **Name:** Fatma E.Sayed A Hassanein - **Phone:** +201000093885 - **Role:** CONTACT **Country:** Egypt **Facility:** Ahmed Maher Teaching Hosipital **Status:** RECRUITING **Zip:** 11565 #### Overall Officials **Official 1:** **Affiliation:** professor **Name:** dalia Ghalwash **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: HIGH - As Found: Xerostomia - 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 ### Condition Browse Module - Meshes - ID: D000014987 - Term: Xerostomia ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: T184 - Name: Hibiscus - Relevance: HIGH - As Found: Coordination exercises ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413537 **Brief Title:** Study of SPG601 in Adult Men With Fragile X Syndrome **Official Title:** A Phase 2a, Randomized, Double-Blinded, Study Evaluating the Neurophysiologic vs Clinical Effects of Single-Dose SPG601 and Placebo in Adult Men With Fragile X Syndrome #### Organization Study ID Info **ID:** SPG601-01 #### Organization **Class:** INDUSTRY **Full Name:** Spinogenix ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Avance Clinical Pty Ltd. #### Lead Sponsor **Class:** INDUSTRY **Name:** Spinogenix #### 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 Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome. **Detailed Description:** This study is a Phase 2 randomized, double blind, placebo-controlled, cross over, single dose of SPG601 and matching Placebo in patients with Fragile X syndrome. This study will entail 2 in person clinic visits to administer oral doses of SPG601 or matching placebo. Participants will receive a dose of either SPG601 or placebo at first visit, and will cross over to receive the other product at the second visit. ### Conditions Module **Conditions:** - Fragile X Syndrome **Keywords:** - Fragile X Syndrome - Fragile X Chromosome - cognitive outcomes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with Fragile X Syndrome will be randomized to receive SPG601 or placebo (8 capsules of 100 mg) one time on days 1 and 8 of the study. **Intervention Names:** - Drug: SPG601 **Label:** Experimental: Active SPG601 to be administered to participants with Fragile X Syndrome **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants with Fragile X Syndrome will be randomized to receive SPG601 or placebo (8 capsules of 100 mg) one time on days 1 and 8 of the study. **Intervention Names:** - Drug: Placebo **Label:** Placebo Comparator: Placebo comparator to be administered to participants with Fragile X Syndrome **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: Active SPG601 to be administered to participants with Fragile X Syndrome **Description:** synthetic small molecule **Name:** SPG601 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo Comparator: Placebo comparator to be administered to participants with Fragile X Syndrome **Description:** Placebo **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in clinician rated measures on scale of 1 to 7, higher value indicates more severe symptom presentation **Measure:** Clinical Global Impressions Improvement scale as determined by the treating clinician **Time Frame:** 15 days **Description:** Change in caregiver rated measures on scale of 1 to 7, higher value indicates more severe symptom presentation **Measure:** Clinical Global Impressions Improvement scale as determined by the caregiver **Time Frame:** 15 days **Description:** Change in notation on Visual Analog scale as determined by the patient caregiver. Rater will indicate on linear measurement scale of 1 to 100 centimeters, with higher score indicating more severe symptoms **Measure:** Visual Analog scale as determined by the patient caregiver **Time Frame:** 15 days **Description:** Auditory test will be evaluated for difference in responses to stimuli. **Measure:** Change in auditory response to chirp stimulus **Time Frame:** 15 days #### Secondary Outcomes **Description:** KiTAP Tests of Attentional Performance for Children, to measure alertness and assessments of visual reactions **Measure:** Change in attention and inhibition symptoms **Time Frame:** 15 days **Description:** National Institute of Health (NIH)- Toolbox Cognitive Battery (TCB): A series of tests will be conducted to assess reading, vocabulary, and speed matching. These tests are scored from zero to 100. A higher score indicate better performance. **Measure:** Change in cognitive outcomes measured by NIH Cognitive Toolbox **Time Frame:** 15 days **Description:** This test will measure eye tracking and movement in response to stimuli, and social gaze version, with a Likert scale of 1-5 for behavior rating. **Measure:** Change in eye tracking for social gaze **Time Frame:** 15 days **Description:** RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is scored from -4 to 4, with higher values indicate higher memory and cognitive assessment **Measure:** Change in memory and cognitive assessment with RBANS list learning. **Time Frame:** 15 days **Description:** Auditory test will be evaluated for difference in responses to stimuli. **Measure:** Change in auditory response to steady state auditory stimuli **Time Frame:** 15 days **Description:** This test will measure the electrical activity in the retina in response to stimuli **Measure:** Change in eye tracking measured by electroretinography **Time Frame:** 15 days **Description:** Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) **Measure:** Safety and tolerability of SPG601 in patients with Fragile X Syndrome **Time Frame:** 15 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult males aged 18 to 45 years * Diagnosis of Fragile X as confirmed with genetic testing * Patient must have caregiver * Must be in good health with no significant medical history * Clinical laboratory values within normal range or \< 1.2 times ULN * Contraceptive use by men or women consistent with local regulations * Able and willing to provide written informed consent * Stable dosing of psychotropic drugs for at least 4 weeks Exclusion Criteria: * Any physical or psychological condition that prohibits study completion * Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months. * Auditory or visual impairments that can not be corrected * History of suicidal behavior or suicidal ideation * Screening vital signs that are abnormal per protocol specification * ECG that are clinically significant abnormal * History of substance abuse or dependence within 6 months * Other investigational products within 30 days **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sarah.richter@cchmc.org **Name:** Sarah Richter **Phone:** 513-803-3324 **Role:** CONTACT **Contact 2:** **Email:** Craig.Erickson@cchmc.org **Name:** Craig Erickson, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Email:** sarah.richter@cchmc.org, - **Name:** Sarah Richter - **Phone:** 513-803-3324 - **Role:** CONTACT ***Contact 2:*** - **Email:** ashley.dapore@cchmc.org - **Name:** Ashley Dapore - **Role:** CONTACT ***Contact 3:*** - **Name:** Craig A Erikson, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Ernest Pedapati, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Cincinnati Children's Hospital Medical Center **State:** Ohio **Zip:** 45229 #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital Medical Center, Cincinnati **Name:** Craig Erickson, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000038901 - Term: Mental Retardation, X-Linked - ID: D000008607 - Term: Intellectual Disability - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000025064 - Term: Sex Chromosome Disorders - ID: D000025063 - Term: Chromosome Disorders - ID: D000000013 - Term: Congenital Abnormalities - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000040181 - Term: Genetic Diseases, X-Linked - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M8721 - Name: Fragile X Syndrome - Relevance: HIGH - As Found: Fragile X Syndrome - ID: M11589 - Name: Intellectual Disability - Relevance: LOW - As Found: Unknown - ID: M24774 - Name: Mental Retardation, X-Linked - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M23023 - Name: Chromosome Disorders - Relevance: LOW - As Found: Unknown - ID: M23024 - Name: Sex Chromosome Disorders - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M24877 - Name: Genetic Diseases, X-Linked - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: T2370 - Name: Fragile X Syndrome - Relevance: HIGH - As Found: Fragile X Syndrome ### Condition Browse Module - Meshes - ID: D000005600 - Term: Fragile X Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413524 **Brief Title:** The Effects of Different Vibration Exercises on COPD Patients **Official Title:** The Effects of Different Vibration Exercises on the Strength of Lower Extremity Muscles, Exercise Endurance, and Quality of Life Among COPD Patients #### Organization Study ID Info **ID:** N202403010 #### Organization **Class:** OTHER **Full Name:** Taipei Medical University ### Status Module #### Completion Date **Date:** 2025-06-13 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Taipei Medical University WanFang Hospital #### Lead Sponsor **Class:** OTHER **Name:** Taipei Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training. COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients. **Detailed Description:** Background Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training. Purpose To enhance the effectiveness of pulmonary rehabilitation, the vibration rehabilitation system will be applied on COPD patients to validate the effectiveness of direct and indirect vibration interventions on lower extremity muscle strength and functional performance in COPD patients, and test the effectiveness of vibration in improving lower extremity muscle strength, exercise tolerance, and COPD- related quality of life in COPD patients. Methods COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients. Expected outcome To establish an optimal model for lower extremity vibration and to validate the effectiveness of direct vibration on the lower extremities and whole body vibration in COPD patients undergoing pulmonary rehabilitation. ### Conditions Module **Conditions:** - COPD - COPD Chronic Obstructive Pulmonary Disease - Vibration Therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Whole-body Vibration Therapy **Label:** Whole-body Vibration Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Device: Local Vibration Therapy **Label:** Local Vibration Training Group **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Device: Sham Comparator **Label:** Control Group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Whole-body Vibration Training Group **Description:** Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of vibration training, and 10 minutes of stretching exercises at the end. Each session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. For the starting position, the patient stands relaxed on the platform, holding the WBV platform handles. After vibration starts, the patient squat and stand at a steady pace until the two minutes are over. **Name:** Whole-body Vibration Therapy **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Local Vibration Training Group **Description:** Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of vibration training, and a final 10-minute stretching exercise. Each session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. After the warm-up exercise, the researcher helps the patient wear the localized vibration instrument. After the vibration begins, the patient squat and stand at a steady pace until the two minutes are over. **Name:** Local Vibration Therapy **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Control Group **Description:** Patients are instructed to perform squatting and standing exercises at home without vibration equipment. Health education is provided at the time of enrollment, and patients are instructed to perform the exercises twice a week at home, with follow-up via telephone to check compliance. Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of squatting and standing exercises, and a final 10-minute stretching exercise. Each session includes six series, each lasting 2 minutes, with a 60-second rest interval between series. After the warm-up exercises, participants should hold onto large household furniture or walls and squat and stand at a steady pace until the two minutes are up. **Name:** Sham Comparator **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** 6 Minute Walking Test **Time Frame:** Base line, Week12, Week16 **Measure:** Maximal voluntary contraction force **Time Frame:** Base line, Week12, Week16 #### Secondary Outcomes **Measure:** Five Times Sit to Stand Test (FTSST) **Time Frame:** Base line, Week12, Week16 **Measure:** Clinical COPD Questionnaire score, CCQ **Time Frame:** Base line, Week12, Week16 **Measure:** COPD assessment Test, CAT **Time Frame:** Base line, Week12, Week16 **Measure:** mMRC dyspnea scale, mMRC **Time Frame:** Base line, Week12, Week16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 40. 2. Diagnosis of chronic obstructive pulmonary disease (COPD) based on the criteria established by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). 3. Disease Severity: FEV1 \&lt; 50% or COPD patients who have used systemic corticosteroids due to an acute exacerbation of COPD within the past year and are currently in a stable condition. 4. Willingness to participate in vibration exercise intervention and ability to comply with the study activities, including signing the informed consent form. 5. Clear consciousness, normal cognitive function, and ability to communicate in Mandarin or Taiwanese for understanding experimental procedures and relevant instructions. Exclusion Criteria: 1. Engages in regular physical activity, exercising at least 3 times a week for over 30 minutes, with a Borg Scale rating of 3 for breathlessness after exercise. 2. The interval since the last pulmonary rehabilitation is less than three months. 3. Contraindications to vibration therapy: pregnancy, cardiovascular diseases (with a pacemaker or stent), intervertebral disc diseases, tendinitis, arthritis, hernia, presence of tumors, orthopedic or trauma-related conditions, epilepsy, history of deep vein thrombosis, patients with internal implants. 4. Inability to undergo training or walk due to physical factors, such as being bedridden for an extended period, relying on a ventilator for an extended period, prone to dizziness, central nervous system disorders, etc. 5. Underwent lower limb-related surgery within the past year or is in the recovery period post-surgery. 6. Currently diagnosed with cancer or undergoing cancer treatment. 7. Participation in other research studies. **Maximum Age:** 99 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gracelin@tmu.edu.tw **Name:** Yu-Huei Lin, Associate professor **Phone:** 0227361661 **Phone Ext:** 3620 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei City **Contacts:** ***Contact 1:*** - **Email:** cherry85420@gmail.com - **Name:** XUANYU LIAO, Master student - **Phone:** 0229307930 - **Phone Ext:** 2968 - **Role:** CONTACT **Country:** Taiwan **Facility:** Taipei Medical University WanFang Hospital **State:** Wenshan Dist **Zip:** 116 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** DadeMatthews OO, Agostinelli PJ, Neal FK, Oladipupo SO, Hirschhorn RM, Wilson AE, Sefton JM. Systematic review and meta-analyses on the effects of whole-body vibration on bone health. Complement Ther Med. 2022 May;65:102811. doi: 10.1016/j.ctim.2022.102811. Epub 2022 Jan 29. **PMID:** 35093509 **Citation:** Iodice P, Bellomo RG, Gialluca G, Fano G, Saggini R. Acute and cumulative effects of focused high-frequency vibrations on the endocrine system and muscle strength. Eur J Appl Physiol. 2011 Jun;111(6):897-904. doi: 10.1007/s00421-010-1677-2. Epub 2010 Nov 10. Erratum In: Eur J Appl Physiol. 2013 Nov;113(11):2871. **PMID:** 21063726 **Citation:** Gupta N, Pinto LM, Morogan A, Bourbeau J. The COPD assessment test: a systematic review. Eur Respir J. 2014 Oct;44(4):873-84. doi: 10.1183/09031936.00025214. Epub 2014 Jul 3. **PMID:** 24993906 **Citation:** Djibo DA, Goldstein J, Ford JG. Prevalence of disability among adults with chronic obstructive pulmonary disease, Behavioral Risk Factor Surveillance System 2016-2017. PLoS One. 2020 Feb 27;15(2):e0229404. doi: 10.1371/journal.pone.0229404. eCollection 2020. **PMID:** 32106254 **Citation:** Berner K, Albertyn SCS, Dawnarain S, Hendricks LJ, Johnson J, Landman A, Burger M. The effectiveness of combined lower limb strengthening and whole-body vibration, compared to strengthening alone, for improving patient-centred outcomes in adults with COPD: A systematic review. S Afr J Physiother. 2020 Jun 11;76(1):1412. doi: 10.4102/sajp.v76i1.1412. eCollection 2020. **PMID:** 32671277 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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 - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive - ID: D000008173 - Term: Lung Diseases, Obstructive ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413511 **Brief Title:** A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Moderate to Severe Systemic Lupus Erythematosus **Official Title:** A Phase 1b, Dose Escalation, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Participants With Moderate to Severe Systemic Lupus Erythematosus #### Organization Study ID Info **ID:** 221615 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2025-11-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### 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 goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with moderate to severe systemic lupus erythematosus (SLE). ### Conditions Module **Conditions:** - Systemic Lupus Erythematosus **Keywords:** - Systemic Lupus Erythematosus - Belantamab (GSK2857914) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Belantamab **Label:** Belantamab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Belantamab **Description:** Belantamab will be administered. **Name:** Belantamab **Other Names:** - GSK2857914 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants with adverse events (AEs) and serious adverse events (SAEs) **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in vital signs **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in electrocardiogram **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in echocardiogram **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in haematology **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in clinical chemistry **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in urinalysis parameters **Time Frame:** Up to Week 12 **Measure:** Number of participants with clinically important findings in corneal toxicity **Time Frame:** Up to Week 12 #### Secondary Outcomes **Measure:** Change from baseline in anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibodies **Time Frame:** Baseline (Day 1) and at Week 6 **Measure:** Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab **Time Frame:** Up to 12 weeks **Measure:** Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab **Time Frame:** Up to 12 weeks **Measure:** Maximum observed plasma drug concentration [Cmax] of belantamab **Time Frame:** Up to 12 weeks **Measure:** Number of participants with Anti-Drug Antibodies (ADAs) against belantamab **Time Frame:** Up to 12 weeks **Measure:** Titers of ADAs against belantamab **Time Frame:** Up to 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height\^2), inclusive, and body weight of ≥40 kg * Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria * Moderate to Severe SLE disease * Positive anti-dsDNA autoantibody test results * Sex and Contraceptive/Barrier requirements for males and females Exclusion Criteria: * Any acute, severe lupus related flare during the Screening Period that needs immediate treatment * Has any unstable or progressive manifestation of SLE * Significant, likely irreversible organ damage related to SLE * Major Diseases/Conditions/Morbidities including participants with any uncontrolled medical conditions (other than SLE) that in the opinion of the investigator puts the participant at unacceptable risk **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** GSKClinicalSupportHD@gsk.com **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** GSKClinicalSupportHD@gsk.com **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Medley **Contacts:** ***Contact 1:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ramon Moreda - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Florida **Zip:** 33166 **Location 2:** **City:** Peachtree Corners **Contacts:** ***Contact 1:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Darrell Murray - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Georgia **Zip:** 30071 **Location 3:** **City:** Memphis **Contacts:** ***Contact 1:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ramesh Gupta - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Tennessee **Zip:** 38119 ### IPD Sharing Statement Module **Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. **Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. **URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008180 - Term: Lupus Erythematosus, Systemic ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413498 **Acronym:** iMMagine-3 **Brief Title:** A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma **Official Title:** A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma #### Organization Study ID Info **ID:** KT-US-679-0788 #### Organization **Class:** INDUSTRY **Full Name:** Gilead Sciences #### Secondary ID Infos **Domain:** European Medicines Agency **ID:** 2024-511188-26 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2031-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Arcellx, Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** Kite, A Gilead Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC). **Detailed Description:** After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years. ### Conditions Module **Conditions:** - Multiple Myeloma **Keywords:** - Multiple Myeloma - CAR-T - ddBCMA - BCMA ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1. **Intervention Names:** - Drug: Anitocabtagene Autoleucel - Drug: Cyclophosphamide - Drug: Fludarabine **Label:** Anitocabtagene Autoleucel **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive the investigator's choice of one of the following therapies: * pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles) * daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles) * carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles) * carfilzomib and dexamethasone (Kd) (28-day cycles) **Intervention Names:** - Drug: Pomalidomide - Drug: Bortezomib - Drug: Dexamethasone - Drug: Daratumumab - Drug: Carfilzomib **Label:** Standard of Care Therapy (SOCT) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Anitocabtagene Autoleucel **Description:** A single infusion of CAR+ transduced autologous T cells **Name:** Anitocabtagene Autoleucel **Other Names:** - CART-ddBCMA **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Anitocabtagene Autoleucel **Description:** Administered intravenously **Name:** Cyclophosphamide **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Anitocabtagene Autoleucel **Description:** Administered intravenously **Name:** Fludarabine **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Standard of Care Therapy (SOCT) **Description:** Tablet administered orally **Name:** Pomalidomide **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Standard of Care Therapy (SOCT) **Description:** Administered intravenously or subcutaneously **Name:** Bortezomib **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Standard of Care Therapy (SOCT) **Description:** Tablet administered orally **Name:** Dexamethasone **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - Standard of Care Therapy (SOCT) **Description:** Administered intravenously or subcutaneously **Name:** Daratumumab **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - Standard of Care Therapy (SOCT) **Description:** Administered intravenously **Name:** Carfilzomib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as the time from randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first. **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to 4 years #### Secondary Outcomes **Description:** CR rate is defined as the proportion of participants who achieved a best overall response of CR or sCR per IMWG criteria as determined by IRC. **Measure:** Complete Response (CR) Rate (CR/ Stringent Complete Response (sCR)) **Time Frame:** Up to 4 years **Description:** Overall MRD negativity, defined as the proportion of any MRD negativity in participants with bone marrow aspirate (\< 1 in 10\^5 nucleated cells per IMWG criteria using next-generation sequencing (NGS)) at any time after randomization until disease progression, subsequent anti-multiple myeloma (MM) therapy, or death. **Measure:** Overall Minimal Residual Disease (MRD) Negativity **Time Frame:** Up to 7 years **Description:** OS is defined as the time from randomization to death due to any cause. **Measure:** Overall survival (OS) **Time Frame:** Up to 7 years **Description:** ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, very good partial response (VGPR), or PR) per IMWG criteria. **Measure:** Overall Response Rate (ORR) **Time Frame:** Up to 7 years **Description:** MRD-negative CR/sCR is defined as the proportion of participants achieving MRD-negative CR/sCR until disease progression, subsequent anti-MM therapy, or death. **Measure:** MRD-negative CR/sCR **Time Frame:** Up to 7 years **Description:** MRD-negative VGPR+ is defined as the proportion of participants achieving MRD negativity and sCR/CR/VGPR until disease progression, subsequent anti-MM therapy, or death. **Measure:** MRD-negative VGPR+ **Time Frame:** Up to 7 years **Description:** Sustained MRD negativity is defined as the proportion of participants remaining MRD-negative at the 10\^-5 sensitivity threshold for the specified number of months starting from the first MRD-negative assessment date to the last MRD-negative assessment date prior to disease progression, subsequent anti-MM therapy, or death. Duration may include ≥ 12 months. Sustained MRD negativity will be evaluated for overall MRD negativity, MRD-negative CR/sCR, and MRD-negative VGPR+. **Measure:** Sustained MRD Negativity **Time Frame:** Up to 7 years **Description:** DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first. **Measure:** Duration of Response (DOR) **Time Frame:** Up to 7 years **Description:** Time to progression is defined as the time from randomization to the first documented disease progression per IMWG criteria, or death due to disease progression, whichever occurs first. **Measure:** Time to Progression **Time Frame:** Up to 7 years **Description:** Time to next treatment is defined as the time from randomization to the start of subsequent anti-MM therapy or death from any cause, whichever occurs first. **Measure:** Time to Next Treatment **Time Frame:** Up to 7 years **Measure:** Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) **Time Frame:** First dose up to 7 years **Measure:** Percentage of Participants With Anti-Anitocabtagene Autoleucel CAR Antibodies (Anitocabtagene Autoleucel Arm) **Time Frame:** Up to 7 years **Measure:** Percentage of Participants With Presence of Replication-Competent Lentivirus (Anitocabtagene Autoleucel Arm) **Time Frame:** Up to 7 years **Description:** The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a high level of symptoms. **Measure:** Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score **Time Frame:** Up to 7 years **Description:** The EORTC QLQ-MY20 has 20 items across 4 independent subscales; 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of one week. Scores from each subscale are transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. **Measure:** Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score **Time Frame:** Up to 7 years **Description:** The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). The total score for EQ-5D-5L index is presented on a range where higher scores indicate better outcome. A positive change from Baseline indicates improvement. **Measure:** Change From Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Score **Time Frame:** Up to 7 years **Description:** Healthcare resource utilization will be assessed based on the numbers of hospitalizations, intensive care unit (ICU) inpatient days, and non-ICU inpatient days. **Measure:** Percentage of Participants Using Healthcare Resources **Time Frame:** Up to 7 years ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Documented historical diagnosis of multiple myeloma (MM) * Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy. * Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen * Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio * Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) Key Exclusion Criteria: * Prior B-cell maturation antigen (BCMA)-targeted therapy * Prior T-cell engager therapy * Prior CAR therapy or other genetically modified T-cell therapy * Active or prior history of central nervous system (CNS) or meningeal involvement of MM * Cardiac atrial or cardiac ventricular MM involvement * History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis * Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. * Prior auto-SCT within 12 weeks before randomization * Prior allogeneic stem cell transplant (allo-SCT) * High-dose (eg, cumulative \> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization * Live vaccine ≤ 4 weeks before randomization * Contraindication to fludarabine or cyclophosphamide * History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded. * Life expectancy \< 12 weeks Note: Other protocol defined Inclusion/Exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medinfo@kitepharma.com **Name:** Medical Information **Phone:** 844-454-5483(1-844-454-KITE) **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Kite, A Gilead Company **Name:** Kite Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Combined - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown - ID: M376 - Name: Bortezomib - Relevance: HIGH - As Found: 14 days - ID: M272211 - Name: Daratumumab - Relevance: HIGH - As Found: 50% - ID: M233261 - Name: Pomalidomide - Relevance: HIGH - As Found: 1 day - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone - ID: D000003520 - Term: Cyclophosphamide - ID: C000024352 - Term: Fludarabine - ID: D000069286 - Term: Bortezomib - ID: C000556306 - Term: Daratumumab - ID: C000467566 - Term: Pomalidomide ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413485 **Brief Title:** Canadian Beach Cohort Study **Official Title:** Canadian Beach Cohort Study: Prospective Study to Assess the Burden of Recreational Water Illness #### Organization Study ID Info **ID:** TorontoMetropolitan #### Organization **Class:** OTHER **Full Name:** Toronto Metropolitan University ### Status Module #### Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Waterloo **Class:** OTHER **Name:** University of Guelph **Class:** OTHER_GOV **Name:** Health Canada **Class:** OTHER_GOV **Name:** Public Health Agency of Canada (PHAC) **Class:** OTHER_GOV **Name:** Toronto Public Health **Class:** OTHER_GOV **Name:** Vancouver Coastal Health **Class:** UNKNOWN **Name:** Government of Manitoba **Class:** UNKNOWN **Name:** Public Health Niagara Region **Class:** OTHER **Name:** McMaster University **Class:** UNKNOWN **Name:** Halifax Regional Municipality #### Lead Sponsor **Class:** OTHER **Name:** Toronto Metropolitan University #### Responsible Party **Investigator Affiliation:** Toronto Metropolitan University **Investigator Full Name:** Ian Young **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Swimming and other water activities at public beaches are increasingly popular leisure activities among Canadians. However, these activities can lead to increased risks of acquiring acute gastrointestinal illness and respiratory, skin, ear, and eye infections among beachgoers. These illnesses have a significant health and economic burden on society, with young children having much higher rates of illness than other age groups. Currently, baseline data are lacking on the risk of recreational water illness in Canada, and beachgoers may lack awareness and understanding of these risks and how to prevent them. This study will identify the burden of recreational water illness among Canadian beachgoers. The results will be used to develop recommendations for improving recreational water quality guidelines for safe swimming in Canada, as well as public health risk management and communication strategies with beachgoers. The study will use a mixed-methods approach, consisting of a prospective cohort study and a qualitative study of beachgoers. The investigators will determine the risk of acquiring recreational water illness outcomes in beachgoers that engage in different levels of water and sand contact. The investigators will examine differences in illness risks by beachgoer gender, age, and location. The investigators will examine relationships between fecal indicator bacteria (E. coli), environmental conditions, and host-specific biomarkers with the risk of gastrointestinal illness among beachgoers. The investigators will also evaluate beachgoer risk perceptions and behaviours toward recreational water quality. The study will take place at five targeted beach sites in British Columbia, Manitoba, and Ontario. The study will be coordinated by a multidisciplinary research team, with activities guided by a stakeholder steering group consisting of key knowledge users. The long-term goal is to reduce the burden of recreational water illness in Canada, contributing to improved public health. **Detailed Description:** Swimming and other beach water activities are increasingly popular outdoor leisure activities among Canadians. However, these activities increase the risk of acquiring acute gastrointestinal illness (AGI) and other acute illnesses among beachgoers. Recreational water illness (RWI) has a significant health burden, with young children having the highest rates of illness. These illnesses result in substantial costs to society due to healthcare costs and lost productivity. Data are lacking in Canada on the risk and burden of RWI, and beachgoers may lack awareness and understanding of RWI risks and how to prevent them. There is a critical need to conduct timely research on the burden of RWI in Canada to inform recreational water quality guidelines and public health risk management. The purpose of this study is to identify the burden of RWI among Canadian beachgoers and to develop recommendations for improving recreational water quality risk management, communication, and pollution source prevention. The objectives are to: 1. Measure the risk and burden of five different RWI outcomes (AGI, respiratory, eye, ear, and skin infections) in beachgoers that engage in different levels of water and sand contact; 2. Identify differences in RWI risks by beachgoer gender, age, and beach location; 3. Determine relationships between fecal indicator bacteria, environmental parameters, host-specific biomarkers, and the risk of AGI among beachgoers; and 4. Understand beachgoer risk perceptions and behaviours related to recreational water quality and socio-political issues that may impact RWI risks among beachgoers. The study will use a mixed-methods approach, consisting of a prospective cohort study (Objectives 1-3) with embedded qualitative research (Objective 4). The cohort study will involve enrolling participants at public beaches, ascertaining their water and sand contact exposure status, then following-up to determine the incidence of acute RWI outcomes. The investigators will combine beachgoer exposure data with routinely collected secondary data on environmental parameters and E. coli levels in beach water. The investigators will also test for enterococci as another fecal indicator using rapid molecular methods and will conduct microbial source tracking to determine the contribution of different sources of fecal contamination (e.g., human, avian) to AGI. The study will take place at eight targeted freshwater and marine beach sites in British Columbia, Manitoba, and Ontario. The qualitative research will consist of focus groups to determine beachgoer risk perceptions and behaviours toward recreational water quality and key informant interviews with stakeholders to provide additional socio-political insights and context. The long-term goal of this study is to reduce the burden of RWI in Canada, contributing to improved public health. The study will be led by an experienced, diverse, and multi-disciplinary research team, including engagement with public health and environmental authorities. Activities will be guided by a stakeholder steering group consisting of key knowledge-users (KUs). This integrated KT approach will help to ensure that the results are relevant and useful to KUs, facilitating their direct uptake to influence recreational water quality policies and practice. ### Conditions Module **Conditions:** - Water-Related Diseases - Gastrointestinal Diseases **Keywords:** - Epidemiology - Beach water - Water quality - Fecal pollution - Cohort study - Mixed methods - Environmental health ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 5000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Beachgoing families and households to one or more Canadian beaches during the summers of 2023 to 2026. **Intervention Names:** - Behavioral: Level of recreational water contact activities **Label:** Beachgoers ### Interventions #### Intervention 1 **Arm Group Labels:** - Beachgoers **Description:** We will examine a graded classification of this exposure based on individuals' minimum level of water contact: 1) no water contact; 2) minimal contact; 3) body immersion; 4) swallowed water. Minimal contact is defined as water contact that does not result in body immersion (e.g., wading below one's waist, boating, fishing). Body immersion is defined as entering the water above one's waist (e.g., swimming, surfing, snorkelling), and swallowing water as ingestion of any amount of water. **Name:** Level of recreational water contact activities **Other Names:** - Sand contact at beaches **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Self-reported AGI in the 7-day period following beach water contact. Defined as one or more of: (a) diarrhea (≥3 loose stools in 24 hrs); (b) vomiting; (c) nausea with stomach cramps; or (d) nausea or stomach cramps that interfere with regular daily activities (e.g., missed work or school). **Measure:** Acutre gastrointestinal illness (AGI) **Time Frame:** Within 7 days of beach visit/water contact #### Secondary Outcomes **Description:** Self-reported fever with sore throat, fever with nasal congestion, or cough with phlegm **Measure:** Acute respiratory illness **Time Frame:** Within 7 days of beach visit/water contact **Description:** Self-reported rash or itchy skin **Measure:** Skin infection **Time Frame:** Within 7 days of beach visit/water contact **Description:** Self-reported ear infection or earache **Measure:** Ear infection or earache **Time Frame:** Within 7 days of beach visit/water contact **Description:** Self-reported eye infection or irritation **Measure:** Eye infection or irritation **Time Frame:** Within 7 days of beach visit/water contact ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to provide informed consent for the study and complete the surveys in English or French * Home address in Canada or the U.S. * Must not have participated in the study in the past 21 days Exclusion Criteria: * Not a Canadian or U.S. resident. **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Beachgoing households and individuals present at one of the targeted study beach sites during the recruitment period. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** iyoung@torontomu.ca **Name:** Ian Young **Phone:** 416-979-5000 **Phone Ext:** 557614 **Role:** CONTACT **Contact 2:** **Email:** jtustin@torontomu.ca **Name:** Jodan Tustin **Phone:** 4169795000 **Phone Ext:** 553021 **Role:** CONTACT #### Locations **Location 1:** **City:** Vancouver **Contacts:** ***Contact 1:*** - **Email:** iris.chan@vch.ca - **Name:** Iris Chan - **Role:** CONTACT ***Contact 2:*** - **Email:** michael.schwandt@vch.ca - **Name:** Michael Schwandt - **Phone:** 866-884-0888 - **Role:** CONTACT **Country:** Canada **Facility:** English Bay Beach and Kitsilano Beach **State:** British Columbia **Status:** RECRUITING **Location 2:** **City:** Winnipeg **Contacts:** ***Contact 1:*** - **Email:** Dylan.lyng@gov.mb.ca - **Name:** Dylan Lyng - **Phone:** 431-337-7880 - **Role:** CONTACT **Country:** Canada **Facility:** Grand Beach **State:** Manitoba **Status:** RECRUITING **Location 3:** **City:** Halifax **Contacts:** ***Contact 1:*** - **Email:** Elizabeth.Montgomery@halifax.ca - **Name:** Elizabeth Montgomery - **Phone:** 902.943.1954 - **Role:** CONTACT **Country:** Canada **Facility:** Birch Cove Beach **State:** Nova Scotia **Status:** NOT_YET_RECRUITING **Location 4:** **City:** Fort Erie **Contacts:** ***Contact 1:*** - **Email:** brandon.krupa@niagararegion.ca - **Name:** Brandon Krupa - **Phone:** 888-505-6074 - **Role:** CONTACT **Country:** Canada **Facility:** Bay Beach and Nickel Beach **State:** Ontario **Status:** NOT_YET_RECRUITING **Location 5:** **City:** Toronto **Country:** Canada **Facility:** Sunnyside and Marie Curtis Park East beaches **State:** Ontario **Status:** COMPLETED #### Overall Officials **Official 1:** **Affiliation:** School of Occupational and Public Health, Toronto Metropolitan University **Name:** Ian Young **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Anonymized data will be made publicly available following the study conclusion and publication of results. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Study protocol will be submitted for publication in 2024, and will contain the analysis plan. The final consent form and code will be shared with publication of the results later in the study timeframe (2027-2028). **URL:** https://www.canadianbeachwater.ca/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M471 - Name: Waterborne Diseases - Relevance: HIGH - As Found: Water-Related Diseases - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000069578 - Term: Waterborne Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413472 **Brief Title:** Comparing Formulations of Mechanical Power Using Geometric Methods **Official Title:** Comparing Formulations of Mechanical Power Using Geometric Methods at Different Inspiratory Rise and Pause Times: A Validation Study #### Organization Study ID Info **ID:** 2024-37 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Furkan Tontu **Investigator Title:** Doctor of Anesthesiology and Reanimation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We aimed to compare different formulations of mechanical power using geometric methods at varying inspiratory rise and pause times. **Detailed Description:** One of the formulas used to calculate mechanical power (MP) is the dynamic mechanical power formula (MPdyn) developed by Asar et al. This formula, in Volume-Controlled Ventilation (VCV) mode, calculates the same MP values as the comprehensive mechanical power formula (MPrs) from Gattinoni et al., without requiring the inspiratory resistance value. Similarly, in Pressure-Controlled Ventilation (PCV) mode, the MPdyn formula calculates mechanical power values comparable to those from the mechanical power formula (MPlm) proposed by Trinkle et al., also without the need for inspiratory resistance. However, the MPdyn formula has not been compared with the geometric method, considered the gold standard for mechanical power calculation. This limitation has been highlighted as a drawback for clinical use, particularly when applying the formula in both VCV and PCV modes. In this study, we aim to compare the MPdyn formula with the MPLM and MPrs formulas, against the standard geometric method (MPstd), for mechanical power calculations in ARDS patients during both pressure-controlled and volume-controlled ventilation, at varying inspiratory rise (Tslope) and pause times (Tpause). ### Conditions Module **Conditions:** - Ventilator-Induced Lung Injury - Acute Respiratory Distress Syndrome ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV). **Intervention Names:** - Procedure: Mechanical ventilator adjustment for PCV **Label:** ARDS patients-PCV #### Arm Group 2 **Description:** Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV). **Intervention Names:** - Procedure: Mechanical ventilator adjustment for VCV **Label:** ARDS patients-VCV ### Interventions #### Intervention 1 **Arm Group Labels:** - ARDS patients-PCV **Description:** In Pressure-Controlled Ventilation (PCV) mode, adjustments to the Tslope time will be made at every 5-minute interval, with incremental increases of 5% (ranging from 5 to 20), for each I:E ratio (1:2 and 1:1). After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained (Figure 1). A total of 40 P-V loop screenshots will be captured over a 40-minute period (20 for the 1:2 ratio and 20 for the 1:1 ratio), which will be stored in the ventilator's memory. The stored data will then be transferred from the ventilator's memory to a computer via a flash drive. **Name:** Mechanical ventilator adjustment for PCV **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - ARDS patients-VCV **Description:** In Volume-Controlled Ventilation (VCV) mode, at each I:E ratio (1:2 and 1:1), adjustments to the Tpause duration will be made every 40 minutes, with 10% increases at intervals of 10%, 20%, and 30%; for the Tslope duration, adjustments will be made every 5 minutes with 5% increases at intervals of 5%, 10%, 15%, and 20%. This will result in a total of 120 P-V loop screenshots taken over a 120-minute period (60 for the 1:2 ratio, with 4x5x3=60, and 60 for the 1:1 ratio, also with 4x5x3=60). These screenshots will be stored in the ventilator's memory and subsequently transferred to a computer via a flash drive. **Name:** Mechanical ventilator adjustment for VCV **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The mechanical power value measured using the geometric method (MPstd). **Measure:** MPstd **Time Frame:** 120 minute **Description:** The mechanical power value measured using the dynamic mechanical power formula (MPdyn) developed by Asar et al. **Measure:** MPdyn **Time Frame:** 120 minute **Description:** The mechanical power value measured using Gattinoni et al.'s comprehensive formula (MPrs). **Measure:** MPrs **Time Frame:** 120 minute **Description:** The mechanical power value measured using the formula developed by Trinkle et al (MPlm). **Measure:** MPlm **Time Frame:** 120 minute ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The study will include ARDS patients who are deeply sedated and ventilated in Pressure-Controlled Ventilation (PCV or PRVC) or Volume-Controlled Ventilation (VCV) modes during the 24-48 hour period of their stay in the intensive care unit. Exclusion Criteria: Patients with incomplete data, those with COPD and heart failure, pregnant patients, those with a thoracopleural fistula, and hemodynamically unstable patients will be excluded from the study. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** "Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital." ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Basaksehir Cam Sakura City Hospital ### IPD Sharing Statement Module **Description:** Not yet decided. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5. **PMID:** 35644896 **Citation:** Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. **PMID:** 27620287 **Citation:** Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5. **PMID:** 30291378 **Citation:** Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2. **PMID:** 31931417 **Citation:** Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8. **PMID:** 31773328 **Citation:** Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11. **PMID:** 32780353 **Citation:** Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available. **PMID:** 31101961 **Citation:** van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available. **PMID:** 31359082 **Citation:** Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4. **PMID:** 35224956 **Citation:** Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6. **PMID:** 38117345 **Citation:** ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. **PMID:** 22797452 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000013898 - Term: Thoracic Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M28144 - Name: Acute Lung Injury - Relevance: HIGH - As Found: Acute Respiratory Distress Syndrome - ID: M28143 - Name: Lung Injury - Relevance: HIGH - As Found: Lung Injury - ID: M28152 - Name: Ventilator-Induced Lung Injury - Relevance: HIGH - As Found: Ventilator-Induced Lung Injury - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M10279 - Name: Infant, Premature, Diseases - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M16657 - Name: Thoracic Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Acute Respiratory Distress Syndrome - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn - ID: D000055371 - Term: Acute Lung Injury - ID: D000055370 - Term: Lung Injury - ID: D000055397 - Term: Ventilator-Induced Lung Injury ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413459 **Acronym:** BioMol-MA **Brief Title:** Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis **Official Title:** Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis #### Organization Study ID Info **ID:** BioMol-MA #### Organization **Class:** OTHER **Full Name:** Ospedale San Raffaele ### Status Module #### Completion Date **Date:** 2027-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2021-04-08 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico #### Lead Sponsor **Class:** OTHER **Name:** Ospedale San Raffaele #### Responsible Party **Investigator Affiliation:** Ospedale San Raffaele **Investigator Full Name:** Nicola Lore **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:** In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M. abscessus lung disease in patients suffering from cystic fibrosis with the aim of increasing current knowledge available on the development and progression of lung disease. **Detailed Description:** Main objective: Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis. Secondary objectives * Identify cellular expression profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome * Identify biomarkers or molecular profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome * Expand pathogenetic knowledge to support disease progression pulmonary disease from M. abscessus in patients with cystic fibrosis and evaluate their ability to predict clinical outcome. * Describe the reciprocal interactions between cellular and humoral components of the response inflammatory disease during M. abscessus infection with/without M. abscessus lung disease. ### Conditions Module **Conditions:** - Non-Tuberculous Mycobacterial Pneumonia - Cystic Fibrosis Lung **Keywords:** - scRNASec ### Design Module #### Bio Spec **Description:** PBMCs and Plasma **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Luminex; scRNAsec **Label:** CF patients with chronic M. abscessus infection #### Arm Group 2 **Intervention Names:** - Other: Luminex; scRNAsec **Label:** CF patients with M. abscessus pulmonary disease #### Arm Group 3 **Intervention Names:** - Other: Luminex; scRNAsec **Label:** CF patients with no history of M. abscessus infection #### Arm Group 4 **Intervention Names:** - Other: Luminex; scRNAsec **Label:** Healty Controls ### Interventions #### Intervention 1 **Arm Group Labels:** - CF patients with M. abscessus pulmonary disease - CF patients with chronic M. abscessus infection - CF patients with no history of M. abscessus infection - Healty Controls **Description:** Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses **Name:** Luminex; scRNAsec **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis **Measure:** profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CF **Time Frame:** One month after enrollment visit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a certain diagnosis of cystic fibrosis and visited during normal clinical practice, in accordance with the standard operating procedures in force at the Centres. * Both sexes * Age \>18 years * Obtaining informed consent for patients (based on the procedures established by the protocol). Exclusion Criteria: * Patients unable to understand the instructions and information provided and be able to adequately accept the study methods. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with cystic fibrosis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lore.nicolaivan@hsr.it **Name:** Nicola I Lorè, PhD **Phone:** +390226434902 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** nicolaivanlore@hsr.it - **Name:** Nicola I Lorè, PhD - **Phone:** +390226434902 - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale San Raffaele **State:** MI **Status:** RECRUITING **Zip:** 20132 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000017563 - Term: Lung Diseases, Interstitial ### 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: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M6755 - Name: Cystic Fibrosis - Relevance: HIGH - As Found: Cystic Fibrosis - ID: M12119 - Name: Mycobacterium Infections - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M14512 - Name: Pulmonary Fibrosis - Relevance: HIGH - As Found: Fibrosis Lung - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: LOW - As Found: Unknown - ID: T1710 - Name: Cystic Fibrosis - Relevance: HIGH - As Found: Cystic Fibrosis - ID: T3976 - Name: Mycobacterium Abscessus - Relevance: HIGH - As Found: Mycobacterium Abscessus ### Condition Browse Module - Meshes - ID: D000003550 - Term: Cystic Fibrosis - ID: D000008171 - Term: Lung Diseases - ID: D000011658 - Term: Pulmonary Fibrosis - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413446 **Brief Title:** Evaluation of the Effectiveness of Genicular Block in Postoperative Analgesia in Patients Undergoing Knee Arthroscopy **Official Title:** Evaluation of the Effectiveness of Genicular Block in Postoperative Analgesia in Patients Undergoing Knee Arthroscopy #### Organization Study ID Info **ID:** 2024-296 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-12-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Sevil Azazoglu ERBEK **Investigator Title:** specialist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The effectiveness of genicular block in postoperative analgesia management in arthroscopy cases are intended to be evaluated. **Detailed Description:** Relieving postoperative arthroscopy pain requires multimodal approaches of pain The most common treatment options are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and local infiltration of anesthetics is used. Due to the side effects of NSAIDs and opioids application of regional analgesia techniques, while providing better analgesia quality. It can reduce complications . Peripheral blocks such as genicular block, reduce side effects by reducing the use of other analgesics . Pain, it is considered one of the most important factors affecting the quality of recovery. ### Conditions Module **Conditions:** - Knee Pain Chronic ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Outcomes Module #### Primary Outcomes **Description:** The primary implication of this study is the perioperative effect of genicular block in arthroscopy surgery. To show that it has sufficient contribution to multimodal analgesia. **Measure:** the perioperative effect of genicular block **Time Frame:** 06.10.2024-12.10.2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Our patients who will be included in the research are patients who underwent arthroscopy under elective conditions. It consists of volunteers over the age of 18, regardless of gender. - Exclusion Criteria: * Infection in the block area * Coagulation disorder, * Known allergy to local anesthetics * Pregnancy * Patient with neuropathy * Uncooperative patient * The patient who refused to participate in the study * Patients under 18 years of age **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Our patients who will be included in the research are patients who underwent arthroscopy under elective conditions. It consists of volunteers over the age of 18, regardless of gender. - ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dr.sevilazazoglu@gmail.com **Name:** sevil azazoğlu erbek **Phone:** 5383373818 **Phone Ext:** 90 **Role:** CONTACT ### References Module #### References **Citation:** Singh S, Singh S, Nachimuthu M, Kassim AF, Bhullar AK, Veerakumaran R, Kol GN, Roslan NAM. Effectiveness of Ultrasound-guided versus Anatomical Landmark-guided Genicular Nerve Block to Treat Chronic Knee Osteoarthritis: A Retrospective Cohort Study. Oman Med J. 2023 Sep 28;38(5):e550. doi: 10.5001/omj.2023.103. eCollection 2023 Sep. **PMID:** 38225997 **Citation:** Pietrantoni P, Cunat T, Nuevo-Gayoso M, Martin N, Tio M, Basora M, Sastre S, Sala-Blanch X. Ultrasound-guided genicular nerves block: an analgesic alternative to local infiltration analgesia for total knee arthroplasty: A noninferiority, matched cohort study. Eur J Anaesthesiol. 2021 Aug 1;38(Suppl 2):S130-S137. doi: 10.1097/EJA.0000000000001546. **PMID:** 34038916 **Citation:** Sahoo RK, Krishna C, Kumar M, Nair AS. Genicular nerve block for postoperative pain relief after total knee replacement. Saudi J Anaesth. 2020 Apr-Jun;14(2):235-237. doi: 10.4103/sja.SJA_611_19. Epub 2020 Mar 5. **PMID:** 32317883 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413433 **Acronym:** ENGAGE **Brief Title:** Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol **Official Title:** A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED) #### Organization Study ID Info **ID:** SOL-BED-301 #### Organization **Class:** INDUSTRY **Full Name:** Axsome Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Axsome Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults. **Detailed Description:** Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks. ### Conditions Module **Conditions:** - Binge-Eating Disorder **Keywords:** - Binge eating disorder - BED - Solriamfetol - Sunosi - Axsome - Non-stimulant therapy - Dopamine norepinephrine reuptake inhibitor - Trace amine-associated receptor 1 (TAAR1) agonist ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Up to 12 weeks **Intervention Names:** - Drug: Solriamfetol 150 mg **Label:** Solriamfetol 150 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Up to 12 weeks **Intervention Names:** - Drug: Solriamfetol 300 mg **Label:** Solriamfetol 300 mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Up to 12 weeks **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Solriamfetol 150 mg **Description:** Solriamfetol tablets, taken once daily **Name:** Solriamfetol 150 mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Solriamfetol 300 mg **Description:** Solriamfetol tablets, taken once daily **Name:** Solriamfetol 300 mg **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** Placebo tablets, taken once daily **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from Baseline to Week 12 in number of binge eating episodes **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary diagnosis of BED according to DSM-5 criteria. * Provides written informed consent to participate in the study before the conduct of any study procedures. * Male or female, aged 18 to 55 inclusive. Exclusion Criteria: * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription. * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator. **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sol-bed-301@axsome.com **Name:** Study Director **Phone:** 212-332-5061 **Role:** CONTACT #### Locations **Location 1:** **City:** Encino **Country:** United States **Facility:** Clinical Research Site **State:** California **Status:** RECRUITING **Zip:** 91316 **Location 2:** **City:** Newport Beach **Country:** United States **Facility:** Clinical Research Site **State:** California **Status:** RECRUITING **Zip:** 92660 **Location 3:** **City:** San Diego **Country:** United States **Facility:** Clinical Research Site **State:** California **Status:** RECRUITING **Zip:** 92103 **Location 4:** **City:** Clermont **Country:** United States **Facility:** Clinical Research Site **State:** Florida **Status:** RECRUITING **Zip:** 34711 **Location 5:** **City:** Jacksonville **Country:** United States **Facility:** Clinical Research Site **State:** Florida **Status:** RECRUITING **Zip:** 32256 **Location 6:** **City:** Orlando **Country:** United States **Facility:** Clinical Research Site **State:** Florida **Status:** RECRUITING **Zip:** 32801 **Location 7:** **City:** Orlando **Country:** United States **Facility:** Clinical Research Site **State:** Florida **Status:** RECRUITING **Zip:** 32806 **Location 8:** **City:** Marietta **Country:** United States **Facility:** Clinical Research Site **State:** Georgia **Status:** RECRUITING **Zip:** 30060 **Location 9:** **City:** Overland Park **Country:** United States **Facility:** Clinical Research Site **State:** Kansas **Status:** RECRUITING **Zip:** 66210 **Location 10:** **City:** Methuen **Country:** United States **Facility:** Clinical Research Site **State:** Massachusetts **Status:** RECRUITING **Zip:** 01844 **Location 11:** **City:** Saint Charles **Country:** United States **Facility:** Clinical Research Site **State:** Missouri **Status:** RECRUITING **Zip:** 63304 **Location 12:** **City:** Cherry Hill **Country:** United States **Facility:** Clinical Research Site **State:** New Jersey **Status:** RECRUITING **Zip:** 08002 **Location 13:** **City:** Raleigh **Country:** United States **Facility:** Clinical Research Site **State:** North Carolina **Status:** RECRUITING **Zip:** 27607 **Location 14:** **City:** Memphis **Country:** United States **Facility:** Clinical Research Site **State:** Tennessee **Status:** RECRUITING **Zip:** 38119 **Location 15:** **City:** Austin **Country:** United States **Facility:** Clinical Research Site **State:** Texas **Status:** RECRUITING **Zip:** 73787 **Location 16:** **City:** San Antonio **Country:** United States **Facility:** Clinical Research Site **State:** Texas **Status:** RECRUITING **Zip:** 78229 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Axsome Therapeutics Website **URL:** http://www.axsome.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000006963 - Term: Hyperphagia - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5304 - Name: Bulimia - Relevance: HIGH - As Found: Binge Eating - ID: M28641 - Name: Binge-Eating Disorder - Relevance: HIGH - As Found: Binge Eating Disorder - ID: M26956 - Name: Bulimia Nervosa - Relevance: LOW - As Found: Unknown - ID: M4380 - Name: Feeding and Eating Disorders - Relevance: HIGH - As Found: Eating Disorders - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10014 - Name: Hyperphagia - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002032 - Term: Bulimia - ID: D000001068 - Term: Feeding and Eating Disorders - ID: D000056912 - Term: Binge-Eating Disorder ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413420 **Brief Title:** SUNOSI® (Solriamfetol) Pregnancy Registry **Official Title:** SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring #### Organization Study ID Info **ID:** JZP110-402 #### Organization **Class:** INDUSTRY **Full Name:** Axsome Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2029-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2029-09 **Type:** ESTIMATED #### Start Date **Date:** 2019-07-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Axsome Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA). **Detailed Description:** The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions. The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. ### Conditions Module **Conditions:** - Narcolepsy - Obstructive Sleep Apnea - Pregnant Women and Their Offspring **Keywords:** - Solriamfetol - SUNOSI - Axsome - Narcolepsy - Obstructive Sleep Apnea - Non-stimulant therapy - Dopamine norepinephrine reuptake inhibitor - Pregnancy outcomes - Infant outcomes ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1731 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 12 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant women with a diagnosis of narcolepsy or OSA **Intervention Names:** - Drug: Sunosi (solriamfetol) **Label:** Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA #### Arm Group 2 **Description:** Pregnant women with a diagnosis of narcolepsy or OSA **Intervention Names:** - Other: No treatment **Label:** Cohort 2: Unexposed participants with narcolepsy or OSA #### Arm Group 3 **Description:** Pregnant women with a diagnosis of narcolepsy or OSA **Intervention Names:** - Drug: Other prescription wake-promoting medications or stimulants **Label:** Cohort 3: Other-exposed participants with narcolepsy or OSA #### Arm Group 4 **Description:** Pregnant women without a diagnosis of narcolepsy or OSA **Intervention Names:** - Drug: Sunosi (solriamfetol) **Label:** Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA #### Arm Group 5 **Description:** Pregnant women without a diagnosis of narcolepsy or OSA **Intervention Names:** - Drug: Other prescription wake-promoting medications or stimulants **Label:** Cohort 5: Other-exposed participants without narcolepsy or OSA ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA - Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA **Description:** Exposure to at least 1 dose of solriamfetol at any time during pregnancy. **Name:** Sunosi (solriamfetol) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort 3: Other-exposed participants with narcolepsy or OSA - Cohort 5: Other-exposed participants without narcolepsy or OSA **Description:** Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy. **Name:** Other prescription wake-promoting medications or stimulants **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Cohort 2: Unexposed participants with narcolepsy or OSA **Description:** No treatment **Name:** No treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Long-term Safety **Time Frame:** Baseline up to 12 months after pregnancy outcome ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women of any age * Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy * Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA * Provides written informed consent to participate in the study * Authorization for her HCP(s) to provide data to the registry Exclusion Criteria: * Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC) * Inclusion of a prior pregnancy in the main analysis population **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sunosipregnancyregistry@ppd.com **Name:** Study Director **Phone:** 1-877-283-6220 **Role:** CONTACT #### Locations **Location 1:** **City:** Morrisville **Country:** United States **Facility:** Evidera, a PPD business unit **State:** North Carolina **Status:** RECRUITING **Zip:** 27560 **Location 2:** **City:** Wilmington **Country:** United States **Facility:** PPD, Inc. **State:** North Carolina **Status:** RECRUITING **Zip:** 28401 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Axsome Therapeutics Website **URL:** http://www.axsome.com **Label:** Sunosi Pregnancy Registry Recruitment Website **URL:** https://sunosipregnancyregistry.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001049 - Term: Apnea - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000006970 - Term: Disorders of Excessive Somnolence - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M12241 - Name: Narcolepsy - Relevance: HIGH - As Found: Narcolepsy - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: M1717 - Name: Sleepiness - Relevance: LOW - As Found: Unknown - ID: M10021 - Name: Disorders of Excessive Somnolence - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T4044 - Name: Narcolepsy - Relevance: HIGH - As Found: Narcolepsy ### Condition Browse Module - Meshes - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive - ID: D000009290 - Term: Narcolepsy ### Intervention Browse Module - Ancestors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: HIGH - As Found: Reader - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000697 - Term: Central Nervous System Stimulants ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413407 **Brief Title:** Tai Chi Exercise and Receptive Music Therapy for the Elderly **Official Title:** The Effect of Tai Chi Exercise and Receptive Music Therapy Applied to Elderly Individuals on Frailty Levels and Mental Health #### Organization Study ID Info **ID:** NihanT #### Organization **Class:** OTHER **Full Name:** Ataturk University ### Status Module #### Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ataturk University #### Responsible Party **Investigator Affiliation:** Ataturk University **Investigator Full Name:** NİHAN TÜRKOĞLU **Investigator Title:** Assist Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Frailty has become a major public health issue with the global aging population. In general, severe physical impairments and accompanying frailty in older adults are associated with adverse clinical outcomes. In addition to physical disorders, psychosocial disorders are also important in the formation of frailty. Depression is one of the most common psychosocial disorders among older adults, with prevalence ranging from 6.5% to 25.3%. Frail people may develop depression, and depressive symptoms negatively affect the physical functioning of the body, contributing to the development of frailty. This interrelationship between depression and frailty can lead to a vicious cycle with detrimental consequences for older adults. It is reported in the literature that elderly individuals experience low levels of well-being as well as depression. Spiritual well-being means that the individual is aware of his or her own abilities, feels at peace, is not affected by the stresses that may exist in his or her life, and is not in a state of spiritual turmoil. Poor mental health in the elderly increases fragility. This explains that frailty in elderly individuals affects all physical, social and psychological health components, and seriously negatively affects the quality of life and the formation and management of diseases. Most of the research literature on frailty has focused on physical health. But mental health, which includes positive aspects such as cognition, sleep, social interactions and well-being, is just as important as that related to physical illness and disability. There is a serious need for similar research focusing on psychosocial interventions to prevent and manage frailty. Studies are needed to show that promoting components such as resilience, social participation, and emotional regulation reduces stress levels in older adults, positively impacts mental health, increases healthy behaviors, and improves lifestyle, thereby reducing the risk of frailty. When the literature is evaluated, scientific studies in which music therapy and physical activity are applied have shown that these methods have positive effects on conditions that negatively affect mental health such as anxiety, stress and depression. There are no studies in the literature that discuss relaxing exercise and music therapy together for frailty in the elderly. **Detailed Description:** The aim of this study is to determine the effect of relaxing exercise and music therapy on the level of fragility and mental health in the elderly, who are considered to be a risk group in terms of public health. ### Conditions Module **Conditions:** - Elderly - Exercise - Therapy **Keywords:** - Tai Chi Exercise - Receptive Music Therapy - Elderly - Vulnerability - Depression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** As an intervention for this group, only Tai Chi Exercise will be applied. **Intervention Names:** - Behavioral: Tai Chi Exercise **Label:** Tai Chi Exercise Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** As an intervention for this group, only Receptive Music Therapy Group will be applied. **Intervention Names:** - Behavioral: Receptive Music Therapy **Label:** Receptive Music Therapy Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** As an intervention, both Tai Chi Exercise and Receptive Music Therapy will be applied to this group. **Intervention Names:** - Behavioral: Experimental **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** No intervention will be applied to this group. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Tai Chi Exercise Group **Description:** Tai Chi Exercise will be applied to this group. **Name:** Tai Chi Exercise **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Receptive Music Therapy Group **Description:** Receptive Music Therapy will be applied to this group. **Name:** Receptive Music Therapy **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Experimental **Description:** Tai Chi Exercise and Receptive Music Therapy techniques will be applied together to this group. **Name:** Experimental **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The four-point Likert-type scale developed by Lovibond and Lovibond (1995) consists of 14 depression, 14 anxiety and 14 stress dimensions; The short form of the scale, which consists of seven items each, consists of 21 items in order to have faster and more effective access to resources and more qualified use of time. It is presented in a four-point Likert form as "Not at All Appropriate (0) Somewhat Appropriate (1) Generally Appropriate (2) Completely Appropriate (4)" and shows that as the scores obtained from the scale increase, depression, anxiety and stress symptoms increase. Turkish validity and reliability studies were carried out by Yılmaz et al. Considering the reliability values, Cronbach's Alpha values for the dimensions are between 0.75-0.82; It is seen that the factor load Omega values for the dimensions are between 0.76 and 0.82 (Yılmaz et al., 2017). **Measure:** Depression, Anxiety, Stress Scale (DASS-21) **Time Frame:** two week **Description:** In order to evaluate frailty in the elderly, Rolfson et al. The validity and reliability study of the scale developed by Aygör in our country was carried out by Aygör. The scale consists of 11 questions and is evaluated in the range of 0-20 points. If the score obtained from the scale is in the range of 0-4, the elderly person is not fragile; A score of 5-6 is considered visibly vulnerable, a score of 7-8 is considered slightly fragile, a score of 9-10 is considered moderately fragile, and a score of 11 and above is considered severely fragile. In Aygör's study, the Cronbach alpha coefficient was determined as 0.75. **Measure:** Edmonton Frail Scale **Time Frame:** Two week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being 65 years or older * Not having any obstacle to exercise * He has no problems with his hearing Exclusion Criteria: * Not volunteering to participate in the study **Healthy Volunteers:** True **Maximum Age:** 95 Years **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nihan-25-kilic@hotmail.com **Name:** Nihan Türkoğlu **Phone:** +904422312689 **Role:** CONTACT **Contact 2:** **Name:** Nihan Türkoğlu **Phone:** 05315740889 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Ataturk University **Name:** Nihan Türkoğlu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M1175 - Name: Frailty - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413394 **Brief Title:** Virtual Reality, Empathy and Environmental Ethics. **Official Title:** The Effect of Virtual Reality Supported Environmental Ethics Approaches Education on Nurse's Empathy and Environmental Ethics Awareness Levels #### Organization Study ID Info **ID:** ArdahanUniversiserhatduzenci01 #### Organization **Class:** OTHER **Full Name:** Ardahan University ### Status Module #### Completion Date **Date:** 2023-06-15 **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:** 2023-04-30 **Type:** ACTUAL #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ardahan 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:** Environmental ethics is a sub-branch of ethics that determines moral values and principles towards the environment. It is the common responsibility of all humanity to improve and protect the environment/nature and to hand it over to the next generations. For this reason, every segment of society should have environmental ethics awareness. Empathy is an important concept in raising awareness of environmental ethics. It is stated that the awareness of environmental ethics is also developed in people who have developed empathy skills. For this reason, it is recommended to create training programs that enable people to develop their empathy skills. The formation and establishment of environmental ethics awareness in people can prevent the occurrence of environmental problems. This can be achieved by providing an effective environmental education. Technological developments such as virtual reality can be used in environmental education. Virtual reality technologies are called empathy machines as they create a sense of presence in users. For this reason, the perception of presence in virtual reality and being included in the narrative are effective in developing empathy in the person. It is stated that the perspectives acquired in virtual reality develop empathy and encourage behaviors in favor of society in a few weeks. Virtual reality technologies are useful for us researchers, both in terms of developing empathy towards environmental problems and creating awareness of environmental ethics as an educational tool. For this reason, in this study, the effect of virtual reality supported environmental education on nurses' empathy and environmental ethics awareness levels was tried to be examined with a quasi-experimental research. **Detailed Description:** RESEARCH DESIGN This research is a three-arm randomized controlled experimental study conducted prospectively to compare the effect of virtual reality-supported environmental education on nurses' environmental ethics approaches and empathy levels. LOCATION AND CHARACTERISTICS OF THE STUDY This research was conducted at a State Hospital located in a province in the Eastern Anatolia Region between 01.10.2022 and 31.04.2023. The hospital consists of primary adult intensive care, secondary adult intensive care, secondary neonatal intensive care, six-bedded wards, operating theatre service, emergency department, palliative care unit, dialysis unit, and outpatient care service. The working hours of the hospital are organized in two shifts, 08.00-16.00 and 16.00-08.00, or 24 hours (full day). POPULATION AND SAMPLE SELECTION The research was conducted with 91 nurses who volunteered to participate from among 101 nurses working at a State Hospital in a province in the Eastern Anatolia Region between 01.10.2022 and 31.04.2023. The total sample size was calculated as 90 (n=90) using G-POWER program with .4 (Cohen) effect size, 92% power, and .05 error margin based on percentage measurement values of the methods to be studied obtained from literature review (Faul et al., 2007). Considering possible losses, 33 nurses were planned to be included in each group, and randomization was performed over 91 nurses. None of the nurses included in the study met the exclusion criteria, and the study was concluded with 91 nurses. Inclusion Criteria for the Sample * Being a nurse working at the relevant State Hospital * Volunteering to participate in the research * Not having received virtual reality-supported environmental education before Exclusion Criteria for the Sample * Not being a nurse working at the relevant State Hospital * Not volunteering to participate in the research * Having received virtual reality-supported environmental education before Criteria for Withdrawal from the Sample * Being absent at any time during the research process * Not completing the environmental education Dependent and Independent Variables of the Study The main independent variable of the study is virtual reality-supported environmental education. Other sub-variables are data obtained through the "Nurse Introduction Form" and the "Empathy Level Determination Scale." The dependent variable of the study is data obtained through the "Environmental Ethics Approaches Scale." FORMS AND SCALES USED IN DATA EVALUATION The "Nurse Introduction Form," "Empathy Level Determination Scale," and "Environmental Ethics Approaches Scale" were used in the study ### Conditions Module **Conditions:** - Virtual Reality ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 91 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** virtual reality supported environmental education group **Intervention Names:** - Other: environmental education **Label:** Virtual reality supported environmental education group #### Arm Group 2 **Description:** the group that will not receive virtual reality-supported environmental education **Intervention Names:** - Other: environmental education **Label:** The group that will not receive virtual reality-supported environmental education #### Arm Group 3 **Description:** control group **Label:** Control group ### Interventions #### Intervention 1 **Arm Group Labels:** - The group that will not receive virtual reality-supported environmental education - Virtual reality supported environmental education group **Description:** environmental education **Name:** environmental education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Scale for environmental ethics approaches pre-test **Measure:** Scale for Environmental Ethics Approaches **Time Frame:** 15/11/2022-31/12/2022 **Description:** Scale for environmental ethics approaches post-test **Measure:** Scale for Environmental Ethics Approaches **Time Frame:** 16/02/2023-28/03/2023 **Description:** Adaptation of Empathy Quotient (EQ) Scale pre-test **Measure:** Adaptation of Empathy Quotient (EQ) Scale **Time Frame:** 15/11/2022-31/12/2022 **Description:** Adaptation of Empathy Quotient (EQ) Scale post-test **Measure:** Adaptation of Empathy Quotient (EQ) Scale **Time Frame:** 16/02/2023-28/03/2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Nurses working in ardahan state hospital Exclusion Criteria: * Nurses not working in ardahan state hospital **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Nurses ### Contacts Locations Module #### Locations **Location 1:** **City:** Ardahan **Country:** Turkey **Facility:** Ardahan Devlet Hastanesi **State:** Centrium **Zip:** 75000 #### Overall Officials **Official 1:** **Affiliation:** Ardahan University **Name:** Bahanur Malak Akgün **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** gender, total working time, age, marital status **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413381 **Brief Title:** RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS **Official Title:** RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS #### Organization Study ID Info **ID:** ENDOFAIL - 01 #### Organization **Class:** OTHER **Full Name:** IRCCS Azienda Ospedaliero-Universitaria di Bologna ### Status Module #### Completion Date **Date:** 2029-11-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Azienda Ospedaliero-Universitaria di Bologna #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Determine the proportion of patients with endometriosis unresponsive to medical therapy and to compare the clinical and ultrasonographic characteristics of this group of patients (study group) with the clinical and ultrasonographic characteristics of patients responsive to medical therapy (control group). ### Conditions Module **Conditions:** - Endometriosis **Keywords:** - pelvic pain - endometriosis - hormone therapy - therapeutic non-response - risk factors - reproduction - infertility ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** non-responsive patients to medical treatment **Label:** Focus group #### Arm Group 2 **Description:** responsive patients to medical treatment **Label:** Control group ### Outcomes Module #### Primary Outcomes **Description:** determine the rate of patients with endometriosis who were non-responsive to medical treatment at 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients responsive to medical treatment (control group). **Measure:** Rate of patients with endometriosis non-responsive to medical treatment at 12 months **Time Frame:** 12 months #### Secondary Outcomes **Description:** determine the rate of patients with endometriosis who were non-responsive to medical treatment at 6 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients responsive to medical treatment (control group). **Measure:** Rate of patients with endometriosis non-responsive to medical treatment at 6 months **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age between 18 and 50 years; * patients with endometriosis-related pain symptoms (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting Numerical Pain Rating Scale intensity \> 5); * indication for administration of oral hormonal medical treatment for endometriosis; * acquisition of informed consent. Exclusion Criteria: * patients with contraindications to oral hormone treatment * current or previous pelvic infections * history of malignancy or current suspicion of gynecologic malignant lesions * previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, bowel resections) * positive history of other causes of chronic pelvic pain * post-menopausal status **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Patients with clinical and ultrasound diagnosis of endometriosis with indication for administration of hormone therapy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** alessandro.arena6@unibo.it **Name:** Alessandro Arena **Phone:** +390512144385 **Role:** CONTACT #### Locations **Location 1:** **City:** Bologna **Contacts:** ***Contact 1:*** - **Email:** alessandro.arena6@unibo.it - **Name:** Alessandro Arena, MD - **Phone:** +390512144385 - **Role:** CONTACT ***Contact 2:*** - **Name:** Renato Seracchioli, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Alessandro Arena, MD - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola **State:** BO **Status:** RECRUITING **Zip:** 40138 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: LOW - As Found: Unknown - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413368 **Brief Title:** Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study **Official Title:** Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study #### Organization Study ID Info **ID:** CHLA-23-00352 #### Organization **Class:** OTHER **Full Name:** Children's Hospital Los Angeles ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital Los Angeles #### Responsible Party **Investigator Affiliation:** Children's Hospital Los Angeles **Investigator Full Name:** Jaya Punati **Investigator Title:** Medical Staff/USC Faculty CWR **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Chronic constipation is a feature of children with cystic fibrosis (CF). This is postulated to be a result of inhibition of secretory activity of the gastrointestinal luminal cells due to ineffective chloride channel function. Typical laxatives that work as osmotic agents fail to produce adequate relief in this population. Maralixibat is a non-systemic bile acid transport inhibitor (IBATi) that acts by interrupting bile acid reabsorption in the ileum thus interrupting the normal enterohepatic circulation. This interruption results in a larger volume of bile acids reaching the colon and being excreted in stool. Bile acids are known to decrease bowel transit time, increase mucosal permeability and secretions, as well as alter gut microbiota resulting in diarrhea. The overarching hypothesis of the study is that Maralixibat will improve stool consistency in children (Age \<18 years) with cystic fibrosis and constipation (Bristol Stool Scale \<4). Specifically, we aim to test the hypothesis that IBATi improves the consistency of stool to Bristol scale \>4 in children with CF and constipation. We will recruit a total of 20 patients with CF and constipation (defined as Bristol Stool Scale \<4 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks.) Design is a 'Within-Subjects' study by which each enrolled patient will take Maralixibat for 2 weeks total in addition to their stable laxative regimen during the study. Stool consistency \& ease of defecation will be recorded before and during the study period by families of enrolled patients via materials provided by the investigators. Stool consistency and ease of defecation will be compared before and after initiation of Maralixibat. The primary endpoint: Improvement in stool consistency to Bristol scale \>4 in children with CF and constipation. The secondary endpoint: Improvement in ease of defecation in children with CF and constipation. This will be measured via survey using a standardized scale (Bristol Stool Scale) and questionnaires developed by the research team. Analysis will involve comparison of pre-intervention to post-intervention stool consistency \& survey **Detailed Description:** Study Title Maralixibat in Patients with Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study Objectives Primary Objective: The primary aim of the study is to assess improvement in stool consistency in children (1 - 18 years of age) with cystic fibrosis. We will recruit a total of 20 patients with CF and constipation. Constipation will be defined as Bristol Stool Scale of \< 3 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks. They will receive Maralixibat for 3 weeks. Questionnaires via REDCap survey will be administered by the investigators pre- and post-intervention to assess changes in stool consistency and frequency after adding Maralixibat to their constipation regimen. Secondary Objective: The secondary aims include assessment for improved ease of defecation (as subjectively judged by patients \& their parents) after adding Maralixibat to their constipation regimen. Questionnaires via REDCap survey will be administered by the investigators pre and post intervention to assess changes in ease of defecation after adding Maralixibat to their constipation regimen. Design and Outcomes This study is a Within-Subjects Clinical Pilot study to examine the effect Maralixibat has on constipation in children (1 - 18 years of age) with cystic fibrosis (CF). We will recruit a total of 20 patients with CF and chronic constipation (defined as Bristol stool scale of \< 3 for 1 week prior to enrollment while on stable medication regimen for at least 4 weeks). They will receive IBATi for 3 weeks in addition to their stable conventional constipation medication regimen. Questionnaires via REDCap survey will be administered by the investigators pre and post intervention to assess changes in stool consistency, frequency, and ease of defecation after adding Maralixibat to their constipation regimen. Estimated Study Timelines: * The duration of an individual subject's participation in the study: 3 weeks * The duration anticipated to enroll all study subjects: 2 years * The estimated date for the investigators to complete this study (complete primary analyses): 30 months Interventions and Duration This study will compare a conventional constipation regimen for chronic constipation (stool softeners, stimulant laxatives, dietary changes, etc.) to conventional constipation regimen + Maralixibat. * Conventional Constipation Regimen: Stable regimen for at least 4 weeks * Conventional Constipation Regimen + Maralixibat: 3 weeks Sample Size and Population Target Population: Children (1 - 18 years of age) with Cystic Fibrosis \& Chronic Constipation (defined as Bristol stool scale of \< 3 for 1 week prior to enrollment while on stable medication regimen for at least 4 weeks). Number of Participants: 20 This is a Within-Subjects study design, so there will not be randomization and all patients will receive the study intervention. The period prior to initiation of Maralixbat with serve as the 'baseline' or 'control' of our primary outcomes. ### Conditions Module **Conditions:** - Constipation Chronic Idiopathic - Cystic Fibrosis **Keywords:** - Maralixibiat - Cystic Fibrosis - Chronic Constipation - Bristol Stool ### 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 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** within - subjects study **Intervention Names:** - Drug: Maralixibat 9.5 MG/ML [Livmarli] **Label:** treatment arm **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - treatment arm **Description:** Within Study subjects receiving 2 weeks of treatment with Maralixibat 9.5 MG/ML \[Livmarli\] and compare to baseline treatment. **Name:** Maralixibat 9.5 MG/ML [Livmarli] **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Constipation is defined as stool consistency of Bristol Scale 1 to 3. Our primary endpoint is looking for a change of 1 unit of the scale or transition to a scale of \>3 **Measure:** Change in stool consistency by 1 point in Bristol scale or transition to Bristol scale > 3 after study drug **Time Frame:** baseline to 3 weeks #### Secondary Outcomes **Description:** Maralixibat inhibits baseline absorption which in turn results in looser stools by osmosis. We will use a questionnaire to record subjective report of ease of stooling by patients from baseline prior to intervention using a Likert score of 1-5 1. - cannot stool 2. - Difficulty stooling 3. - neither easy nor difficult 4. - Easier stooling with medication 5. - No issues with stooling **Measure:** Change in subjective scoring in ease of stooling with the addition of Maralixibat to a conventional constipation medication regimen via subjective questionnaire. **Time Frame:** Baseline - 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 1-18 years Proven diagnosis of Cystic Fibrosis (via genetic testing or sweat chloride testing) Proven diagnosis of Chronic constipation (Bristol stool scale rating of \< 3 while on stable conventional therapy regimen) On stable (no medication changes or dose adjustments) conventional constipation medication regimen for chronic constipation (stool softeners, stimulant laxatives, dietary interventions) for at least 4 weeks. Exclusion Criteria: * The following are exclusion criteria for our study. All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation: Uncontrolled fat-soluble vitamin deficiency (Vitamin A, E, D, or K) Changes to conventional constipation medication regimen \<4 weeks prior to initiation of Maralixibat Adequately treated chronic constipation on conventional regimen (Bristol stool scale rating of \> 3) Allergy or sensitivity to the study drugs or their ingredients Inability or unwillingness of individual or legal guardian/representative to given written informed consent. **Maximum Age:** 18 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jpunati@chla.usc.edu **Name:** Jaya Punati, MD **Phone:** 3233615924 **Role:** CONTACT **Contact 2:** **Email:** mhook@chla.usc.edu **Name:** Michael Hook, MD **Phone:** 3233615924 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** jpunati@chla.usc.edu - **Name:** Jaya Punati, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Jaya Punati, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Children's Hospital Los Angeles **State:** California **Zip:** 90027 #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital Los Angeles **Name:** Jaya Punati, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M6755 - Name: Cystic Fibrosis - Relevance: HIGH - As Found: Cystic Fibrosis - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1710 - Name: Cystic Fibrosis - Relevance: HIGH - As Found: Cystic Fibrosis ### Condition Browse Module - Meshes - ID: D000003550 - Term: Cystic Fibrosis - ID: D000005355 - Term: Fibrosis - ID: D000003248 - Term: Constipation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413355 **Brief Title:** FAPI-74 PET/CT in Adults With Fibrosis **Official Title:** Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions #### Organization Study ID Info **ID:** 19923 #### Organization **Class:** OTHER **Full Name:** Abramson Cancer Center at Penn Medicine ### Status Module #### Completion Date **Date:** 2027-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Abramson Cancer Center at Penn Medicine #### 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 protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/CT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis. **Detailed Description:** A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, post-infection, post-radiation, pre or post-transplant, cardiac, liver, kidney or pulmonary fibrosis). This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/ CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis. \[18F\]-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomography/computed tomography (PET/CT) scan that will be completed in each subject who has a clinical suspicion of fibrotic disease. PET/CT imaging will be used to evaluate the distribution of fibroblast activating protein (FAP) in major organs and other tissues affected with fibrotic diseases or conditions. This is an observational study in that \[F-18\]-FAPI-74 PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[F-18\]-FAPI-74 PET/CT results, any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria. After injection of \[F-18\]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of \[F-18\]-FAPI-74 intravenously. Data will be collected to evaluate uptake of \[F-18\]-FAPI-74 in sites of suspected fibrosis and in major organs. An optional second PET/CT using \[F-18\]-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point. This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition, or to observe changes in \[F-18\]- FAPI-74 uptake in response to therapeutic interventions. ### Conditions Module **Conditions:** - Fibrosis (Morphologic Abnormality) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Head and neck cancer (up to 5 subjects), post tubercular lung disease (PTLD, up to 10 subjects) and exploratory (up to 10 subjects) with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, postinfection, post-radiation, pre/post-transplant, cardiac, liver, kidney or pulmonary fibrosis). **Intervention Names:** - Drug: [F-18]-FAPI-74 **Label:** FAPI-74 PET/CT Scan **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - FAPI-74 PET/CT Scan **Description:** A positron-emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo expression of FAP with positron emission tomography (PET/CT). **Name:** [F-18]-FAPI-74 **Other Names:** - [18F] aluminium fluorine ((S)-2,2'(7- (2-(4-(3-(4-(2-(2- cyanopyrrolidin-1-yl)-2 oxoethylcarbamoyl)quinolin-6-yloxy) propyl)piperazin-1-yl)-2-oxoethyl)-1,4,7- triazonane-1,4-diyl)diacetic acid **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The overall quality of the generated images will be evaluated. Initial imaging of the vertex to mid-thigh will be used to investigate regional tracer uptake in suspected sites of fibrosis and normal tissues for this novel radiotracer. Uptake and retention of \[F-18\]-FAPI-74 in known or suspected sites of fibrotic disease will be evaluated visually by trained radiology readers, the principal investigator, or designee. A number of analysis methods may be tested to identify the optimal method for analyses for future studies with this radiotracer. \[F-18\]-FAPI-74 PET/CT scans will be interpreted both qualitatively and quantitatively. **Measure:** Overall FAPI-74 PET/CT Image Analysis **Time Frame:** 3 years **Description:** \[18F\]-FAPi74 PET/CT data: Areas of uptake in tumors and healthy tissue will be measured by SUVmax and semiquantitative analysis will be conducted. In each case, lesion uptake will be marked as low, medium, and high avidity. Each lesion and lymph node will be separately measured and quantified. Measurements will be made by Dr. Sellmyer and co-Investigators (n=3). **Measure:** Head and Neck Cancer FAPI-74 PET/CT Image Analysis **Time Frame:** 3 years **Description:** Quantitative interpretation of FAP expression, will be recorded as a Standardized Uptake Value (SUV). Max, mean, and peak SUV values will be recorded for a region-of-interest encompassing a single primary lesion. **Measure:** PTLD FAPI-74 PET/CT Image Analysis **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Head and Neck Cancer Cohort: 1. Participants will be ≥ 21 years of age 2. Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC) 3. Determined to be surgical candidates PTLD Cohort: 1. Participants will be ≥ 21 years of age 2. Diagnosed with microbiologically confirmed DS-pTB (culture positive) 3. Completed DS-pTB treatment according to IDSA guidelines in the past 3 months to 2 years 4. Negative test for sputum Mtb culture at least two consecutive times during TB treatment without a subsequent positive Mtb culture (indicating cure as per CDC guidelines) All Cohorts: 1. History of known or suspected fibrosis-inducing medical condition 2. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: Head and Neck Cancer Cohort: 1. Participant is not eligible for tissue resection PTLD Cohort: 1. Diagnosed with TB that is resistant to rifampin 2. History of alternative pulmonary disease 3. Have been administered corticosteroids or any other systemic investigational agents within 3 months of screening 4. Have symptoms or signs suggestive of active TB at the time of screening All Cohorts: 1. Women of childbearing potential may not be pregnant or breastfeeding. A negative pregnancy test will be required before \[F-18\]- FAPI-74injection. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study 4. Treatment with a therapeutic agent targeting fibroblast activation protein (FAP) within 1 month prior to study enrollment. **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** erinschu@pennmedicine.upenn.edu **Name:** Erin Schubert **Phone:** 215-573-6569 **Role:** CONTACT **Contact 2:** **Email:** mary.hansbury@pennmedicine.upenn.edu **Name:** Mary Hansbury **Phone:** 215-746-8192 **Role:** CONTACT #### Locations **Location 1:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Email:** erinshu@pennmedicine.upenn.edu - **Name:** Erin Schubert - **Phone:** 215-573-6569 - **Role:** CONTACT ***Contact 2:*** - **Email:** mark.sellymer@pennmedicine.upenn.edu - **Name:** Mark A Sellymer, MD, PhD - **Role:** CONTACT ***Contact 3:*** - **Name:** Mark A Sellmyer, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** Mark A Sellmyer, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis ### Condition Browse Module - Meshes - ID: D000005355 - Term: Fibrosis ### Intervention Browse Module - Ancestors - ID: D000000969 - Term: Antinematodal Agents - ID: D000000871 - Term: Anthelmintics - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M8587 - Name: Fluorides - Relevance: LOW - As Found: Unknown - ID: M1815 - Name: Piperazine - Relevance: HIGH - As Found: Prevnar 13™ - ID: M11446 - Name: Mebendazole - Relevance: HIGH - As Found: Prevnar 13™ - ID: M234880 - Name: Piperazine citrate - Relevance: HIGH - As Found: Prevnar 13™ - ID: M256301 - Name: DMP 777 - Relevance: HIGH - As Found: Prevnar 13™ - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M4196 - Name: Anthelmintics - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077489 - Term: Piperazine - ID: D000008463 - Term: Mebendazole - ID: C000006589 - Term: Piperazine citrate - ID: C000105999 - Term: DMP 777 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413342 **Brief Title:** Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma **Official Title:** Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Randomized, Multi-center Phase II Clinical Trial #### Organization Study ID Info **ID:** ZJCCRT006 #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2028-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Cancer Hospital #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Yang Yang **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy. Patients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status (positive vs negative) and randomized in a 1:1 ratio into two groups: the treatment group receiving sintilimab (for patients with a weight \<60 kg: 3 mg/kg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) and the observation group receiving regular follow-up. Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or other circumstances where the investigator determines treatment should be discontinued, whichever occurs first. The maximum duration of sintilimab treatment is 12 months (from the start of treatment), while the observation group will be followed up every 3 months for at least one year. No other anti-tumor treatments are allowed during the study period. The study aims to compare the effects of the two treatment modalities on progression-free survival, overall survival, tumor response, toxicity reactions, and quality of life in elderly patients with esophageal cancer. ### Conditions Module **Conditions:** - Esophageal Cancer - Chemoradiotherapy - Sintilimab - Immunotherapy - Elderly Patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 191 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in treatment group receive sintilimab (for patients with a weight \<60 kg: 3 mg/kg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) . **Intervention Names:** - Drug: Sintilimab **Label:** Sintilimab group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the observation group receive regular follow-up and observation. **Label:** Observation group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Sintilimab group **Description:** Patients should receive their first dose of sintilimab within 42 days after completing the final radiotherapy session and continue treatment until disease progression, occurrence of intolerable toxicity, loss to follow-up, death, or as determined by the investigator, whichever comes first. The maximum duration of sintilimab treatment is 12 months (from the initiation of therapy). No other anti-tumor therapies are permitted during the treatment period. **Name:** Sintilimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Median Progression-free survival (PFS) assessed in the intention-to-treat (ITT) population according to RECIST 1.1 criteria. **Measure:** mPFS **Time Frame:** The time from the start of treatment, for half of the participants in a study to experience disease progression or death from any cause #### Secondary Outcomes **Description:** The length of time from the start of treatment until the point of death from any cause. **Measure:** OS **Time Frame:** occurence or end of follow-up（2 years after enrollment）, which comes first **Description:** objective response rate **Measure:** ORR **Time Frame:** 2 months after enrollment **Description:** Duration of Response **Measure:** DoR **Time Frame:** occurence or end of follow-up（2 years after enrollment）, which comes first ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, clinically staged before treatment (8th edition of the UICC/AJCC TNM staging system for esophageal squamous cell carcinoma) as stage II-IVb (cT1N2-3M0-1, cT2-4bN0-3M0-1, M1 limited to supraclavicular lymph node metastasis). 2. Candidates for curative esophageal cancer surgery who are unable to tolerate surgery or refuse surgery. 3. Age 70 to 85 years. 4. ECOG performance status of 0-1. 5. The minimum technical standard for radiotherapy is intensity-modulated radiotherapy (IMRT). The total dose of radiotherapy is 54Gy ± 10%. Note: It is recommended that study centers conduct screening within 14 days after subjects complete synchronous chemoradiotherapy. 6. Concurrent chemotherapy regimen: Single-agent S-1 70mg/m2, days 1-14 and 29-42, synchronized with radiotherapy for 14 days or longer. 7. The last cycle of chemotherapy must end before or concurrently with the last session of radiotherapy. Consolidation chemotherapy after radiotherapy is not allowed, and chemotherapy before chemoradiotherapy is not accepted. Patients who have not progressed after chemoradiotherapy, including complete response (CR), partial response (PR), and stable disease (SD), can be enrolled in this study. 8. Except for hearing loss, hair loss, and fatigue, all toxicities from previous anti-tumor treatments must have recovered to grade ≤1 (according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) or baseline level before enrollment. 9. The first dose of study medication must be administered within 42 days after completion of chemoradiotherapy. 10. No esophageal perforation or active esophageal bleeding, no significant invasion of the trachea or major blood vessels in the chest. No interstitial pneumonia or history of interstitial pneumonia. FEV1 ≥ 0.8L. 11. Expected survival ≥ 3 months. 12. Laboratory criteria: 1. Serum hemoglobin ≥ 90g/L, platelets ≥ 100 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L. 2. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min. 3. Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN. 4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with an INR within the expected therapeutic range for anticoagulant therapy can be screened). 13. Patients must sign formal informed consent forms indicating their understanding that this study complies with hospital policies and ethical requirements. Exclusion Criteria: * 1. Patients who underwent surgical resection for esophageal cancer prior to the start of this trial or have previously received treatment with immune checkpoint inhibitors such as anti-PD-1/PD-L1 or CTLA-4 inhibitors. 2. Patients staged as cT1-3N1-2M0, deemed suitable for surgical resection, and requiring surgery. 3. Experience disease progression after chemoradiotherapy. 4. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation. 5. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary conditions. 6. Poor nutritional status, with a BMI less than 18.5kg/m2, or PG-SGA score ≥9. 7. Inability to comprehend trial requirements or likelihood of non-compliance with trial requirements. 8. Presence of hematogenous metastases. 9. Presence of other malignant lesions, excluding curable non-melanoma skin cancer, cervical carcinoma in situ, or malignancies with a cure ≥5 years. 10. Known grade 3 to 4 allergic reactions to any treatment component. 11. Participation in other clinical trials within the past 30 days. 12. Active autoimmune diseases or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); exceptions include vitiligo or resolved atopic asthma without the need for intervention in adulthood; patients with stable doses of thyroid replacement hormone therapy for autoimmune-mediated hypothyroidism and patients with stable doses of insulin for type I diabetes can be included. 13. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation. 14. Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or higher heart failure (2) Unstable angina (3) Myocardial infarction within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 15. Active pulmonary tuberculosis infection detected by history or CT examination, or history of active pulmonary tuberculosis infection within the past year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago without proper treatment. 16. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 1× 104 copies/mL), hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the assay). 17. According to the investigator's judgment, concurrent diseases that pose a serious risk to patient safety or may interfere with patient completion of the study, or other reasons deemed unsuitable for enrollment by the investigator. **Maximum Age:** 85 Years **Minimum Age:** 70 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yangyang@zjcc.org.cn **Name:** Yang Yang, M.D. **Phone:** 057188128182 **Role:** CONTACT **Contact 2:** **Email:** xuwz@zjcc.org.cn **Name:** Weizhen Xu **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** Yongling Ji **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 - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000004938 - Term: Esophageal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: HIGH - As Found: Esophageal Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - 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: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077277 - Term: Esophageal Squamous Cell Carcinoma ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413329 **Brief Title:** The Association Between Physical Activity Level and Post-operative Prognosis **Official Title:** The Association Between Physical Activity Level and Post-operative Prognosis #### Organization Study ID Info **ID:** K5803 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study. ### Conditions Module **Conditions:** - Elective Operation Patients ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 324 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients' preoperative exercise level met the standard of American Exercise guidelines. **Intervention Names:** - Behavioral: preoperative physical activity level within 3 months **Label:** exposure #### Arm Group 2 **Description:** Patients' preoperative exercise level did not meet the standard of American Exercise guidelines **Label:** control ### Interventions #### Intervention 1 **Arm Group Labels:** - exposure **Description:** The exercise compliance criteria are moderate exercise of at least 150 minutes per week or high-intensity exercise of at least 75 minutes per week. **Name:** preoperative physical activity level within 3 months **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** EQ-5D-3L index will be collected and calculated for evaluation of patients' quality of life after the surgery **Measure:** Quality of life after the surgery **Time Frame:** two weeks, one month and three months after surgery #### Secondary Outcomes **Description:** from surgery to discharge **Measure:** postoperative hospitalization days **Time Frame:** one week after discharge **Description:** ICU length of stay **Measure:** ICU length of stay **Time Frame:** one week after discharge **Description:** Complications occurring within three months after surgery **Measure:** postoperative complications **Time Frame:** three months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients undergoing elective surgery at Peking Union Medical College Hospital Exclusion Criteria: * 1. Patients scheduled for surgery with minimal impact on overall health (including eye surgery, abortion, hysteroscopy, conization, gastroscopy, vascular angiography, and superficial surgery, etc.) 2. Orthopedic and cardiac surgery patients 3. Patients who are unable to live independently or have significant limitations in physical activity prior to surgery 4. Patients who have difficulty communicating verbally and cannot complete the questionnaire 5. Pregnant women. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients undergoing elective surgery at Peking Union Medical College Hospital. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yuxuerong@pumch.com **Name:** Xuerong Yu, PHD **Phone:** +8613651370641 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413316 **Brief Title:** ABC-CT Pre-School Feasibility Study **Official Title:** Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study #### Organization Study ID Info **ID:** 2000036974 #### Organization **Class:** OTHER **Full Name:** Yale University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Duke University **Class:** OTHER **Name:** Boston Children's Hospital **Class:** OTHER **Name:** Children's Hospital Los Angeles **Class:** OTHER **Name:** University of Washington **Class:** FED **Name:** Food and Drug Administration (FDA) **Class:** OTHER **Name:** University of Alabama at Birmingham **Class:** OTHER **Name:** University of California, Los Angeles **Class:** OTHER **Name:** Seattle Children's Hospital **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Lead Sponsor **Class:** OTHER **Name:** Yale University #### Responsible Party **Investigator Affiliation:** Yale University **Investigator Full Name:** James C. McPartland **Investigator Title:** Professor - Child Study Center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to advance the long term objective of developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old. **Detailed Description:** The ABC-CT Pre-School Feasibility Study will collect data in a cohort of participants to determine feasibility of the measures used in the ABC-CT Phase 1 study and ABC-CT Confirmation study in 3-5 year old participants. We will be able to examine distributional and psychometric properties of the measures in this group and obtain preliminary estimates of group differences and associations with clinical measures. In addition, we aim to determine the viability of EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD. Viability will be evaluated in terms of (a) valid data acquisition, including adequate levels of participant compliance, (b) reliability of data collection across sites, (c) construct validity in relation to social function, and (d) distributional/psychometric properties. Primary Objectives: 1. To evaluate the feasibility of collecting EEG and ET assessments used in the Phase 1 and Confirmation studies in 3-5 year old. 2. To determine the viability of adapted EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD. To further evaluate the psychometric properties of the ET and EEG biomarkers in the 3-5 year old population. Secondary Objectives: * To collect blood samples from all ASD subjects and their biological parents for future genomic analyses and to share raw, processed, and analyzed data via the National Database for Autism Research (NDAR) and National Institute of Health / National Institute of Mental Health (NIH/NIMH) Data Repositories to create a community resource accessible for use by all qualified investigators. * To compare estimates of key distributional parameters across the original, confirmation and feasibility samples to determine whether the markers profiles are sufficiently compatible to use in studies combining pre-school and school-aged children. The Preschool Feasibility sample will be evenly divided (25 ASD, 25 TD), aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US. Endpoints: To collect and analyze a new cohort of participants to evaluate the feasibility of ET and EEG acquisition in 3-5 year olds. We will also evaluate ET and EEG measures for potential utility as biomarkers in clinical trials. Primary endpoints include evaluation of (1) Acquisition, (2) Construct Validity, (3) Discriminant Validity. Primary Biomarker Outcome Variables. 1. N170 Latency to Upright Human Faces: The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 3 to 5 years of age. 2. Oculomotor Index of Gaze to Human Faces (OMI): Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays. ### Conditions Module **Conditions:** - Autism Spectrum Disorder **Keywords:** - Biomarker ### Design Module #### Bio Spec **Description:** Biological samples (blood) will be obtained for DNA analysis from both ASD participants and their biological parents after consent. All biospecimens will be collected and shipped as defined by the Biospecimen Standard Operating Procedure. Briefly, blood samples can be collected by an appropriately trained research staff member, traveling phlebotomist, or at a clinic. A parent and a trained laboratory member may help alleviate any anxiety the child might have, including by the use of numbing cream or cooling spray as standard practice. Participants with ASD and their biological parent(s) will each have up to 30 mL of blood drawn. Blood draws for this study will be conducted in accordance with NIH guidelines. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During Screening Visits, Diagnosis of ASD will be based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist. **Label:** Autism Spectrum Disorder #### Arm Group 2 **Description:** Typically Developing (TD) participants from each site will be roughly matched by age and sex to the ASD group. **Label:** Typical Development ### Outcomes Module #### Primary Outcomes **Description:** The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children. **Measure:** N170 Latency to Upright Human Faces **Time Frame:** Baseline **Description:** The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children. **Measure:** N170 Latency to Upright Human Faces **Time Frame:** 1 Month **Description:** Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays. **Measure:** Oculomotor Index of Gaze to Human Faces (OMI) **Time Frame:** Baseline **Description:** Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays. **Measure:** Oculomotor Index of Gaze to Human Faces (OMI) **Time Frame:** 1 Month #### Secondary Outcomes **Description:** The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors of children and adults with neurodevelopmetnal disorder at home, in residential facilities, ICFs/MR, and work training centers. It is also useful for classifying problem behaviors of children and adolescents with neurodevelopmetnal disorder in educational settings, residential and community-based facilities, and developmental centers **Measure:** Aberrant Behavior Checklist (ABC) **Time Frame:** Baseline **Description:** The Autism Impact Measure (AIM) uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact) **Measure:** Autism Impact Measure (AIM) **Time Frame:** Baseline **Description:** The Behavior Assessment System for Children, Third Edition (BASC-3) offers several different forms designed to aid in collecting information regarding at-risk adaptive behavioral and/or emotional problems. **Measure:** Behavior Assessment System for Children -3 (BASC-3) **Time Frame:** Baseline **Description:** The PDD-BI is an assessment tool for children on the autism spectrum. PDDBI profiles can provide guidance to clinicians regarding the child's problems as perceived by the informants, how a particular child compares to most children their age with ASD, and the skills and abilities of the child. **Measure:** PDD Behavior Inventory (PDD-BI) **Time Frame:** Baseline **Description:** The Social Responsiveness Scale 2 (SRS-2) is completed in just 15 to 20 minutes and identifies social impairment associated with autism spectrum disorders (ASDs) and quantifies its severity. **Measure:** Social Responsiveness Scale 2 (SRS-2) **Time Frame:** Baseline **Description:** Differential Ability Scales - Second Edition; DAS-II (Elliott C, 2007): The DAS-II is a clinical instrument designed to assess cognitive ability include variables such as verbal cluster, spatial cluster, nonverbal cluster, special nonverbal composite **Measure:** Cognitive Assessment **Time Frame:** Baseline **Description:** Resting State EEG (Eyes Open) provides a reference for the event-related EEG measures and a baseline biomarker of EEG spectral power across frequencies, neurofunctional connectivity and coherence, and hemispheric asymmetry and will always be done prior to the other EEG paradigms. Participants will be presented with non-social, abstract moving videos in random order. **Measure:** Resting State EEG **Time Frame:** Baseline **Description:** Faces processing is a foundation for social perception and attention and serves as a promising and robust biomarker of social impairment in ASD and a potential index of subgroup differences. As the primary non-resting paradigm, the FACES task will always **Measure:** Faces Processing EEG **Time Frame:** Baseline **Description:** The Kaufman Assessment Battery for Children (KABC) is a clinical instrument (psychological diagnostic test) for assessing cognitive development. Its construction incorporates several recent developments in both psychological theory and statistical methodology. **Measure:** Kaufman Assessment Battery for Children (K-ABC Face Recognition) **Time Frame:** Baseline **Description:** The Emotional Competence Inventory 2.0 (ECI) measures 18 competencies organized into four clusters: Self-Awareness, Self-Management, Social Awareness, and Relationship Management. The Emotional Competence Inventory takes approximately 30-45 minutes to complete. **Measure:** Emotional Competence Inventory (ECI) **Time Frame:** Baseline **Description:** Mullen Scales of Early Learning is a developmentally integrated system that assesses language, motor, and perceptual abilities, measures cognitive ability and motor development quickly and reliability. **Measure:** Mullen Scales of Early Learning **Time Frame:** Baseline **Description:** Administered in person visit or via parent phone interview. The Socialization score is based on 3 subdomains of Interpersonal Relationships, Play \& Leisure, Coping Scales. The V-Scaled scores, which are specifically designed to measure change over time, are only available for the subdomains. The primary norm-referenced scores for the subdomains are v-scale scores, which have a mean of 15 and standard deviation (SD) of 3. The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. **Measure:** VABS: Vineland Adaptive Behavior Scales- III Socialization **Time Frame:** Baseline **Description:** ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins. Color images depicting 12 different female faces with direct gaze and the same faces with averted gaze will be presented. Twelve different exemplars from each of five categories (alarm clocks, mobile phones, birds, cars, and shoes) will be used as distracters. Twelve different slides will each contain six images (one face and five distracters, one from each category) placed at an equal distance from the center of the screen. Each slide contains a different set of six images, each image being shown only once in the experiment. This measure examines scanning patterns towards arrays of objects, synthetic stimuli, and faces as well as towards more complex naturalistic (static) scenes. This task examines complex scene processing and attentional selection. **Measure:** Eye-tracking (ET) Static Social Scenes Task **Time Frame:** Baseline **Description:** ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins. Pupillary Light Reflex (PLR) Task is measured following a stimuli that consist of a central fixation point on a black background that flashes white for 133 milliseconds. The constriction of the pupil in response to a bright flash indexes function of the parasympathetic nervous system. **Measure:** Eye-tracking (ET) Pupillary Light Reflex Task **Time Frame:** Baseline **Description:** ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins. Interactive Social Task (IST) is taps similar constructs as the activity monitoring task in a more naturalistic, dynamic, and complex context. Following a central fixation, children will be presented with interactive social trails in which two children engage in a natural interactive play session. **Measure:** Eye-tracking (ET) Social Interactive Task **Time Frame:** Baseline **Description:** ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins. Activity Monitoring Task is measured following central fixation. Children will be presented with multiple activity monitoring trails depicting two actresses engaging in a controlled joint activity such as assembling a puzzle. **Measure:** Eye-Tracking (ET) Activity Monitoring Task **Time Frame:** Baseline **Description:** Visual Evoked Potentials (VEPs) index low-level visual processing and reflect the functional integrity of the visual pathway. VEPs reflect excitatory (glutamatergic) and inhibitory (GABAergic) activity and may index subgroups of ASD with low-level visual impairments. VEPs also serve as a control for assessment of higher-order activity in social visual paradigms. Subjects will be presented with black and white checkerboards that reverse phase at a defined interval. The order of the VEP and Biomotion paradigms will be counterbalanced. **Measure:** Visual Evoked Potentials (VEPs) EEG **Time Frame:** Baseline **Description:** (CSI-4) is a behavior rating scale for evaluating the symptoms of DSM-IV and DSM-5 emotional and behavioral disorders among children between 5 and 12 years old who are attending elementary school (kindergarten thru 6th grade). There are both parent- and teacher-completed versions. The CSI-4: Parent Checklist contains 97 items for over a dozen emotional and behavioral disorders, and the CSI-4: Teacher Checklist contains 77 items. The CSI-4 can be scored to derive symptom count cutoff scores (diagnostic model) or symptom severity scores (T scores based on a dimensional model). Scoring is quick and easy with user-friendly score sheets. **Measure:** Child Symptom Inventory-4 (CSI-4) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For All Subjects: 1. Children (regardless of biological sex) Age 3 - 5. Participants must be able to complete the study before turning 6. 2. Written parental permission will be obtained prior to any study procedures. Child verbal assent will be obtained. 3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition or developmental level via Mullen Scales of Early Learning Composite (ELC). 4. Participant and parent/guardian must be English speaking. For ASD Participants (only): 1. Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist. 2. If parents are biological, a minimum of the child and one parent will be required to consent to the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure. The inability to obtain blood samples will not be exclusionary. Exclusion Criteria: For All Subjects: 1. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants) 1. This does not include events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome, Dup 15q Syndrome). 2. Specific cases will be discussed with the clinical team who will make a final determination, as needed. 2. History of epilepsy or seizure disorder a. This does not include history of simple febrile seizures or if the child is seizure free (regardless of the seizure type) for the past year. 3. Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible. 4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to D1. a. Medication is not exclusionary. Children taking neurological or psychiatric medications, including anti epileptics and psychopharmacological agents, must be stable on the medication and dose for 8 weeks prior to D1. 5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs). 6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event). 7. Any other factor that the investigator feels would make assessment or measurement performance invalid. For ASD Participants (only): 1. Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.) For TD Participants (only): 1. Known historical diagnosis of ASD or a sibling with ASD. 2. Criteria score in the ASD range on the BOSA/ADOS 3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition. 1. Participants will be screened using the (ECI-5 or CSI-4). Due to the instrument's high sensitivity and potential for false positives, any score in the clinical range will be reviewed by research staff for determination of eligibility. **Maximum Age:** 5 Years **Minimum Age:** 3 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** james.mcpartland@yale.edu **Name:** James McPartland, PhD **Phone:** 203-785-7179 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** morozco@chla.usc.edu - **Name:** Shafali Jeste, MD - **Phone:** 323-361-2471 - **Role:** CONTACT **Country:** United States **Facility:** Children's Hospital Los Angeles **State:** California **Zip:** 90027 **Location 2:** **City:** New Haven **Contacts:** ***Contact 1:*** - **Email:** asdbiomarkers@yale.edu - **Name:** James McPartland, PhD - **Phone:** 203-737-4586 - **Role:** CONTACT **Country:** United States **Facility:** Yale Child Study Center **State:** Connecticut **Zip:** 06510 **Location 3:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** ABC-CT@childrens.harvard.edu - **Name:** Susan Faja, PhD - **Phone:** 617-919-4108 - **Role:** CONTACT **Country:** United States **Facility:** Boston Children's Hospital **State:** Massachusetts **Zip:** 02445 **Location 4:** **City:** Durham **Contacts:** ***Contact 1:*** - **Email:** autismresearch@dm.duke.edu - **Name:** Geraldine Dawson, PhD - **Phone:** 888-691-1062 - **Role:** CONTACT **Country:** United States **Facility:** Duke University **State:** North Carolina **Zip:** 27708 **Location 5:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Email:** klab@uw.edu - **Name:** Natalia Kleinhans, PhD - **Phone:** 206-221-6604 - **Role:** CONTACT **Country:** United States **Facility:** University of Washington **State:** Washington **Zip:** 98195 #### Overall Officials **Official 1:** **Affiliation:** Yale University **Name:** James McPartland, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Per NDA access requirements. **Description:** IPD will be uploaded to the National Institute of Mental Health Data Archive. **IPD Sharing:** YES **Time Frame:** Data is uploaded every 6 months throughout the study. **URL:** http://nda.nih.gov/ ## 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 ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3595 - Name: Adenosine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413303 **Brief Title:** The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy **Official Title:** The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy #### Organization Study ID Info **ID:** K3955 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College 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:** A multi-center, prospective, randomized controlled clinical trial was conducted to explore the effect of experiential classroom on establishing healthy behaviors during pregnancy. **Detailed Description:** Adverse pregnancy outcomes, including maternal complications (eg, gestational hypertension, preeclampsia (PE), gestational diabetes mellitus (GDM), placental abruption) and fetal complications (eg, preterm birth, intrauterine growth restriction, large for gestational age (LGA), small for gestational age (SGA), macrosomia) , pose a significant public healthy problem which needs to be addressed. Several studies found that the health status and behaviors of mothers during pregnancy, including dietary patterns, physical activity and emotional well-being, not only affect pregnancy outcomes such as GDM and PE, but also have the long-term implications for the health of the offspring. Therefore, through effective preconception education, helping pregnant women establish healthy behaviors during pregnancy is of great significance in reducing the incidence of adverse pregnancy outcomes. However, traditional educational methods, mostly in the form of face-to-face lectures, have proven to be ineffective. On the other hand, experiential classroom emphasizes putting pregnant women at the center, based on their subjective willingness and previous knowledge and experience, creating an environment for free discussion, exchange, and reflection, and utilizing peer education to fully mobilize the subjective initiative of pregnant women. This approach allows them to explore, discuss, reflect, and learn autonomously, aiming to truly absorb, master, and apply theoretical knowledge. Therefore, to explore the impact of experiential classroom on the establishment of healthy behaviors during pregnancy, we conducted a multicenter, prospective, randomized controlled clinical trial. The study included pregnant women aged 20 and above, married, with singleton pregnancies in early pregnancy, who were randomly assigned to either the experiential classroom group or the routine prenatal care group. Both groups received routine prenatal care. The pregnant women in the personalized exercise guidance group learned about perinatal health knowledge under the guidance of multidisciplinary teachers and were supervised and managed through WeChat groups. The primary outcome measure was the total weight gain during pregnancy. ### Conditions Module **Conditions:** - Experiential Classroom - Health Behavior - Preconception Education - Adverse Pregnancy Outcome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 136 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants accept experiential class to establish healthy behaviors. They are also managed continuously through WeChat group chat during prenatal clinical interval. **Intervention Names:** - Behavioral: Experiential Classroom **Label:** Experiential Classroom Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants accept regular routine prenatal care following Chinese standard. **Label:** Standard Clinic Prenatal Care Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experiential Classroom Group **Description:** Experiential classroom emphasizes putting pregnant women at the center, based on their subjective willingness and previous knowledge and experience, creating an environment for free discussion, exchange, and reflection, and utilizing peer education to fully mobilize the subjective initiative of pregnant women. This approach allows them to explore, discuss, reflect, and learn autonomously, aiming to truly absorb, master, and apply theoretical knowledge. **Name:** Experiential Classroom **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Weight before delivery minus weight before pregnancy. **Measure:** Gestational weight gain **Time Frame:** From date of enrollment until the date of delivery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Older than 20. * Singleton pregnancy. * The first trimester. * Be able to undergo regular prenatal follow-ups and delivery in PUMCH. * Be able to participate in each experiential classroom on time. * Capable of independently completing questionnaire surveys. Exclusion Criteria: * With severe mental illness. * Severe impairment of liver and kidney function. * With malignant tumors. * With contraindications to exercise during pregnancy. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** maliangkun@pumch.cn **Name:** Liangkun Ma **Phone:** 13021961166 **Phone Ext:** +86 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** maliangkun@pumch.cn - **Name:** Liangkun Ma - **Phone:** 13021961166 - **Phone Ext:** +86 - **Role:** CONTACT **Country:** China **Facility:** Department of ob gyn, Peking Union Medical College Hospital **Status:** RECRUITING **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College **Name:** Liangkun Ma **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:** NCT06413290 **Brief Title:** Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery **Official Title:** Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery #### Organization Study ID Info **ID:** 18/12 #### Organization **Class:** OTHER_GOV **Full Name:** Antalya Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-10-29 **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:** 2024-09-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-10 ### 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 effect of pectointercostal fascial plane block on regional haemodynamic parameters in patients undergoing cardiac surgery. **Detailed Description:** Perioperative pain management has become an important component of Enhanced Recovery After Surgery (ERAS) protocols in patients undergoing cardiac surgery. Pain is most intense in the first two days after cardiac surgery. Inadequate pain control has been shown to cause an increase in pulmonary complications due to inadequate mobility and coughing, an increase in sympathetic activation, an increase in myocardial infarction and thromboembolic events, delayed wound healing, and prolonged hospital and intensive care unit stay. Non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, opioids, epidural anesthesia and ultrasound-guided fascial plane blocks are widely used for pain management after cardiac surgery. The pectointercostal fascial plane (PIFP) block is an ultrasound-guided, superficial fascial plane block that can be applied as part of multimodal postoperative analgesia, especially after cardiac surgery. PIFB block has been shown to reduce postoperative analgesic consumption and improve pain scores not only in patients undergoing cardiac surgery but also in non-cardiac surgeries and thoracic procedures. The aim of this study was to evaluate the effect of PIFP block on regional haemodynamic parameters in patients undergoing cardiac surgery. ### Conditions Module **Conditions:** - Cardiovascular Surgery **Keywords:** - regional anesthesia - postoperative pain - doppler ultrasound - cardiovascular surgery ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Before the anesthesia induction, PIFP block will be performed **Intervention Names:** - Other: PIFP block group **Label:** PIFP block group #### Arm Group 2 **Description:** No intervention **Intervention Names:** - Other: Control group **Label:** Control group ### Interventions #### Intervention 1 **Arm Group Labels:** - PIFP block group **Description:** Ultrasound-guided PIFP block will be performed approximately 30 minutes before surgery in patients undergoing cardiac surgery **Name:** PIFP block group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group **Description:** No intervention **Name:** Control group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The regional haemodynamic impact of PIDB block will be evaluated by Doppler ultrasound **Measure:** blood volume **Time Frame:** 1 hour #### Secondary Outcomes **Description:** The amount of postoperative opioid consumption will be recorded **Measure:** postoperative opioid consumption **Time Frame:** 24 hours **Description:** The postoperative pain intensity will be assessed with NRS pain scores (0=no pain, 10=worst possible pain) **Measure:** postoperative Numerical Rating Scale (NRS) pain scores **Time Frame:** 24 hours **Description:** The interval from the end of the surgery until the patient's discharge will be recorded. **Measure:** length of hospital stay **Time Frame:** 5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * elective cardiac surgery * over 18 years, adult * American Society of Anaesthesiology (ASA) I-III Exclusion Criteria: * history of cerebrovascular disease * history of Alzheimer's disease * mental disorder * emergency surgery * re-operated due to surgery-related complications * allergy to local anaesthetics * declining to give written informed consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** It is planned to include ASA I-III adult patients who are planned to undergo elective cardiac surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** arzukaraveli@hotmail.com **Name:** Arzu Karaveli **Phone:** +90 2422494400 **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 Research Hospital **State:** Muratpaşa **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital **Name:** Arzu O Karaveli, M.D. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24. **PMID:** 32798172 **Citation:** Ata F, Yilmaz C. Retrospective Evaluation of Fascial Plane Blocks in Cardiac Surgery With Median Sternotomy in a Tertiary Hospital. Cureus. 2023 Mar 3;15(3):e35718. doi: 10.7759/cureus.35718. eCollection 2023 Mar. **PMID:** 37016643 ## 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: M13069 - Name: Pain, Postoperative - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413277 **Brief Title:** Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial **Official Title:** Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain: HOPE Trial #### Organization Study ID Info **ID:** 1351927 #### Organization **Class:** OTHER **Full Name:** Ainsworth Institute of Pain Management ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-09 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Saluda Medical Pty Ltd #### Lead Sponsor **Class:** OTHER **Name:** Ainsworth Institute of Pain Management #### 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 aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord). **Detailed Description:** Primary Objective Evaluate the efficacy of ECAP CL-SCS in treating chronic pelvic pain. Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency. Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters. Study design This protocol describes an observational, prospective, single-arm, single center study. Eligible subjects will undergo an implant procedure as per standard of care for SCS. The system will be used within its licensed use. Data will be collected prospectively from 1 US study center. Time points of data collection are at baseline, trial, device implant and at 3-, 6-, -12 months post-implant. Study population Subjects with chronic, intractable pelvic pain will be screened for participation in this study. Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo a trial procedure. Following the trial phase subjects may receive a permanent implant and be followed up at 3-, 6-, and 12-months following the permanent implant. Enrollment will continue until 15 subjects receive a permanent implant. We estimate that up to 20 subjects will be enrolled in this study. Statistical analyses will be conducted using an appropriate software package (e.g., SAS, SPSS, R, Statistics). Standard summary statistics will be used to summarize endpoints and key study variables. Categorical variables, including the incidence of adverse events, will be summarized via counts and percentages. Continuous variables will be summarized via mean, median, standard deviation, and range. 95% confidence intervals will also be included with summary statistics for primary and secondary endpoints as well as other variables where appropriate. Any p-values for secondary or other endpoints will be nominal and not adjusted for multiplicity. ### Conditions Module **Conditions:** - Chronic Pelvic Pain - Pudendal Neuralgia **Keywords:** - Chronic Pelvic Pain - Pudendal Neuralgia - Levator Ani Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation **Name:** Saluda Evoke Smart SCS System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores. **Measure:** Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline **Time Frame:** 12 months #### Secondary Outcomes **Description:** Evaluate changes in impact of pain on activities of daily living from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Disability Index (PDI). **Measure:** Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in Pain quality from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using the Short Form-McGill Pain Questionnaire-2 (SF-MPQ2). **Measure:** Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline **Time Frame:** 12 months **Description:** Evaluate changes in health-related quality of life from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using EQ-5D-5L (The EuroQol 5 Dimension 5 Level self-report survey). **Measure:** Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in sleep quality and disturbances from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pittsburgh Sleep Quality Index (PSQI) questionnaire. **Measure:** Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in Anxiety and Depression from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Hospital Anxiety and Depression Scale (HADS). **Measure:** Changes in Anxiety and Depression: Proportion of patients achieving at least 50% and 80% reduction in anxiety and depression compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in Pain Catastrophizing from baseline to at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Catastrophizing Scale (PCS). **Measure:** Changes in Pain Catastrophizing: Proportion of patients achieving at least 50% and 80% reduction in pain catastrophizing compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in Global improvement with treatment at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Patient global impression of change (PGIC) questionnaire. **Measure:** Global Improvement: Proportion of patients achieving at least 50% and 80% increase in global improvement compared to baseline. **Time Frame:** 12 months **Description:** Evaluate changes in Urinary Urgency Frequency Patient Symptoms from baseline to 3-, 6-, and 12- month post ECAP CL-SCS Implant using Pelvic Pain and Urinary Urgency Frequency (PUF) Patient Symptom Scale. **Measure:** Changes in Urinary Urgency Frequency: Proportion of patients achieving at least 50% and 80% reduction of urinary urgency frequency compared to baseline. **Time Frame:** 12 months **Description:** Evaluate safety of ECAP CL-SCS in treating chronic pelvic pain by analyzing the incidence of study-related adverse event (AE) and serious AE (SAE). **Measure:** Safety of ECAP CL-SCS: Number of participants who experience study-related adverse events (AEs) and serious AEs (SAEs), the seriousness and severity of the AEs/SAEs and how the AEs/SAEs relate to procedure, device, and/or stimulation. **Time Frame:** 12 months **Description:** Device settings and data (e.g., ECAP target, amplitude, pulse width, frequency, programmed electrodes, recharge characteristics and patient usage) will be collected and summarized at the end of the study. **Measure:** Optimal device settings: Device settings at which participants achieved at least 50% and 80% increase in global improvement compared to baseline. **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject is 18 years of age or older at the time of enrollment. 2. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline. 3. Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months. 4. Subject has pain resulting from a known injury (surgery or trauma). 5. Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause. 6. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. 7. Subject is willing and capable of giving informed consent. 8. Subject is willing and able to comply with study-related requirements, procedures, and visits. Exclusion Criteria: 1. Subject is pregnant or nursing. 2. Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim. 3. Subject's mechanism of pain is unknown. 4. Suspected cause and onset of pain are more than 30 days apart. 5. Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain. 6. Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing. 7. Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator. 8. Subject has a history of sexual abuse and/or sexual trauma. 9. Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms. 10. Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline. 11. Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes. 12. Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion). 13. Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator. 14. Subject is concomitantly participating in another clinical study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients aged 18 or older with chronic, intractable pelvic pain ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zsmith@ainpain.com **Name:** Zoey Smith **Phone:** (212) 203 2813 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** zsmith@ainpain.com - **Name:** Zoey Smith - **Phone:** 212-203-2813 - **Role:** CONTACT ***Contact 2:*** - **Name:** Corey W Hunter, MD, FIPP - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jeanmarie Tari, NP - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Ainsworth Institute of Pain Management **State:** New York **Status:** RECRUITING **Zip:** 10022 #### Overall Officials **Official 1:** **Affiliation:** Ainsworth Institute of Pain Management **Name:** Corey W Hunter, MD, FIPP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hunter CW, Falowski S. 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Epub 2017 Oct 12. **PMID:** 29031895 **Citation:** Carey ET, Martin CE, Siedhoff MT, Bair ED, As-Sanie S. Biopsychosocial correlates of persistent postsurgical pain in women with endometriosis. Int J Gynaecol Obstet. 2014 Feb;124(2):169-73. doi: 10.1016/j.ijgo.2013.07.033. Epub 2013 Oct 31. **PMID:** 24290537 **Citation:** Hunter C, Dave N, Diwan S, Deer T. Neuromodulation of pelvic visceral pain: review of the literature and case series of potential novel targets for treatment. Pain Pract. 2013 Jan;13(1):3-17. doi: 10.1111/j.1533-2500.2012.00558.x. Epub 2012 Apr 23. **PMID:** 22521096 **Citation:** Janicki TI. Chronic pelvic pain as a form of complex regional pain syndrome. Clin Obstet Gynecol. 2003 Dec;46(4):797-803. doi: 10.1097/00003081-200312000-00009. No abstract available. **PMID:** 14595221 **Citation:** Baranowski AP. Chronic pelvic pain. Best Pract Res Clin Gastroenterol. 2009;23(4):593-610. doi: 10.1016/j.bpg.2009.04.013. **PMID:** 19647692 **Citation:** Ploteau S, Labat JJ, Riant T, Levesque A, Robert R, Nizard J. New concepts on functional chronic pelvic and perineal pain: pathophysiology and multidisciplinary management. Discov Med. 2015 Mar;19(104):185-92. **PMID:** 25828522 **Citation:** Lee RB, Stone K, Magelssen D, Belts RP, Benson WL. Presacral neurectomy for chronic pelvic pain. Obstet Gynecol. 1986 Oct;68(4):517-21. **PMID:** 3748502 **Citation:** Ingber MS, Peters KM, Killinger KA, Carrico DJ, Ibrahim IA, Diokno AC. Dilemmas in diagnosing pelvic pain: multiple pelvic surgeries common in women with interstitial cystitis. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Mar;19(3):341-5. doi: 10.1007/s00192-007-0453-2. Epub 2007 Sep 18. **PMID:** 17876490 **Citation:** Udoji MA, Ness TJ. New directions in the treatment of pelvic pain. Pain Manag. 2013 Sep;3(5):387-94. doi: 10.2217/pmt.13.40. **PMID:** 24654872 **Citation:** Buffenoir K, Rioult B, Hamel O, Labat JJ, Riant T, Robert R. Spinal cord stimulation of the conus medullaris for refractory pudendal neuralgia: a prospective study of 27 consecutive cases. Neurourol Urodyn. 2015 Feb;34(2):177-82. doi: 10.1002/nau.22525. Epub 2013 Nov 19. **PMID:** 24249588 **Citation:** Fritz J, Chhabra A, Wang KC, Carrino JA. Magnetic resonance neurography-guided nerve blocks for the diagnosis and treatment of chronic pelvic pain syndrome. Neuroimaging Clin N Am. 2014 Feb;24(1):211-34. doi: 10.1016/j.nic.2013.03.028. Epub 2013 Aug 1. **PMID:** 24210321 **Citation:** Hayek SM, Veizi E, Hanes M. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database. Neuromodulation. 2015 Oct;18(7):603-8; discussion 608-9. doi: 10.1111/ner.12312. Epub 2015 Jun 5. **PMID:** 26053499 **Citation:** Levine AB, Parrent AG, MacDougall KW. Stimulation of the Spinal Cord and Dorsal Nerve Roots for Chronic Groin, Pelvic, and Abdominal Pain. Pain Physician. 2016 Jul;19(6):405-12. **PMID:** 27454271 **Citation:** Saifuddin A, Burnett SJ, White J. The variation of position of the conus medullaris in an adult population. A magnetic resonance imaging study. Spine (Phila Pa 1976). 1998 Jul 1;23(13):1452-6. doi: 10.1097/00007632-199807010-00005. **PMID:** 9670396 **Citation:** Nashold BS Jr, Grimes J, Friedman H, Semans J, Avery R. Electrical stimulation of the conus medullaris in the paraplegic. A 5-year review. Appl Neurophysiol. 1977-1978;40(2-4):192-207. doi: 10.1159/000102443. **PMID:** 309311 **Citation:** Kapural L, Narouze SN, Janicki TI, Mekhail N. Spinal cord stimulation is an effective treatment for the chronic intractable visceral pelvic pain. Pain Med. 2006 Sep-Oct;7(5):440-3. doi: 10.1111/j.1526-4637.2006.00165.x. **PMID:** 17014604 **Citation:** Simopoulos T, Yong RJ, Gill JS. Treatment of Chronic Refractory Neuropathic Pelvic Pain with High-Frequency 10-kilohertz Spinal Cord Stimulation. Pain Pract. 2018 Jul;18(6):805-809. doi: 10.1111/papr.12656. Epub 2018 Jan 11. **PMID:** 29106051 **Citation:** Gorecki JP, Burt T, Wee A. Relief from chronic pelvic pain through surgical lesions of the conus medullaris dorsal root entry zone. Stereotact Funct Neurosurg. 1992;59(1-4):69-75. doi: 10.1159/000098920. **PMID:** 1295050 **Citation:** Howell B, Lad SP, Grill WM. Evaluation of intradural stimulation efficiency and selectivity in a computational model of spinal cord stimulation. PLoS One. 2014 Dec 23;9(12):e114938. doi: 10.1371/journal.pone.0114938. eCollection 2014. Erratum In: PLoS One. 2015;10(4):e0123485. **PMID:** 25536035 **Citation:** Ranger MR, Irwin GJ, Bunbury KM, Peutrell JM. Changing body position alters the location of the spinal cord within the vertebral canal: a magnetic resonance imaging study. Br J Anaesth. 2008 Dec;101(6):804-9. doi: 10.1093/bja/aen295. Epub 2008 Oct 19. **PMID:** 18936040 **Citation:** Fettes PD, Leslie K, McNabb S, Smith PJ. Effect of spinal flexion on the conus medullaris: a case series using magnetic resonance imaging. Anaesthesia. 2006 Jun;61(6):521-3. doi: 10.1111/j.1365-2044.2006.04641.x. **PMID:** 16704583 **Citation:** Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012 Jan-Feb;15(1):1-12. **PMID:** 22270733 **Citation:** Parker JL, Karantonis DM, Single PS, Obradovic M, Cousins MJ. Compound action potentials recorded in the human spinal cord during neurostimulation for pain relief. Pain. 2012 Mar;153(3):593-601. doi: 10.1016/j.pain.2011.11.023. Epub 2011 Dec 19. **PMID:** 22188868 **Citation:** Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751. **PMID:** 37640452 ## 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: D000009408 - Term: Nerve Compression Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: HIGH - As Found: Pelvic Pain - ID: M29660 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - 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: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic - ID: T4805 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - ID: T3408 - Name: Levator Syndrome - Relevance: LOW - As Found: Unknown - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000060545 - Term: Pudendal Neuralgia - ID: D000017699 - Term: Pelvic Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413264 **Acronym:** USP **Brief Title:** Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients **Official Title:** Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL) #### Organization Study ID Info **ID:** T/IM-NF/Gen.Surg/23/118 #### Organization **Class:** OTHER **Full Name:** All India Institute of Medical Sciences, Bhubaneswar ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-28 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** All India Institute of Medical Sciences, Bhubaneswar #### Responsible Party **Investigator Affiliation:** All India Institute of Medical Sciences, Bhubaneswar **Investigator Full Name:** Dr. Prakash Kumar Sasmal **Investigator Title:** Professor of General Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Bariatric Surgery for morbid obesity is indicated when BMI \> 40 kg/m2 without comorbidities or BMI \> 35 kg/m2 with co-morbidities. Different surgeries performed for obesity are classified as restrictive, malabsorptive, and hybrid procedures. Because laparoscopic surgery has increased the interest and growth of bariatric surgery, soaring demand for laparoscopic bariatric surgery from patients has boosted the boom in bariatric surgery worldwide. Achieving pneumoperitoneum is the initial and one of the most crucial steps in any laparoscopic surgery, giving the surgeon working space to operate on a particular organ/organ system. Usually, pneumoperitoneum is achieved either by a closed technique with a veress needle or an open technique with many variations like finger assisted or the conventional open technique. Given the excess amount of subcutaneous fat in morbidly obese patients, putting a veress needle to achieve pneumoperitoneum successfully is particularly challenging which takes a toll on the operating surgeon when he/she is trying to locate the midline one can either overshoot to cause omental emphysema or undershoot getting lost in the subcutaneous fat. It is usually done in the supra umbilical area. Sometimes, due to previous surgical scars other sites are preferred. Sonography is routinely used by radiologists with negligible radiation exposure. Anesthesiologists in the operating room have used it for many assisted procedures like central line insertion / giving nerve blocks. It can also be used in obese patients undergoing metabolic surgery to assist in creating pneumoperitoneum by a veress needle. Advantages of Intraoperative ultrasonography in this particular study : 1. To quantify the thickness of subcutaneous fat 2. To visualise the linea alba and guide the veress needle safely into the peritoneal cavity 3. Real-time visualisation of the pneumoperitoneum created 4. Avoid complications like omental emphysema, bowel or vascular injury **Detailed Description:** All patients above the age of 18 years with morbid obesity planned for Laparoscopic bariatric surgery will be considered for inclusion in the study. The patient will be explained about the study and asked to sign an informed consent form. The patient's eligibility for the study will be checked by a competent radiologist through pre-operative ultrasonography. All patients will undergo metabolic surgery by a single competent surgeon per the standard operating protocol under general anaesthesia. A single dose of prophylactic antibiotic will be administered 30 minutes before the incision, the patient will be well strapped, and the port sites will be measured and marked. In group A, Ultrasonography will be used to locate the midline precisely and for subsequent puncturing with a Veress needle to enter the peritoneal cavity and the pneumoperitoneum created under real-time vision. In group B, the veress needle is inserted blindly, as regularly done in any other laparoscopic surgery, and the successful pneumoperitoneum is confirmed by percussion on the abdomen. Time taken and the number of attempts for achieving pneumoperitoneum and complications, if any, in both groups will be recorded by an independent assessor. Sample size calculation : There are no similar studies done before to assess the role of Ultrasonography in achieving pneumoperitoneum. Hence, the sample size was calculated for a pilot study, as per the recommendation of Sim J and Lewis M, considering precision, proportion, and efficiency. The trial was planned through a study of a continuous variable in two independent, Blind vs. USG guided Veress needle insertions to determine if the two study groups differ in the time taken to start pneumoperitoneum successfully. The study used for calculating sample size : Total sample size: 20 in each arm Blinding: Single blinded where only the patient is blinded ### Conditions Module **Conditions:** - Pneumoperitoneum - Morbid Obesity - Bariatric Surgery Candidate **Keywords:** - pneumoperitoneum - closed technique - Veress needle - ultrasonography-guided - morbidly obese - bariatric surgery - metabolic surgery - access-related injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Single blinded randomised controlled study where only the patient is blinded ##### Masking Info **Masking:** SINGLE **Masking Description:** Only patients will be blinded about the allocations. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ultrasonography-guided Veress needle will be inserted, and a real-time pneumoperitoneum will be created as the first step of a laparoscopic bariatric surgical procedure. The bariatric procedures include laparoscopic sleeve gastrectomy and gastric bypass procedures. The ultrasound's high-frequency (10-13Hz) linear probe will be used peri-operatively to identify the planes of the abdominal wall. Once the Veress needle is successfully inserted into the peritoneal cavity in real-time visualisation and pneumoperitoneum created, thereafter the bariatric procedures will be continued as routinely done. **Intervention Names:** - Procedure: Ultrasonography guided Veress needle insertion for creating pneumoperitoneum **Label:** USG-guided Veress needle insertion **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Veress needle is inserted blindly, as regularly done in any other laparoscopic surgery, and the successful pneumoperitoneum is confirmed by aspiration of the needle, saline drop test and percussion on the abdomen. **Intervention Names:** - Procedure: Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum **Label:** Blind Veress needle insertion **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - USG-guided Veress needle insertion **Description:** A real-time visualisation of the path of the Veress needle entry by the use of high frequency (13-6 MHz) probe ultrasonography. **Name:** Ultrasonography guided Veress needle insertion for creating pneumoperitoneum **Other Names:** - Sonosite Edge II Portable Ultrasound machine **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Blind Veress needle insertion **Description:** The Veress needle is inserted blindly and guided by the resistance of tissues and the click sounds of layers of abdominal wall. **Name:** Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum **Other Names:** - Stainless steel spring loaded reusable hollow needle of 2mm in diameter and 15-18cm long **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The time in seconds between the first attempt to insert the Veress needle into the peritoneal cavity and the onset of successful pneumoperitoneum (confirmed by either ultrasonography/saline drop/percussion) in morbidly obese patients undergoing laparoscopic bariatric procedures. A comparison of the time taken to successfully place the Veress needle in the peritoneal cavity by ultrasonography-guided insertion and by blind technique will be made. **Measure:** Time taken to successfully insert the Veress needle into the peritoneal cavity in both the arms. **Time Frame:** Time taken till the Veress needle tip enters the peritoneal cavity #### Secondary Outcomes **Description:** The number of attempts of Veress needle insertion made before successful intraperitoneal placement (confirmed by either ultrasonography/saline drop/percussion) in morbidly obese patients undergoing laparoscopic bariatric procedures. A comparison of the number of attempts of Veress needle insertion to successfully place it in the peritoneal cavity by ultrasonography-guided insertion and by the blind technique will be made. **Measure:** Number of attempts of Veress needle insertion **Time Frame:** Veress needle tip enters the peritoneal cavity (Maximum 3 attempts) **Description:** To compare the incidence of complications like omental emphysema, bowel injury and vascular injury. **Measure:** Incidences of complications out of Veress needle insertion for creating pneumoperitoneum **Time Frame:** At the beginning of the laparoscopic surgical procedure, during the diagnostic laparoscopy, the complications (omental emphysema, bowel /vascular injury), if any inadvertently done will be recorded ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients in the age group of 18 -65 years undergoing laparoscopic bariatric surgery with weight \>100 kg * Subcutaneous fat thickness of more than 5 cm as determined by pre-operative ultrasonography * BMI \> 40 kg/m2 Exclusion Criteria: * Patients who don't give consent and do not understand the nature of the study * Patients undergoing a re-do surgery **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drpksasmal@gmail.com **Name:** Dr Prakash K. Sasmal, MS, FACS **Phone:** +919438884255 **Role:** CONTACT **Contact 2:** **Email:** surg_pradeep@aiimsbhubaneswar.edu.in **Name:** Dr Pradeep K. Singh, MS, FACS **Phone:** +919438884254 **Role:** CONTACT #### Locations **Location 1:** **City:** Bhubaneswar **Country:** India **Facility:** All India Institute of Medical Sciences **State:** Odisha **Zip:** 751019 #### Overall Officials **Official 1:** **Affiliation:** Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India **Name:** Prof. Prakash K. Sasmal, MS, FACS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The study outcome will be shared after the end of the trial. An interim study outcome will be shared after half of the study subjects are recruited. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000010532 - Term: Peritoneal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Morbid Obesity - ID: M13917 - Name: Pneumoperitoneum - Relevance: HIGH - As Found: Pneumoperitoneum - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M13441 - Name: Peritoneal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011027 - Term: Pneumoperitoneum - ID: D000009767 - Term: Obesity, Morbid ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413251 **Brief Title:** Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension **Official Title:** Boxing Training Effects on Cardiovascular Risk, Quality of Life, Endothelial Function, and Blood Flow Patterns in Individuals With Elevated Blood Pressure or Stage 1 Hypertension #### Organization Study ID Info **ID:** 1364179-3 #### Organization **Class:** OTHER **Full Name:** University of Texas, El Paso ### Status Module #### Completion Date **Date:** 2020-03-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03-15 **Type:** ACTUAL #### Start Date **Date:** 2020-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2023-11-22 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Texas, El Paso #### 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 determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals. The main questions it aims to answer are (1) if boxing training reduces peripheral and central blood pressure and (2) if boxing training improves cardiovascular function in elevated blood pressure or hypertension stage 1 individuals. Participants with elevated blood pressure or hypertension stage 1 will be randomly divided into a control group or an intervention group. The latter group will be involved in boxing training, 3 days per week for 6 weeks. Researchers will compare clinical and cardiovascular outcomes between the control and the intervention group. ### Conditions Module **Conditions:** - Elevated Blood Pressure - Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be recruited from the University of Texas at El Paso and its surroundings. They will be identified by a preliminary blood pressure screening and a health questionnaire. The inclusion criteria will consist on: (1) ≥18 years old, (2) SBP between 120-139 mmHg or DBP between 80-89 mmHg obtained from 2 different days, (3) an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA Pooled Cohort Equations, and (4) no current participation in 3 or more days per week of endurance or resistance exercise training. Exclusion criteria will include non-controlled cardiac, pulmonary, or metabolic diseases, smoking, consumption of nutritional supplements containing antioxidants, and any physical impairment to exercise. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks **Intervention Names:** - Other: Boxing Training **Label:** Boxing **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will perform three days per week 10 minutes a flexibility intervention. **Intervention Names:** - Other: Control flexibility **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Boxing **Description:** The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks. Participants will be instructed to complete 10 rounds of three minutes with a one-minute resting period interspersed. Four rounds will consist of heavy bag punching (e.g. straight, jab, hook) at 60% VO2max and three rounds at 90-95% VO2max, while the remaining 3 rounds will be focused on mitt work at 60% VO2max. **Name:** Boxing Training **Other Names:** - Exercise **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control **Description:** The control group will perform three days per week 10 minutes of dynamic articular movement, five minutes of uni pedal stance, and five minutes of stretching of the upper limbs for six weeks. **Name:** Control flexibility **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Resting systolic and diastolic blood pressure (mmHg) **Measure:** Change from baseline brachial blood pressure after week six **Time Frame:** pre-intervention and immediately after the intervention #### Secondary Outcomes **Description:** Pulse wave analysis (mmHg) **Measure:** Central Blood Pressure **Time Frame:** pre-intervention and immediately after the intervention **Description:** Flow mediated dilation (%) **Measure:** Vascular function **Time Frame:** pre-intervention and immediately after the intervention **Description:** Forearm and Calf Blood Flow (ml/min/100 ml tissue) **Measure:** Plethysmography **Time Frame:** pre-intervention and immediately after the intervention **Description:** Cardiopulmonary Test (ml/kg/min) **Measure:** Maximum Oxygen Uptake **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker NOx (μmol/L) **Measure:** Nitric Oxide Bioavailability **Time Frame:** pre-intervention and immediately after the intervention **Description:** Dual energy x-ray absorptiometry Scan to assess Body Fat % **Measure:** Body Fat Percentage **Time Frame:** pre-intervention and immediately after the intervention **Description:** Dual energy x-ray absorptiometry Scan to assess lean mass (kg) **Measure:** Lean Mass **Time Frame:** pre-intervention and immediately after the intervention **Description:** The short form 36 (SF-36) is a short survey that covers a total of 8 sub-dimensions related to physical and mental health: (1) Physical Functioning, (2) Role Limitations due to Physical Problems, (3) Social Functioning, (4) Bodily Pain, (5) General Mental Health, (6) Role Limitations due to Mental Problems, (7) Vitality, and (8) General Health Perceptions. The SF-36 includes a diverse mixture of continuous item scaling methods and is comprised of 10 items with balanced multi-item response formats (range from 1 to 5), 7 items with a dichotomous response format (1 or 2), and 19 items with non-balanced multi-item response formats (nine items range from 1 to 3 and ten items range from 1 to 6). To obtain the raw score for each sub-dimension, 10 items are reversed. Then, raw values for each sub-dimension are summed. Finally, the raw scores are transformed to a 0-to-100 scale for each sub-dimension. Higher scores indicate higher Quality of Life from 0 (worst) to 100 (best). **Measure:** Quality of Life measured by the short-form 36 (SF-36) **Time Frame:** pre-intervention and immediately after the intervention **Description:** Pulse wave velocity from carotid to femoral artery (m/s) **Measure:** Arterial Stiffness **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker CRP (mg/L) **Measure:** C Reactive Protein (CRP) to assess inflammation **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker IL-6 (pg/ml) **Measure:** Interleukin-6 (IL-6) to assess inflammation **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker TNFα (pg/ml) **Measure:** Tumor necrosis factor alfa (TNFα) to assess inflammation **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker 8-isoprostane (pg/ml) **Measure:** 8-isoprostane to assess inflammation **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker SOD (mU/ml) **Measure:** Superoxide dismutase (SOD) to assess oxidative stress **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarker TAC (mM/ml) **Measure:** Total Antioxidant Capacity (TAC) to assess oxidative stress **Time Frame:** pre-intervention and immediately after the intervention **Description:** Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl) **Measure:** Lipid Profile **Time Frame:** pre-intervention and immediately after the intervention **Description:** Weight in kilograms **Measure:** Weight **Time Frame:** pre-intervention and immediately after the intervention **Description:** Height in meters **Measure:** Height **Time Frame:** pre-intervention and immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years old. * Systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg obtained from 2 different days. * an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA Pooled Cohort Equations. * no current participation in 3 or more days per week of endurance or resistance exercise training. Exclusion Criteria: * non-controlled cardiac, pulmonary, or metabolic diseases. * smoking, consumption of nutritional supplements containing antioxidants. * any physical impairment to exercise. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** El Paso **Country:** United States **Facility:** The University of Texas at El Paso **State:** Texas **Zip:** 79968 ### IPD Sharing Statement Module **Description:** Only the PI will analyze the collected data. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2023-12-11 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Size: 254468 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2023-12-12T10:45 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Elevated Blood Pressure - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413238 **Brief Title:** Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study **Official Title:** Investigating the Effects of Curcumin and Saffron on Fertility, Sugar, Lipid and Anthropometric Indicators in Women With Diabetes Mellitus of Reproductive Age #### Organization Study ID Info **ID:** fatememoshirenia4420185791 #### Organization **Class:** OTHER **Full Name:** Tarbiat Modarres University #### Secondary ID Infos **Domain:** curcuminsaffaron **ID:** f.moshirenia40120262004 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2025-01-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Tarbiat Modarres University #### Lead Sponsor **Class:** OTHER **Name:** Fateme Moshirenia #### Responsible Party **Investigator Affiliation:** Tarbiat Modarres University **Investigator Full Name:** Fateme Moshirenia **Investigator Title:** Department of Midwifery & Reproductive Health, Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** ## Study Hypotheses Summary: \*\*Primary Hypothesis:\*\* Women with diabetes mellitus receiving the intervention will exhibit significantly lower levels of sugar indicators (FBS, HA1c, 2HPP) and lipid indicators (LDL, HDL, TG) compared to the placebo group. \*\*Secondary Hypotheses:\*\* 1. \*\*Psychological Outcomes:\*\* The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group. 2. \*\*Sexual Health Outcomes:\*\* The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group. 3. \*\*Diabetes Management Outcomes:\*\* The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group. 4. \*\*Medication Adherence:\*\* The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence. **Detailed Description:** The study is a four-arm trial testing the effectiveness of curcumin, saffron, and a combination of both compared to a placebo in women with diabetes. The trial will measure glucose and lipid levels, medication side effects, adherence to treatment, and various other health indicators at different time points. Participants will be recruited from a specialty diabetes clinic in Yazd province, Iran, with specific eligibility criteria including age, diabetes diagnosis, and exclusion criteria such as allergies and certain medication use. The diagnostic criteria for diabetes mellitus are outlined by the American Diabetes Association. ### Conditions Module **Conditions:** - Women of Reproductive Age - Diabetes Mellitus **Keywords:** - diabetes - reproductive age - curcumin - saffron - lipid profile - sugar profile - enterometric indices ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In Arm curcumin, participants will receive two curcumin capsules, each with a dose of 500 mg, in addition to routine treatments. In Arm saffaron, participants will use one 15 mg saffron capsule and one placebo capsule, in addition to routine treatments. In Arm combination, participants will use one 500 mg curcumin capsule and one 15 mg saffron capsule, in addition to routine treatments. In Arm plasebo , participants will use two placebo capsules (500 mg starch flour), in addition to routine treatments ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The study will involve capsules with different combinations of curcumin, saffron, and placebos, labeled as ABCD. The capsules will be identical in appearance and smell to maintain blinding. The researcher, participants, and pharmacist will be unaware of the capsule contents. This three-way blind method aims to eliminate bias in the study. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** curcumin **Intervention Names:** - Drug: curcumin, saffron, Combination of saffron and curcumin and placebo **Label:** curcumin **Type:** OTHER #### Arm Group 2 **Description:** saffron **Intervention Names:** - Drug: curcumin, saffron, Combination of saffron and curcumin and placebo **Label:** saffron **Type:** OTHER #### Arm Group 3 **Description:** Combination of saffron and curcumin **Intervention Names:** - Drug: curcumin, saffron, Combination of saffron and curcumin and placebo **Label:** Combination **Type:** OTHER #### Arm Group 4 **Description:** placebo **Intervention Names:** - Drug: curcumin, saffron, Combination of saffron and curcumin and placebo **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination - curcumin - placebo - saffron **Description:** This study investigates the individual and combined effects of curcumin and saffron on diabetes compared to a placebo group. It will assess the effects on both clinical and laboratory diabetes symptoms within and between groups. Participants will receive either two 500mg curcumin capsules in arm 1, one 15mg saffron capsule with a 500mg starch flour placebo in arm 2, one 500mg curcumin and one 15mg saffron capsule in arm 3, and two 500mg starch flour placebos in arm 4. **Name:** curcumin, saffron, Combination of saffron and curcumin and placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Sugar and lipid indicators will be measured using Delta DP diagnostic kits. The Delta DP diagnostic kits have an inter-assay CV of \<3% and an intra-assay CV of \<2%, indicating highly accurate and reliable test results within the same assay and between different assays. **Measure:** Sugar and lipid indicators **Time Frame:** Sugar and lipid indicators will be measured at baseline Post-intervention . #### Secondary Outcomes **Description:** stress, anxiety, and depression will be measured by DASS21 questionnaire **Measure:** stress, anxiety and depression **Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) **Description:** Sexual performance will be FSFI questionnaire **Measure:** Sexual performance **Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) **Description:** quality of sexual life will be measured by SQOL-F questionnaire **Measure:** quality of sexual **Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) **Description:** marital satisfaction will be measured by SQOL-F questionnaire **Measure:** marital satisfaction **Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) **Description:** adherence to treatment will be measured by Morisky questionnaire **Measure:** adherence to treatment **Time Frame:** at baseline ,Completion of the intervention and Follow up period (6 weeks after Completion of the intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * being married, having type 2 diabetes(according to American Diabetes Association provides guidelines) that had been diagnosed and treated for at least one year, not being dependent on insulin, being between the ages of 18-45 and having a body mass index between 18.5 and 30. Additionally, Absence of menorrhagia on the basis of the PBLAC chart Exclusion Criteria: * Participants who are allergic to turmeric or saffron plant essence will be excluded from the study. Additionally, women who do not regularly use supplements or take drugs for at least 7 consecutive days per month were excluded. Anticoagulant use, pregnancy, and breastfeeding will be also exclusion criteria. Finally, participants who had taken multivitamins or supplements affecting metabolism in the last three months will be not included in the study. Exclusion criteria for the study will include changes in diet and physical activity, experiencing a stressful event during the intervention (as reported by the research unit), and the use of drugs that affect sexual performance (as reported by the research unit) **Gender Based:** True **Gender Description:** women with diabetes mellitus of reproductive age **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** f.moshirenia@gmail.com **Name:** fateme moshirenia, Master's degree **Phone:** 09135264607 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** starting 6 months after publication **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES ## 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: 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 ### 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: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6685 - Name: Curcumin - Relevance: HIGH - As Found: Prevalence - 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: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003474 - Term: Curcumin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413225 **Brief Title:** Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc® **Official Title:** A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc® #### Organization Study ID Info **ID:** CP 21-001-UK01 #### Organization **Class:** INDUSTRY **Full Name:** Synergy Spine Solutions ### Status Module #### Completion Date **Date:** 2034-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-22 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** MCRA #### Lead Sponsor **Class:** INDUSTRY **Name:** Synergy Spine Solutions #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. ### Conditions Module **Conditions:** - Cervical Degenerative Disc Disease **Keywords:** - radiculopathy - myelopathy - disc replacement - motion preservation ### 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:** All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements. **Intervention Names:** - Device: Synergy cervical disc system **Label:** Prospective #### Arm Group 2 **Description:** Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations. **Intervention Names:** - Device: Synergy cervical disc system **Label:** Retrospective ### Interventions #### Intervention 1 **Arm Group Labels:** - Prospective - Retrospective **Description:** motion preservation disc **Name:** Synergy cervical disc system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score. **Measure:** Neck Disability Index (NDI) **Time Frame:** 12 months **Description:** Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event **Measure:** device Related or Device Procedure Related Adverse Events **Time Frame:** 12 months #### Secondary Outcomes **Description:** Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point. **Measure:** Visual Analog Scale Neck and Arm Pain Measurement **Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively **Description:** patient completed questionnaire on their satisfaction with the disc replacement surgery **Measure:** Patient Satisfaction **Time Frame:** 6 week, 3 month, 6 month, 12 month, annually post-operatively **Description:** maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit) **Measure:** Motor and Sensory Function in the Arm **Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively **Description:** Disease status as characterized by physician at each time point **Measure:** Nurick's Criteria **Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively **Description:** surgical outcome characterized by physician at each post operative visit **Measure:** Odom's criteria **Time Frame:** 6 week, 3 month, 6 month, 12 month, annually post-operatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject Exclusion Criteria: * Inclusion Criteria: All answers must be YES to be eligible for the study. 1. Age 21 or above at the time of the surgery. 2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted 3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) 3. Failed a minimum of 6 weeks conservative treatment 5. Written informed consent given by subject Exclusion Criteria: All answers must be NO to be eligible for the study. 1. Moderate to advanced spondylosis 2. Diagnosis of osteoporosis 3. Active systemic infection or infection at the operative site 4. Pregnancy 5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs 6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level 7. Severe pathology of the facet joints of the involved vertebral bodies 8. Previous diagnosis of osteopenia or osteomalacia 9. More than one immobile vertebral level between C1 and T1 from any cause 10. Morbid obesity 11. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity) **Minimum Age:** 21 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** janejacob@synergyspinesolutions.com **Name:** Jane M Jacob **Phone:** 5122895370 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** gordan.grahovac@nhs.net - **Name:** Gordan Grahovac, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Gordan Grahovac, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Kings College Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions ### Condition Browse Module - Browse Leaves - ID: M14689 - Name: Radiculopathy - Relevance: LOW - As Found: Unknown - ID: M28405 - Name: Intervertebral Disc Degeneration - Relevance: HIGH - As Found: Degenerative Disc Disease - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055959 - Term: Intervertebral Disc Degeneration ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413212 **Brief Title:** Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing **Official Title:** Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing #### Organization Study ID Info **ID:** TJ-IRB20230704 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-01-14 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Beijing GeneX MedLab Co., Ltd #### Lead Sponsor **Class:** OTHER **Name:** Liu Huang #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Liu Huang **Investigator Title:** Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy. **Detailed Description:** This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients. ### Conditions Module **Conditions:** - Lung Cancer - Breast Cancer - Gastric Cancer - Colorectal Cancer **Keywords:** - PTC: Patient-derived tumor-like cell clusters ### Design Module #### Bio Spec **Description:** Malignant effusion **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 55 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who were diagnosed as advanced malignancy and would receive 2 cycles of personal therapy based on PTC drug screening tests. **Intervention Names:** - Diagnostic Test: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing. **Label:** Case group ### Interventions #### Intervention 1 **Arm Group Labels:** - Case group **Description:** Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome. **Name:** Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing. **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Length is measured in millimeters, refers to RECIST 1.1. **Measure:** Complete Response (CR) **Time Frame:** up to 12 months **Description:** At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST.1.1. **Measure:** Partial Response (PR) **Time Frame:** up to 12 months **Description:** At least a 20% increase in the sum of diameters of taraet lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1. **Measure:** Progressive Disease (PD) **Time Frame:** up to 12 months **Description:** Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1. **Measure:** Stable Disease (SD) **Time Frame:** up to 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. 18 to 75 years old, regardless of gender. 2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023. 3. Advanced and unresectable malignancy confirmed by biopsy diagnosis. 4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases. 5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2. 6. Anticipated survival exceed six months. 7. At least one measurable lesions (according to RECIST 1.1) 8. Resistance or intolerance to standard therapy regimens. 9. Signed informed consent form voluntarily. Exclusion Criteria: 1. Pregnant or lactating women. 2. Have Participated other clinical trials in six months. 3. Severe liver dysfunction. 4. Severe renal dysfunction. 5. Patients with cognitive disorder, mental diseases and terrible compliance. 6. Allergic to known chemotherapeutic agents. 7. Other circumstance not suitable to participate in this trial determined by investigators. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Cancer patients with malignant effusion, above 18 years of age, at Tongji Hospital, Tongji Medical College of HUST ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** huangliu@tjh.tjmu.edu.cn **Name:** Liu Huang **Phone:** 63639656 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** huangliu@tjh.tjmu.edu.cn - **Name:** Liu Huang - **Phone:** 63639656 - **Role:** CONTACT **Country:** China **Facility:** Tongji Hospital **State:** Hubei **Status:** RECRUITING **Zip:** 430030 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** Liu Huang **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Lim ZF, Ma PC. Emerging insights of tumor heterogeneity and drug resistance mechanisms in lung cancer targeted therapy. J Hematol Oncol. 2019 Dec 9;12(1):134. doi: 10.1186/s13045-019-0818-2. **PMID:** 31815659 **Citation:** Leonetti A, Sharma S, Minari R, Perego P, Giovannetti E, Tiseo M. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. Br J Cancer. 2019 Oct;121(9):725-737. doi: 10.1038/s41416-019-0573-8. Epub 2019 Sep 30. **PMID:** 31564718 **Citation:** Passaro A, Janne PA, Mok T, Peters S. Overcoming therapy resistance in EGFR-mutant lung cancer. Nat Cancer. 2021 Apr;2(4):377-391. doi: 10.1038/s43018-021-00195-8. Epub 2021 Apr 15. **PMID:** 35122001 **Citation:** Doroshow DB, Sanmamed MF, Hastings K, Politi K, Rimm DL, Chen L, Melero I, Schalper KA, Herbst RS. Immunotherapy in Non-Small Cell Lung Cancer: Facts and Hopes. Clin Cancer Res. 2019 Aug 1;25(15):4592-4602. doi: 10.1158/1078-0432.CCR-18-1538. Epub 2019 Mar 1. **PMID:** 30824587 **Citation:** Wojas-Krawczyk K, Kalinka E, Grenda A, Krawczyk P, Milanowski J. Beyond PD-L1 Markers for Lung Cancer Immunotherapy. Int J Mol Sci. 2019 Apr 18;20(8):1915. doi: 10.3390/ijms20081915. **PMID:** 31003463 **Citation:** Reck M, Remon J, Hellmann MD. First-Line Immunotherapy for Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Feb 20;40(6):586-597. doi: 10.1200/JCO.21.01497. Epub 2022 Jan 5. Erratum In: J Clin Oncol. 2022 Apr 10;40(11):1265. **PMID:** 34985920 **Citation:** Blackley EF, Loi S. Targeting immune pathways in breast cancer: review of the prognostic utility of TILs in early stage triple negative breast cancer (TNBC). Breast. 2019 Nov;48 Suppl 1:S44-S48. doi: 10.1016/S0960-9776(19)31122-1. **PMID:** 31839159 **Citation:** Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. doi: 10.1001/jama.2020.23370. Erratum In: JAMA. 2022 May 17;327(19):1929. **PMID:** 33300950 **Citation:** Yamaguchi K, Yoshida K, Tanahashi T, Takahashi T, Matsuhashi N, Tanaka Y, Tanabe K, Ohdan H. The long-term survival of stage IV gastric cancer patients with conversion therapy. Gastric Cancer. 2018 Mar;21(2):315-323. doi: 10.1007/s10120-017-0738-1. Epub 2017 Jun 14. **PMID:** 28616743 **Citation:** Pozzo C, Basso M, Cassano A, Quirino M, Schinzari G, Trigila N, Vellone M, Giuliante F, Nuzzo G, Barone C. Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients. Ann Oncol. 2004 Jun;15(6):933-9. doi: 10.1093/annonc/mdh217. **PMID:** 15151951 **Citation:** Alberts SR, Horvath WL, Sternfeld WC, Goldberg RM, Mahoney MR, Dakhil SR, Levitt R, Rowland K, Nair S, Sargent DJ, Donohue JH. Oxaliplatin, fluorouracil, and leucovorin for patients with unresectable liver-only metastases from colorectal cancer: a North Central Cancer Treatment Group phase II study. J Clin Oncol. 2005 Dec 20;23(36):9243-9. doi: 10.1200/JCO.2005.07.740. Epub 2005 Oct 17. **PMID:** 16230673 **Citation:** Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; Gruppo Oncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007 May 1;25(13):1670-6. doi: 10.1200/JCO.2006.09.0928. **PMID:** 17470860 **Citation:** Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774. **PMID:** 29472484 **Citation:** Yin S, Xi R, Wu A, Wang S, Li Y, Wang C, Tang L, Xia Y, Yang D, Li J, Ye B, Yu Y, Wang J, Zhang H, Ren F, Zhang Y, Shen D, Wang L, Ying X, Li Z, Bu Z, Ji X, Gao X, Jia Y, Jia Z, Li N, Li Z, Ji JF, Xi JJ. Patient-derived tumor-like cell clusters for drug testing in cancer therapy. Sci Transl Med. 2020 Jun 24;12(549):eaaz1723. doi: 10.1126/scitranslmed.aaz1723. **PMID:** 32581131 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000010995 - Term: Pleural Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M4509 - Name: Ascites - Relevance: HIGH - As Found: Ascites - ID: M9931 - Name: Hydrothorax - Relevance: HIGH - As Found: Hydrothorax - ID: M13885 - Name: Pleural Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006876 - Term: Hydrothorax - ID: D000001201 - Term: Ascites ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413199 **Brief Title:** Adaptive Response of Brain Towards Resistance Training in Healthy Individuals **Official Title:** Adaptive Response of Brain Towards Resistance Training in Healthy Individuals #### Organization Study ID Info **ID:** PSRDHospital #### Organization **Class:** OTHER **Full Name:** Pakistan Society for Rehabilitation of Differently Abled Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-29 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2023-10-31 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Karachi #### Lead Sponsor **Class:** OTHER **Name:** Pakistan Society for Rehabilitation of Differently Abled 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 novelty of this study is to identify the mechanism of nervous system by applying resistance training intervention in healthy individuals. **Detailed Description:** Resistance training is a form of exercise that is popular particularly for its role in improving athletic performance by increasing muscular strength, power and speed, hypertrophy, local muscular endurance, motor performance, balance and coordination. The objective of the study is to find out the effects of resistance training on Central and Peripheral Nervous System in healthy individuals. A total of 100 participants will be included in the study including both male and female. The study will be divided into two main groups. Experimental group will perform 8-12 Reps with 1.5 sec concentric and 1.5 sec eccentric contraction of bench press with 90 sec of rest between sets with 2 sets per week for 2 months. 1RM of control group will be calculated through the same method and the training protocol for the Control group consisted of 5 attempts to lift as much weight as possible one time for that training visit with 90 seconds of rest between attempts. The load was progressively increased each attempt to try to reach or exceed their previous 1RM. ### Conditions Module **Conditions:** - Resistance Training **Keywords:** - Resistance Training - Performance - Nervous Response - Muscle growth - Exercise Induced Performance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 2 training session per week for 2 months, 1 set of 10 unloaded repetitions in arms as a warm-up, 4 sets with a goal of 8-12 repetitions with 90 seconds of rest between sets and elbows had to be fully locked out to be counted as a repetition, 1.5 seconds for concentric and 1.5 seconds for eccentric portion. **Intervention Names:** - Other: Hyper Training **Label:** Hyper Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2 training session per week for 2 months, 1 set of 10 unloaded repetitions in arms as a warm-up, training protocol consisted of 5 attempts to lift as much weight as possible one time for that training visit with 90 seconds of rest between attempts. The load was progressively increased each attempt to try to reach or exceed their previous 1RM. **Intervention Names:** - Other: 1 Repetition maximum training group **Label:** 1 Repetition Maximum Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Hyper Training Group **Description:** Experimental group will perform 2 training session per week for 2 months, 1 set of 10 unloaded repetitions in arms as a warm-up, 4 sets with a goal of 8-12 Reps with 90 seconds rest between sets. 1.5 second concentric and 1.5 second eccentric contraction of bench press, The elbows had to be fully locked out to be counted as a repetition. **Name:** Hyper Training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - 1 Repetition Maximum Group **Description:** 2 training session per week for 8 weeks, 1 set of 10 unloaded repetitions in arms as a warm-up, 1 Repetition maximum training group consisted of 5 attempts to lift as much weight as possible one time for that training visit with 90 seconds of rest between attempts, the load was progressively increased each attempt to try to reach or exceed their previous 1 repetition maximum. **Name:** 1 Repetition maximum training group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To determine how fast or slow the nerves are conducting an electrical current using F wave **Measure:** NCS (Motor Nerve Conduction Study) **Time Frame:** • 0 week • 8th week **Description:** To measure the electrical activity of the brain using alpha and beta waves **Measure:** EEG (Electroencephalography) **Time Frame:** • 0 week • 8th week **Description:** To measure the strength after resistance training **Measure:** Dynamometer **Time Frame:** • 0 week • 4th week • 8th week **Description:** To measure the total amount of protein in blood and effects of resistance training **Measure:** Estimation of Albumin & Globulin ratio **Time Frame:** • 0 week • 8th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Body Mass Index should be 18.5-24.9 kg/m2. * Participants were untrained and had not engaged in resistance exercise within 6 months prior to beginning the study. Exclusion Criteria: * Participants with any kind of Gastrointestinal Tract disturbance will be excluded from the study. * Participants with any kind of Musculoskeletal injury will be excluded from the study. * Participant with any kind of Neurological disturbance will be excluded from the study. * Participants who use tobacco products within the previous 6 months. * Participants who take any type of medication within the previous 6 months. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** faheem78601@gmail.com **Name:** Muhammad Faheem Afzal, PhD* **Phone:** 00923336966697 **Role:** CONTACT #### Locations **Location 1:** **City:** Lahore **Contacts:** ***Contact 1:*** - **Email:** faheem78601@gmail.com - **Name:** Muhammad Faheem Afzal, PhD* - **Phone:** 00923336966697 - **Role:** CONTACT ***Contact 2:*** - **Name:** Danish Latif, PhD* - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** PSRD Hospital **State:** Punjab **Status:** RECRUITING **Zip:** 54000 #### Overall Officials **Official 1:** **Affiliation:** PSRD College of Rehabilitation Sciences **Name:** Danish Latif, PhD* **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Comfort P, Haigh A, Matthews MJ. Are changes in maximal squat strength during preseason training reflected in changes in sprint performance in rugby league players? J Strength Cond Res. 2012 Mar;26(3):772-6. doi: 10.1519/JSC.0b013e31822a5cbf. **PMID:** 22310512 **Citation:** Brooks JH, Fuller CW, Kemp SP, Reddin DB. Incidence, risk, and prevention of hamstring muscle injuries in professional rugby union. Am J Sports Med. 2006 Aug;34(8):1297-306. doi: 10.1177/0363546505286022. Epub 2006 Feb 21. **PMID:** 16493170 **Citation:** Kristensen J, Franklyn-Miller A. Resistance training in musculoskeletal rehabilitation: a systematic review. Br J Sports Med. 2012 Aug;46(10):719-26. doi: 10.1136/bjsm.2010.079376. Epub 2011 Jul 26. **PMID:** 21791457 **Citation:** Hakkinen K, Alen M, Komi PV. Changes in isometric force- and relaxation-time, electromyographic and muscle fibre characteristics of human skeletal muscle during strength training and detraining. Acta Physiol Scand. 1985 Dec;125(4):573-85. doi: 10.1111/j.1748-1716.1985.tb07760.x. **PMID:** 4091001 **Citation:** Mitchell CJ, Churchward-Venne TA, West DW, Burd NA, Breen L, Baker SK, Phillips SM. Resistance exercise load does not determine training-mediated hypertrophic gains in young men. J Appl Physiol (1985). 2012 Jul;113(1):71-7. doi: 10.1152/japplphysiol.00307.2012. Epub 2012 Apr 19. **PMID:** 22518835 **Citation:** Taber CB, Vigotsky A, Nuckols G, Haun CT. Exercise-Induced Myofibrillar Hypertrophy is a Contributory Cause of Gains in Muscle Strength. Sports Med. 2019 Jul;49(7):993-997. doi: 10.1007/s40279-019-01107-8. No abstract available. **PMID:** 31016546 **Citation:** Deumens R, Bozkurt A, Meek MF, Marcus MA, Joosten EA, Weis J, Brook GA. Repairing injured peripheral nerves: Bridging the gap. Prog Neurobiol. 2010 Nov;92(3):245-76. doi: 10.1016/j.pneurobio.2010.10.002. Epub 2010 Oct 13. **PMID:** 20950667 **Citation:** Dankel SJ, Counts BR, Barnett BE, Buckner SL, Abe T, Loenneke JP. Muscle adaptations following 21 consecutive days of strength test familiarization compared with traditional training. Muscle Nerve. 2017 Aug;56(2):307-314. doi: 10.1002/mus.25488. Epub 2017 Mar 3. **PMID:** 27875635 **Citation:** Mattocks KT, Buckner SL, Jessee MB, Dankel SJ, Mouser JG, Loenneke JP. Practicing the Test Produces Strength Equivalent to Higher Volume Training. Med Sci Sports Exerc. 2017 Sep;49(9):1945-1954. doi: 10.1249/MSS.0000000000001300. **PMID:** 28463902 **Citation:** Kacin A, Strazar K. Frequent low-load ischemic resistance exercise to failure enhances muscle oxygen delivery and endurance capacity. Scand J Med Sci Sports. 2011 Dec;21(6):e231-41. doi: 10.1111/j.1600-0838.2010.01260.x. Epub 2011 Mar 8. **PMID:** 21385216 **Citation:** Jessee MB, Buckner SL, Mouser JG, Mattocks KT, Dankel SJ, Abe T, Bell ZW, Bentley JP, Loenneke JP. Muscle Adaptations to High-Load Training and Very Low-Load Training With and Without Blood Flow Restriction. Front Physiol. 2018 Oct 16;9:1448. doi: 10.3389/fphys.2018.01448. eCollection 2018. **PMID:** 30386254 **Citation:** Andersen LL, Andersen JL, Zebis MK, Aagaard P. Early and late rate of force development: differential adaptive responses to resistance training? Scand J Med Sci Sports. 2010 Feb;20(1):e162-9. doi: 10.1111/j.1600-0838.2009.00933.x. Epub 2009 May 26. **PMID:** 19793220 **Citation:** Bickel CS, Cross JM, Bamman MM. Exercise dosing to retain resistance training adaptations in young and older adults. Med Sci Sports Exerc. 2011 Jul;43(7):1177-87. doi: 10.1249/MSS.0b013e318207c15d. **PMID:** 21131862 **Citation:** Dankel SJ, Kang M, Abe T, Loenneke JP. Resistance training induced changes in strength and specific force at the fiber and whole muscle level: a meta-analysis. Eur J Appl Physiol. 2019 Jan;119(1):265-278. doi: 10.1007/s00421-018-4022-9. Epub 2018 Oct 24. **PMID:** 30357517 **Citation:** Griffin L, Cafarelli E. Transcranial magnetic stimulation during resistance training of the tibialis anterior muscle. J Electromyogr Kinesiol. 2007 Aug;17(4):446-52. doi: 10.1016/j.jelekin.2006.05.001. Epub 2006 Aug 7. **PMID:** 16891123 **Citation:** Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Neural adaptation to resistance training: changes in evoked V-wave and H-reflex responses. J Appl Physiol (1985). 2002 Jun;92(6):2309-18. doi: 10.1152/japplphysiol.01185.2001. **PMID:** 12015341 **Citation:** Krutki P, Mrowczynski W, Baczyk M, Lochynski D, Celichowski J. Adaptations of motoneuron properties after weight-lifting training in rats. J Appl Physiol (1985). 2017 Sep 1;123(3):664-673. doi: 10.1152/japplphysiol.00121.2017. Epub 2017 Jun 8. **PMID:** 28596267 **Citation:** Canepari M, Rossi R, Pellegrino MA, Orrell RW, Cobbold M, Harridge S, Bottinelli R. Effects of resistance training on myosin function studied by the in vitro motility assay in young and older men. J Appl Physiol (1985). 2005 Jun;98(6):2390-5. doi: 10.1152/japplphysiol.01103.2004. Epub 2005 Jan 27. **PMID:** 15677736 **Citation:** Chin ER, Olson EN, Richardson JA, Yang Q, Humphries C, Shelton JM, Wu H, Zhu W, Bassel-Duby R, Williams RS. A calcineurin-dependent transcriptional pathway controls skeletal muscle fiber type. Genes Dev. 1998 Aug 15;12(16):2499-509. doi: 10.1101/gad.12.16.2499. **PMID:** 9716403 **Citation:** Westerblad H, Allen DG. Changes of myoplasmic calcium concentration during fatigue in single mouse muscle fibers. J Gen Physiol. 1991 Sep;98(3):615-35. doi: 10.1085/jgp.98.3.615. **PMID:** 1761971 **Citation:** Coelho HJ Junior, Rodrigues B, de Oliveira Goncalves I, Uchida MC. Effects of a short-term detraining period on muscle functionality and cognition of strength-trained older women: a preliminary report. J Exerc Rehabil. 2017 Oct 30;13(5):559-567. doi: 10.12965/jer.1735010.505. eCollection 2017 Oct. **PMID:** 29114531 **Citation:** Ribeiro AS, Tomeleri CM, Souza MF, Pina FL, Schoenfeld BJ, Nascimento MA, Venturini D, Barbosa DS, Cyrino ES. Effect of resistance training on C-reactive protein, blood glucose and lipid profile in older women with differing levels of RT experience. Age (Dordr). 2015 Dec;37(6):109. doi: 10.1007/s11357-015-9849-y. Epub 2015 Oct 26. **PMID:** 26499819 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413186 **Brief Title:** Effect of Placenta Delivery Method on Pain, Bleeding and Comfort **Official Title:** Examining the Effect of Placenta Delivery Method on Postpartum Pain, Bleeding and Comfort of Women: Randomized Controlled Study #### Organization Study ID Info **ID:** Sengul Ulucam #### Organization **Class:** OTHER **Full Name:** Tarsus University ### Status Module #### Completion Date **Date:** 2025-03-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tarsus University #### Responsible Party **Investigator Affiliation:** Tarsus University **Investigator Full Name:** Şengül Uluçam **Investigator Title:** midwife, Student on master degree program at Tarsus University Midwife **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this thesis is to examine the effect of the placenta delivery method on women's postpartum pain, bleeding and comfort. It is a randomized controlled experimental study. The research will be conducted at Mersin Tarsus state hospital between March 2024 and August 2024. The study will be conducted with 140 primiparous women, 70 primiparous pregnant women in the experimental group and 70 primiparous pregnant women in the control group, who meet the research criteria and apply to the delivery room of Tarsus State Hospital between these dates. The research will be carried out with a control group (those receiving routine hospital protocol/where the placenta is delivered with controlled cord traction) and an experimental group (physiological separation of the placenta with a mixed method). Interventions applied to research groups vary depending on the characteristics of the group. In both groups, interventions in the delivery room will be performed by the researcher midwife. If any complications develop during the research, independent of the interventions, if the woman undergoes a cesarean section, or if situations that meet the exclusion criteria occur, that woman will be excluded from the sample. The researcher will apply a routine hospital birth management protocol to both groups during the first three stages of labor. However, the way the placenta is delivered in the third stage (physiological with mixed management or controlled cord traction with active management) will differ. The researcher will apply the Visual Analogue Scale (VAS) twice, at the beginning and at the end of the third phase of labor, apply the Postpartum Comfort Scale at the 4th postpartum hour, and record hemoglobin and hematocrit values at admission to the hospital, which is the hospital's routine protocol, and in the hemogram test at the 6th hour postpartum. HB and HCT values will be used to interpret the amount of postpartum bleeding. The hypotheses of the research are as follows; H1: In the active management of the 3rd stage of labor, delivery of the placenta with controlled cord traction affects the woman's perception of postpartum pain. H2: In the active management of the 3rd stage of labor, delivering the placenta with controlled cord traction affects the woman's amount of postpartum bleeding. H3: In the active management of the 3rd stage of labor, delivering the placenta with controlled cord traction affects the woman's postpartum comfort level. H4: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the woman's perception of postpartum pain. H5: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the amount of postpartum bleeding of the woman. H6: In the mixed management of the 3rd stage of labor, physiological delivery of the placenta affects the woman's postpartum comfort level. ### Conditions Module **Conditions:** - Placenta Abruptio **Keywords:** - placenta - labor pain - birt comfort - third stage of labor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a parallel group, randomized controlled study conducted at the public hospital in Tarsus district of Mersin province. It will consist of primiparas (women who will give birth for the first time) who apply to the delivery room of Tarsus State Hospital. The sample of the research was calculated with the G-Power program. The sample size was calculated as 64 primiparous and 128 primiparous in each group. in total. However, assuming that there will be at least 10% data loss during the research, the study will be carried out with a total of 140 primiparas, 70 primiparas in each group. 70 primiparas who meet the inclusion criteria for the study will be assigned to the experimental group (physiological separation of the placenta using a mixed method), and 70 primiparas will be assigned to the control group (controlled cord traction will be used to deliver the placenta). ) through randomization. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be delivered physiologically. **Intervention Names:** - Drug: Uteratonic administration - Other: cord clamping - Other: delivery of the placenta **Label:** Delivery of the placenta by mixed method **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In this group; As soon as the baby is born, 10 IU oxytocin will be administered IV to the woman. The newborn will be placed on the mother's chest for skin-to-skin contact, Uterine tone will be evaluated while the baby is at the mother's breast, The cord will be clamped late (after the pulse in the cord stops/within 1-3 minutes after the baby is born), The placenta will be removed with controlled cord traction. **Intervention Names:** - Drug: Uteratonic administration - Other: cord clamping - Other: delivery of the placenta **Label:** Delivery of the placenta by active method **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Delivery of the placenta by active method - Delivery of the placenta by mixed method **Description:** Administer IV 10 IU oxytocin **Name:** Uteratonic administration **Other Names:** - Oxytocin administration **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Delivery of the placenta by active method - Delivery of the placenta by mixed method **Description:** delayed cord clamping **Name:** cord clamping **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Delivery of the placenta by active method - Delivery of the placenta by mixed method **Description:** Applying controlled core traction **Name:** delivery of the placenta **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It is a scale in which the person marks the part expressing his/her pain on a 10 cm ruler where painlessness and unbearable pain are shown at each end. VAS was preferred because it is easy to use, sensitive in measuring pain intensity, and reliable. In the evaluation of VAS, 0-2 cm indicates "no pain", 3-4 cm indicates "mild pain", 5-6 cm indicates "Moderate pain", 7-8 cm indicates "Severe pain" and 9-10 cm indicates "Unbearable". shows "pain" **Measure:** Visual Analog Skala (VAS) **Time Frame:** 15-30 minutes #### Secondary Outcomes **Description:** It was developed by Karakaplan and Yıldız in 2010 to measure the physical, psychospiritual and sociocultural comfort of women giving birth. The scale has a 5-point Likert structure ("totally agree: 5 points" and "strongly disagree: 1 point") and consists of a total of 34 items. "Totally agree" in the positive items in the scale indicates high comfort (5 points), while negative items indicate low comfort (1 point). score). As the scores obtained from the scale increase, it shows that the comfort level increases. As a result of the study, scores close to 170 indicate that the person's comfort is high. **Measure:** Postpartum Comfort Scale **Time Frame:** 15-30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Agreeing to participate in the research * No communication problems * Between 19-35 years old * 38-42 weeks of gestation * Having a single and healthy fetus and newborn * Having a vaginal birth * Firstborn * Women who are not at risk during birth and postpartum period Exclusion Criteria: Women who develop complications during birth and the postpartum period (placenta not separating, part of the placenta remaining in the uterus, development of atony, manual rupture of the uterus, cord rupture, etc.) * Those receiving anticoagulant treatment during pregnancy * The duration of the 3rd stage of labor lasts more than 30 minutes * Instrumental (using vacuum/forceps) birth **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 19 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 220931001@tarsus.edu.tr **Name:** Şengül Uluçam **Phone:** +905531600361 **Role:** CONTACT **Contact 2:** **Email:** guluzarsade@tarsus.edu.tr **Name:** Gülüzar Sade **Phone:** +905467339555 **Role:** CONTACT #### Locations **Location 1:** **City:** Mersin **Country:** Turkey **Facility:** Tarsus üniversitesi **State:** Tarsus **Zip:** 33400 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Begley CM, Guilliland K, Dixon L, Reilly M, Keegan C. Irish and New Zealand midwives' expertise in expectant management of the third stage of labour: the 'MEET' study. Midwifery. 2012 Dec;28(6):733-9. doi: 10.1016/j.midw.2011.08.008. Epub 2011 Oct 19. **PMID:** 22015217 **Citation:** Begley CM, Gyte GM, Devane D, McGuire W, Weeks A, Biesty LM. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD007412. doi: 10.1002/14651858.CD007412.pub5. **PMID:** 30754073 **Citation:** Dixon L, Tracy SK, Guilliland K, Fletcher L, Hendry C, Pairman S. Outcomes of physiological and active third stage labour care amongst women in New Zealand. Midwifery. 2013 Jan;29(1):67-74. doi: 10.1016/j.midw.2011.11.003. Epub 2011 Dec 20. **PMID:** 22188999 **Citation:** Herman A, Zimerman A, Arieli S, Tovbin Y, Bezer M, Bukovsky I, Panski M. Down-up sequential separation of the placenta. Ultrasound Obstet Gynecol. 2002 Mar;19(3):278-81. doi: 10.1046/j.1469-0705.2002.00557.x. **PMID:** 11896951 **Citation:** Hofmeyr GJ, Mshweshwe NT, Gulmezoglu AM. Controlled cord traction for the third stage of labour. Cochrane Database Syst Rev. 2015 Jan 29;1(1):CD008020. doi: 10.1002/14651858.CD008020.pub2. **PMID:** 25631379 **Citation:** Munoz M, Stensballe J, Ducloy-Bouthors AS, Bonnet MP, De Robertis E, Fornet I, Goffinet F, Hofer S, Holzgreve W, Manrique S, Nizard J, Christory F, Samama CM, Hardy JF. Patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage. A NATA consensus statement. Blood Transfus. 2019 Mar;17(2):112-136. doi: 10.2450/2019.0245-18. Epub 2019 Feb 6. **PMID:** 30865585 **Citation:** Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev. 2000;(3):CD000007. doi: 10.1002/14651858.CD000007. **PMID:** 10908457 **Citation:** Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x. **PMID:** 17567419 **Citation:** Gulmezoglu AM, Widmer M, Merialdi M, Qureshi Z, Piaggio G, Elbourne D, Abdel-Aleem H, Carroli G, Hofmeyr GJ, Lumbiganon P, Derman R, Okong P, Goudar S, Festin M, Althabe F, Armbruster D. Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial. Reprod Health. 2009 Jan 21;6:2. doi: 10.1186/1742-4755-6-2. **PMID:** 19154621 **Citation:** Gunaydin B. Management of Postpartum Haemorrhage. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):396-402. doi: 10.5152/TJAR.2022.21438. **PMID:** 36511487 **Citation:** Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205. **PMID:** 26526404 **Citation:** Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427. **PMID:** 12011870 **Citation:** McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3. **PMID:** 23843134 **Citation:** Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003248. doi: 10.1002/14651858.CD003248.pub3. **PMID:** 22895933 #### See Also Links **Label:** Durmaz A, Kömürcü N. (2018). Postpartum Kanamada Risk Belirleme, Önleme ve Yönetim: Kanıta Dayalı Uygulamalar. Sağlık Bilimleri ve Meslekleri Dergisi, 5(3), 494-502.https:// doi.org/10.17681/hsp.385553 **URL:** https://dergipark.org.tr/tr/download/article-file/547877 **Label:** Ekşi Z. (2019). Doğum Sonu Dönem. Hemşirelik ve Ebelik İçin Kadın Sağlığı ve Hastalıkları, Bölüm 12, Arslan Ö.E. (editör), Akademisyen Kitabevi, Ankara. **URL:** https://dergipark.org.tr/tr/download/issue-full-file/62207 **Label:** Erdemir F, Çırlak A. (2013). Rahatlık kavramı ve hemşirelik kullanımı. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 6(4), 224-230. **URL:** https://dergipark.org.tr/tr/download/article-file/753452 **Label:** FIGO/ICM Joint Statement. Management of the Third Stage of Labour to Prevent Post-partum Haemorrhage. 2007. **URL:** https://www.figo.org/joint-statement-recommendation-uterotonics-prevention-pph **Label:** Güngör İ, Yıldırım-Rathfisch G. (2009). Normal doğum eyleminin ikinci ve üçüncü evresinde kanıta dayalı uygulamalar. Hemşirelikte Araştırma Geliştirme Dergisi, 2:56-65. **URL:** https://dergipark.org.tr/tr/download/article-file/984224 **Label:** Karakaplan S, Yıldız H.( 2010). Doğum sonu konfor ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1), 55-65. **URL:** https://toad.halileksi.net/olcek/dogum-sonu-konfor-olcegi/ **Label:** Kolcaba K. (2003). Comfort theory and practice: a vision for holistic health care and research. Springer Publishing Co, New York **URL:** https://books.google.com.tr/books?id=nduGie_ouQkC&pg=PR3&hl=tr&source=gbs_selected_pages&cad=1#v=onepage&q&f=false **Label:** Kuğuoğlu S, Karabacak Ü. (2008). Genel konfor primipar ve multipar gebelerde doğum ve doğum sonu döneme ilişkin endişelerin ölçeğinin Türkçe' ye uyarlanması. İstanbul Üniversitesi Florence Nightingale Hemşirelik Dergisi, 16(61), 16-23. **URL:** https://dergipark.org.tr/tr/download/article-file/95252 **Label:** National Institute for Health and Care Excellence. Intrapartum care for healthy women and babies. Intrapartum Care for Healthy Women and Babies, Guideline CG190. London: National Institute for Health and Care Excellence, 2014. **URL:** https://www.nice.org.uk/guidance/cg190 **Label:** Özdilek R, Dutucu N, Coşkun AM. (2019). Postpartum Kanama Miktarını Tahminde Gerçeğe Ne Kadar Yaklaşıyoruz?. Sağlık Bilimleri ve Meslekleri Dergisi, 6(1), 84-90.https:// doi.org/10.17681/hsp.412939 **URL:** https://dergipark.org.tr/tr/download/article-file/594108 **Label:** Potur DÇ, Merih YD, Külek H, Gürkan ÖC. (2015). Doğum konforu ölçeğinin Türkçe geçerlik ve güvenirlik çalışması. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 18(4), 252-258. **URL:** https://dergipark.org.tr/tr/download/article-file/773243 **Label:** Sarı E, Fışkın G, Karakaş S. (2020). Ebelik Öğrencilerinin Doğum Ağrısı ve Yönetimi Hakkındaki Bilgi Düzeylerinin Belirlenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 23(1), 1-8. **URL:** https://dergipark.org.tr/tr/download/article-file/1013476 **Label:** T.C. Sağlık Bakanlığı Halk Sağlığı Genel Müdürlüğü Kadın ve Üreme Sağlığı Dairesi Başkanlığı, Doğum Sonu Bakım Yönetim Rehberi, Ankara, 2018. **URL:** https://hsgm.saglik.gov.tr/depo/birimler/kadin-ve-ureme-sagligi-db/Rehberler/dogum_sonu_bakim_2020.pdf **Label:** TÜİK (2018). Anne Ölüm Oranı **URL:** https://data.tuik.gov.tr **Label:** Türk Neonatoloji Derneği (TND). (2021). Doğum Salonu Yönetimi Rehberi 2021 Güncellemesi. https://www.neonatology. org.tr/wp-content/uploads/2021/08/Dogum-Salonu-Yonetimi- Reh-beri-2021-Guncellemesi-1.pdf **URL:** https://neonatology.org.tr/uploads/content/tan%C4%B1-tedavi/6_min.pdf **Label:** Ünal E, Şenol DK (2022). Primipar annelerde doğum şeklinin doğum sonu konfor ve emzirme başarısına etkisi. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 5(2), 158-165. **URL:** https://dergipark.org.tr/tr/download/article-file/1654977 **Label:** Ünal İ, Can HÖ, Oran NT. (2019). Doğum Eyleminde Ebelik Gereksinimlerinin Orem Özbakım Yetersizlik Kuramına Göre Değerlendirilmesi. Life Sciences, 14(2), 41-47. **URL:** https://dergipark.org.tr/tr/download/article-file/708480 **Label:** World Health Organization. (2012). WHO recommendations for the prevention and treatment of postpartum haemorrhage. **URL:** https://iris.who.int/bitstream/handle/10665/75411/9789241548502_eng.pdf;jsessionid=FF2B57F78B26844C943223EF5CD9E357?sequence=%201 **Label:** World Health Organization(2014).Guideline:Delayed umbilical cord clamping for improved maternal and infant health and nutrition outcomes. Geneva: World Health Organization **URL:** https://www.who.int/publications/i/item/9789241508209 **Label:** Yücel ŞÇ. (2011). Kolcaba'nın Konfor Kuramı. Ege Üniversitesi Hemşirelik Yüksek Okulu Dergisi 27 (2), 79-88. **URL:** https://dergipark.org.tr/tr/download/article-file/825497 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000010922 - Term: Placenta Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M26008 - Name: Labor Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M36 - Name: Abruptio Placentae - Relevance: HIGH - As Found: Placenta Abruptio - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M13812 - Name: Placenta Diseases - Relevance: LOW - As Found: Unknown - ID: T4583 - Name: Placenta Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000037 - Term: Abruptio Placentae ### Intervention Browse Module - Ancestors - ID: D000010120 - Term: Oxytocics - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13041 - Name: Oxytocin - Relevance: HIGH - As Found: Acupuncture ### Intervention Browse Module - Meshes - ID: D000010121 - Term: Oxytocin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413173 **Brief Title:** Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric) **Official Title:** Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI #### Organization Study ID Info **ID:** NMCSD.2023.0048 #### Organization **Class:** FED **Full Name:** United States Naval Medical Center, San Diego ### Status Module #### Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Minneapolis Veterans Affairs Medical Center **Class:** OTHER **Name:** University of Minnesota **Class:** FED **Name:** United States Department of Defense **Class:** OTHER **Name:** Center for Veterans Research and Education **Class:** FED **Name:** The Defense and Veterans Brain Injury Center **Class:** UNKNOWN **Name:** General Dynamics Information Technology #### Lead Sponsor **Class:** FED **Name:** United States Naval Medical Center, San Diego #### Responsible Party **Investigator Affiliation:** United States Naval Medical Center, San Diego **Investigator Full Name:** Lars Hungerford **Investigator Title:** Senior Clinical Research Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome. **Detailed Description:** Objectives: Attention, concentration, and working memory (i.e., complex attention) deficits are the most reported neurocognitive sequelae of mild traumatic brain injury (mTBI) and have been associated with patterns of decreased neural activation. Existing cognitive rehabilitation interventions require significant time and effort and are limited by small-to-moderate effect sizes and uncertain durability/generalization of effects. Novel, neuroplasticity-based interventions that improve complex attention and can be administered remotely are needed to increase access to care, decrease recovery time, and improve outcomes and quality of life following mTBI. This multi-site study will investigate remotely-supervised tDCS (RS-tDCS) combined with cognitive training in the chronic phase of recovery (≥3 months) from mTBI to 1) increase accessibility to care, 2) improve cognitive functioning, post-concussion symptom outcomes, and quality of life and 3) investigate the durability of the intervention in Active Duty Service Members (ADSM; at the Naval Medical Center San Diego (NMCSD) and Veterans (at the Minneapolis VA Health care System (MVAHCS)). Research Plan and Methods: This is a double-blind, randomized, sham-controlled study. 80 Veterans from the MVAHCS and 80 ADSM from NMCSD (total N=160) will be recruited. Participants will have a history of mTBI and self-reported attention and/or concentration difficulties. Baseline assessment will include self-reported symptoms and objective neurocognitive performance. Resting state functional connectivity changes will be measured with functional magnetic resonance imaging (fMRI) and oscillatory brain activity will be measured with EEG, both collected at baseline and at post-intervention assessments. Participants will be randomized to either active RS-tDCS or sham RS-tDCS, using stratified randomization by baseline cognitive scores. The intervention sessions will occur in the participant's home, 10 sessions within 2 weeks. Two post-intervention assessments, mirroring the baseline assessment, will occur approximately 1 week and 6 weeks after the intervention. Additionally, the investigators will collect longitudinal real-time data, daily, on TBI symptoms, cognitive, and mood factors during the 6 weeks post-intervention using Ecological Momentary Assessment (EMA). Clinical Relevance: RS-tDCS+ addresses two major obstacles of current TBI treatments: Accessibility and adherence. RS-tDCS+ offers several benefits as it can be monitored remotely, and can be self-administered in the home after the first session. If RS-tDCS proves effective, this non-invasive intervention could dramatically improve access to a validated treatment that can be rapidly implemented within various DOD and VA settings to reduce TBI-related symptoms, improve cognition, enhance recovery, bolster occupational performance, and improve quality of life. ### Conditions Module **Conditions:** - Brain Concussion - Brain Trauma - Attention Concentration Difficulty - Brain Injuries - Brain Injuries, Traumatic - Neurocognitive Dysfunction - Attention Impaired - Memory Impairment - Mild Traumatic Brain Injury - Mild Cognitive Impairment - Post Concussive Symptoms **Keywords:** - Military Health - Brain Stimulation - Cognitive Training - Cognitive Rehabilitation - Telehealth - Neuromodulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a double-blind, randomized, placebo (sham) controlled pilot study. ##### Masking Info **Masking:** TRIPLE **Masking Description:** The tDCS unit software has a double-blind selection, blinding all study members, care providers, and participants until blinds are broken. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation. Stimulation will be applied for 20 minutes at the beginning of each session. Current will be ramped from 0 mA to 2 mA over 30 seconds, and then ramped down from 2 mA to 0 mA at the end of 20 minutes. Current will be applied via two electrodes consisting of a pre-inserted carbon rubber snap electrode that is pre-saturated with saline and connects directly to designated electrode sites located on the tDCS headband. The anodal stimulating electrode will be at location F3 (based on the 10-20 EEG location system) and the cathodal electrode at location F4. **Intervention Names:** - Combination Product: Active tDCS and Cognitive Training Intervention **Label:** Active tDCS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Electrodes will be placed at the same positions as for active stimulation (F3 and F4), but current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning. Thus, participants feel the initial tingling sensation associated with tDCS, but will receive no active current for the rest of the stimulation period **Intervention Names:** - Combination Product: Sham tDCS and Cognitive Training Intervention **Label:** Sham tDCS **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active tDCS **Description:** Cognitive training will occur concurrently with active tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment. **Name:** Active tDCS and Cognitive Training Intervention **Type:** COMBINATION_PRODUCT #### Intervention 2 **Arm Group Labels:** - Sham tDCS **Description:** Cognitive training will occur concurrently with sham tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment. **Name:** Sham tDCS and Cognitive Training Intervention **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Standardized neuropsychological assessment measure of visual attention and working memory **Measure:** Symbol Digit Modalities Test (SDMT) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning **Measure:** Neuropsychological Assessment Battery (NAB) Attention Module **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms. **Measure:** Neurobehavioral Symptom Inventory (NSI) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands. **Measure:** Electroencephalogram (EEG) - Resting State Functional Connectivity **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** Resting State EEG will be collected to assess spectral power of standard frequency bands (delta, theta, alpha, beta, and gamma). **Measure:** Electroencephalogram (EEG) - Resting State Spectral Power **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** MRI will be used to collect a T1-weighted (structural scan) pulse sequence of the brain. **Measure:** Magnetic Resonance Imaging (MRI) - T1 (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** MRI will be used to collect a T2-weighted pulse sequence of the brain. **Measure:** Magnetic Resonance Imaging (MRI) - T2 (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** MRI will be used to collect a T2\*-weighted (BOLD-contrast fMRI / Resting State) pulse sequence of the brain. **Measure:** Magnetic Resonance Imaging (MRI) - T2* (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** MRI will be used to collect a Diffusion Weighted Imaging (DWI) pulse sequence of the brain (white-matter tractography). **Measure:** Magnetic Resonance Imaging (MRI) - DWI (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** MRI will be used to collect an Arterial Spin Labeling (ASL / Blood Flow Rate) pulse sequence of the brain. **Measure:** Magnetic Resonance Imaging (MRI) - ASL (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** T2\*-weighted (Resting State) images will be analyzed with Region of Interest (ROI) time-courses to generate a partial correlation value (Fisher Z) that depicts functional connectivity. **Measure:** Magnetic Resonance Imaging (MRI) - ROI Analysis (optional) **Time Frame:** Baseline & 1-week post intervention **Description:** Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities. **Measure:** NIH Toolbox Quality of Life Assessment (NeuroQoL) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia. **Measure:** Insomnia Severity Index (ISI) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** The PHQ is a self-report inventory that is used as a screening and diagnostic tool for depressive disorders using a 4-point Likert scale (e.g., 0 = not at all, 3 = nearly every day), yielding a total score from 0 - 21. The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical research studies. **Measure:** Patient Health Questionnaire (PHQ-8) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** A 17-item self-report rating scale used as a screening tool for posttraumatic stress disorder (PTSD) using a 5-point Likert scale (e.g., 1 = not at all, 5 = extremely), yielding a total score from 17 - 85. This version asks about symptoms in relation to generic "stressful experiences" and can be used with any population. It simplifies assessment based on multiple traumas because symptom endorsements are not attributed to a specific event. Importantly, the PCL-C has been established as a valid measure of PTSD severity in Active Duty Service Members and Veterans. **Measure:** PTSD Checklist- Civilian Version (PCL-C) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Specifically, individuals are asked to calculate the difference between their current and previous health state based on a Likert scale. They are required to answer the question "Since beginning treatment at this clinic, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life, related to your painful condition." Score ranges from 1 (no change or condition got worse) to 7 (a great deal better). They are then required to circle a number between 0 to 10 that reflects the degree of change since the start of the intervention. The test takes approximately 2 minutes to complete. **Measure:** Patient Global Impression of Change (PGIC) **Time Frame:** 1-week post & 6-weeks post intervention **Description:** A test of reflection impulsivity. It presents a series of trials with an array of 25 grey boxes arranged in a 5x5 matrix. The grey boxes conceal yellow or blue squares on each trial. The subject decides which of the two underlying colors (yellow or blue) lay in the majority. The subject can open as many boxes as they wish to make a decision. Correct decisions are awarded a number of points. **Measure:** Information Sampling Task (IST) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** A cognitive test of spatial working memory and error monitoring that has been shown to be sensitive to detecting longitudinal change in cognitive ability.78 It consists of a 10 x 10 grid of grey tiles. To complete the maze, the participant must click on the tiles to follow a hidden pathway through the grid from the top left corner to the bottom right corner. They must only click on adjacent tiles, and return to the previous tile if an error is made before moving on. The participant receives visual and auditory feedback for correct and incorrect moves. There are various types of errors (e.g., perseverative error, rule-break error) recorded depending on which type of rule has been broken, and the time to complete the maze is recorded. The trial ends once the participant reaches the bottom right corner of the grid of tiles. **Measure:** Groton Maze Learning Task (GMLT) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** For the BEAM subtask, the subject will be directed to change his/her fixation from a crosshair displayed at the center of screen to a white circle appearing randomly on the left or right side of the screen. The subject will press a button labeled either "Left" or "Right" based on whether the circle appeared on the left or right of the screen. In a small percentage of the trials in which a red arrow appears in the center of the screen, the subject will be instructed not to look at the circle nor press any buttons (inhibition test). Saccadic eye movements, pupil responses, and manual response time (RT) in addition to errors will be recorded. **Measure:** Fusion Task: BEAM **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** For the N-Back subtask, the subject will be directed to change his/her fixation from a cross sign displayed at the center of screen to a colored circle (Green or Blue) that randomly appears on the left or right side of the screen. In the first, '0-back' condition, the subject shall push a response button labeled either (1) "GREEN" or (2) "BLUE" in accordance with the color of the circle currently on the screen. In the second, '1-back' condition, immediately upon recognition of the color of the circle, the subject shall push a response button labeled with either (1) "SAME" if the color matches the circle that appeared previously, or (2) "DIFFERENT" if the color does not match. Saccadic eye movements, pupil responses, and manual response time (RT) in addition to errors will be recorded. **Measure:** Fusion Task: N-Back **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention **Description:** Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms. **Measure:** tDCS Symptom Rating Questionnaire (SRQ) **Time Frame:** Assessment collected daily during the intervention block (b/t baseline & 1-week post) **Description:** A data capture technique that involves repeated sampling of thoughts, feelings, or behaviors as close in time to the experience as possible in the naturalistic environment. A series of 18 self-report questions rated on a 10-point Likert scale (Q1 - Q15) and 5-point Likert scale (Q16 - Q18) regarding mood, current cognitive state, and environment. EMA data is used to look for relationships between variables with the causal discovery analysis. **Measure:** Ecological Momentary Assessment (EMA) **Time Frame:** Assessment collected daily during the intervention block (b/t baseline & 1-week post) #### Secondary Outcomes **Description:** Subjective workload assessment of level of effort, mental demand, frustration, and performance during cognitive training, rated on a 10-point Likert scale (1-10); with low scores corresponding to less effort or mental demand and high scores corresponding to more effort or mental demand. **Measure:** BrainHQ Task Load Index (TLX) **Time Frame:** Collected during the Intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post) **Description:** An assessment tool that rates perceived workload to assess a participant's ability and level of performance on the sub-components of the Fusion task. Participants will answer questions regarding their level of effort, mental demand, frustration, physical demand, temporal demand, and performance on each task. **Measure:** Fusion Task Load Index (F-TLX) **Time Frame:** Baseline, 1-week post, & 6-weeks post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Active-Duty Service Members. 2. Ages 18 to 60. 3. All genders. 4. All racial and ethnic groups. 5. History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment. 6. Self-reported attention and/or concentration difficulties. 7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale. Exclusion Criteria: 1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania. 2. History of prior treatment with ECT or neuromodulation in the last 12 months. 3. Current, diagnosed substance dependence. 4. Newly prescribed medication within the previous 3 weeks. 5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70). 6. Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk. 7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records 8. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp) 9. A positive pregnancy report. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lars.d.hungerford.ctr@health.mil **Name:** Lars D Hungerford, PhD **Phone:** 619.532.5715 **Role:** CONTACT **Contact 2:** **Email:** sean.m.molnar2.ctr@health.mil **Name:** Sean M Molnar, M.A. **Phone:** 424.341.8860 **Role:** CONTACT #### Locations **Location 1:** **City:** San Diego **Contacts:** ***Contact 1:*** - **Email:** lars.d.hungerford.ctr@health.mil - **Name:** Lars D Hungerford, Ph.D - **Phone:** 619-532-5715 - **Role:** CONTACT ***Contact 2:*** - **Email:** sean.m.molnar2.ctr@health.mil - **Name:** Sean M Molnar, M.A. - **Phone:** 424.341.8860 - **Role:** CONTACT ***Contact 3:*** - **Name:** Lars D Hungerford, Ph.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Naval Medical Center San Diego **State:** California **Zip:** 92134 **Location 2:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Email:** casey.gilmore2@va.gov - **Name:** Casey Gilmore, Ph.D - **Phone:** 612-629-7466 - **Role:** CONTACT ***Contact 2:*** - **Email:** larki124@umn.edu - **Name:** Florence Larkin, B.S. - **Phone:** 612.685.7269 - **Role:** CONTACT ***Contact 3:*** - **Name:** Casey Gilmore, Ph.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Minneapolis VA Health Case System **State:** Minnesota **Zip:** 55417 #### Overall Officials **Official 1:** **Affiliation:** United States Naval Medical Center, San Diego **Name:** Lars D Hungerford, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2023-11-01 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 387091 - Type Abbrev: ICF - Upload Date: 2024-04-26T19:49 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000016489 - Term: Head Injuries, Closed - ID: D000014949 - Term: Wounds, Nonpenetrating ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Neurocognitive Dysfunction - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Brain Injuries, Traumatic - ID: M5201 - Name: Brain Concussion - Relevance: HIGH - As Found: Brain Concussion - ID: M24734 - Name: Post-Concussion Syndrome - Relevance: HIGH - As Found: Post-Concussive Symptoms - ID: M16355 - Name: Syndrome - 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: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M18892 - Name: Head Injuries, Closed - Relevance: LOW - As Found: Unknown - ID: M17687 - Name: Wounds, Nonpenetrating - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000001924 - Term: Brain Concussion - ID: D000038223 - Term: Post-Concussion Syndrome - ID: D000014947 - Term: Wounds and Injuries - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413160 **Acronym:** JoCRMSSurvey **Brief Title:** The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan **Official Title:** The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan #### Organization Study ID Info **ID:** CVA/JoCRM-2/2024 #### Organization **Class:** OTHER **Full Name:** Jordan Collaborating Cardiology Group ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Cardiovascular Academy **Class:** UNKNOWN **Name:** The Association of Jordanian Medical Laboratory Specialists AJMLS #### Lead Sponsor **Class:** OTHER **Name:** Jordan Collaborating Cardiology Group #### Responsible Party **Investigator Affiliation:** Jordan Collaborating Cardiology Group **Investigator Full Name:** Ayman J Hammoudeh, MD, FACC **Investigator Title:** Director, Department of Clinical Research **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual. Surveying this syndrome in a large population in Jordan aims at studying the risk factors, components and stages of the syndrome, thus helping early screening, diagnosing and treating disease and its risk factors. **Detailed Description:** Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual. CRM syndrome reflects the intersection of cardiovascular disease with chronic kidney disease (CKD), and metabolic disease and risk factors (RF). A critical combination of these diseases and their risk factors in the same individual has a profound impact on quality of life and overall mortality. The clinical implications of the presence of CRM are significant, with premature morbidity and mortality, multiple organ-system disease, and high health care budgets mainly driven by the burden of cardiovascular disease (CVD). There are high prevalence rates of all components of CRM and its RF on a global level and in the Middle East. Of note is the high prevalence of CV in the young, smoking, diabetes mellitus, obesity and dyslipidemia. The current study will evaluate the prevalence of components and RF of CRM disease in a large population in North, central and South of Jordan. In the Middle East, no systematic study has evaluated the definition of CRM, definition of its stages, and prevalence of its RF and its relation to the coexisting social determinants of health. The study will provide new and contemporary knowledge on the definition, staging, and comprehensive approaches to care for patients with CRM, and subsequently exploring opportunities for prevention and care optimization by life style modification and pharmacotherapy. There are different aspects that explain the interaction between the components of CRM. (A) The bidirectional association between the heart failure and the kidneys (cardiorenal syndrome) in addition to the risk of CAD in patients with CKD, (B) adipose tissue link to atherosclerosis mediated by inflammation, insulin resistance and endothelial dysfunction, and risk for DM (C) DM link to CVD, heart failure and kidney dysfunction., and many other links as well. Screening for CRM is an important pillar in promoting health in every community. The CRM staging system facilitates identifying individuals at progressive levels of severity starting from the preclinical phase to delay or avoid the onset of clinical CVD and CKD. To appropriately find individuals at stage 0 (i.e., asymptomatic stage) it is important to undertake active screening within the population. ### Conditions Module **Conditions:** - Cardiovascular-renal-metabolic Syndrome ### Design Module #### Bio Spec **Description:** Centrifuged plasma obtained from peripheral blood sample of the participants **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** 1. CVD A. Coronary heart disease: Silent and clinical CAD (chronic stable coronary disease, acute coronary disease \[ST-elevation myocardial infarction and non-ST-elevation acute coronary syndrome\]. B. Heart failure. C. Atrial fibrillation. D. Stroke. E. Peripheral artery disease 2. Renal: chronic kidney disease 3. Metabolic: A. Obesity/ B. Diabetes mellitus (DM). **Measure:** Prevalence of cardiovascular-renal-metabolic syndrome **Time Frame:** From date of study entry through study completion, an average of 1 year #### Secondary Outcomes **Description:** Elevated level of lipoprotein (a) , homocysteine, high sensitivity C-Reactive Protein, insulin resistance, and Urine Creatinine/Albumin ratio. **Measure:** Elevated levels of blood markers **Time Frame:** From date of study entry through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (age 18 years and above). * Willing to sign an informed consent. Exclusion Criteria: * None. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Consecutive individuals (N=10,000) visiting allocated medical laboratories in North, Center, and South sections of the country during public free blood testing campaigns planned in August 2024 to June 2025. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hammoudeh_ayman@yahoo.com **Name:** Ayman Hammoudeh, MD, FACC **Phone:** 065001000 **Role:** CONTACT **Contact 2:** **Email:** alhaddad63@gmail.com **Name:** Imad A Alhaddad, MD, FACC **Phone:** 065608080 **Role:** CONTACT #### Locations **Location 1:** **City:** Amman **Contacts:** ***Contact 1:*** - **Email:** hammoudeh_ayman@yahoo.com - **Name:** Ayman Hammoudeh, MD FACC - **Phone:** 065001000 - **Role:** CONTACT **Country:** Jordan **Facility:** Istishari Hospital **Zip:** 11184 #### Overall Officials **Official 1:** **Affiliation:** Istisjhari Hospital **Name:** Ayman Hammoudeh, MD, FACC **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Jordan Hospital **Name:** Imad A Alhaddad, MD, FACC **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413147 **Brief Title:** Long-term Procedural and Device Related Complications of PFO Closure **Official Title:** Long-term Procedural and Device Related Complications of PFO Closure #### Organization Study ID Info **ID:** yinchunlin_PFO safety #### Organization **Class:** OTHER **Full Name:** Xuanwu Hospital, Beijing ### Status Module #### Completion Date **Date:** 2029-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **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:** Xuanwu Hospital, Beijing #### Responsible Party **Investigator Affiliation:** Xuanwu Hospital, Beijing **Investigator Full Name:** yinchunlin **Investigator Title:** Xuanwu Hospital, Capital Medical University **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure. ### Conditions Module **Conditions:** - Patent Foramen Ovale ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Surgery of PFO closure **Name:** PFO closure **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** ischemic stroke, Hemorrhagic stroke or transient ischemic attack **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years #### Secondary Outcomes **Measure:** atrial fibrillation **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years **Measure:** Hemorrhage related to the use of antithrombotic drugs **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years **Measure:** residual leaks **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years **Measure:** death **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years **Measure:** open-heart surgery **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years **Measure:** Other severe events related to PFO closure **Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients who underwent PFO closure Exclusion Criteria: * Unable to complete or adhere to the study **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** All patients who underwent PFO closure and willing to participate in this study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yinclmail@163.com **Name:** Chunlin Yin **Phone:** 13552566227 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006344 - Term: Heart Septal Defects, Atrial - ID: D000006343 - Term: Heart Septal Defects - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M27570 - Name: Foramen Ovale, Patent - Relevance: HIGH - As Found: Patent Foramen Ovale - ID: M9431 - Name: Heart Septal Defects - Relevance: LOW - As Found: Unknown - ID: M9432 - Name: Heart Septal Defects, Atrial - Relevance: LOW - As Found: Unknown - ID: M9418 - Name: Heart Defects, Congenital - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054092 - Term: Foramen Ovale, Patent ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413134 **Brief Title:** TheraPAP Adherence Crossover Study **Official Title:** A Prospective, Randomized, Crossover Study of Therapy Adherence With TheraPAP Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA) #### Organization Study ID Info **ID:** Home 0001 #### Organization **Class:** INDUSTRY **Full Name:** SleepRes Inc. ### Status Module #### Completion Date **Date:** 2025-01-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** SleepRes Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** TheraPAP is a novel therapy approach being developed by SleepRes, LLC. for the treatment of obstructive sleep apnea (OSA). This algorithm has been integrated into the Sefam S.Box CPAP (continuous positive airway pressure) device and both standard CPAP/APAP (auto-titrated PAP) as well as TheraPAP can be delivered. TheraPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until some point in late expiration. In this randomized crossover study, the comparative adherence to therapy between TheraPAP and APAP will be compared. Each therapy will be used by the patient for six-week periods with randomly assigned order, and the usage during each arm will be compared. **Detailed Description:** The TheraPAP Adherence Study is a randomized, crossover study in treatment naive participants with OSA in which the adherence to therapy will be compared between TheraPAP and standard APAP. Because all participants will breathe on both therapy types and those therapy types are individually unique in feel, blinding is not possible. Participants will be chosen from a pool of patients who are PAP-naïve and who have received either a PSG (in-lab polysomnogram), split-night study (in-lab PSG and pressure titration) or home sleep study (HST) within the previous 3 months. Upon signing an informed consent, participants will be randomly assigned to start on either the TheraPAP or APAP arms when they arrive at the office to pick up their Sefam S.Box with TheraPAP algorithms integrated. Each participant will then be given their new equipment and will be trained in proper use for both arms of the study so that they will not need to appear at the office again until the study is completed. In both the APAP and TheraPAP arms, participants will have their therapy set to 5-20 cmH2O for three nights. The pressure range will then be narrowed to ± 2 cmH2O around their 95% pressure level as assessed during the third night. This same pressure range will be used during the second arm for each patient. Within the TheraPAP arm, participants will be set to a double Comfort Setting drop according to the following table. This drop schedule will be implemented even while the TheraPAP device is operating with automatic pressure adjustment. Pset Drop 1 Drop 2 5.0 - 5.9 0 0 6.0 - 6.9 1 0 7.0 - 7.9 2 0 8.0 - 8.9 2 1 9.0 - 9.9 2 2 10.0 - 20.0 2 3 Participants will use their starting therapy nightly at home for 6 weeks after which time they will undergo a washout period of 1 week where no therapy will be used. Following the washout period, they will initiate another 6-week usage with the second therapy. Afterward, they will return to the office to receive their permanent equipment. Phone calls as reminders to end the first arm, start the washout period, then to start the second arm will be made. Immediately after both arms of the study are completed, the following will occur: * Eligibility criteria will be reviewed and confirmed * Participants will be asked to respond to the following ESS (Epworth Sleepiness Scale) FOSQ (Functional Outcomes of Sleep Questionnaire) During the home use period, subjects will be called at the following time points during each arm of the study. At each time point, adverse events and compliance with the device will be assessed. Subjects using the device less than an average of 5 hours per night during the first week will be contacted on a more regular basis (weekly until 5 hour per night use is achieved) to address any problems and encourage use. If patients discontinue use of the device during the home use period, they will still be encouraged to return for all testing per protocol. If a patient refuses to come in for further testing, they will be considered a lost to follow up and excluded from efficacy analysis. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** There will be two, 6-week arms where patients will breathe on standard APAP therapy and the test therapy, TheraPAP. Starting therapy will be randomly assigned, but all participants will sleep using both therapies. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will not be told what therapy they will be using in either arm, and since they are naive to PAP therapy, they would be more blinded than adherent patients. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will breathe on APAP for 6 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration. **Intervention Names:** - Device: APAP **Label:** 6-weeks breathing on APAP **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Patients will breathe on TheraPAP for 6 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration. **Intervention Names:** - Device: TheraPAP **Label:** 6-weeks breathing on TheraPAP **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 6-weeks breathing on TheraPAP **Description:** TheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP/APAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase. **Name:** TheraPAP **Other Names:** - KPAP **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - 6-weeks breathing on APAP **Description:** Standard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode. **Name:** APAP **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Number of hours for which therapy is used per night **Measure:** Usage **Time Frame:** Averaged over every night for each 6-week arm #### Secondary Outcomes **Description:** Epworth Sleepiness Scale - a standard questionnaire to assess sleep quality. Scoring goes from 0 to 24 and higher scores means worsening sleepiness. **Measure:** ESS Questionnaire **Time Frame:** Filled out twice, once after completion of each 6-week arm (after week 6 and after week 13) **Description:** Functional Outcomes of Sleep Questionnaire - 10 - a standard questionnaire to assess sleep quality. Scoring goes from 10 to 40 and higher scores means better functional outcome. **Measure:** FOSQ-10 Questionnaire **Time Frame:** Filled out twice, once after completion of each 6-week arm (after week 6 and after week 13) **Description:** Excess leak is patient circuit leak in excess of the normal leak required to prevent rebreathing in a CPAP device, which exits the circuit from the exhaust valve. Examples of excess leak include mask sealing leak or mouth opening. This excess leak will be averaged per night. **Measure:** Excess Leak or Leak **Time Frame:** Averaged over every night for each 6-week arm **Description:** Standard CPAP measurement - pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period **Measure:** P95/P90 **Time Frame:** Averaged over every night for each 6-week arm **Description:** Apnea/Hypopnea Index - measure of the number of obstructive breathing events per hour experienced by the patient **Measure:** AHI **Time Frame:** Averaged over every night for each 6-week arm ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. AHI \> 10 on a previous PSG or HST (hypopneas requiring 4% desaturation). 2. Central apneas \< 25% of events 3. PLM (Periodic Limb Movements) arousal index \< 15 Exclusion Criteria: 1. A female of child-bearing potential that is pregnant or intends to become pregnant. 2. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI). 3. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc. 4. The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc). 5. Prior therapy or treatment for OSA. 6. Chronic oxygen therapy. 7. Excessive alcohol consumption (\>14 drinks/week). 8. The use of any illegal drug(s). 9. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** abinash.joshi@sleepcenterinfo.com **Name:** Abinash Joshi, MD **Phone:** 615-893-4896 **Role:** CONTACT **Contact 2:** **Email:** bhete@sleepres.com **Name:** Bernard Hete, PhD **Phone:** 412-398-2846 **Role:** CONTACT #### Locations **Location 1:** **City:** Murfreesboro **Contacts:** ***Contact 1:*** - **Email:** csalazar@sleepcenterinfo.com - **Name:** Craig Salazar - **Phone:** 615-893-4896 - **Role:** CONTACT ***Contact 2:*** - **Email:** dave.lannom@sleepcenterinfo.com - **Name:** Dave Lannom - **Phone:** 615-893-4896 - **Role:** CONTACT ***Contact 3:*** - **Name:** Bernard Hete, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** William H Noah, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Sleep Centers of Middle Tennessee **State:** Tennessee **Zip:** 37129 #### Overall Officials **Official 1:** **Affiliation:** SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC **Name:** William H Noah, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001049 - Term: Apnea - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413121 **Brief Title:** Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV **Official Title:** An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL® #### Organization Study ID Info **ID:** SII-wHEXA/IN-03 #### Organization **Class:** INDUSTRY **Full Name:** Serum Institute of India Pvt. Ltd. ### Status Module #### Completion Date **Date:** 2026-05-31 **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:** 2025-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Serum Institute of India Pvt. Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV. SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens. Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme. **Detailed Description:** This is an observer-blind, randomized, active-controlled, multi-centric study in healthy infants and toddlers to assess the immunogenicity and safety of SIIPL reduced IPV hexavalent vaccine in comparison with the licensed SIIPL HEXASIIL® vaccine. One thousand five hundred and fifty-seven infants aged 6-8 weeks (42 to 56 days, both days inclusive) will be randomized in a 2:1 ratio (1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL® group), to receive a 3-dose primary vaccination series followed by their booster doses, respectively. The safety and immunogenicity data collected up to 28 days following third vaccination i.e., Visit 7, shall be submitted to the regulatory authority. All subjects will be followed up further for booster dose. After Visit 7 (i.e., 28 days following completion of primary vaccination series) subjects will be followed up for safety every 3 months starting from the age of 6 months (i.e., at 6, 9, 12, 15, 18, and 21 months of age) until they receive the booster dose anytime between 12-24 months. There will be post booster follow up visit (EOS visit) 28 days after the booster immunization i.e., Visit 10 to assess the safety and post booster immunogenicity. ### Conditions Module **Conditions:** - Diptheria Immunization - Tetanus Immunization - Pertussis Immunization - Hepatitis B Immunization - Haemophilus Influenzae Type B Immunization - Polio Immunization ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1557 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. **Intervention Names:** - Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV **Label:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. **Intervention Names:** - Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV **Label:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV **Description:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. **Name:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV **Description:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. **Name:** Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV **Type:** BIOLOGICAL ### Outcomes Module #### Other Outcomes **Description:** Local and systemic solicited AEs occurring up to 7 days and unsolicited AEs and SAEs till 28 days post completion of booster vaccination. **Measure:** Pre- and post-booster safety of SIIPL reduced IPV hexavalent vaccine and comparator vaccine, SIIPL HEXASIIL® in toddlers. **Time Frame:** Safety assessment from 28 days post completion of the 3-dose primary schedule till 28 days post booster. **Description:** GMTs/ GMCs and Percentage of toddlers achieving seroprotection/seroconversion for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3 and pertussis, prior to booster dose and 28 days after a booster dose. **Measure:** Pre- and post-booster immunogenicity of SIIPL reduced IPV hexavalent vaccine and comparator vaccine, SIIPL HEXASIIL® in toddlers. **Time Frame:** Immunogenicity at prebooster and 28 days post booster dose between 12-24 months of age. #### Primary Outcomes **Description:** Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3, seroresponse for anti-B. pertussis and seroconversion for anti-pertussis toxin, 28 days post completion of a 3-dose primary vaccination series. **Measure:** Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine. **Time Frame:** 28 days post completion of 3-dose primary vaccination series in infants. #### Secondary Outcomes **Description:** local and systemic solicited AEs, unsolicited AEs and serious adverse events (SAEs) **Measure:** Assessment of occurrence, severity, and relationship of adverse events (AEs) **Time Frame:** Local and systemic solicited AEs occurring up to 7 days following each vaccination, unsolicited AEs and SAEs till 28 days post completion of a 3-dose primary vaccination series. **Description:** Geometric mean concentrations/ Geometric mean titres (GMCs/GMTs) for anti diphtheria, anti-tetanus, anti-B. pertussis, anti-pertussis toxin, anti-HBsAg, anti- polyribosylribitol phosphate (PRP) and anti-polio types 1, 2 \& 3 antibodies, 28 days post completion of the 3 dose primary vaccination series in infants. **Measure:** Assessment of immunogenicity of SIIPL reduced IPV hexavalent vaccine with the comparator vaccine, SIIPL HEXASIIL® and to assess lot-to-lot consistency among 3 lots of SIIPL reduced IPV Hexavalent vaccine **Time Frame:** 28 days post completion of the 3-dose primary vaccination series in infants. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female infants aged 6-8 weeks at the time of first vaccination. * Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator. * Informed consent form signed by at least one parent. * Infants born at full term pregnancy (≥ 37 weeks). * Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment. * Willingness of subjects' parent to comply with the requirements of the protocol. Exclusion Criteria: * History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae type b/ poliomyelitis infection(s). * Presence of fever ≥ 38°C/ 100.4°F. * Acute illness of moderate to severe intensity according to the clinical judgment of the investigator . * Receipt of antibiotics in the past 3 days * Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period. * Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination. * History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment. * History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives. * History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine. * Infants with known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to study entry * Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy. * Known thrombocytopenia or a bleeding disorder. * Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity. * Planned surgery during the study. * Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response. * Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial. * Infants whose families are planning to leave the area of the study site before the end of the study period. **Healthy Volunteers:** True **Maximum Age:** 8 Weeks **Minimum Age:** 6 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drhjs@seruminstitute.com **Name:** Hitt Sharma **Phone:** +912026602451 **Role:** CONTACT **Contact 2:** **Email:** sameer.parekh@seruminstitute.com **Name:** Sameer Parekh **Phone:** +912026602139 **Role:** CONTACT #### Locations **Location 1:** **City:** Dhaka **Contacts:** ***Contact 1:*** - **Email:** kzaman@icddrb.org - **Name:** K Zaman, MD - **Phone:** +880-1713047100 - **Role:** CONTACT **Country:** Bangladesh **Facility:** International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) **Status:** NOT_YET_RECRUITING **Zip:** 128 **Location 2:** **City:** New Delhi **Contacts:** ***Contact 1:*** - **Email:** drafreen.himsr@gmail.com - **Name:** Afreen Khan - **Phone:** +91-7503857784 - **Role:** CONTACT **Country:** India **Facility:** Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH) **State:** Delhi **Status:** RECRUITING **Zip:** 110062 **Location 3:** **City:** Mangalore **Contacts:** ***Contact 1:*** - **Email:** veenak@manipal.edu - **Name:** Dr Veena Kamath - **Role:** CONTACT **Country:** India **Facility:** Manipal Academy of Higher Education, Manipal **State:** Karnataka **Status:** RECRUITING **Zip:** 576104 **Location 4:** **City:** Mysore **Contacts:** ***Contact 1:*** - **Email:** ravimdped@gmail.com - **Name:** Ravi M D - **Phone:** +91-9880629506 - **Role:** CONTACT **Country:** India **Facility:** JSS Medical College and Hospital **State:** Karnataka **Status:** NOT_YET_RECRUITING **Zip:** 570004 **Location 5:** **City:** Pune **Contacts:** ***Contact 1:*** - **Email:** sonali.palkar@bharatividyapeeth.edu - **Name:** Dr Sonali Palkar, M. D. - **Phone:** +91-9881008717 - **Role:** CONTACT **Country:** India **Facility:** Bharati Vidyapeeth Medical College and Hospital, Pune **State:** Maharashtra **Status:** RECRUITING **Zip:** 411043 **Location 6:** **City:** Pune **Contacts:** ***Contact 1:*** - **Email:** anand.kawade@kemhrcvadu.org - **Name:** Dr. Anand Kawade - **Phone:** +91-9850559983 - **Role:** CONTACT **Country:** India **Facility:** KEM Hospital and Research Centre, Vadu **State:** Maharashtra **Status:** RECRUITING **Zip:** 412216 **Location 7:** **City:** Chennai **Contacts:** ***Contact 1:*** - **Email:** umapathy.p@sriramachandra.edu.in - **Name:** Dr Umapathy P, M. D. - **Phone:** +91-9841663959 - **Role:** CONTACT **Country:** India **Facility:** Sri Ramachandra Medical Centre, Chennai **State:** Tamil Nadu **Status:** RECRUITING **Zip:** 600116 **Location 8:** **City:** Kolkata **Contacts:** ***Contact 1:*** - **Email:** kheyauttam@yahoo.co.in - **Name:** Dr Kheya Ghosh, M. D. - **Phone:** +91-9830297578 - **Role:** CONTACT **Country:** India **Facility:** Institute of Child Health, Kolkata **State:** West Bengal **Status:** NOT_YET_RECRUITING **Zip:** 700017 **Location 9:** **City:** Chandigarh **Contacts:** ***Contact 1:*** - **Email:** madhugupta21@gmail.com - **Name:** Dr Madhu Gupta, MD - **Role:** CONTACT **Country:** India **Facility:** Post Graduate Institute of Medical Education and Research (PGIMER) **Status:** NOT_YET_RECRUITING **Zip:** 160012 #### Overall Officials **Official 1:** **Affiliation:** KEM Hospital Research Centre, Pune, India **Name:** Anand Kawade **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, India **Name:** Sonali Palkar **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** JSS Hospitla, Mysore, India **Name:** M D Ravi **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Manipal Academy of Higher Education, Kasturba Medical College, Udipi and Karkala,India **Name:** Veena Kamat **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Sri Ramchndra Institute of Higher Education and Research, Chennai, India **Name:** P Umapathy **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Institute of Child Health, Kolkata, India **Name:** Kheya Ghosh **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Post Graduate Institute of Medical Education and Research, Chandigarh, India **Name:** Madhu Gupta **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** Hamdard Institute of Medical Sciences and Research (HIMSR), New Delhi, India **Name:** Afreen khan **Role:** PRINCIPAL_INVESTIGATOR **Official 9:** **Affiliation:** Yashwantrao Chavan Memorial Hospital, Pimpri, Pune, India **Name:** Deepali Ambike **Role:** PRINCIPAL_INVESTIGATOR **Official 10:** **Affiliation:** International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh **Name:** K Zaman **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal may be provided the access afterSponsor permission and if signed data-access agreements are in place. **Description:** Summary results for primary and secondary objectives **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 6 months after the study completion ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000003354 - Term: Corynebacterium Infections - ID: D000000193 - Term: Actinomycetales Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M7347 - Name: Diphtheria - Relevance: HIGH - As Found: Diphtheria - ID: M17656 - Name: Whooping Cough - Relevance: LOW - As Found: Unknown - ID: M16511 - Name: Tetanus - Relevance: LOW - As Found: Unknown - ID: M16515 - Name: Tetany - Relevance: LOW - As Found: Unknown - ID: M13939 - Name: Poliomyelitis - Relevance: LOW - As Found: Unknown - ID: M9284 - Name: Haemophilus Infections - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - 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: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M6574 - Name: Corynebacterium Infections - Relevance: LOW - As Found: Unknown - ID: T1885 - Name: Diphtheria - Relevance: HIGH - As Found: Diphtheria - ID: T2646 - Name: Haemophilus Influenzae - Relevance: HIGH - As Found: Haemophilus Influenzae - ID: T5926 - Name: Whooping Cough - Relevance: LOW - As Found: Unknown - ID: T5607 - Name: Tetanus - Relevance: LOW - As Found: Unknown - ID: T4606 - Name: Poliomyelitis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006509 - Term: Hepatitis B - ID: D000004165 - Term: Diphtheria - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: HIGH - As Found: Other - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014612 - Term: Vaccines ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413108 **Brief Title:** Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali **Official Title:** A Phase 1/2a Single Centre, Randomised, Placebo-controlled, Double-blind, Dose-escalation, Age De-escalation, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Malaria-exposed Malian Adults and Children #### Organization Study ID Info **ID:** TB31F Mali #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Malaria Research and Training Center, Bamako, Mali **Class:** OTHER **Name:** London School of Hygiene and Tropical Medicine #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat this disease. The monoclonal antibody TB31F shows promise in reducing the transmission of malaria. This clinical trial will evaluate the safety and efficacy of the monoclonal antibody TB31F. ### Conditions Module **Conditions:** - Malaria,Falciparum **Keywords:** - transmission-reducing - monoclonal antibody ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** We will perform two sequential stages of clinical research, each recruiting a distinct cohort of participants to confirm: 1. TB31F safety and 2. TB31F efficacy. The safety cohort will be composed of the three dose groups in adults (groups 1, 2 and 3) and two dose groups in children (groups 4 and 5). The efficacy cohort will be composed of two dose groups in adults and children (group 6). Participants will be randomised within each treatment group to receive a single sub-cutaneous dose of TB31F or placebo. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** This is a double-blind randomised controlled trial. The treating physician and staff involved with assessing all laboratory outcomes of the study are blinded. The study pharmacist will be unblinded and responsible for randomisation and treatment preparation. Entomology staff involved in the mosquito feeding assays will be blinded for the parasitology results. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 165 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 0.2 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 1A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** 0.2 mL (10 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 1B: 10 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 2 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 2A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** 2 mL (100 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 2B:100 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** 4 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 3A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 6 **Description:** 4 mL (200 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 3B: 200 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** 0.2 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 4A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 8 **Description:** 0.2 mL (10 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 4B: 10 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** 2.0 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 5A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 10 **Description:** 2.0 mL (100 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 5B: 100 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 11 **Description:** 0.6 or 2.0 mL normal saline **Intervention Names:** - Other: Normal saline **Label:** 6A: control **Type:** PLACEBO_COMPARATOR #### Arm Group 12 **Description:** 0.6 mL (30 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 6B: 30 mg TB31F **Type:** EXPERIMENTAL #### Arm Group 13 **Description:** 2.0 mL (100 mg) TB31F **Intervention Names:** - Drug: TB31F **Label:** 6C: 100 mg TB31F **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1B: 10 mg TB31F - 2B:100 mg TB31F - 3B: 200 mg TB31F - 4B: 10 mg TB31F - 5B: 100 mg TB31F - 6B: 30 mg TB31F - 6C: 100 mg TB31F **Description:** transmission-blocking monoclonal antibody TB31F **Name:** TB31F **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 1A: control - 2A: control - 3A: control - 4A: control - 5A: control - 6A: control **Description:** normal saline as control (placebo) **Name:** Normal saline **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Quantification of the effect of nutritional and protein metabolism status **Measure:** Total serum immunoglobulin G level **Time Frame:** day 0 [baseline] **Description:** Quantification of the effect of nutritional and protein metabolism status **Measure:** Serum leptin level **Time Frame:** day 0 [baseline] **Description:** Quantification of the effect of nutritional and protein metabolism status **Measure:** Total protein level **Time Frame:** day 0 [baseline] **Description:** Quantification of the effect of nutritional and protein metabolism status **Measure:** Albumin level **Time Frame:** day 0 [baseline] **Description:** Quantification of the effect of nutritional and protein metabolism status **Measure:** Pre-albumin level **Time Frame:** day 0 [baseline] **Description:** To assess the transmission-blocking activity of participant serum after TB31F administration as assessed in the Standard Membrane Feeding Assay (SMFA) at each dose level in adults and school-age children **Measure:** Transmission-blocking activity measured as the percent reduction in mosquito infection prevalence compared to experimental controls, compared within and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 5, 14, 28, 56, and 84 **Measure:** The concentration of TB31F in serum that provides >80% reduction in the average proportion of infected mosquitoes as measured in direct skin feeding assay after TB31F administration. **Time Frame:** day 0 [baseline], 1, and 5. **Measure:** The concentration of TB31F in serum that provides >80% reduction in the average proportion of infected mosquitoes as measured in direct membrane feeding assays after TB31F administration. **Time Frame:** day 0 [baseline], 1, 5, and 14. **Measure:** The concentration of TB31F in serum that provides >80% transmission blocking activity relative to experimental controls as measured in standard membrane feeding assay after TB31F administration. **Time Frame:** day 0 [baseline], 5, 14, 28, 56, and 84 **Measure:** Measure the concentration of TB31F in serum that provides >80% reduction in the average mosquito infection intensity (oocyst number) as measured in direct skin feeding assay after TB31F administration. **Time Frame:** day 0 [baseline], 1, and 5. **Measure:** The concentration of TB31F in serum that provides >80% reduction in the average mosquito infection intensity (oocyst number) as measured in direct membrane feeding assays after TB31F administration. **Time Frame:** day 0 [baseline], 1, 5, and 14. **Measure:** The concentration of TB31F in serum that provides >80% transmission reducing activity relative to experimental controls as measured in standard membrane feeding assay after TB31F administration. **Time Frame:** day 0 [baseline], 5, 14, 28, 56, and 84 #### Primary Outcomes **Measure:** Occurrence of at least possibly related solicited local and systemic adverse events **Time Frame:** within 7 days of monoclonal antibody TB31F administration **Measure:** Occurrence of at least possibly related unsolicited adverse events **Time Frame:** within 28 days of monoclonal antibody TB31F administration **Measure:** Terminal serum half-life (t½) of monoclonal antibody TB31F in serum **Time Frame:** day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84. **Measure:** Maximum observed serum concentration (Cmax) of monoclonal antibody TB31F in serum **Time Frame:** day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84. **Measure:** Time to reach maximum serum concentration (tmax) of monoclonal antibody TB31F in serum **Time Frame:** day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84. **Measure:** Accumulation index (Racc) of monoclonal antibody TB31F in serum **Time Frame:** day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84. **Measure:** Area under the serum concentration-time curve (AUC0-τ, AUC0-t and AUC) of monoclonal antibody TB31F in serum **Time Frame:** day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84. **Measure:** Within-group percent reduction in the proportion of mosquitoes infected at day 5 post-treatment compared to baseline (day 0), assessed through direct membrane feeding assays and measured as oocyst prevalence **Time Frame:** day 0 [baseline] & 5 #### Secondary Outcomes **Measure:** Within-group percent reduction in the proportion of mosquitoes infected in direct skin feeding assay (DSF), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, and 5 **Measure:** Within-group percent reduction in the proportion of mosquitoes infected in direct membrane feeding assays (DMFA), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, 5, and 14 **Measure:** Mosquito infection prevalence, assessed by direct skin feed and measured as the proportion dissected with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, and 5 **Measure:** Mosquito infection prevalence, assessed by DMFA and measured as the proportion dissected with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, 5, and 14 **Measure:** Mosquito infection intensity, assessed by direct skin feed and measured as the number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, and 5 **Measure:** Mosquito infection intensity, assessed by DMFA and measured as the average number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, 5, and 14 **Measure:** Participant infection prevalence, assessed by DSF as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, and 5 **Measure:** Participant infection prevalence, assessed by DMFA as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 1, 5, and 14 **Measure:** Transmission-reducing activity in school-age children and adults, measured as the percent reduction in mean oocyst intensity compared to experimental controls, compared within groups and between groups at all feeding timepoints. **Time Frame:** day 0 [baseline], 5, 14, 28, 56, and 84 ### Eligibility Module **Eligibility Criteria:** SAFETY COHORT (STUDY ARM 1-5) Inclusion Criteria: 1. Written/signed informed consent 2. Adult cohorts: 18-50 years of age 3. School-age children cohorts: 10-15 years of age 4. Haemoglobin ≥10 g/dL 5. Non-lactating females of childbearing potential agree to the use of continuous adequate contraception for 28 days after having received investigational product 6. Subject agrees to refrain from blood donation during the study and for 5 months after having received investigational product 7. Subjects are available to attend all study visits 8. In opinion of the investigator, the subject can and will comply with the requirements of the protocol Exclusion Criteria: 1. Women who are pregnant (tested at baseline and at day 28 after administration of investigational product by urine and/or serum pregnancy testing (β-hCG)) or lactating 2. Symptomatic malaria 3. Current acute or chronic disease, including clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history or physical examination 4. Clinically significant abnormal blood chemistries and haematology 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 year 6. History of adverse reactions to monoclonal antibodies 7. Administration of immunoglobulin and/or blood products within the three months preceding the first dose of the investigational product or planned administration during the study period 8. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol EFFICACY COHORT (STUDY ARM 6) Inclusion Criteria: 1. Written/signed informed consent 2. 10-50 years of age 3. Haemoglobin ≥10 g/dL 4. Non-lactating females of childbearing potential agree to the use of continuous adequate contraception for 28 days after having received investigational product 5. Subject agrees to refrain from blood donation during the study and for 5 months after having received investigational product 6. Subjects are available to attend all study visits 7. In opinion of the investigator, the subject can and will comply with the requirements of the protocol 8. Asymptomatic P. falciparum mono-infection with asexual parasite densities \<3000 parasites/µL 9. Presence of P. falciparum gametocytes on thick blood film at a density \>16 gametocytes/µL Exclusion Criteria: 1. Women who are pregnant (tested at baseline and at day 28 after administration of investigational product by urine and/or serum pregnancy testing (β-hCG)) or lactating 2. Symptomatic malaria 3. Current acute or chronic disease, including clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history or physical examination 4. Clinically significant abnormal blood chemistries and haematology 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years 6. History of adverse reactions to monoclonal antibodies 7. Administration of immunoglobulin and/or blood products within the three months preceding the first dose of the investigational product or planned administration during the study period 8. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol 9. Use of anti-malarial drug treatment in the last 14 days 10. Prior receipt of an antimalarial monoclonal antibody 11. Prior receipt of a P. falciparum transmission-blocking vaccine **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### IPD Sharing Statement Module **Info Types:** - SAP - ICF **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011528 - Term: Protozoan Infections - ID: D000010272 - Term: Parasitic Diseases - ID: D000007239 - Term: Infections - ID: D000096724 - Term: Mosquito-Borne Diseases - ID: D000079426 - Term: Vector Borne Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11280 - Name: Malaria - Relevance: HIGH - As Found: Malaria - ID: M19133 - Name: Malaria, Falciparum - Relevance: HIGH - As Found: Malaria,Falciparum - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14388 - Name: Protozoan Infections - Relevance: LOW - As Found: Unknown - ID: M13185 - Name: Parasitic Diseases - Relevance: LOW - As Found: Unknown - ID: M3255 - Name: Mosquito-Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M2054 - Name: Vector Borne Diseases - Relevance: LOW - As Found: Unknown - ID: T3571 - Name: Malaria - Relevance: HIGH - As Found: Malaria ### Condition Browse Module - Meshes - ID: D000008288 - Term: Malaria - ID: D000016778 - Term: Malaria, Falciparum ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413095 **Brief Title:** PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS **Official Title:** Pembrolizumab Alone and in Combination(s) With MK-0482 and MK-4830 Via Intratumoral Injection in Patients With Head and Neck Squamous Cell Carcinoma or Soft Tissue Sarcoma Prior to Planned Surgical Intervention #### Organization Study ID Info **ID:** MST01-MSD-03 #### Organization **Class:** INDUSTRY **Full Name:** Presage Biosciences #### Secondary ID Infos **Domain:** Presage Biosciences **ID:** PBI-MST-01 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2023-06-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-22 **Type:** ACTUAL #### Start Date **Date:** 2022-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-01 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** Presage Biosciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native tumor microenvironment (TME) following intratumoral microdosing via the CIVO device in patients with surface accessible Head and Neck Squamous Cell Carcinoma (HNSCC) or Soft Tissue Sarcoma (STS) lesion(s) who are scheduled for tumor and/or regional node dissection as part of their standard treatment. **Detailed Description:** The CIVO Microdose Injection Device (MID) simultaneously delivers multiple drugs and drug combinations (up to 8), each in microdose amounts, into a single patient tumor and enables comparisons of the resulting biomarker responses that occurred while that tumor was still in the native microenvironment. The microdose injection procedure is conducted ahead of the patient's scheduled surgical intervention and localized biomarker responses are then evaluated in the injected tumor tissue following surgery. This enables assessments of drug-induced changes to the tumor, stroma, and local immune cells within the unique landscape of each individual patient and their respective tumor genomic profile and immune system functional status. CIVO is a research tool used only to assess the responses of tumor cells and other cell populations with the TME following intratumoral administration of drug microdoses; it is not a therapeutic device. MK-0482, MK-4830, and pembrolizumab have distinct mechanisms of action (MOAs) that affect the TME, including relief of immune suppression and enhanced T-cell activation. Surgery is the standard primary treatment for most patients with STS, and surgical intervention of the primary tumor and cervical lymph node dissection may be recommended for patients with HNSCC. Dysfunction of the immune system (e.g., immune evasion, expression of suppressive immune checkpoint receptors, etc.) plays a major role in the development and progression of HNSCC and STS. Therefore, in this Phase 0 study, the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation within the native TME in patients with HNSCC or STS will be assessed. Pembrolizumab, alone and in combination with MK-0482 or MK-4830, will be injected in microdose quantities at tumor sites in HNSCC or STS patients with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment. Injected tumors will be resected as per surgical standard of care following 2 to 4 days in situ exposure. Thereafter, the CIVO-injected portion of the tissue will be analyzed for localized response at sites of drug exposure in the TME. ### Conditions Module **Conditions:** - Head and Neck Squamous Cell Carcinoma - Soft Tissue Sarcoma **Keywords:** - HNSCC - head and neck cancer - head and neck squamous cell carcinoma - STS - soft tissue sarcoma - intratumoral microdosing - microdose injection - microdosing - in vivo oncology - tumor microenvironment - multiplexed immunohistochemistry - pharmacodynamic biomarkers - CIVO - master protocol - precision oncology - spatial biology ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This is a cohort substudy of a Master Protocol (PBI-MST-01, NCT04541108) framework, under which comparisons will not be made between substudy cohorts. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 13 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient with HNSCC or STS with surface accessible lesions who are scheduled for tumor or regional node dissection as part of their standard treatment will be injected two to four days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of pembrolizumab as a single agent or in combination with MK-0482 or MK-4830. Each microdose is simultaneously injected in a columnar fashion through each of 5 or 8 needles by the CIVO Micodose Injection Device (MID) into a single solid tumor or effaced metastatic lymph node. **Intervention Names:** - Biological: Pembrolizumab - Combination Product: MK-0482 + Pembrolizumab - Combination Product: MK-4830 + Pembrolizumab **Label:** Pembrolizumab Alone or in Combination with MK-0482 or MK-4830 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pembrolizumab Alone or in Combination with MK-0482 or MK-4830 **Description:** Intratumoral microdose injection by the CIVO device. **Name:** Pembrolizumab **Other Names:** - Keytruda, MK-3475 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Pembrolizumab Alone or in Combination with MK-0482 or MK-4830 **Description:** Intratumoral microdose injection by the CIVO device. **Name:** MK-0482 + Pembrolizumab **Type:** COMBINATION_PRODUCT #### Intervention 3 **Arm Group Labels:** - Pembrolizumab Alone or in Combination with MK-0482 or MK-4830 **Description:** Intratumoral microdose injection by the CIVO device. **Name:** MK-4830 + Pembrolizumab **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around injection sites in resected patient samples by IHC, ISH, or spatial biology platforms. An aggregate analysis of this quantification may be done across patient samples in each substudy to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to, markers associated with macrophage polarization states (e.g., CD163), markers of infiltrating T cells (e.g., CD8/Granzyme B), and proinflammatory cytokines (e.g., interferon gamma). **Measure:** Quantification of Immune Cell Biomarkers by Immunohistochemistry (IHC), In Situ Hybridization (ISH), and/or Spatial Biology Platforms **Time Frame:** 2 to 4 days after microdose injection #### Secondary Outcomes **Description:** Safety of the microdose injection procedure and injected content will be assessed by quantification of the frequency, intensity, and relatedness of all reported Adverse Events and/or Adverse Device Effects. **Measure:** Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability] **Time Frame:** Up to 28 days after microdose injection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Ability and willingness to comply with the study's visit and assessment schedule. 2. Male or female ≥18 years of age at Visit 1 (Screening). 3. Pathologic diagnosis of HNSCC or STS. 4. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5. At least one lesion (primary tumor, recurrent tumor, or metastatic lymph node) of at least approximately 2.5 cm in the shortest diameter that is surface accessible for CIVO injection that contains viable minimum tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indication lesion with appropriate viable tumor volume, without excessive cysts or necrosis) and for which there is a planned surgical intervention. 6. Female patients who: * Are postmenopausal for at least one year before the screening visit, OR * Are surgically sterile, OR * Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) through up to 120 days after the tumor injection procedure OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from donating ova during study participation. Male patients, even if surgically sterile (i.e., status post-vasectomy), who: * Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from donating sperm during study participation. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Patients who have received neoadjuvant therapy associated with the surgical intervention described in Inclusion Criterion #5 within 6 months of the CIVO injection procedure. 2. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient. 3. Female patients who are: * Both lactating and breastfeeding, OR * Have a positive beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening verified by the Investigator. 4. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives. 5. Patients with a history of concurrent second cancers requiring active, ongoing systemic treatment. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 6. Patients with a diagnosis of immunodeficiency. 7. Patients with known HIV/AIDS with uncontrolled viral load and CD4 less than 200, or those with concurrent active hepatitis B (defined as HBsAg positive or detectable HBV DNA) or hepatitis C (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: HIV infected participants with a history of Kaposi's sarcoma or Multicentric Castleman's Disease are excluded. Hepatitis B and C screening tests are not required unless: * Patient has a known history of hepatitis B/C infection * Mandated by local health authority 8. Patients that have received a live or live-attenuated vaccine within 4 weeks of the baseline/screening visit. 9. Use of any of the following ≤ 2 weeks prior to CIVO injection: 1. Chronic systemic immunosuppressive therapy or corticosteroids (in dosing exceeding 10 mg daily of prednisone equivalent). Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular injection), or steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication) are exceptions to this criterion. 2. Biological response modifiers for treatment of active autoimmune disease. 3. Hematopoietic growth factors. 10. Patients who have received prior treatment with radiation or systemic therapy (e.g., cytotoxic chemotherapy, targeted agents, or checkpoint inhibitor immunotherapy, etc.), or have participated in a study of an investigational device within 6 months of the CIVO injection procedure. Note: Participants must have recovered from all radiation-related toxicities, must not require corticosteroids, and must not have had radiation pneumonitis. 11. Patients who have a history of (noninfectious) pneumonitis that required steroids or have current pneumonitis. 12. Patients who have had allogenic tissue/solid organ transplant. 13. Patients who have had severe hypersensitivity (≥Grade 3) to pembrolizumab, MK-4830, MK-0482, or any of their excipients. 14. Patients with an active infection requiring systemic therapy. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sacramento **Country:** United States **Facility:** UC Davis **State:** California **Zip:** 95817 **Location 2:** **City:** Atlanta **Country:** United States **Facility:** Emory Winship Cancer Institute **State:** Georgia **Zip:** 30308 **Location 3:** **City:** Shreveport **Country:** United States **Facility:** LSU Health Sciences Center - Shreveport **State:** Louisiana **Zip:** 71115 **Location 4:** **City:** Bronx **Country:** United States **Facility:** Montefiore Medical Center **State:** New York **Zip:** 10467 **Location 5:** **City:** Chapel Hill **Country:** United States **Facility:** University of North Carolina **State:** North Carolina **Zip:** 27599 **Location 6:** **City:** Cincinnati **Country:** United States **Facility:** UC Health **State:** Ohio **Zip:** 45219 **Location 7:** **City:** Portland **Country:** United States **Facility:** Oregon Health & Science University (OHSU) **State:** Oregon **Zip:** 97239 **Location 8:** **City:** Philadelphia **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19107 **Location 9:** **City:** Charleston **Country:** United States **Facility:** Sarah Cannon Medical Center **State:** South Carolina **Zip:** 29406 **Location 10:** **City:** Houston **Country:** United States **Facility:** UT Health Houston **State:** Texas **Zip:** 77401 **Location 11:** **City:** Seattle **Country:** United States **Facility:** University of Washington **State:** Washington **Zip:** 98109 #### Overall Officials **Official 1:** **Affiliation:** Presage Biosciences **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Derry JMJ, Burns C, Frazier JP, Beirne E, Grenley M, DuFort CC, Killingbeck E, Leon M, Williams C, Gregory M, Houlton J, Clayburgh D, Swiecicki P, Huszar D, Berger A, Klinghoffer RA. Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment. Clin Cancer Res. 2023 Sep 15;29(18):3813-3825. doi: 10.1158/1078-0432.CCR-23-0827. **PMID:** 37389981 **Citation:** Gundle KR, Deutsch GB, Goodman HJ, Pollack SM, Thompson MJ, Davis JL, Lee MY, Ramirez DC, Kerwin W, Bertout JA, Grenley MO, Sottero KHW, Beirne E, Frazier J, Dey J, Ellison M, Klinghoffer RA, Maki RG. Multiplexed Evaluation of Microdosed Antineoplastic Agents In Situ in the Tumor Microenvironment of Patients with Soft Tissue Sarcoma. Clin Cancer Res. 2020 Aug 1;26(15):3958-3968. doi: 10.1158/1078-0432.CCR-20-0614. Epub 2020 Apr 16. **PMID:** 32299817 **Citation:** Klinghoffer RA, Bahrami SB, Hatton BA, Frazier JP, Moreno-Gonzalez A, Strand AD, Kerwin WS, Casalini JR, Thirstrup DJ, You S, Morris SM, Watts KL, Veiseh M, Grenley MO, Tretyak I, Dey J, Carleton M, Beirne E, Pedro KD, Ditzler SH, Girard EJ, Deckwerth TL, Bertout JA, Meleo KA, Filvaroff EH, Chopra R, Press OW, Olson JM. A technology platform to assess multiple cancer agents simultaneously within a patient's tumor. Sci Transl Med. 2015 Apr 22;7(284):284ra58. doi: 10.1126/scitranslmed.aaa7489. **PMID:** 25904742 **Citation:** Frazier JP, Bertout JA, Kerwin WS, Moreno-Gonzalez A, Casalini JR, Grenley MO, Beirne E, Watts KL, Keener A, Thirstrup DJ, Tretyak I, Ditzler SH, Tripp CD, Choy K, Gillings S, Breit MN, Meleo KA, Rizzo V, Herrera CL, Perry JA, Amaravadi RK, Olson JM, Klinghoffer RA. Multidrug Analyses in Patients Distinguish Efficacious Cancer Agents Based on Both Tumor Cell Killing and Immunomodulation. Cancer Res. 2017 Jun 1;77(11):2869-2880. doi: 10.1158/0008-5472.CAN-17-0084. Epub 2017 Mar 31. **PMID:** 28364003 **Citation:** Dey J, Kerwin WS, Grenley MO, Casalini JR, Tretyak I, Ditzler SH, Thirstrup DJ, Frazier JP, Pierce DW, Carleton M, Klinghoffer RA. A Platform for Rapid, Quantitative Assessment of Multiple Drug Combinations Simultaneously in Solid Tumors In Vivo. PLoS One. 2016 Jun 30;11(6):e0158617. doi: 10.1371/journal.pone.0158617. eCollection 2016. **PMID:** 27359113 **Citation:** Moreno-Gonzalez A, Olson JM, Klinghoffer RA. Predicting responses to chemotherapy in the context that matters - the patient. Mol Cell Oncol. 2015 Jun 10;3(1):e1057315. doi: 10.1080/23723556.2015.1057315. eCollection 2016 Jan. **PMID:** 27308571 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Soft Tissue Sarcoma - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M18592 - Name: Ichthyosis, X-Linked - Relevance: LOW - As Found: Unknown - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Head and Neck Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Soft Tissue Sarcoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000012509 - Term: Sarcoma - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413082 **Acronym:** ALTUM **Brief Title:** Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment **Official Title:** Pharmacogenetics of Hypertension: a Single-centre Randomized Study in Patients With Essential Hypertension Treated With Spironolactone or Torasemide #### Organization Study ID Info **ID:** ALTUM #### Organization **Class:** OTHER **Full Name:** Ospedale San Raffaele ### Status Module #### Completion Date **Date:** 2023-09-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-07 **Type:** ACTUAL #### Start Date **Date:** 2021-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2023-09-04 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ospedale San Raffaele #### Responsible Party **Investigator Affiliation:** Ospedale San Raffaele **Investigator Full Name:** Chiara Lanzani **Investigator Title:** medical doctor in nephrology unit, nephrologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Phase III interventional study to evaluate the different efficacy of Torasemide and Spironolactone in reducing systolic blood pressure in carriers and non-carriers of the different genotypic combinations for Lanosterol and Uromodulin **Detailed Description:** The investigators will enroll 144 naïve hypertensive subjects who will undertake 2-4 weeks of run-in and 4 weeks of treatment (7 day window at each visit). During this period partecipants will follow a low sodium diet (about 5g/day) and will be monitored with blood chemistry tests ### Conditions Module **Conditions:** - Hypertension - Genetic Predisposition - Drug Effect **Keywords:** - hypertension - genetics - torasemide - spironolactone - pharmacogenetics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** single-center, nationwide, randomized, phase III prospective interventional outpatient study, in two arms, in parallel groups ##### Masking Info **Masking:** DOUBLE **Masking Description:** The study will be double-blind with respect to the genetic analysis and open-label with an observer blind with respect to the primary endpoint. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study involves the administration of Torasemide 2.5 mg. **Intervention Names:** - Drug: Torasemide **Label:** Torasemide **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The study involves the administration of Spironolactone 50 mg orally every day. **Intervention Names:** - Drug: Spironolactone **Label:** Spironolactone **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Torasemide **Description:** The assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups **Name:** Torasemide **Other Names:** - Demadex - Tortas - Wator - Torsemide **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Spironolactone **Description:** The assignment to each drug will be carried out randomly in each genotypic group with the aim of reaching the same number of patients treated with the two drugs in the different genotypic groups **Name:** Spironolactone **Other Names:** - Aldactone - Carospir **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** the difference in the reduction of systolic blood pressure (deltaSBP) values in essential hypertensive patients who are carriers and noncarriers of the different genotypic combinations for the LSS (lanosterol synthase) and UMOD (uromodulin) genes in response to Spironolactone or Torasemide **Measure:** difference in the change of systolic blood pressure(deltaSBP) **Time Frame:** week 4 vs. week 0 #### Secondary Outcomes **Description:** the difference in the reduction of diastolic blood pressure (deltaDBP) values in essential hypertensive patients who are carriers and noncarriers of the different genotypic combinations for the LSS (lanosterol synthase) and UMOD (uromodulin) genes in response to Spironolactone or Torasemide **Measure:** difference in diastolic blood pressure change after treatment with Spironolactone or difference in diastolic blood pressure reduction (deltaDBP) **Time Frame:** week 4 vs. week 0 **Description:** variation of plasma aldosterone levels in the different genotypic and treatment groups after 4 weeks of treatment. **Measure:** variation of plasma aldosterone **Time Frame:** week 4 vs. week 0 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * male (25-65 years) and female (45-65 years in menopause defined as "12 consecutive months of amenorrhea for which no other physiological or pathological cause has been identified in woman over 45 years of age") * newly diagnosed hypertensive patients never treated before or on single antihypertensive drug therapy * hypertension grade I or II (according to 2013 ESH guidelines, in the patient untreated or despite therapy), defined as the following: * at visits T-4 and T-2 (week -4 and week -2 ± 7 days, run-in period) the mean of the last 3 consecutive SBP measurements must be \>=140 mmHg and/or diastolic BP\>= 90mmHg * at the T0 visit (week 0 ± 7 days, enrollment), the mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg and \<180 mmHg and diastolic BP must be \>=90 mmHg and \<110 mmHg * signing of the informed consent for participation in the study and for genotyping. Exclusion Criteria: * known causes of secondary hypertension * stage II hypertension (SBP\>= 180 and SBP\>=110 mmHg * history of renal artery stenosis * significant kidney disease (eGFR-CK-EPI less than 60 mL/min) * refractory hypokalemia or hyponatremia (Napl \< 126 mEq/L) * hyperkalemia (K \> 5.5 mEq/l) * hypercalcemia * symptomatic hyperuricemia * liver disease (transaminases greater than 3 times the maximum laboratory value) * cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.) * diabetes (fasting blood sugar \>126mg/dL) -. current statin treatment * obesity (BMI \>30 kg/m2) * ongoing pregnancy * breastfeeding in progress * anuria * hypovolemia and dehydration * known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients * ongoing therapy with aminoglycosides or cephalosporins * participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug * patients unable to express valid consent **Maximum Age:** 65 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Milan **Country:** Italy **Facility:** San Raffaele Hospital **State:** Lombardia **Zip:** 20132 **Location 2:** **City:** Milan **Country:** Italy **Facility:** IRCCS Ospedale San Raffaele **Zip:** 20132 #### Overall Officials **Official 1:** **Affiliation:** San Raffaele Hospital Milan, Italy **Name:** Paolo Manunta, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** IDP will be stored in the institutional repository. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000004198 - Term: Disease Susceptibility - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M1470 - Name: Essential Hypertension - Relevance: LOW - As Found: Unknown - ID: M21875 - Name: Genetic Predisposition to Disease - Relevance: HIGH - As Found: Genetic Predisposition - ID: M7380 - Name: Disease Susceptibility - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000020022 - Term: Genetic Predisposition to Disease ### Intervention Browse Module - Ancestors - ID: D000000451 - Term: Mineralocorticoid Receptor Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000062865 - Term: Diuretics, Potassium Sparing - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000049994 - Term: Sodium Potassium Chloride Symporter Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1912 - Name: Torsemide - Relevance: HIGH - As Found: Behavioral counseling - ID: M15943 - Name: Spironolactone - Relevance: HIGH - As Found: Wrist - ID: M3797 - Name: Mineralocorticoid Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M11871 - Name: Mineralocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M26153 - Name: Sodium Potassium Chloride Symporter Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077786 - Term: Torsemide - ID: D000013148 - Term: Spironolactone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413069 **Acronym:** AGAMEMNON **Brief Title:** Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON) **Official Title:** Effects of Almonds in Glucose-intolerant Adults - a Randomised Controlled Study on Muscle Mass and Obesity, Energy Metabolism and Lipidome, NON-alcoholic Fatty Liver and Inflammation (AGAMEMNON) #### Organization Study ID Info **ID:** AGAMEMNON #### Organization **Class:** OTHER **Full Name:** Charite University, Berlin, Germany ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-01-29 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Almond Board of California #### Lead Sponsor **Class:** OTHER **Name:** Charite University, Berlin, Germany #### Responsible Party **Investigator Affiliation:** Charite University, Berlin, Germany **Investigator Full Name:** Stefan Kabisch **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:** Tree nuts - such as almonds - contribute to beneficial effects of the Mediterranean diet on risk for cardiovascular events, type 2 diabetes, dyslipidemia, hypertension, inflammation and non-alcoholic fatty liver disease. Almonds provide few carbohydrates, but lots of unsaturated fat and dietary fiber. But to which extent and by which mechanisms may almonds improve all aspects of the Metabolic Syndrome? Previous clinical trials showed weaker effects than rodent studies, most possibly due to low statistical power and metabolically insusceptible patients. The 3-year AGAMEMNON project aims to investigate, if 16 weeks of supplementation with almonds (vs. no treatment) in 150 patients with prediabetes and NAFLD leads to significant improvements in glycemia and liver fat, lipid metabolism, body composition and inflammation. The isocaloric design will outrule effects of weight loss and will allow the analysis of metabolic pathways between fat depots, inflammation, insulin resistance and gut function. Lipidomics are assessed as novel predictor of disease progression and metabolic response. **Detailed Description:** Background / Significance: T2D affects 5-10 % of the global population, challenging societies, health systems, economy and quality of life. Dietary treatment may avoid disease burdens, save money and protect general health resources, but is often limited to unspecific weight loss recommendations and advise for physical activity. Despite being the common advice, body weight reduction is faced with inconclusive evidence for its impact on long-term risks (obesity paradox?), lack of long-term compliance and irresponsive or ineligible subgroups of patients. The Mediterranean diet provides the ideal dietary composition and reduces CVD risk, improving every axis of the Metabolic Syndrome, including liver fat. It is unclear, though, to which extent tree nuts contribute to this effect. In meta-analyses, almonds improve glycemia and lipids. Benefits on body composition and inflammation are also expected, these might extend to NAFLD. n6-PUFAs (typical components of tree nuts) reduce T2D risk and liver fat in humans. This was shown for sunflower oil, but not yet for nuts. Evidence for NAFLD benefits by almonds in humans is limited to observational studies, post-hoc analyses of mixed interventions, and underpowered RCTs. Aims / Rationale: Nuts are safe for NAFLD patients. Previous data indicate, that almonds may elicit benefits on glycemia and liver fat in patients susceptible to this treatment. Therefore, the investigators' project aims to investigate whole almonds as dietary treatment for glucose intolerance and NAFLD in patients with this typical combined phenotype. NAFLD independently predicts T2D progression and late complications. (Pre)diabetes patients with NAFLD are at higher risk for the entire metabolic syndrome and for early onset of nephropathy and CVD. On the other hand, prediabetes/T2D patients with NAFLD are also especially susceptible to lifestyle treatments. The investigators hypothesize to detect benefits of almonds with respect to glycemia and liver fat, but also lipid metabolism, body composition and inflammation compared to standard diet. Treatment period of 16 weeks is longer than earlier almond studies. The investigators intend to show, that the metabolic improvement is independent from weight loss and, even in the opposite, supports maintenance of muscle mass. The research group wants to investigate mechanistic links between the metabolic pathways of visceral fat accumulation, inflammation, NAFLD, insulin resistance, dyslipidemia and the gut microbiome. Finally, the investigators aim to assess the lipidome (analysed from the erythrocyte membranes, full blood and plasma samples), which was recently established as a novel biomarker to predict disease progression, metabolic response and treatment-specific improvement. ### Conditions Module **Conditions:** - PreDiabetes - NAFLD **Keywords:** - almonds - dietary treatment - diabetes prevention - metabolic syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** parallel, single-blinded, prospective, randomised controlled trial in waiting list design ##### Masking Info **Masking:** DOUBLE **Masking Description:** masking not possible; subjects are aware of their allocation after initiation of the intervention **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. **Intervention Names:** - Dietary Supplement: Raw whole almonds **Label:** Almond treatment **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients of the no-nut group will receive 6,7 kgs of almonds after completing 16 weeks of waiting time, supporting their compliance as untreated group. **Label:** Control condition **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Almond treatment **Description:** Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. Patients of the no-nut group will receive 6,7 kgs of almonds after finishing the study, supporting their compliance as untreated group. **Name:** Raw whole almonds **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** change in liver fat content (magnetic resonance spectroscopy) **Measure:** Liver fat content **Time Frame:** 16 weeks **Description:** change in concentration of fasting plasma glucose **Measure:** concentration of fasting plasma glucose **Time Frame:** 16 weeks **Description:** change in concentration of 2-h plasma glucose (75 g oGTT) **Measure:** concentration of 2-h plasma glucose (75 g oGTT) **Time Frame:** 16 weeks #### Secondary Outcomes **Description:** change in whole body fat content **Measure:** whole body fat content (%; measured with BIA) **Time Frame:** 16 weeks **Description:** change in whole body fat content **Measure:** whole body fat content (kg; measured with BIA) **Time Frame:** 16 weeks **Description:** change in insulin sensitivity (Matsuda) **Measure:** insulin sensitivity (Matsuda) **Time Frame:** 16 weeks **Description:** change in insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion **Measure:** insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion **Time Frame:** 16 weeks **Description:** change in blood pressure (sys/dia) **Measure:** blood pressure (sys/dia) **Time Frame:** 16 weeks **Description:** change in serum concentration of CRP **Measure:** serum concentration of CRP **Time Frame:** 16 weeks **Description:** change in serum concentration of IL-6 **Measure:** serum concentration of IL-6 **Time Frame:** 16 weeks **Description:** change in serum concentration of IL-10 **Measure:** serum concentration of IL-10 **Time Frame:** 16 weeks **Description:** change in serum concentration of IL-1ß **Measure:** serum concentration of IL-1ß **Time Frame:** 16 weeks **Description:** change in serum concentration of IL-18 **Measure:** serum concentration of IL-18 **Time Frame:** 16 weeks **Description:** change in serum concentration of IL-22 **Measure:** serum concentration of IL-22 **Time Frame:** 16 weeks **Description:** change in fasting triglyceride levels **Measure:** fasting triglyceride levels **Time Frame:** 16 weeks **Description:** change in LDL, HDL, LDL/HDL ratio **Measure:** LDL, HDL, LDL/HDL ratio **Time Frame:** 16 weeks **Description:** change in serum lipidome (hundreds of lipid species) **Measure:** concentration of serum lipidome parameters (hundreds of lipid species) **Time Frame:** 16 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples * NAFLD (MR-S: \>5,56 %) * BMI between 25 and 40 kg/m² Exclusion Criteria: * Treatment with antidiabetic drugs * Overt diabetes mellitus of any kind * Severe cardiovascular or pulmonary disorder * Renal disorder / Renal insufficiency (eGFR \< 60 ml/min/m²) * Severe psychiatric disorder (schizophrenia, severe depression; eating disorders) * Current or recent (\< 5 years) cancer diagnosis * Liver disease other than NAFLD * Use of corticosteroid treatments * Alcohol abuse * Smoking * Ongoing or recently finished (3 months before) weight loss * Current participation in other intervention studies * Pregnancy * Metal implants, claustrophobia * Allergy to almonds **Maximum Age:** 70 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** stefan.kabisch@charite.de **Name:** Stefan Kabisch, Dr. med. **Phone:** 0049-30-450514 **Phone Ext:** 429 **Role:** CONTACT **Contact 2:** **Email:** felizitas.kalinowski@charite.de **Name:** Felizitas Kalinowski **Phone:** 0049-30450514 **Phone Ext:** 428 **Role:** CONTACT #### Locations **Location 1:** **City:** Berlin **Contacts:** ***Contact 1:*** - **Email:** stefan.kabisch@charite.de - **Name:** Stefan Kabisch, Dr. med. - **Phone:** 030 450 514 429 - **Role:** CONTACT **Country:** Germany **Facility:** Charite University Hospital Berlin **Status:** RECRUITING **Zip:** 12203 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetes - ID: M20295 - Name: Glucose Intolerance - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M8375 - Name: Fatty Liver - Relevance: LOW - As Found: Unknown - ID: M30540 - Name: Non-alcoholic Fatty Liver Disease - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T5868 - Name: Visceral Steatosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011236 - Term: Prediabetic State ### 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:** NCT06413056 **Brief Title:** Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection **Official Title:** Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial #### Organization Study ID Info **ID:** micafungin in neonates #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2023-08-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-20 **Type:** ACTUAL #### Start Date **Date:** 2022-10-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-03-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Mariam Ibrahim **Investigator Title:** Assistant Professor of Paediatrics, Ain Shams university **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The incidence of fungal infection has increased dramatically over the past few decades.This is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . The resistance to antifungal agents has increased. This study will assess the efficacy of micafungin versus amphotericin B in neonates with positive fungal culture. **Detailed Description:** Neonatal candidiasis is associated with significant mortality and morbidity and high rates of neuro-developmental impairment on follow up Prevalence of invasive fungal infection (IFI) has increased in neonates during the last two decades due to increased survival rate even in the extremely premature neonates. Candida albicans and Candida parapsilosis are responsible for the majority of candidiasis in the neonatal intensive care unit (NICU) According to the European Society for Clinical Microbiology and Infectious Diseases (ESCMID)guidelines published in 2012, Micafungin, amphotericin B deoxycholate, and fluconazole are recommended as first line treatment of invasive candidiasis in neonates Currently, fluconazole and micafungin are among the most frequently used antifungal agents for the treatment of neonatal invasive candidiasis High dose of micafungin (8 to 15 mg/kg/day) can be used with neonates and infant with invasive candidiasis In this study we will explore the effectiveness and safety of micafungin for treatment of candidiasis after fluconazole for preterm neonates with invasive fungal infection and to compare it with amphotericin B. ### Conditions Module **Conditions:** - Neonatal Infection - Invasive Fungal Infections **Keywords:** - preterm - neonate - invasive fungal infection - micafungin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Primary aim; to study the effectiveness of micafungin in treatment of fungal infection in preterm neonates. Secondary aim; to test the safety of micafungin in treatment of fungal infection in preterm neonates. Tertiary aim; to compare the effectiveness and safety of micafungin versus amphotericin B in treatment of invasive fungal infection. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Randomized controlled, Double Blinded Clinical Trial. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive micafungin at a dose of 8 mg/kg/day for 14 day (Auriti et al., 2016). **Intervention Names:** - Drug: Micafungin **Label:** micafungin group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive amphotericin B at a dose of 1 mg /kg/day for 14 days (chen et al.,2019). **Intervention Names:** - Drug: Amphotericin B **Label:** amphotericin B group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - micafungin group **Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive either micafungin or amphotericin B **Name:** Micafungin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - amphotericin B group **Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. **Name:** Amphotericin B **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** negative blood culture **Measure:** resolution of fungal infection **Time Frame:** 14 days #### Secondary Outcomes **Description:** drug complications **Measure:** complication **Time Frame:** one month **Description:** hospital stay **Measure:** morbidity **Time Frame:** one month **Description:** death **Measure:** mortality **Time Frame:** one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient less than 36 weeks gestational age * started fluconazole either prophylactic or therapeutic dose * and blood culture is positive for fungal infection. Exclusion Criteria: * Any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in AST, ALT, alkhaline phosphatase * Any neonate hypertensive, neutropenic, thrombocytopenic * Any neonate with elevated renal function * Any neonate with arrythmia **Maximum Age:** 28 Days **Minimum Age:** 1 Day **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Ain Shams University Hospitals **State:** Abbassia ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: HIGH - As Found: Fungal Infections - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M1099 - Name: Invasive Fungal Infections - Relevance: HIGH - As Found: Invasive Fungal Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000009181 - Term: Mycoses - ID: D000072742 - Term: Invasive Fungal Infections ### Intervention Browse Module - Ancestors - ID: D000000563 - Term: Amebicides - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000935 - Term: Antifungal Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4002 - Name: Amphotericin B - Relevance: HIGH - As Found: Seen - ID: M255436 - Name: Liposomal amphotericin B - Relevance: HIGH - As Found: Seen - ID: M1829 - Name: Micafungin - Relevance: HIGH - As Found: Triggered - ID: M18296 - Name: Fluconazole - Relevance: LOW - As Found: Unknown - ID: M3904 - Name: Amebicides - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial 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 ### Intervention Browse Module - Meshes - ID: D000000666 - Term: Amphotericin B - ID: C000068538 - Term: Liposomal amphotericin B - ID: D000077551 - Term: Micafungin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413043 **Brief Title:** Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy **Official Title:** Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy: A Randomized Control Trial #### Organization Study ID Info **ID:** PG Thesis/2023-24/122 #### Organization **Class:** OTHER **Full Name:** All India Institute of Medical Sciences, Bhubaneswar ### Status Module #### Completion Date **Date:** 2025-11-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** All India Institute of Medical Sciences, Bhubaneswar #### Responsible Party **Investigator Affiliation:** All India Institute of Medical Sciences, Bhubaneswar **Investigator Full Name:** Sandip Kumar Sahu **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors. **Detailed Description:** The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors. ### Conditions Module **Conditions:** - Thyroid Eye Disease - Graves Ophthalmopathy **Keywords:** - Thyroid Eye Disease - Graves Ophthalmopathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 78 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease **Intervention Names:** - Drug: Selenium **Label:** ADD on Selenium **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Vitamin B Complex supplementation with Standard Treatment for Grave's Disease **Label:** Placebo **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - ADD on Selenium **Description:** Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease **Name:** Selenium **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy, with Best corrected visual Acuity, Clinical activity Score (CAS ), Increase in measured proptosis (bulging of the eyes) \> 2 mm over 1-3 months. Decrease in eye movement limit of \> 8° over 1-3 months. Decrease in visual acuity (2 Snellen chart lines) over 1-3 months. A CAS score greater than 4 is associated with active disease. The positive predictive value of CAS \> 4 is approximately 80%, and the negative predictive value is around 64% **Measure:** To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy **Time Frame:** 90 Days #### Secondary Outcomes **Description:** To study the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns, through the World Health Organization Quality of Life Brief Version- Brief(WHOQOL-BRIEF) questionnaire. The 4 domain scores are each converted into a scale from 0 to 100. For this purpose, the number 4 is subtracted from each of the domain scores, and the difference is multiplied by 100/16 or the number 6.25. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain. Thus, the patient's physical, psychological, social, and environmental state of health are assessed separately. **Measure:** the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns **Time Frame:** 90 Days **Description:** Anomaloscopes are optical instruments in which the observer must manipulate stimulus control knobs to match two colored fields in color and brightness. Measurement Unit: Typically, color vision is assessed qualitatively (normal or deficient). Minimum Value: Normal color vision (able to perceive a wide range of colors). Maximum Value: Color vision deficiency (varies based on the type of deficiency). **Measure:** To Assess the Colour Vison **Time Frame:** 90 Days **Description:** Fundus Examination: Measurement Unit: No specific unit; it's a visual assessment. Minimum Value: Normal fundus appearance (no abnormalities). Maximum Value: Various abnormalities (e.g., diabetic retinopathy, hypertensive retinopathy). **Measure:** To Assess the Fundus **Time Frame:** 90 Days **Description:** Thyroid Function Test: TSH: Normal range is approximately 0.4 to 4.0 μIU/mL. T4: Normal range is around 4.5 to 11.2 μg/dL. T3: Normal range varies but is generally 80 to 200 ng/dL **Measure:** To Examine Thyroid Function Test **Time Frame:** 90 Days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group \>18years With only one or more : * Retraction of lid \<2 mm * Mild soft tissue involvement * Proptosis of \<=3 mm * Corneal exposure that responds to lubricating eyedrops. * Patients with CAS \< = 4 * Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs. * Those who are willing to follow the advised treatment and timely follow ups. Exclusion Criteria: * Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation. * Any treatment with rituximab * Any earlier treatment with teprotumumab. * Any treatment with monoclonal antibody within 3months before presentation. * Lactating or pregnant women **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ophthal_sandip@aiimsbhubaneswar.edu.in **Name:** Sandip Sahu Dr Associate Professor, MS **Phone:** +917978243970 **Role:** CONTACT #### Locations **Location 1:** **City:** Bhubaneswar **Contacts:** ***Contact 1:*** - **Email:** iec@aiimsbhubaneswar.edu.in - **Name:** Ashutosh Biswas Director, MD - **Phone:** 917978243970 - **Role:** CONTACT **Country:** India **Facility:** AIIMS Bhubaneswar **State:** Odisha **Zip:** 751019 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bartalena L, Tanda ML. Current concepts regarding Graves' orbitopathy. J Intern Med. 2022 Nov;292(5):692-716. doi: 10.1111/joim.13524. Epub 2022 Jun 1. **PMID:** 35604323 **Citation:** Burch HB, Perros P, Bednarczuk T, Cooper DS, Dolman PJ, Leung AM, Mombaerts I, Salvi M, Stan MN. Management of thyroid eye disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022 Dec 8;11(6):e220189. doi: 10.1530/ETJ-22-0189. Print 2022 Dec 1. **PMID:** 36479875 **Citation:** Lanzolla G, Marino M, Marcocci C. Selenium in the Treatment of Graves' Hyperthyroidism and Eye Disease. Front Endocrinol (Lausanne). 2021 Jan 26;11:608428. doi: 10.3389/fendo.2020.608428. eCollection 2020. **PMID:** 33574798 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000006111 - Term: Graves Disease - ID: D000005094 - Term: Exophthalmos - ID: D000009916 - Term: Orbital Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000006042 - Term: Goiter - ID: D000006980 - Term: Hyperthyroidism - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Ophthalmopathy - ID: M26148 - Name: Graves Ophthalmopathy - Relevance: HIGH - As Found: Graves Ophthalmopathy - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M9214 - Name: Graves Disease - Relevance: LOW - As Found: Unknown - ID: M8237 - Name: Exophthalmos - Relevance: LOW - As Found: Unknown - ID: M12845 - Name: Orbital Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M9147 - Name: Goiter - Relevance: LOW - As Found: Unknown - ID: M10031 - Name: Hyperthyroidism - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005128 - Term: Eye Diseases - ID: D000049970 - Term: Graves Ophthalmopathy ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014131 - Term: Trace Elements - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M15455 - Name: Selenium - Relevance: HIGH - As Found: Repetitive Transcranial Magnetic Stimulation - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - 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: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000012643 - Term: Selenium ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413030 **Acronym:** SGSF **Brief Title:** Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community **Official Title:** Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community #### Organization Study ID Info **ID:** CEC_FP_2023023 #### Organization **Class:** OTHER **Full Name:** University of Americas ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Americas #### Responsible Party **Investigator Affiliation:** University of Americas **Investigator Full Name:** Karen Córdova-León **Investigator Title:** Academic Leader **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 observational study is to evaluate the relationship of gait speed with dynapenic or sarcopenic obesity in community-dwelling older people. The main questions it aims to answer are: * Is slow walking speed related to overweight in older people in the community? * Is slow walking speed related to dynapenic obesity in older people in the community? * Is gait speed related to sarcopenic obesity in older people in the community? Participants will answer a clinical interview to obtain sociodemographic data and will perform the following clinical tests: (1) 10-meter walk test, (2) Anthropometric measurement; (3) Handgrip dynamometry test, (4) Standing dynamometry test and (5) Physical functionality questionnaires. ### Conditions Module **Conditions:** - Frailty - Obesity - Sarcopenia - Sarcopenic Obesity - Gait Speed **Keywords:** - aged - Aged, 80 and over ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 383 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Persons over 60 years of age attending primary health care centers in the Bio Bio Region of Chile. **Intervention Names:** - Diagnostic Test: 10 Meter Walk Test **Label:** Community-dwelling older adults ### Interventions #### Intervention 1 **Arm Group Labels:** - Community-dwelling older adults **Description:** Gait Speed Test **Name:** 10 Meter Walk Test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** A well-lit, unobstructed flat corridor with an extension of 10 meters is used for the test. Ground markings are added at 0 and 10 meters apart, with 2 meters start (acceleration) and 2 meters end (deceleration) added to allow participants room to accelerate and decelerate their walk outside the data collection area to help reduce the gait variability introduced during these phases. Subjects were instructed to walk at a usual and comfortable speed, without running or stopping. Subjects are allowed to use usual technical aids for walking, including walkers or canes if required. Chronometers based on smartphones to time the route between the second and third line of the route that consists of the 10 timed meters. The stopwatch records the time at which the subject's toe crossed the line. This sequence is repeated three times with 1 minute rest periods. The average of the three trials is used to determine the walking speed. **Measure:** Gait Speed **Time Frame:** Month 1 **Description:** Biospace Inbody: Individuals are placed in a standing position with 30º flexion of the scapulo-humeral joint. 8 electrodes are used located on: feet (metatarso-calcaneus) and hands (metacarpals 2nd-5th finger and phalanx of the thumb). The induction frequency is assessed with 6 different intensities (1, 5, 50, 250, 500 kHz and 1 MHz), with a fat mass estimation sensitivity of 0.1 kg (0.1%). From this measurement we obtain: percentage of muscle mass, percentage of general fat, percentage of visceral fat and bone weight. **Measure:** Anthropometric measures **Time Frame:** Month 1 **Description:** To evaluate manual muscle strength, the Baseline handgrip dynamometer will be used. The assessment is carried out with the subject in a seated position in a chair without armrests, with the back and feet adequately supported on the floor while the hips and knees are at 90°. The position was with shoulders adducted and neutrally rotated, elbows flexed at 90° and forearms in a neutral position. We began by evaluating the dominant hand by positioning the wrist between 15 and 30° of extension and between 0° and 15° of ulnar deviation. The dynamometer must be used in a vertical position, and parallel to the forearm, while the participant grips the handle with a thumbs up. 3 repetitions were performed for each limb, obtaining an average of the measurements, the grip time will be 3 to 6 seconds with a rest time of 1 minute, using the best value for data analysis. **Measure:** Handgrip dynamometry **Time Frame:** Month 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects over 60 years of age * Female and male * Self-sufficient in the instrumental activities of daily living * Subjects with or without drug consumption, capable of carrying out the activity of walking independently or dependent on technical aids. Exclusion Criteria: * Subjects with acute musculoskeletal injuries of the lower extremity. **Healthy Volunteers:** True **Minimum Age:** 60 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Older people who live in the community and attend primary health care centers in the Bio Bio Region of Chile. ### Contacts Locations Module #### Locations **Location 1:** **City:** Concepción **Country:** Chile **Facility:** Universidad de las Américas #### Overall Officials **Official 1:** **Affiliation:** Academic **Name:** Karen Córdova-León, PT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All collected IPD **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **URL:** https://drive.google.com/drive/folders/1MfnO_AQUoTkjYsOZ1DKZ8vQrZhxsQiyN?usp=sharing ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000010335 - Term: Pathologic Processes - ID: D000009133 - Term: Muscular Atrophy - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M12090 - Name: Muscular Atrophy - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055948 - Term: Sarcopenia - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000073496 - Term: Frailty ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413017 **Brief Title:** Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure **Official Title:** Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail #### Organization Study ID Info **ID:** Nim-PC-7 #### Organization **Class:** OTHER **Full Name:** Tianjin Medical University Cancer Institute and Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tianjin Medical University Cancer Institute and Hospital #### Responsible Party **Investigator Affiliation:** Tianjin Medical University Cancer Institute and Hospital **Investigator Full Name:** Jihui Hao **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 is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy **Detailed Description:** This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity ### Conditions Module **Conditions:** - HCC ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment **Intervention Names:** - Drug: Nimotuzumab - Drug: ICIs(Immune checkpoint inhibitors) **Label:** Nimtuzumab combined ICIs **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nimtuzumab combined ICIs **Description:** Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity **Name:** Nimotuzumab **Other Names:** - h-R3 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Nimtuzumab combined ICIs **Description:** Use it as it is describe in the instructions from the specification **Name:** ICIs(Immune checkpoint inhibitors) **Other Names:** - PD-1 or PD-L1 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** （Objtective reseponse rate） **Measure:** ORR（Objtective reseponse rate） **Time Frame:** up to 24 month #### Secondary Outcomes **Description:** Time from the first dose to death **Measure:** OS（overall survival） **Time Frame:** up to 24 month **Description:** time form fist dose to tumor progression or death **Measure:** PFS（pregression free survival） **Time Frame:** up to 24 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma； * Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)； * Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ; * Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC; * Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1； * EGFR postive and RAS wildtype； Exclusion Criteria: * Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma； * History of hepatic encephalopathy within 6 months prior to the first dose of this study； * Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose； * Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable) **Maximum Age:** 79 Years **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gaochuntao@tjmuch.com **Name:** Chuntao Gao, Dr **Phone:** 022-2340123 **Phone Ext:** 022-2340123 **Role:** CONTACT #### Locations **Location 1:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** gaochuntao@tjmuch.com - **Name:** Chuntao Gao, MD - **Phone:** 022-2340123 - **Phone Ext:** 3077 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Medical University Cancer Institute and Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Tianjin Medical University Cancer Institute and Hospital **Name:** Jihui Hao, Dr **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: 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 ### 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 ### Condition Browse Module - Meshes - ID: D000008113 - Term: Liver Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: HIGH - As Found: Remitting - ID: M288889 - Name: Nimotuzumab - Relevance: HIGH - As Found: Details - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000501466 - Term: Nimotuzumab - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413004 **Brief Title:** Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS) **Official Title:** Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS) #### Organization Study ID Info **ID:** 2022-06370-02 #### Organization **Class:** OTHER **Full Name:** Sahlgrenska University Hospital, Sweden ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-08-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Magnus Simrén #### Responsible Party **Investigator Affiliation:** Sahlgrenska University Hospital, Sweden **Investigator Full Name:** Magnus Simrén **Investigator Title:** professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity. During this study, the investigators will perform either confocal laser endomiscroscopy (CLE) or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires. **Detailed Description:** The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients with and without Brachyspira infection using advanced imaging. The investigators hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity. Visit 1: inclusion, questionnaires, blood, rectal barostat examination Visit 2: questionnaires, blood, stool, diaries (food and stool), sigmoidoscopy (without laxantives) Allergologist visit (skin prick test and interpretation blood results) Visit 3: stool, confocal laser endomicroscopy (CLE) OR colonoscopic antigen provocation test (COLAP) Visit 4,5 and 6 only if the CLE or COLAP was positive for (at least) 1 food item Visit 4: questionnaires and dietician-led instruction which food item to exclude (positive food item(s) during CLE/COLAP), exclusion for 4 weeks Visit 5: questionnaires, stool diary, instructions re-introduction food item(s) Visit 6: questionnaires QUESTIONNAIRES Baseline questionnaires; demographic, symptoms, symptom/medication/diet history, co-morbid medical conditions IBS symptoms: IBS-Symptom Severity Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS)-IBS Psychological distress: Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ)-9 (both visit 1,4,5,6, generalized Anxiety Disorder 7-item scale (GAD-7) Somatization: PHQ-15 for the number and severity of bodily symptoms. Gastrointestinal specific anxiety: Visceral Sensitivity Index (VSI). Sensitivity: Central Sensitization Inventory (CSI). Food avoidance and restriction: (ARFID). Stool habits and GI symptoms: 14-day GI symptom diary based on Bristol Stool Form Scale (BSFS). Quality of life: IBS-Quality of Life (QOL). Food intake: 4-days food diary, MealQ. COLONOSCOPIC ALLERGEN PROVOCATION TEST, COLAP: * A local allergen provocation test, where dietary antigens (soy, wheat, (egg), gluten and milk), with saline and histamine as negative and positive controls, respectively are injected in the rectosigmoid mucosa (similar to skin prick test used for clinical allergy testing). * The intestinal reaction is determined visually ("wheal and flare reaction"), and biopsies are taken to characterize the immune response. * Bowel preparation before the investigation follows the normal clinical routine for colonoscopy, and i.v. sedatives and opioids are given during the investigation according to clinical routines at the endoscopy unit CONFOCAL LASER ENDOMICROSCOPY, CLE, gastroscopy: * A probe-based endoscopic technique to study intestinal food reactions after iv injection of fluorescein. * Disruption of the small intestinal barrier in duodenum upon exposure to food antigens (soy, wheat, egg, gluten, milk, and control) can be determined. VISCERAL SENSITIVITY: •Rectal barostat sensitivity measurement: With the rectal barostat, the investigators can measure the rectal sensitivity. A balloon is inserted and inflated in the rectum in a controlled setting. The patient indicates when defined sensory thresholds are reached (first feeling of the balloon, urge to empty bowel, discomfort or pain). When the patient indicates discomfort or pain, or another reason to stop, the balloon inflation will be stopped. SIGMOIDOSCOPY: •Flexible sigmoidoscopy without bowel preparation, to interfere as little as possible with the normal gut microenvironment; fresh biopsies for specific analyses and biopsies stored for subsequent analyses. BIOLOGICAL SAMPLES: * Blood - and plasma samples: Fasting blood samples are taken for routine blood tests (exclusion of organic diseases) and to determine the metabolic profile and genetic and immunological markers of relevance to intestinal function and nerve function. Serum samples will be analyzed with nuclear magnetic resonance (NMR) for metabolomic profile and microbial composition. * Fecal - and urine sample: The investigators will characterize the composition and function of the metabolome in detail via 16S analysis, metagenomics, transcriptomics, metabolomics, cell culture and cell count. Urine and fecal samples will also be analyzed with nuclear magnetic resonance (NMR) for metabolomic profile and microbial composition. * Biopsies (location based on the performed endoscopic examination): The investigators will conduct a detailed analysis of immune cells, proteins, nerve cells, and intestinal bacteria which will allow detailed mapping of intestinal function with respect to nerve, immune and barrier function. ### Conditions Module **Conditions:** - Irritable Bowel Syndrome - Food Sensitivity **Keywords:** - Irritable Bowel Syndrome - Food Sensitivity - Confocal Laser Endomicroscopy - Colonoscopic Antigen Provocation Test ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Unblinded elimination and re-introduction of a positive tested food item, identified during CLE or COLAP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The food item(s) which were positive during CLE (fluorescein leakage and cell shedding) or COLAP (swelling). **Intervention Names:** - Other: Elimination and re-introduction of CLE or COLAP positive food item(s) **Label:** Positive food item during CLE or COLAP **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Positive food item during CLE or COLAP **Description:** Elimination (4 weeks) and re-introduction (4 weeks) of all CLE or COLAP positive food item(s) **Name:** Elimination and re-introduction of CLE or COLAP positive food item(s) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** the proportion of participants with an IBS-SSS reduction of ≥50 points, measured before (visit 4) and after (visit 5) exclusion of the CLE or COLAP positive food item(s) (= responders). IBS-SSS: higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500. **Measure:** IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion). **Time Frame:** 4 weeks after exclusion #### Secondary Outcomes **Description:** IBS-SSS: absolute change of IBS-SSS, measured before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500. **Measure:** IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (absolute) **Time Frame:** 4 weeks after exclusion **Description:** IBS-SSS: the proportion of participants with an IBS-SSS increase of ≥50 points, measured before (visit 5) and after (visit 6) the REINTRODUCTION of the CLE or COLAP positive food item(s): responders vs non-responders (as based on the primary outcome). Higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500. **Measure:** IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (proportion) **Time Frame:** 4 weeks after reintroduction **Description:** IBS-SSS: the absolute change of IBS-SSS, measured before (visit 5) and after (visit 6) the REINTRODUCTION of the CLE or COLAP positive food item(s): total group and responders vs non-responders (as based on the primary outcome) **Measure:** IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (absolute) **Time Frame:** 4 weeks after reintroduction **Description:** change of total and subscores before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher GSRS-IBS indicate more severe symptoms. After calculating of the average scores, those range 1-7. **Measure:** GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after exclusion **Time Frame:** 4 weeks after exclusion **Description:** change of total and subscores before (visit 5) and after (visit 6) REINTRODUCTION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher GSRS-IBS indicate more severe symptoms. After calculating of the average scores, those range 1-7. **Measure:** GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after reintroduction **Time Frame:** 4 weeks after reintroduction **Description:** change of total and subscores before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher HAD scores indicate more symtoms of anxiety and depression. Total score ranging 0-42 and the two subscores (anxiety and depression) ranging 0-21. **Measure:** HAD (Hospital Anxiety and Depression scale) after exclusion **Time Frame:** 4 weeks after exclusion **Description:** change of total and subscores before (visit 5) and after (visit 6) REINTRODUCTION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher HAD scores indicate more symtoms of anxiety and depression. Total score ranging 0-42 and the two subscores (anxiety and depression) ranging 0-21. **Measure:** HAD (Hospital Anxiety and Depression scale) after reintroduction **Time Frame:** 4 weeks after reintroduction **Description:** change of scores before (visit 4) and after (visit 5) EXCLUSION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher PHQ12 scores indicate more bothersome non-GI somatic symptoms. Scores ranging 0-24, with a subanalysis excluding mentrual problems, leading to a range 0-22. **Measure:** PHQ12 (the Patient Health Questionnaire - 12) after exclusion **Time Frame:** 4 weeks after exclusion **Description:** change of scores before (visit 5) and after (visit 6) REINTRODUCTION of the CLE or COLAP positive food item(s). Total group and responders vs non-responders (as based on the primary outcome). Higher PHQ12 scores indicate more bothersome non-GI somatic symptoms. Scores ranging 0-24, with a subanalysis excluding mentrual problems, leading to a range 0-22. **Measure:** PHQ12 (the Patient Health Questionnaire - 12) after reintroduction **Time Frame:** 4 weeks after reintroduction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with IBS diagnosis according to their treating physician (ROME IV). * Association between intake of food and GI symptoms. * Witnessed written informed consent prior to any study procedures. * Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements. Exclusion Criteria: * Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and active malignant disease (not those that were in remission at least 5 years). * Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility. * Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test). * Clinical history of severe allergic reactions. * Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year. * Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion. * Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** magnus.simren@medicine.gu.se **Name:** Magnus Simrén, MD PhD **Phone:** 0046313428107 **Role:** CONTACT **Contact 2:** **Email:** magtarmlab.su@vgregion.se **Name:** MagTarmlab office **Phone:** 0046313428107 **Role:** CONTACT #### Locations **Location 1:** **City:** Gothenburg **Contacts:** ***Contact 1:*** - **Email:** magtarmlab.se@vgregion.se - **Name:** MagTarmlab - **Phone:** +46 31 342 81 07 - **Role:** CONTACT ***Contact 2:*** - **Phone:** 00460313428107 - **Role:** CONTACT **Country:** Sweden **Facility:** Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital **Status:** RECRUITING **Zip:** 413 45 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-29 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 273244 - Type Abbrev: Prot - Upload Date: 2024-05-06T08:15 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000007154 - Term: Immune System Diseases - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Sensitivity - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000006967 - Term: Hypersensitivity - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412991 **Brief Title:** Pedal Movement - Implementing Cycling as a Mobility Option **Official Title:** Implementing Cycling as a Mobility Option for Operative and Non-operative Patients With Small Bowel Obstruction and Ileus Admitted by Northeast Acute Care Surgery at Atrium Health Cabarrus #### Organization Study ID Info **ID:** IRB00111263 #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **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:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cycling has been a proven exercise for decades as a low impact option to strengthen the lower body and improve cardiovascular health. There is also evidence that cycling helps to stimulate the contraction of the muscles in the intestine. Other outcomes frequently examined when considering benefits of ambulation include decreased rates of venous thromboembolic events, pneumonia, and decreased hospital length of stays. Therefore, there is added value to consider alternate mobility modalities. **Detailed Description:** Ileus is a common post operative occurrence, one that not only causes patient discomfort but also contributes to considerable economic impact and can potentially progress to other serious complications. Historically ileus has been difficult to define. Review of the literature produces a general definition to include a varying time frame upon which a patient is not tolerating an oral diet, unable to pass flatus or stool, symptoms of nausea, vomiting, and sometimes abdominal pain. Small bowel obstruction, while different pathophysiology than ileus, presents similar manifestations. Often ileus and small bowel obstruction follow the same pathway aimed at attempted resolution with attempts at conservative management. Efforts to resolve ileus and nonoperative small bowel obstruction include bowel rest, nasogastric decompression, and encouraging mobility. Many studies support the practice of mobilization through ambulation as an effort to encourage return of bowel function. What is lacking in review of the literature however are other modalities to offer the patient in efforts to assist and encourage patients to mobilize outside of ambulation. ### Conditions Module **Conditions:** - Ileus **Keywords:** - bowel function - bowel obstruction - cycle therapy - mobility ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Any patient admitted to the NorthEast Acute Care Surgery service on the Post Surgical Care 1 unit diagnosed with ileus, non-operative small bowel obstruction, or has had bowel surgery and with post operative small bowel obstruction and/or ileus. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patient will either ambulate a short distance to recumbent bike which will be stored on the postsurgical 1 unit or be assisted out of bed to use floor cycle bike. After the patient demonstrates individual competency with either cycle modality, the patient may participate in this activity with nursing staff but will not require Physical Therapy (PT) presence at the time of use. This will allow the patient to participate multiple times a day if they choose. **Intervention Names:** - Behavioral: Cycle Therapy **Label:** Cycle therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** ambulation by surgical team **Label:** ambulation as mobilization modality **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Cycle therapy **Description:** The patient will either ambulate a short distance to recumbent bike which will be stored on the postsurgical 1 unit or be assisted out of bed to use floor cycle bike. **Name:** Cycle Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Length of time to first Bowel Movement **Measure:** Length of time to first Bowel Movement (BM) **Time Frame:** Day 30 **Description:** Length of time to first flatus **Measure:** Length of time to first flatus **Time Frame:** Day 30 #### Secondary Outcomes **Description:** VTE occurrence within 30 days post discharge **Measure:** Rates of Venous thromboembolism (VTE) **Time Frame:** Day 30 **Description:** Pneumonia occurrence within 30 days post discharge **Measure:** Rates of pneumonia **Time Frame:** Day 30 **Description:** Length of hospital stay **Measure:** Hospital length of stay **Time Frame:** Day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Admission to NorthEast Acute Care Surgery * Admitted on Post Surgical Care 1 unit * Diagnosis of small bowel obstruction * Diagnosis of ileus * Any patient that has had intestinal surgery * Age 18-90 Exclusion Criteria: * Age \< 18 * Pregnancy * Incarceration * Non-English speaking **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mallory.ragan@atriumhealth.org **Name:** Mallory Royall, NP, DNP **Phone:** 704.403.7070 **Role:** CONTACT #### Locations **Location 1:** **City:** Concord **Contacts:** ***Contact 1:*** - **Email:** mallory.ragan@atriumhealth.org - **Name:** Mallory Royall, NP, DNP - **Phone:** 704-403-7070 - **Role:** CONTACT **Country:** United States **Facility:** Northeast Acute Care Surgery **State:** North Carolina **Zip:** 28025 #### Overall Officials **Official 1:** **Affiliation:** Wake Forest University Health Sciences **Name:** Mallory Royall, NP, DNP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007415 - Term: Intestinal Obstruction - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M25585 - Name: Ileus - Relevance: HIGH - As Found: Ileus - ID: M10449 - Name: Intestinal Obstruction - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000045823 - Term: Ileus ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412978 **Brief Title:** Post-Operative Cesarean Section Cosmesis **Official Title:** Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section #### Organization Study ID Info **ID:** IRB00109639 #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique. **Detailed Description:** Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis. ### Conditions Module **Conditions:** - Cesarean Delivery **Keywords:** - cosmetic improvement - surgical correction - Cosmesis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** trial comparing skin closure with absorbable subcuticular staples with subcuticular suture ##### Masking Info **Masking:** SINGLE **Masking Description:** Scars will be digitally photographed by study staff and scored by 2 independent judges. The judges will be blinded to the closure method at time of scar evaluation. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Insorb absorbable staples are used for skin closure **Intervention Names:** - Procedure: absorbable subcuticular polyglycolic acid staples (INSORB) **Label:** subcuticular absorbable polyglycolic acid (INSORB) staples **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Monocryl absorbable staples are used for skin closure **Intervention Names:** - Procedure: subcuticular, polyglecaprone suture (Monocryl) **Label:** subcuticular absorbable polyglecaprone suture (Monocryl) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - subcuticular absorbable polyglycolic acid (INSORB) staples **Description:** Insorb absorbable staples are used for skin closure **Name:** absorbable subcuticular polyglycolic acid staples (INSORB) **Other Names:** - INSORB **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - subcuticular absorbable polyglecaprone suture (Monocryl) **Description:** Monocryl absorbable staples are used for skin closure **Name:** subcuticular, polyglecaprone suture (Monocryl) **Other Names:** - Monocryl **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst). **Measure:** scar cosmetic score **Time Frame:** Week 6 #### Secondary Outcomes **Description:** wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence) **Measure:** Number of Wound complications **Time Frame:** Week 6 **Description:** days spent in hospital **Measure:** length of hospital stay **Time Frame:** Week 6 **Description:** amount of in-hospital intravenous opiate analgesic use **Measure:** amount of in-hospital intravenous opiate analgesic use **Time Frame:** Week 6 **Description:** amount of in-hospital oral NSAID analgesic use **Measure:** amount of in-hospital oral NSAID analgesic use **Time Frame:** Week 6 **Description:** amount of in-hospital oral opiate analgesic use **Measure:** amount of in-hospital oral opiate analgesic use **Time Frame:** Week 6 **Description:** patient rated subjective pain score (0-10 based on visual analog scale) - 100-mm visual analog scale (VAS) ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. **Measure:** patient rated subjective pain score **Time Frame:** Week 6 **Description:** The Patient and Observer Scar Assessment Scale (POSASA) All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). Higher scores meaning more scarring **Measure:** patient's overall satisfaction with cosmesis scores **Time Frame:** Week 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-44 * Any race * Any parity * Scheduled cesarean section * Neuraxial analgesia Exclusion Criteria: * Non-English Speaking * Incarcerated * Maternal Connective Tissue Disorder * Systemic maternal steroid use * Three prior cesarean deliveries * Body Mass Index (BMI) \>40 **Gender Based:** True **Gender Description:** Females requiring Cesarean Section **Healthy Volunteers:** True **Maximum Age:** 44 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ctulbert@wakehealth.edu **Name:** Christina Tulbert **Phone:** 336.716.2383 **Role:** CONTACT #### Locations **Location 1:** **City:** Winston-Salem **Contacts:** ***Contact 1:*** - **Email:** ctulbert@wakehealth.edu - **Name:** Christina Tulbert - **Phone:** 336-716-2383 - **Role:** CONTACT ***Contact 2:*** - **Name:** Joshua F Nitsche, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Wake Forest University Health Sciences **State:** North Carolina **Zip:** 27157 #### Overall Officials **Official 1:** **Affiliation:** Wake Forest University Health Sciences **Name:** Joshua F Nitsche, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Investigators whose propose use of the data that has been approved by an Institutional Review Board **Description:** All of the participant data collected during the trial and after deidentification **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Beginning 9 months and ending 36 months following article publication **URL:** https://ctulbert@wakehealth.edu ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412965 **Acronym:** Adelphi DSP **Brief Title:** Reliability of Rimegepant for the Acute Treatment of Migraine **Official Title:** Evaluation of the Reliability of Effect of Rimegepant for the Acute Treatment of Migraine Across Multiple Attacks #### Organization Study ID Info **ID:** C4951066 #### Organization **Class:** INDUSTRY **Full Name:** Pfizer ### Status Module #### Completion Date **Date:** 2024-01-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-03 **Type:** ACTUAL #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-16 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pfizer #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This protocol describes the analysis of the Adelphi Real World (ARW) Migraine Disease Specific Programme(TM) 2022, a cross-sectional study which used both physician and patient surveys to assess the perception of the acute treatment for migraine attacks. **Detailed Description:** This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant, to evaluate the satisfaction with Rimegepant, to evaluate willingness to continue using Rimegepant, and to explore proportion optimized on treatment with Rimegepant. The data will be extracted from the Adelphi Real World (ARW) Migraine Disease Specific ProgrammeTM (DSP) 2022 database, which was conducted across a number of countries including United States, between May 2022 and November 2022. The DSP was an observational study of clinical practice. Treatment practice data were collected by physicians (physician survey) who were asked to provide information for the next 10 patients consulting for migraine. These patients were then invited to fill out a self-completion form (patient survey) providing their own assessment on the disease and treatments. ### Conditions Module **Conditions:** - Migraine Disorders ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 91 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Physicians who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™ **Label:** Physician Survey #### Arm Group 2 **Description:** Patients who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™ **Label:** Patient survey ### Outcomes Module #### Primary Outcomes **Description:** Frequency of patients for which the physician reports that fail to achieve pain freedom at 2 hours post dose on more than half of occasions measured by using answers on the physician survey **Measure:** Failure to achieve pain freedom within 2 hours post dose (physician perspective) **Time Frame:** 2 hours post dose **Description:** Frequency of patients who reported migraine pain freedom within 2 hours post dosing in 0 out of every 5 attacks, 1 out of every 5 attacks, 2 out of every 5 attacks, 3 out of every 5 attacks, 4 out of every 5 attacks, or 5 out of every 5 attacks measured by using answers on the patient survey **Measure:** Number of migraine attacks acute treatment achieves pain freedom within 2 hours post dose (patient perspective) **Time Frame:** 2 hours post dose **Description:** Description of the reasons why the physician chooses the acute treatment considering the following domains: type of control and effects; formulation/dosage; quality of life; side effects and safety; patient types; and general attributes measured by using answers on the physician survey **Measure:** Reason for choice of current acute treatment - 'consistency of response after repeated use' (physician perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Frequency with which the physician is extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the patient´s acute treatment prescription measured by using answers on the physician survey **Measure:** Satisfaction with current acute treatment (physician perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Description of the reasons why the physician is not satisfied with patient´s treatment prescription measured by using answers on the physician survey **Measure:** Drivers for lack of satisfaction with current acute treatment (physician perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Frequency of patients who reported being extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the treatment for their migraine attacks measured by using answers on the patient survey **Measure:** Satisfaction with current acute treatment (patient perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Description of the reasons why the patients are not satisfied or extremely satisfied with their acute treatment measured by using answers on the patient survey **Measure:** Drivers for lack of satisfaction with current acute treatment (patient perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Frequency of patients who reported willingness to continue using their acute treatment, categorized into definitely yes, probably yes, do not know, probably not, or definitely not measured by using answers on the patient survey **Measure:** Patient willingness to continue use of acute treatment (patient perspective) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Mean and median of total scores. The mTOQ-6 score is calculated by summing individual question scores (score range of 6-24), with higher scores indicating better acute treatment optimization **Measure:** Migraine treatment optimization questionnaire (mTOQ6) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Frequency of each item with the response options (never, rarely, less than half of the time, or half of the time or more) **Measure:** Migraine Treatment Optimization Questionnaire (m-TOQ6) **Time Frame:** Over the last 3 months prior completing the survey **Description:** Frequency of patients who usually take their acute treatment: before any sign of a migraine attack, but in anticipation of one starting; or at the first sign of a migraine attack (before the pain starts); or when the pain starts; or after the pain has started and have an idea of how severe it is measured by using answers on the patient survey **Measure:** When patients takes acute prescription treatment **Time Frame:** Over the last 3 months prior completing the survey **Description:** Average number of days per month the patient takes the acute treatment measured by using answers on the patient survey **Measure:** How many days per month patient takes acute prescription treatment **Time Frame:** Over the last 3 months prior completing the survey ### Eligibility Module **Eligibility Criteria:** Inclusion criteria * Patients who have episodic and/or chronic migraine * Patients age \> 18 * Currently prescribed rimegepant for the acute treatment of migraine Exclusion criteria * currently prescribed rimegepant for prevention of migraine or for both the acute treatment \& prevention of migraine * Currently prescribed an acute treatment for migraine other than rimegepant **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Physician personally responsible for treatment decision of migraine patients were enrolled in the survey. Each physician then enrolled consecutive patients to complete a patient self-completion questionnaire. ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** Pfizer **State:** New York **Zip:** 10001 #### Overall Officials **Official 1:** **Affiliation:** Pfizer **Name:** Pfizer CT.gov Call Center **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** To obtain contact information for a study center near you, click here. **URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C4951066 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous 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: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412952 **Brief Title:** 68Ga-NOTA-RM26 PET/CT in Glioma Patients **Official Title:** 68Ga-NOTA-RM26 PET/CT in Glioma Patients #### Organization Study ID Info **ID:** PUMCH-68Ga-RM26 in Glioma #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College 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 investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT). **Detailed Description:** The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma. ### Conditions Module **Conditions:** - Glioma ### 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:** Inject 68Ga-Pentixafor and then perform PET/CT scan. **Intervention Names:** - Drug: 68Ga-RM26 **Label:** 68Ga-RM26, PET/CT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 68Ga-RM26, PET/CT **Description:** Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of 68Ga- RM26 will be used to image lesions of glioma by PET/CT. **Name:** 68Ga-RM26 **Other Names:** - 68Ga-GRPR antagonist **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT. **Measure:** SUVmax **Time Frame:** through study completion, an average of 1.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * suspected or confirmed untreated glioma patients * signed written consent. Exclusion Criteria: * pregnancy * breastfeeding * known allergy against Pentixafor * any medical condition that in the opinion of the investigator,may * significantly interfere with study compliance **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 13611093752@163.com **Name:** Zhaohui Zhu **Phone:** +8613611093752 **Role:** CONTACT **Contact 2:** **Email:** pumch_jacobwong@163.com **Name:** Rongxi Wang **Phone:** +8615584172170 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** pumch_jacobwong@163.com - **Name:** Zhaohui Zhu, MD - **Phone:** +8619800370331 - **Role:** CONTACT **Country:** China **Facility:** Chinese Academy of Medical Science & Peking Union Medical College Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Zhaohui Zhu **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - 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: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - 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: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M261652 - Name: 68Ga-NOTA-RM26 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412939 **Acronym:** Agile **Brief Title:** Retrospective Study on Clinical Performance and Safety Profile of Agile Nail **Official Title:** Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of Agile Nail in Paediatric Patients Who Have Suffered Femoral Shaft and Subtrochanteric Fractures or Have Performed Prophylactic Nailing of Impending Pathologic Fractures or Have Undergone Fixation of Femurs That Have Been Surgically Prepared for Deformity Correction: Agile Study #### Organization Study ID Info **ID:** OCI_2304 #### Organization **Class:** INDUSTRY **Full Name:** Orthofix s.r.l. #### Secondary ID Infos **Domain:** IRAS project ID (UK) **ID:** 335551 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Orthofix s.r.l. #### 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 aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals. **Detailed Description:** The study will be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of pediatric patients with femoral shaft and subtrochanteric fractures and deformity correction procedures or have performed prophylactic nailing of impending pathologic fractures, where the usage of AGILE NAIL (known as AGILE) was part of the normal clinical practice. Investigator of both study sites will provide data for a maximum of 45 patients meeting inclusion and exclusion criteria (Considering a drop-out or a non-evaluable rate of 10% of the procedures) that will contribute for approximately 45 procedures in which AGILE was used. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied. The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice. Therefore, patients will be retrospectively enrolled in the study. Patients who have undergone AGILE implantation from 04/2018 to 12/2022 are considered for the study. The observation period of study subjects will comprise from surgery until the last follow up visit available. Medical records of the participating sites are expected to contain all the required information. In United Kingdom, no study visit will be required but according to local legislation, it will be essential that before collecting any information from medical records, participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place. However, in France, due to the use of primary data and the foreseen exemption of the informed consent (IC) form (see Section 14.2 Informed Consent), no study visit will be required. ### Conditions Module **Conditions:** - Fractures, Bone - Impending Fracture - Deformity; Bone **Keywords:** - nail - intramedullary - rigid nail - pediatric ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The full analysis set includes all paediatric patients who that have been treated for femoral shaft and subtrochanteric fractures or have performed prophylactic nailing of impending pathologic fractures or have undergone fixation of femurs that have been surgically prepared for deformity correction with the Agile nail, that will be systematically consecutive screened at the centers. **Intervention Names:** - Device: Agile Nail **Label:** Patients in pediatric age (> 18 month and < 18 years) at the time of surgery ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients in pediatric age (> 18 month and < 18 years) at the time of surgery **Description:** Intramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation **Name:** Agile Nail **Other Names:** - Rigid intramedullary nail **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union **Measure:** Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit **Time Frame:** After 5 month (approximately) from surgery **Description:** The measurement will be used to assess efficacy **Measure:** Post-treatment fracture-free survival **Time Frame:** up to 1 year **Description:** The measurement will be used to assess efficacy **Measure:** Percentage of procedures in which deformity correction was maintained according to investigator's opinion (only for procedure where the indication is "Deformity Correction") **Time Frame:** from the date of surgery until the last follow-up, assessed up to 1 year **Description:** This outcome will be used to measure safety **Measure:** Percentage of procedures with at least one serious/not serious adverse event certainly related or possibly related to Agile Nail (ADEs/SADEs) **Time Frame:** from the date of surgery until the last follow-up, assessed up to 1 year **Description:** This outcome will be used to measure safety **Measure:** Percentage of procedures who experienced at least one MDDs that caused an effect on the patient **Time Frame:** from the date of surgery until the last follow-up, assessed up to 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient has been adequately informed by providing the PIS. 1.1 The patient expressed his willingness to participate in the Study by signing and dating informed consent (valid only for UK patients according to local law). 2. Patients who had a regular indication for surgical intervention with Agile Nail according to the manufacturer's IFU. 3. Patients in pediatric age ((\> 18 month and \< 18 years) at the time of surgery. 4. Patients skeletally immature. 5. Patients who underwent surgery performed with Agile Nail. 6. Patients with clinical data registered in her/him medical records sufficient to assess the safety and efficacy endpoint of the study: in particular, the patient has at least one followup at minimum 3 months from the surgery where is possible for the investigator to assess the consolidation of the treated bone. 7. The patient had surgery at least 1 year before enrollment. Exclusion Criteria: 1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet. 2. Patient who had/has a concomitant not permitted device which cannot be safely removed. 3. Patient for whom there are other concurrent medical or other conditions that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study. 4. The patient had surgery less than 1 year before enrollment. **Maximum Age:** 18 Years **Minimum Age:** 18 Months **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** The full analysis set includes all paediatric patients who that have been treated for femoral shaft and subtrochanteric fractures or have performed prophylactic nailing of impending pathologic fractures or have undergone fixation of femurs that have been surgically prepared for deformity correction with the Agile nail, that will be systematically consecutive screened at the centers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** EdoKnijff@orthofix.it **Name:** Edo Knijff **Phone:** +390456719000 **Role:** CONTACT **Contact 2:** **Name:** Tommaso Marano **Phone:** +390456719000 **Role:** CONTACT #### Locations **Location 1:** **City:** Leeds **Contacts:** ***Contact 1:*** - **Email:** patrick.foster@nhs.net - **Name:** Patrick Foster, MD - **Phone:** +4401132432799 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Leeds Teaching Hospitals NHS Trust **Zip:** LS9 7TF ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Deformity - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M8719 - Name: Fractures, Spontaneous - Relevance: LOW - As Found: Unknown - ID: M12084 - Name: Muscle Rigidity - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000013 - Term: Congenital Abnormalities - ID: D000050723 - Term: Fractures, Bone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412926 **Brief Title:** A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants **Official Title:** A Crossover Treatment, Phase 1, Open-label, Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Single Doses of 2 Formulations of Emodepside (BAY 44-4400), and to Assess the Effect of Food in Healthy Male and Female Participants. #### Organization Study ID Info **ID:** 22534 #### Organization **Class:** INDUSTRY **Full Name:** Bayer #### Secondary ID Infos **Domain:** EMA - EU CT Number **ID:** 2023-508905-26-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-08-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-27 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness. Soil-transmitted helminthiasis is an infection caused by various parasitic worms, such as whipworm, hookworm, and roundworm in the intestines. The infection spreads through eggs found in the feces of infected people. This contaminates the soil in areas with poor sanitation. Common symptoms include stomach pain, loose stools, loss of blood and proteins, delayed development in children, and reduced work performance in adults. Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis. Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women. It works by activating a protein called 'SLO-1', which causes paralysis and death of the parasitic worms. The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet, as a single dose. Researchers also want to find the effect of food on the absorption of the new emodepside tablet. The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food. The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food. The number of participants who experience medical problems during this study will be documented. During this study, participants will receive 2 different types of emodepside tablets. These include the newly developed tablet and an existing tablet that has already been used in other clinical studies. At the start of the study, the researchers will ask participants about their medical and surgical history. They will also perform a health check-up for all participants, and pregnancy tests for women. During the study, participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood. The study doctors will confirm that the participants can take part in the study. This may take up to 21 days. This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each. On Day 1 of each period, participants will receive the treatments, but the order of the treatment will be different. • Periods 1 and 2: Each participant will receive a single oral dose of the new or the existing emodepside tablet without food. After Period 2, an initial analysis will be performed. This analysis will help decide the doses for the next periods. * Period 3: Participants will receive a selected dose of the new emodepside tablet either with or without food. * Period 4 (optional): If needed, participants may receive a selected dose of the new emodepside tablet either with or without food. The decisions to conduct Period 4 will depend on the results of the initial analysis. Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period (either Period 3 or 4). Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up. This study will include participants who are healthy and will gain no benefit from taking emodepside. However, the results of the study will provide useful information to support the further development of the new emodepside tablet. The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside. Participants will be closely monitored by the study doctors for any medical problems. ### Conditions Module **Conditions:** - Soil-transmitted Helminth Infection - Onchocerciasis (River Blindness) **Keywords:** - Soil-transmitted helminth infection; Onchocerciasis (river blindness) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The study will be conducted in a single-center, randomized, open label, cross over design. The study will investigate the relative bioavailability, pharmacokinetics, safety and tolerability of single doses of 2 formulations of emodepside and assess the effect of food on Test formulation (Formulation B) in healthy male participants and healthy female participants of non-childbearing potential. The crossover design is used for intra-individual comparison of treatment effects to reduce impact of inter-individual variability. A preliminary PK analysis is planned after Period 2 to determine the appropriate dose to be tested for food effect. Treatment allocation is conducted in a randomized manner prior to Period 1 in order to reduce the likelihood of period or seasonal effects confounding the study assessments. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 1 Formulation A, fasted **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All subjects will receive either Formulation A or Formulation B per randomisation scheme as a single dose in fasted state. **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 1 Formulation B, fasted **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 2 - Crossover Formulation A, fasted **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** All subjects will receive either Formulation A or Formulation B Cross-over: dependent on what they received in period 1 per randomisation scheme as a single dose in fasted state **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 2 - Crossover Formulation B fasted **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** If no dose adjustment was needed after Period 2, all subjects will receive Formulation B in fed state **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 3 - no dose adjustment after Period 2 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 3 - dose adjustment after Period 2, fasted **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** If dose adjustment was needed after period 2, all subjects will receive Formulation B as single dose either in fasted or in fed state **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 3- dose adjustment after Period 2, fed **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** All subjects will receive Formulation B as single dose either in fasted or in fed state depending on if they were in the fasted or fed group in Period 3 **Intervention Names:** - Drug: BAY 44-4400 **Label:** Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Period 1 Formulation A, fasted - Period 2 - Crossover Formulation A, fasted **Description:** Film-coated tablet, oral use **Name:** BAY 44-4400 **Other Names:** - Formulation A **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Period 1 Formulation B, fasted - Period 2 - Crossover Formulation B fasted - Period 3 - dose adjustment after Period 2, fasted - Period 3 - no dose adjustment after Period 2 - Period 3- dose adjustment after Period 2, fed - Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fasted - Period 4 - crossover following Period 3 (in case of dose adjustment after Period 2), fed **Description:** Film-coated tablet, oral use **Name:** BAY 44-4400 **Other Names:** - Formulation B **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** • To investigate the pharmacokinetics (PK) including * relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A * food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax \> 5%, corrected Cmax parameters accounting for carry-over will be calculated for all participants in addition. **Measure:** Maximum observed concentration (Cmax) (0-72 hrs) **Time Frame:** 0-72 hrs post dose (per period) **Description:** • To investigate the pharmacokinetics (PK) including - relative bioavailability of Formulation B of emodepside (BAY 44-4400) in comparison to Formulation A - food-effect on Formulation B of emodepside (BAY 44-4400) If a relevant carry-over is observed in any participant as defined by C0/Cmax \> 5%, corrected AUC parameters accounting for carry-over will be calculated for all participants in addition. **Measure:** Area under the concentration vs. time curve from zero to infinity after single dose (AUC) (0-72 hrs) **Time Frame:** 0-72 hrs post dose (per period) #### Secondary Outcomes **Description:** To investigate and evaluate the safety and tolerability of single oral doses of emodepside formulations in healthy participants. **Measure:** Number of participants who experienced treatment-emergent adverse events (TEAEs) **Time Frame:** After first administration of study intervention through study completion, an average of 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening * Women that are not breastfeeding and are of non-childbearing potential aged 18 to 55 years of age inclusive, at the time of signing the informed consent, non-smokers, body mass index within the range of 18.0 - 29.9 kg/m2 (inclusive) at Screening * Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, vital signs, and laboratory tests. * Ability to understand and follow study-related instructions. Exclusion Criteria: * Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study * History of relevant eye or vision disorders (except myopia and hyperopia). * History of diabetes mellitus or abnormalities in glucose homeostasis. * Surgery, medical condition, or diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal * Febrile illness within 2 weeks before the start of the first study intervention. * Regular use of prescription drugs, over-the-counter drugs, supplements or herbal products. * Use of any systemic or topical medicines or substances within 2 weeks or 5 half-lives (whichever is longer) before the start of the first administration until follow-up, in particular, use of CYP3A4 inducers (including St John's Wort) or inhibitors. * Clinically relevant findings in the physical examination and vital signs (systolic blood pressure below 90 or above 140 mmHg, diastolic blood pressure below 60 or above 90 mmHg, pulse rate below 50 or above 90 beats per minute, as measured at screening). * Clinically relevant deviations of safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges at screening. * Suspicion of drug or alcohol abuse. * Lack of compliance with study restrictions. * Any vaccination received or planned during the period between 15 days before the first administration of study intervention and the last study visit. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clinical-trials-contact@bayer.com **Name:** Bayer Clinical Trials Contact **Phone:** (+)1-888-84 22937 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Click here to find information for studies related to Bayer products. To find this study enter the NCT number or Bayer Study ID in the search field. **URL:** https://clinicaltrials.bayer.com/study/22534 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000005368 - Term: Filariasis - ID: D000017205 - Term: Spirurida Infections - ID: D000017190 - Term: Secernentea Infections - ID: D000009349 - Term: Nematode Infections - ID: D000010272 - Term: Parasitic Diseases - ID: D000012876 - Term: Skin Diseases, Parasitic - ID: D000012874 - Term: Skin Diseases, Infectious - ID: D000012871 - Term: Skin Diseases - ID: D000015822 - Term: Eye Infections, Parasitic - ID: D000079426 - Term: Vector Borne Diseases - ID: D000015817 - Term: Eye Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare 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: M12787 - Name: Onchocerciasis - Relevance: HIGH - As Found: Onchocerciasis - ID: M9461 - Name: Helminthiasis - Relevance: HIGH - As Found: Helminth Infections - ID: M18381 - Name: Onchocerciasis, Ocular - Relevance: HIGH - As Found: River blindness - ID: M5047 - Name: Blindness - Relevance: HIGH - As Found: Blindness - ID: M17530 - Name: Vision Disorders - 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 - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M7771 - Name: Elephantiasis - Relevance: LOW - As Found: Unknown - ID: M8498 - Name: Filariasis - Relevance: LOW - As Found: Unknown - ID: M12296 - Name: Nematode Infections - Relevance: LOW - As Found: Unknown - ID: M13185 - Name: Parasitic Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15679 - Name: Skin Diseases, Parasitic - Relevance: LOW - As Found: Unknown - ID: M15677 - Name: Skin Diseases, Infectious - Relevance: LOW - As Found: Unknown - ID: M18371 - Name: Eye Infections - Relevance: LOW - As Found: Unknown - ID: M2054 - Name: Vector Borne Diseases - Relevance: LOW - As Found: Unknown - ID: T4245 - Name: Onchocerciasis - Relevance: HIGH - As Found: Onchocerciasis - ID: T2684 - Name: Helminthiasis - Relevance: HIGH - As Found: Helminth Infections - ID: T3528 - Name: Lymphatic Filariasis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009855 - Term: Onchocerciasis - ID: D000006373 - Term: Helminthiasis - ID: D000015827 - Term: Onchocerciasis, Ocular - ID: D000001766 - Term: Blindness ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M259980 - Name: Emodepside - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412913 **Acronym:** MJ-Flex **Brief Title:** Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail **Official Title:** Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of MJ-FLEX in Paediatric Patients Who Have Suffered Diaphyseal Fractures of Long Bones in Daily Practice: MJ-FLEX Study #### Organization Study ID Info **ID:** OCI_2303 #### Organization **Class:** INDUSTRY **Full Name:** Orthofix s.r.l. #### Secondary ID Infos **Domain:** IRAS project ID (UK) **ID:** 334519 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Orthofix s.r.l. #### 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 aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals. **Detailed Description:** The study is planned to be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of pediatric patients with diaphyseal fractures in the clavicle and in upper and lower limbs, where the usage of MJ-Flex The New Metaizeau Nail (known as MJ-Flex) was part of the normal clinical practice. Investigator of both study sites will provide data for a maximum of 61 patients meeting inclusion and exclusion criteria (Considering a drop-out or a non-evaluable rate of 10% of the procedures) that will contribute for approximately 61 procedures in which MJ-Flex was used. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied. The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice. Therefore, patients will be retrospectively enrolled in the study. Patients who have undergone MJ-Flex implantation from 02/2018 to 12/2022 are considered for the study The observation period of study subjects will comprise from surgery until the last follow up visit available. Medical records of the participating sites are expected to contain all the required information. In United Kingdom, no study visit will be required but according to local legislation, it will be essential that before collecting any information from medical records, participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place. However, in France, due to the use of primary data and the foreseen exemption of the informed consent (IC) form (see Section 14.2 Informed Consent), no study visit will be required. ### Conditions Module **Conditions:** - Fractures, Bone **Keywords:** - nail - elastic - elastic nailing - intramedullary - pediatric ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 61 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The full analysis set includes all paediatric patients who that have been treated for diaphyseal fractures of long bones with the MJ-FLEX the will be systematically consecutive screened at the centers. **Intervention Names:** - Device: MJ-Flex The New Metaizeau Nail **Label:** Patients in pediatric age (> 18 month and < 18 years) at the time of surgery ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients in pediatric age (> 18 month and < 18 years) at the time of surgery **Description:** Intramedullary implantation of the MJ-Flex elastic nail in long bones to provide bone fixation **Name:** MJ-Flex The New Metaizeau Nail **Other Names:** - Elastic Nail **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union **Measure:** Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit **Time Frame:** After 5 month (approximately) from surgery **Description:** This outcome will be used to measure safety **Measure:** Percentage of procedures with at least one serious/not serious adverse event certainly related or possibly related to MJ-FLEX (ADEs/SADEs) **Time Frame:** from the date of surgery until the last follow-up, assessed up to 1 year **Description:** This outcome will be used to measure safety **Measure:** Percentage of procedures who experienced at least one MDDs that caused an effect on the patient **Time Frame:** from the date of surgery until the last follow-up, assessed up to 1 year **Description:** This outcome will be used to measure safety **Measure:** Post-treatment fracture-free survival **Time Frame:** up to 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient has been adequately informed by providing the PIS. 1.1 The patient expressed his willingness to participate in the Study by signing and dating informed consent (valid only for UK patients according to local law). 2. Patients who had a regular indication for surgical intervention with MJ-Flex according to the manufacturer's IFU. 3. Patients in pediatric age (\> 18 month and \< 18 years) at the time of surgery. 4. Patients skeletally immature. 5. Patients who underwent surgery performed with MJ-Flex. 6. Patients with clinical data registered in her/him medical records sufficient to assess the safety and efficacy endpoint of the study: in particular, the patient has at least one follow-up at minimum 3 months from the surgery where is possible for the investigator to assess the consolidation of the treated bone. 7. The patient had surgery at least 1 year before enrollment. Exclusion Criteria: 1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet. 2. Patient who had/has a concomitant not permitted device which cannot be safely removed. 3. Patient for whom there are other concurrent medical or other conditions that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study. 4. The patient had surgery less than 1 year before enrollment. **Maximum Age:** 18 Years **Minimum Age:** 18 Months **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** The full analysis set includes all paediatric patients who that have been treated for diaphyseal fractures of long bones with the MJ-FLEX the will be systematically consecutive screened at the centers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** EdoKnijff@orthofix.it **Name:** Edo Knijff **Phone:** +390456719000 **Role:** CONTACT **Contact 2:** **Email:** tommasomarano@orthofix.it **Name:** Tommaso Marano **Phone:** +390456719000 **Role:** CONTACT #### Locations **Location 1:** **City:** Sheffield **Contacts:** ***Contact 1:*** - **Email:** sara.dorman@nhs.net - **Name:** Sara Dorman, MD - **Phone:** +441142717000 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Sheffield Children's NHS Foundation Trust **Zip:** S10 2TH #### Overall Officials **Official 1:** **Affiliation:** Sheffield Children's NHS Foundation Trust **Name:** Sara Dorman, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fractures, Bone - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412900 **Acronym:** RISUS_AI **Brief Title:** Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence **Official Title:** Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence #### Organization Study ID Info **ID:** 31347039 #### Organization **Class:** OTHER **Full Name:** Oslo University Hospital #### Secondary ID Infos **Domain:** Regional Committees for Medical Research Ethics (in Norway) **ID:** 660399 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-03-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Oslo University Hospital #### Responsible Party **Investigator Affiliation:** Oslo University Hospital **Investigator Full Name:** Peter Mæhre Lauritzen **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:** Kidney stone disease causes significant morbidity, and stones obstructing the ureter can have serious consequences. Imaging diagnostics with computed tomography (CT) are crucial for diagnosis, treatment selection, and follow-up. Segmentation of CT images can provide objective data on stone burden and signs of obstruction. Artificial intelligence (AI) can automate such segmentation but can also be used for the diagnosis of stone disease and obstruction. In this project, the aim is to investigate if: Manual segmentation of CT scans can provide more accurate information about kidney stone disease compared to conventional interpretation. AI segmentation yields valid results compared to manual segmentation. AI can detect ureteral stones and obstruction or predict spontaneous passage. **Detailed Description:** Background: Goals and Objectives: The project aims to contribute to personalized and improved treatment and follow-up of patients with kidney stones using radiomics and the development of an artificial intelligence tool for CT examination assessment. The objectives are to assess: * Whether manual segmentation of CT images of the urinary tract provides equivalent or more accurate information about kidney stone disease compared to conventional interpretation and reporting. * Whether segmentation performed with AI yields valid results compared to manual segmentation. * Whether AI can detect ureteral stones and obstruction and/or predict spontaneous passage of stones. Method: Cohort: Patients are recruited to the study at Oslo University Hospital, Radiology Department, Section Aker, which performs approximately 1350 CT examinations for urinary tract stones in approximately 1000 patients each year. Approximately 500 patients with a new episode or newly occurring colic pain and clinical suspicion of kidney stones are expected to be included. Clinical data (where available): * Baseline CT: date and image data * Initial treatment (conservative, URS, PCN, ESWL) decision after baseline CT * Follow-up CT: date and image data * Time to spontaneous stone passage (negative control CT) or completed surgical intervention (URS) * Any other surgical/invasive procedure * Stone chemical analysis * Clinical biochemistry: creatinine/eGFR, CRP, leukocytes (at baseline and follow-ups). Image data: Clinical radiology report: * Stone: (largest calculus and any obstructing calculus): largest diameter in any plane, density (ROI set by clinical judgment, largest possible ROI - in the slice where the stone is largest), location (upper ureter: above crossing of vessels, lower ureter: below crossing of vessels, ostial: in bladder wall) * Renal pelvis: largest diameter of calyx neck lower calyx, clinical assessment of dilation (not dilated/slight/moderate/severe). * Segmentation: * Stone: total segmented stone volume, largest diameter, and density of segmented stone. * Collecting system: total segmented volume of the collecting system and renal pelvis. ### Conditions Module **Conditions:** - Urinary Stone - Renal Colic - Obstruction Ureter - Urosepsis - Urolithiasis - Ureter Stone - Kidney Stone **Keywords:** - Urolithiasis - Computed tomography - Image segmentation - Ureteral obstruction - Artificial intelligence ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Newly occurring colic pain and clinical suspicion of kidney stones or known kidney stone with new/increasing symptoms. Age ≥ 18 years **Label:** Adults investigated with CT for suspected urinary stone disease ### Outcomes Module #### Primary Outcomes **Description:** Stone diameter (in mm) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) **Measure:** Comparison of stone diameter from manual segmentation with radiology report **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** DICE-score for AI-segmentation of stones, compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of stones (DICE-score) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Comparison of differences in dicotomous proportions in paired data according to Newcombe **Measure:** Prospective performance (diagnostic accuracy) of AI detection of ureteral stone (compared to radiology report (gold standard) **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) #### Secondary Outcomes **Description:** Stone density (in Hounsfield Units) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) **Measure:** Comparison of stone density from manual segmentation with radiology report **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Distention of renal pelvis (in mm) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) **Measure:** Comparison of distention of renal pelvis from manual segmentation with radiology report **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Haussdorff distance for AI-segmentation of stones, compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of stones (Hausdorff distance) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Diagnostic accuracy for AI-segmentation of stones compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of stones (diagnostic accuracy) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** DICE-score for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal pelvis (Dice-score) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Hausdorff distance for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal pelvis (Hausdorff distance) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Diagnostic accuracy for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal pelvis (diagnostic accuracy) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** DICE-score for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal parenchyma (DICE-score) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Hausdorff distance for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal parenchyma (Hausdorff distance) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Diagnostic accuracy for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) **Measure:** Comparison of AI-segmentation of renal parenchyma (diagnostic accuracy) with manual segmentation **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) **Description:** Comparison of differences in dicotomous proportions in paired data according to Newcombe **Measure:** Prospective performance (diagnostic accuracy) of AI detection of ureteral obstruction (compared to radiology report (gold standard) **Time Frame:** At time of CT examination (inclusion and follow up - expected average 12 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Referral for CT due to episode of renal colic and clinical suspicion of urinary stone disease or * Referral for CT due to new episode of pain in patient with known urinary stone disease * Age ≥ 18 years Exclusion Criteria: * Referral for control CT of asymptomatic patients with known urinary stone disease * Referral for control CT after treatment * Referral for control CT for spontaneous passage of stone. * Lack of informed consent for any reason. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients referred for CT for new/acute episode of renal colic and suspicion of /or known urinary stone disease. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** petlau@ous-hf.no **Name:** Peter M. Lauritzen, MD, PhD **Phone:** +4795248249 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Oslo University Hospital **Name:** Peter M. Lauritzen, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-30 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 250787 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-08T09:19 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000053040 - Term: Nephrolithiasis - 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: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000014515 - Term: Ureteral Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M10693 - Name: Kidney Calculi - Relevance: HIGH - As Found: Kidney Stone - ID: M27126 - Name: Nephrolithiasis - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: HIGH - As Found: Stone - ID: M27103 - Name: Urolithiasis - Relevance: HIGH - As Found: Urinary Stone - ID: M17295 - Name: Urinary Calculi - Relevance: HIGH - As Found: Urinary Stone - ID: M17267 - Name: Ureteral Obstruction - Relevance: HIGH - As Found: Obstruction Ureter - ID: M28610 - Name: Renal Colic - Relevance: HIGH - As Found: Renal Colic - ID: M6313 - Name: Colic - Relevance: LOW - As Found: Unknown - ID: M17264 - Name: Ureteral Calculi - Relevance: LOW - As Found: Unknown - ID: M27125 - Name: Ureterolithiasis - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M17265 - Name: Ureteral Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007669 - Term: Kidney Calculi - ID: D000052878 - Term: Urolithiasis - ID: D000014545 - Term: Urinary Calculi - ID: D000014517 - Term: Ureteral Obstruction - ID: D000002137 - Term: Calculi - ID: D000056844 - Term: Renal Colic ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412887 **Brief Title:** Effects of Adding Force Control to a VR Game on Brain Activation **Official Title:** Effects of Adding Force Control to a VR Game on Brain Activation #### Organization Study ID Info **ID:** 112-181 #### Organization **Class:** OTHER **Full Name:** National Cheng-Kung University Hospital ### Status Module #### Completion Date **Date:** 2023-08-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-11 **Type:** ACTUAL #### Start Date **Date:** 2023-07-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Cheng-Kung University Hospital #### Responsible Party **Investigator Affiliation:** National Cheng-Kung University Hospital **Investigator Full Name:** Fong Chin Su **Investigator Title:** Chair Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** One of the major contributor for the lower quality of living in the aged population, is the reduction in hand function. To mitigate this, several virtual-reality based hand rehabilitation/training systems have been developed. However, most of these systems are solely controlled by hand gestures, and do not incorporate the force between the fingertips. Which is not the case for grabbing things in real life. With that in mind, the researchers assumed that a virtual-reality based hand rehabilitation/training system that incorporates force control into its input can be more beneficial in terms of recovering one's hand function. To test out this claim, subjects were recruited and tasked to play a game using both input systems (wfc and wofc), while their brain activity while using both input system was simultaneously recorded using functional near infrared spectroscopy and compared ### Conditions Module **Conditions:** - Healthy Aging **Keywords:** - Virtual Reality - functional near infrared spectroscopy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Subjects play the virtual reality game using the wfc input system followed by the wofc input system ##### Masking Info **Masking:** NONE **Masking Description:** The subjects were informed regarding which input system was to be used **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Users play the game using the conventional virtual reality input system with force control **Intervention Names:** - Device: Virtual reality headset **Label:** with force control (wfc) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Users play the game using the conventional virtual reality input system **Intervention Names:** - Device: Virtual reality headset **Label:** without force control (wofc) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - with force control (wfc) - without force control (wofc) **Description:** Meta-Quest 2 virtual reality headset was used in this study **Name:** Virtual reality headset **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions **Measure:** Oxygenated hemoglobin (HbO) **Time Frame:** 1 hour **Description:** This unitless metric counts the number of times the subject initiates a grasp while playing the game, a higher amount of grasp initiated signifies worst performance **Measure:** Game performance1 (Amount of grasp initiated) **Time Frame:** 1 hour **Description:** This percentage is calculated by dividing the amount of correct response by the total amount of response. A larger perrcentage represents better performance **Measure:** Game performance2 (Memory task accuracy) **Time Frame:** 1 hour #### Secondary Outcomes **Description:** The manual dexterity of each participant was measured using the Purdue Pegboard Test at the beginning of the experiment **Measure:** Manual dexterity **Time Frame:** 5 minutes **Description:** The maximum voluntary pinch force of each particapant were measured using the Jamar pinch dynamometer at the beginning of the experiment **Measure:** Maximum voluntary pinch force **Time Frame:** 5 minutes **Description:** The ability to recall information of each particapant was measured using the forward digit span test at the beginning of the experiment **Measure:** Recall **Time Frame:** 5 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * With normal vision or wearing prescription glass that can fit inside the Meta Quest 2 VR headset. * Able to understand English, Chinese, or Taiwanese language. Exclusion Criteria: * Experiencing motion sickness after prolonged usage of VR headsets * Having chronic diseases or injuries that can prevent them from participating in the experiment such as: hand injuries, missing fingers, blindness, deafness, hearing impairments, etc. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tainan **Country:** Taiwan **Facility:** National Cheng Kung University **Zip:** 701 #### Overall Officials **Official 1:** **Affiliation:** Chair Professor **Name:** Fong-Chin Su, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Kivell TL. Evidence in hand: recent discoveries and the early evolution of human manual manipulation. Philos Trans R Soc Lond B Biol Sci. 2015 Nov 19;370(1682):20150105. doi: 10.1098/rstb.2015.0105. **PMID:** 26483538 **Citation:** Vergara M, Sancho-Bru JL, Gracia-Ibanez V, Perez-Gonzalez A. An introductory study of common grasps used by adults during performance of activities of daily living. J Hand Ther. 2014 Jul-Sep;27(3):225-33; quiz 234. doi: 10.1016/j.jht.2014.04.002. Epub 2014 Apr 21. **PMID:** 24878351 **Citation:** Smaby N, Johanson ME, Baker B, Kenney DE, Murray WM, Hentz VR. Identification of key pinch forces required to complete functional tasks. J Rehabil Res Dev. 2004 Mar;41(2):215-24. doi: 10.1682/jrrd.2004.02.0215. **PMID:** 15558375 **Citation:** Kurillo G, Gregoric M, Goljar N, Bajd T. Grip force tracking system for assessment and rehabilitation of hand function. Technol Health Care. 2005;13(3):137-49. **PMID:** 15990417 **Citation:** Magni NE, McNair PJ, Rice DA. Impairments in grip and pinch force accuracy and steadiness in people with osteoarthritis of the hand: A case-control comparison. Musculoskelet Sci Pract. 2021 Oct;55:102432. doi: 10.1016/j.msksp.2021.102432. Epub 2021 Jul 22. **PMID:** 34333399 **Citation:** Strote C, Golz C, Stroehlein JK, Haase FK, Koester D, Reinsberger C, Vieluf S. Effects of force level and task difficulty on force control performance in elderly people. Exp Brain Res. 2020 Oct;238(10):2179-2188. doi: 10.1007/s00221-020-05864-1. Epub 2020 Jul 13. **PMID:** 32661649 **Citation:** Howard, M. C. (2017). A meta-analysis and systematic literature review of virtual reality rehabilitation programs. Computers in Human Behavior, 70, 317-327. https://doi.org/10.1016/j.chb.2017.01.013 **Citation:** Pereira, M. F., Prahm, C., Kolbenschlag, J., Oliveira, E., & Rodrigues, N. F. (2020). A Virtual Reality Serious Game for Hand Rehabilitation Therapy. 2020 IEEE 8th International Conference on Serious Games and Applications for Health (SeGAH), 1-7. https://doi.org/10.1109/SeGAH49190.2020.9201789 **Citation:** Vanbellingen T, Filius SJ, Nyffeler T, van Wegen EEH. Usability of Videogame-Based Dexterity Training in the Early Rehabilitation Phase of Stroke Patients: A Pilot Study. Front Neurol. 2017 Dec 8;8:654. doi: 10.3389/fneur.2017.00654. eCollection 2017. **PMID:** 29276499 **Citation:** Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76. **PMID:** 24885076 **Citation:** Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017. **PMID:** 28473763 **Citation:** Zheng J, Ma Q, He W, Huang Y, Shi P, Li S, Yu H. Cognitive and motor cortex activation during robot-assisted multi-sensory interactive motor rehabilitation training: An fNIRS based pilot study. Front Hum Neurosci. 2023 Feb 9;17:1089276. doi: 10.3389/fnhum.2023.1089276. eCollection 2023. **PMID:** 36845877 **Citation:** Xia W, Dai R, Xu X, Huai B, Bai Z, Zhang J, Jin M, Niu W. Cortical mapping of active and passive upper limb training in stroke patients and healthy people: A functional near-infrared spectroscopy study. Brain Res. 2022 Aug 1;1788:147935. doi: 10.1016/j.brainres.2022.147935. Epub 2022 Apr 29. **PMID:** 35500604 **Citation:** Hummel, J., Dodiya, J., Wolff, R., Gerndt, A., & Kuhlen, T. (2013). An evaluation of two simple methods for representing heaviness in immersive virtual environments. 2013 IEEE Symposium on 3D User Interfaces (3DUI), 87-94. https://doi.org/10.1109/3DUI.2013.6550202 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412874 **Acronym:** ACCESS **Brief Title:** Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer **Official Title:** Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer #### Organization Study ID Info **ID:** STUDY-23-00592 #### Organization **Class:** OTHER **Full Name:** Icahn School of Medicine at Mount Sinai ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2023-10-09 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pfizer #### Lead Sponsor **Class:** OTHER **Name:** Icahn School of Medicine at Mount Sinai #### Responsible Party **Investigator Affiliation:** Icahn School of Medicine at Mount Sinai **Investigator Full Name:** Nihal E Mohamed **Investigator Title:** Nihal Mohamed, Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation. ### Conditions Module **Conditions:** - Screening Tool - Focus Group ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 210 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Screening tool **Label:** Screening tool group #### Arm Group 2 **Label:** Focus group ### Interventions #### Intervention 1 **Arm Group Labels:** - Screening tool group **Description:** Participants will complete a screening tool survey **Name:** Screening tool **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Bladder Cancer Need Assessment Survey (BCNAS) includes 8 subscales: psychological, informational, care and support, logistic, sexuality, physical and daily living, communication with providers; and communication with social partners/family All subscales scored 0-100. Full scale scored from 0- 100. Higher score mean higher levels of unmeet needs. This is a measure of unmet needs. **Measure:** The Bladder Cancer Need Assessment Survey (BCNAS) **Time Frame:** 2023-2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer * between 18 years and older (18-89 years) * have initiated any systemic treatment for advanced urothelial carcinoma * speak English speaking and are able to consent. Exclusion Criteria: * Have a diagnosis of another advanced cancer that has required systemic therapy * Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements. **Maximum Age:** 89 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Bladder cancer survivors ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Talia.Korn@mountsinai.org **Name:** Talia Korn, MA **Phone:** 212-241-4983 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** Talia.Korn@mountsinai.org - **Name:** Talia Korn, MA - **Phone:** 305-610-5218 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nihal Mohamed, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Icahn School of Medicine at Mount Sinai **State:** New York **Status:** RECRUITING **Zip:** 10029 #### Overall Officials **Official 1:** **Affiliation:** Icahn School of Medicine **Name:** Nihal Mohamed, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001749 - Term: Urinary Bladder Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412861 **Brief Title:** Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case **Official Title:** Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases #### Organization Study ID Info **ID:** ilke #### Organization **Class:** OTHER **Full Name:** Ondokuz Mayıs 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:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ondokuz Mayıs University #### Responsible Party **Investigator Affiliation:** Ondokuz Mayıs University **Investigator Full Name:** Ilke Tamdogan **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:** Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort. **Detailed Description:** Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients. Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure. Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively). ) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS \> 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered. ### Conditions Module **Conditions:** - Ketamine - Sedation - Gynecologic Disease **Keywords:** - ketamine - sedation - gynecological case ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. **Intervention Names:** - Drug: Ketamine **Label:** ketamine-propofol **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. **Intervention Names:** - Drug: Fentanyl **Label:** fentanyl-propofol **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ketamine-propofol **Description:** 0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score \> 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. **Name:** Ketamine **Other Names:** - GROUP A **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - fentanyl-propofol **Description:** 1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. **Name:** Fentanyl **Other Names:** - GROUP B **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Surgical satisfaction survey: Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'." **Measure:** Surgical satisfaction **Time Frame:** Postoperative procedure **Description:** The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure **Measure:** Incidence of lower extremity movement during the procedure **Time Frame:** intraoperative #### Secondary Outcomes **Description:** he side effects occurring during the intraoperative and postoperative periods include: Recall events (recall of events during surgery) Apnea (holding breath for \>15 seconds) Desaturation (SpO2 \< 96%) Jaw thrust maneuver Bradycardia (heart rate \< 50 beats/min) Skin rash **Measure:** Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia) **Time Frame:** 30th minute postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between the ages of 18-65, * American Society of Anesthesiologists (ASA) I-II, Exclusion Criteria: * Patients with a known allergy to any of the drugs used in the study, * Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i * intracranial space-occupying lesions, * Pregnant women, * Body mass index (BMI) \> 30 **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:** drilkeipek@gmail.com **Name:** İlke Tamdoğan **Phone:** 905062916678 **Role:** CONTACT #### Locations **Location 1:** **City:** Samsun **Contacts:** ***Contact 1:*** - **Name:** ilke tamdoğan - **Role:** CONTACT **Country:** Turkey **Facility:** Ondokuz Mayıs University Faculty of Medicine **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** ndokuz Mayıs University Faculty of Medicine **Name:** ilke tamdoğan **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available. **PMID:** 9356094 **Citation:** Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016. **PMID:** 10735789 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8943 - Name: Genital Diseases, Female - Relevance: HIGH - As Found: Gynecologic Disease - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005831 - Term: Genital Diseases, Female ### 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 - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000000759 - Term: Adjuvants, Anesthesia ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8418 - Name: Fentanyl - Relevance: HIGH - As Found: Scan - ID: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Provided - ID: M18307 - Name: Propofol - 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 - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005283 - Term: Fentanyl - ID: D000007649 - Term: Ketamine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412848 **Brief Title:** JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study **Official Title:** A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma #### Organization Study ID Info **ID:** MS100070_0209 #### Organization **Class:** INDUSTRY **Full Name:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes. ### Conditions Module **Conditions:** - Urothelial Carcinoma **Keywords:** - Urothelial Carcinoma - Avelumab - JAVEMACS - Locally advanced UC - Metastatic UC ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT). **Intervention Names:** - Drug: Avelumab **Label:** Urothelial Carcinoma Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Urothelial Carcinoma Cohort **Description:** This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT. **Name:** Avelumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To describe the baseline clinical and demographic characteristics of participants. **Measure:** Baseline clinical and demographic characteristics **Time Frame:** Baseline **Measure:** Characteristics of the first line PBCT just prior to avelumab maintenance **Time Frame:** Up to 3 months #### Secondary Outcomes **Measure:** Overall Survival (OS) **Time Frame:** Up to 3 months **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to 3 months **Measure:** Time to Treatment Failure (TTF) **Time Frame:** Up to 3 months **Measure:** Time to Next Treatment (TTNT) **Time Frame:** Up to 3 months **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy * Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab * Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site * Participants aged \>= 18 years old at index date * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participant participated in a clinical trial in la/m UC during the study periods. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants with locally advanced/metastatic Urothelial Carcinoma ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** service@emdgroup.com **Name:** Communication Center **Phone:** +49 6151 72 5200 **Role:** CONTACT #### Locations **Location 1:** **City:** Hirosaki **Country:** Japan **Facility:** Hirosaki University Hospital **State:** Aomori **Status:** NOT_YET_RECRUITING **Zip:** 036-8563 **Location 2:** **City:** Toon **Country:** Japan **Facility:** Ehime University Hospital **State:** Ehime **Status:** NOT_YET_RECRUITING **Zip:** 791-0295 **Location 3:** **City:** Kurume **Country:** Japan **Facility:** Kurume University Hospital **State:** Fukuoka **Status:** NOT_YET_RECRUITING **Zip:** 830-0011 **Location 4:** **City:** Sapporo **Country:** Japan **Facility:** Hokkaido University Hospital **State:** Hokkaido **Status:** NOT_YET_RECRUITING **Zip:** 060-8648 **Location 5:** **City:** Sapporo **Country:** Japan **Facility:** Sapporo Medical University Hospital **State:** Hokkaido **Status:** NOT_YET_RECRUITING **Zip:** 060-8648 **Location 6:** **City:** Kobe **Country:** Japan **Facility:** Kobe University Hospital **State:** Hyogo **Status:** RECRUITING **Zip:** 650-0017 **Location 7:** **City:** Shiwa-gun **Country:** Japan **Facility:** Iwate Medical University Hospital **State:** Iwate **Status:** NOT_YET_RECRUITING **Zip:** 028-3695 **Location 8:** **City:** Kita-gun **Country:** Japan **Facility:** Kagawa University Hospital **State:** Kagawa **Status:** RECRUITING **Zip:** 761-0793 **Location 9:** **City:** Kawasaki **Country:** Japan **Facility:** St. Marianna University Hospital **State:** Kanagawa **Status:** NOT_YET_RECRUITING **Zip:** 216-8511 **Location 10:** **City:** Sagamihara **Country:** Japan **Facility:** Kitasato University Hospital **State:** Kanagawa **Status:** NOT_YET_RECRUITING **Zip:** 252-0374 **Location 11:** **City:** Kashihara **Country:** Japan **Facility:** Nara Medical University Hospital **State:** Nara **Status:** RECRUITING **Zip:** 634-8522 **Location 12:** **City:** Osakasayama **Country:** Japan **Facility:** Kindai University Hospital **State:** Osaka **Status:** NOT_YET_RECRUITING **Zip:** 589-8511 **Location 13:** **City:** Hidaka **Country:** Japan **Facility:** Saitama Medical University International Medical Center **State:** Saitama **Status:** NOT_YET_RECRUITING **Zip:** 350-1298 **Location 14:** **City:** Bunkyo-ku **Country:** Japan **Facility:** Juntendo University Hospital **State:** Tokya **Status:** NOT_YET_RECRUITING **Zip:** 113-0033 **Location 15:** **City:** Bunkyo-ku **Country:** Japan **Facility:** Nippon Medical School Hospital **State:** Tokyo **Status:** NOT_YET_RECRUITING **Zip:** 113-8603 **Location 16:** **City:** Chuo-ku **Country:** Japan **Facility:** National Cancer Center Hospital **State:** Tokyo **Status:** NOT_YET_RECRUITING **Zip:** 104-0045 **Location 17:** **City:** Itabashi-ku **Country:** Japan **Facility:** Teikyo University Hospital **State:** Tokyo **Status:** NOT_YET_RECRUITING **Zip:** 173-8606 **Location 18:** **City:** Akita **Country:** Japan **Facility:** Akita University Hospital **Status:** NOT_YET_RECRUITING **Zip:** 010-0041 **Location 19:** **City:** Fukuoka **Country:** Japan **Facility:** Kyushu Cancer Center **Status:** RECRUITING **Zip:** 811-1347 **Location 20:** **City:** Kumamoto **Country:** Japan **Facility:** Kumamoto University Hospital **Status:** NOT_YET_RECRUITING **Zip:** 860-8556 **Location 21:** **City:** Kyoto **Country:** Japan **Facility:** University Hospital Kyoto Prefectural University of Medicine **Status:** NOT_YET_RECRUITING **Zip:** 602-8566 **Location 22:** **City:** Kyoto **Country:** Japan **Facility:** Kyoto University Hospital **Status:** NOT_YET_RECRUITING **Zip:** 606-8507 **Location 23:** **City:** Osaka **Country:** Japan **Facility:** Osaka International Cancer Institute **Status:** RECRUITING **Zip:** 540-0008 **Location 24:** **City:** Tokushima **Country:** Japan **Facility:** Tokushima University Hospital **Status:** NOT_YET_RECRUITING **Zip:** 770-0042 **Location 25:** **City:** Toyama **Country:** Japan **Facility:** Toyama University Hospital **Status:** NOT_YET_RECRUITING **Zip:** 930-0194 **Location 26:** **City:** Yamagata **Country:** Japan **Facility:** Yamagata University Hospital **Status:** RECRUITING **Zip:** 9902331 #### Overall Officials **Official 1:** **Affiliation:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany **Name:** Medical Responsible **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: HIGH - As Found: Urothelial Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5693 - Name: Transitional Cell Carcinoma - Relevance: HIGH - As Found: Urothelial Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002295 - Term: Carcinoma, Transitional Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M344580 - Name: Avelumab - Relevance: HIGH - As Found: Reach - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000609138 - Term: Avelumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412835 **Brief Title:** Enteral Nutrition Training With Cooperative Learning **Official Title:** The Effect of Cooperative Learning Approach on Nursing Students' Learning of Knowledge and Skills Regarding Enteral Nutrition: A Randomized Controlled Study #### Organization Study ID Info **ID:** Aysun Acun 6 #### Organization **Class:** OTHER **Full Name:** Bilecik Seyh Edebali Universitesi ### Status Module #### Completion Date **Date:** 2024-06-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bilecik Seyh Edebali Universitesi #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Nursing students; education on enteral nutrition has an important place. With cooperative learning, students will make their learning permanent by communicating with each other. This study is carried out to evaluate the effect of cooperative learning on the knowledge level of students. **Detailed Description:** The cooperative learning method is structured on students\&amp;#39; communication and interaction with each other. Many outcomes such as increasing students; academic success, critical thinking, verbal communication, taking responsibility for learning, improving their ability to take responsibility, increasing their ability to evaluate, and being open to feedback are among the benefits of cooperative learning. In cooperative learning, the basic principle is that students form groups and share their knowledge within each group regarding the basic knowledge and skills they want to learn, and then the groups interact with each other. With this method, students can take on learning responsibilities themselves, and they can also develop their knowledge sharing, collaboration and leadership skills within the group. Therefore, cooperative learning is an effective training method by strengthening self-directed learning, as well as supporting effective communication within team members. In a study conducted with nursing students using cooperative learning, it was observed that higher success, more positive relationships between students, and more psychological adaptation developed compared to traditional education methods. In international studies investigating the use of active learning strategies in nursing education, it has been concluded that collaborative learning is of great importance in transforming critical thinking ability, clinical performance, knowledge adequacy and nursing knowledge into clinical skills. In a similar vein, it has been emphasized that cooperative learning is an effective teaching method in improving the knowledge and psychomotor skill levels of nursing students regarding local drug applications and increasing the permanence of information. This study will focus on students; learning of knowledge and skills regarding enteral nutrition through cooperative learning method. A more memorable learning is aimed by students forming groups and transferring information both within and between groups. ### Conditions Module **Conditions:** - Educational Problems **Keywords:** - cooperative learning - nursing students - enteral nutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Knowledge level of nursing students **Intervention Names:** - Other: cooperative learning **Label:** Students' course success **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** self-directed learning **Intervention Names:** - Other: cooperative learning **Label:** self-directed learning **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Students' course success - self-directed learning **Description:** Students working in groups **Name:** cooperative learning **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Nursing students' knowledge levels will be evaluated at the end of the teaching with the cooperative learning model on enteral nutrition. **Measure:** Knowledge level of nursing students **Time Frame:** 5 weeks for each participant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Getting training on enteral nutrition for the first time * Volunteering to participate in the study * Being required to attend class Exclusion Criteria: * Having previously received training on enteral nutrition * Not volunteering to participate in the study * Not participating in the final test and follow-up test **Healthy Volunteers:** True **Maximum Age:** 37 Years **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aysun.acun@bilecik.edu.tr **Name:** Aysun Acun, PhD, PhD, Assistant professor **Phone:** +905072104506 **Role:** CONTACT ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412822 **Brief Title:** Neutrophil Extracellular Traps (NET's) in Prevalent Kidney Stone **Official Title:** Neutrophil Extracellular Traps (NET's) in Prevalent Kidney Stone, Cross-section, Non-drug Clinical Study-Analysis of Biological Fluids (Residual Human Body Material (RHBM)): STONET's Project #### Organization Study ID Info **ID:** STONET's #### Organization **Class:** OTHER **Full Name:** Brugmann University Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **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:** Brugmann University Hospital #### Responsible Party **Investigator Affiliation:** Brugmann University Hospital **Investigator Full Name:** Agnieszka Pozdzik **Investigator Title:** Nephrologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Neutrophils are first responders to any kind of threat the body faces: infection, severe trauma, cancer, surgery... They produce the cytokines, induct oxidative stress and de-granulate toxic proteins to kill pathogens. However the new mechanism related to the neutrophil extracellular traps release has been recognized as a new way of cell necrosis and has been called a NETosis. NETosis is a hugely important new mechanism of human immune responses also described in various forms of acute kidney injury (ischemic, toxic, autoimmune). In certain kidney diseases, neutrophils release NETs and induce cell necrosis. Whether neutrophils die along with NET release, and if they do die, remains under study and is most likely context dependent. Extracellular traps (ETs) can be released also by macrophages. The ETs formation as well as macrophages extracellular traps (MET's) especially in kidney disease are cytotoxic and elicit inflammation, contributing to necro-inflammation of the early-injury phase of acute tubular necrosis in anti-neutrophil cytoplasmic antibody-related renal vasculitis, anti-glomerular basement membrane disease, lupus nephritis. Finally, acute kidney injury-related releases of dying renal cells or ETs promote organ injuries - for example, acute respiratory distress syndrome. According to the recent review the term 'NET formation' has been proposed as a better term to use instead of 'NETosis'. The formation of neutrophil extracellular traps (NETs) has been recently recognized as a unique modality of pathogen fixation (sticky extracellular chromatin) and pathogen killing (cytotoxic histones and proteases) during host immune responses, as well as collateral tissue damage. Histones are potent mediators of injury in various cells. Indeed, extracellular histone induce microvascular endothelial cells and renal epithelial cells death in vitro, forms the pores that disrupt cell integrity and induce the cytolysis by their capacity of binding with membrane phospholipids and activation of inflammasome in the kidney leading to auto-entrainment of inflammation. The activation of inflammation has been demonstrated in the experimental model of crystalline nephropathy related to the uncontrolled oxalate urinary excretion. Inhibition of inflammasome activation has been related with the preservation of kidney function. In patients with kidney stone disease the presence of crystals in the urine has been demonstrated to induce tubular epithelial cells injury that can theoretically trigger the NET's or MET's release and tissue inflammation. NETs are now increasingly described as new targets for therapies, however largely under-estimated. The role of release of ETs from neutrophils and macrophages during the kidney stone disease has never been studied in urine but the neutrophil extracellular trap (NET) formation-NETosis - was found significantly increased in the papillae of patients with brushite stones compared with CaOx stones. The key objectives of this study are: 1. to assess NET/MET's excretion in the urine as a non-invasive method of NET/MET'osis measurement in patients with kidney diseases as a new biomarker of early stage of cells damages reflecting kidney injury occurring in patients with uncontrolled stones and other renal diseases; 2. to compare the NET/MET's concentrations in the urine with those in plasma ### Conditions Module **Conditions:** - Kidney Stone ### Design Module #### Bio Spec **Description:** * plasma sample * serum sample * total blood EDTA for DNA * urine samples: 24h collections, fasting urine and 2nd morning urine **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult subjects with kidney stones disease **Intervention Names:** - Other: Blood sampling - Other: Urine sampling **Label:** STONE group #### Arm Group 2 **Description:** Control group: patients with acute and/or chronic kidney disease (CKD) without stones **Intervention Names:** - Other: Blood sampling - Other: Urine sampling **Label:** NON STONE group ### Interventions #### Intervention 1 **Arm Group Labels:** - NON STONE group - STONE group **Description:** Blood sampling **Name:** Blood sampling **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - NON STONE group - STONE group **Description:** Urine sampling **Name:** Urine sampling **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessment of NET excretion in 24h urine collection **Measure:** Neutrophil extracellular traps (NETs) excretion in 24h urine collection **Time Frame:** 24 hours **Description:** Assessment of NET excretion in fasting urine **Measure:** Neutrophil extracellular traps (NETs) excretion in fasting urine **Time Frame:** 24 hours **Description:** Assessment of NET excretion in 2e morning urine **Measure:** Neutrophil extracellular traps (NETs) excretion in 2e morning urine **Time Frame:** 24 hours **Description:** Assessment of MET's in 24h urine collection **Measure:** Macrophages extracellular traps (MET's) excretion in 24h urine collection **Time Frame:** 24 hours **Description:** Assessment of MET's in fasting urine **Measure:** Macrophages extracellular traps (MET's) excretion in fasting urine **Time Frame:** 24 hours **Description:** Assessment of MET's in 2e morning urine **Measure:** Macrophages extracellular traps (MET's) excretion in 2e morning urine **Time Frame:** 24 hours #### Secondary Outcomes **Description:** Neutrophil extracellular traps (NETs) plasma levels **Measure:** Neutrophil extracellular traps (NETs) plasma levels **Time Frame:** 24 hours **Description:** Macrophages extracellular traps (MET's) plasma levels **Measure:** Macrophages extracellular traps (MET's) plasma levels **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Patients with acute and/or chronic kidney disease, with stones or without stones, ambulatory or hospitalized in CHU Brugmann Brugmann. Exclusion Criteria: * Malignancy or treatment for malignancy within 12 months prior to Screening with the exception of localized basal cell or squamous cell skin cancer. Note: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded. * Psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study. * Participation in another clinical trial. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with acute and/or chronic kidney disease, with stones or without stones, ambulatory or hospitalized in CHU Brugmann Brugmann. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Agnieszka.POZDZIK@chu-brugmann.be **Name:** Agnieszka POZDZIK **Phone:** 3224752639 **Role:** CONTACT #### Locations **Location 1:** **City:** Brussel **Contacts:** ***Contact 1:*** - **Email:** agnieszka.pozdzik@chu-brugmann.be - **Name:** Agnieszka Pozdzik, MD,PhD - **Phone:** +32 (0)2 4752639 - **Role:** CONTACT ***Contact 2:*** - **Name:** Agnieszka Pozdzik, MD,PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Belgium **Facility:** CHU Brugmann **Status:** RECRUITING **Zip:** 1020 #### Overall Officials **Official 1:** **Affiliation:** CHU Brugmann **Name:** Agnieszka POZDZIK **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical - 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: D000052878 - Term: Urolithiasis - ID: D000014545 - Term: Urinary Calculi - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10693 - Name: Kidney Calculi - Relevance: HIGH - As Found: Kidney Stone - ID: M27126 - Name: Nephrolithiasis - Relevance: HIGH - As Found: Kidney Stone - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: 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: M27103 - Name: Urolithiasis - Relevance: LOW - As Found: Unknown - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007669 - Term: Kidney Calculi - ID: D000053040 - Term: Nephrolithiasis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412809 **Brief Title:** Combined Land- and Water-Based Core and Lower Extremity Strength Training in Improving the Jump Performance Among Volleyball and Basketball Players **Official Title:** Combined Land- and Water-Based Core and Lower Extremity Strength Training in Improving the Jump Performance Among Volleyball and Basketball Players: A Randomized Controlled Trial #### Organization Study ID Info **ID:** PT-001 #### Organization **Class:** OTHER **Full Name:** Mariano Marcos State University ### Status Module #### Completion Date **Date:** 2024-05-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-12 **Type:** ACTUAL #### Start Date **Date:** 2024-04-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mariano Marcos State University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Given conflicting studies regarding the effect of land-based and water-based training on the jump performance of volleyball and basketball players, a randomized controlled trial is conducted. This study hypothesizes that combined land- and water-based core and lower strength training significantly increase jump performance of volleyball and basketball players in comparison to either land- and/or water-based training alone. **Detailed Description:** Numerous studies focused on the effect of sole land- or water-based exercise training to improve either core and/or lower extremities alone, which could result in improved jump performance. With the continuously increasing popularity of volleyball and basketball, where players get better and better, competition in these fields is also heightened. Hence, identifying other methods to improve game performance, such as improving muscle strength and jump performance can be explored to contribute to the existing literature and could benefit the volleyball and basketball players themselves, trainers/coaches, universities competing in sports competitions locally, nationally, and even internationally, and to physical therapists who are venturing to sports physical therapy. The study then seeks to investigate whether combined land- and water-based exercises targeting the core and lower extremity muscle strength can enhance the jump performance of basketball and volleyball players. With this, a three-arm, single-blinded randomized controlled trial is being conducted among basketball and volleyball players. Participants are grouped into combined land- and water-based exercise, land-based exercise, and water-based exercise. To proceed with the implementation, the researchers acquired ethical clearance from the MMSU Ethics and Review Board. Recruitment of participants happened within a University at Ilocos Norte, Philippines. Acquisition of informed consent was done before other screening procedures to identify the eligibility of participants to participate in the study. Eligible participants were randomized accordingly to either the three (3) aforementioned groups. The exercises implemented in each group are based on existing literature regarding their effect on either the core or lower extremity strength, and combined to create a new and applicable exercise program, These exercise programs were also verified applicable by two licensed physical therapists who are also well-versed in strength training protocols. The participants are being trained accordingly one hour/day, three days/week for two consecutive weeks. As to the pre-and post-test measurements of the primary and secondary outcomes, assessment is done by two independent licensed physical therapists who are blinded to the participants and interventions. Moreover, the assessors are well-versed in the assessment of the different outcome measurements (Plank core strength test, 1RM, 10-meter Sprint Test, Margaria-Kalaman Power Test) and in using the MyJump Lab Mobile App, duly purchased by the researchers, used for the assessment of countermovement jump and squat jump. The SPSS version 22 will be used for data analysis by an independent statistician. Descriptive and comparative statistics will be used to analyze all data within- and between-groups, respectively. For the descriptive statistics, frequency, percentages, mean, and standard deviation will be utilized, while the two-way ANOVA and/or the paired T-test will be utilized for the comparative statistics. ### Conditions Module **Conditions:** - Athletes **Keywords:** - Strength training - Core strengthening - Jump performance - Basketball players - Volleyball exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Volleyball and basketball players ##### Masking Info **Masking:** SINGLE **Masking Description:** Outcome assessors are blinded to the grouping of the participants and the interventions of the study. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 21 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Core and lower extremity strengthening exercises done on both land and water. **Intervention Names:** - Other: Combined Land- and Water-Based Exercise **Label:** Combined Land- and Water-Based Exercise **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Core and lower extremity strengthening exercises that are implemented solely on land. **Intervention Names:** - Other: Land-Based Exercise **Label:** Land-Based Exercise **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Core and lower extremity strengthening exercises that are implemented solely in water. **Intervention Names:** - Other: Water-Based Exercise **Label:** Water-Based Exercise **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined Land- and Water-Based Exercise **Description:** Strengthening exercises targeting the core and lower extremities (quadriceps, hamstring, and gastrocnemius) were implemented both on land and in water. The exercises are done for approximately one hour/day, three days/week for two consecutive weeks. The following are the included exercises: Land-based exercise: 1. Plank exercise 2. Russian twist 3. Push-up 4. Goblet squat 5. Kettle bell swing Water-based exercise: 1. Flutter kicks 2. Isometric core crunches 3. Jump lunges 4. Kicks 5. Resisted knee flexion **Name:** Combined Land- and Water-Based Exercise **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Land-Based Exercise **Description:** Strengthening exercises targeting the core and lower extremities (quadriceps, hamstring, and gastrocnemius) were implemented on land. The exercises are done for approximately one hour/day, three days/week for two consecutive weeks. The following are the included exercises: 1. Plank exercise 2. Russian twist 3. Dead bug 4. Push-up 5. Goblet squat 6. Nordic hamstring curl 7. Lunges 8. Kettle bell swing 9. Calf raises 10. Bird dog **Name:** Land-Based Exercise **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Water-Based Exercise **Description:** Strengthening exercises targeting the core and lower extremities (quadriceps, hamstring, and gastrocnemius) were implemented in the water. The exercises are done for approximately one hour/day, three days/week for two consecutive weeks. The following are the included exercises: 1. Core pulls 2. Flutter kicks 3. Water cycling 4. Isometric core crunches 5. Seated push-up 6. Jump squats 7. Jump lunges 8. Kicks 9. Ankle jumps 10. Resisted knee flexion **Name:** Water-Based Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This outcome measure is assessed using the manual vertical reach test technique. Unit of measurement is in centimeters (cm). Pre- and post-test measurement will be gathered. **Measure:** Vertical Jump **Time Frame:** 2 weeks **Description:** This outcome measure is assessed using the MyJump Lab Application. Unit of measurement is in centimeters (cm). Pre- and post-test measurement will be gathered. **Measure:** Countermovement Jump **Time Frame:** 2 weeks **Description:** This outcome measure is assessed using the MyJump Lab Application. Unit of measurement is in centimeters (cm). Pre- and post-test measurement will be gathered. **Measure:** Squat Jump **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Best time for plank will be assessed, measured in seconds (s). Pre- and post-test measurement will be gathered. **Measure:** Core Strength **Time Frame:** 2 weeks **Description:** This outcome measure used the 1RM of the participant, measured in pounds (lbs), as measurement of Quadriceps-Hamstring strength. Pre- and post-test measurement will be gathered. **Measure:** Quadriceps-Hamstring Strength **Time Frame:** 2 weeks **Description:** This outcome measure will simply use the Manual Muscle Test (MMT) as the basis, using scale method as elaborated by Brown and Avers (2019)'s Manual Testing 10th edition. Pre- and post-test measurement will be gathered. **Measure:** Gastrocnemius strength **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria. Volleyball and basketball players, specifically who: * are at least 18 years-old, * are enrolled in an Ilocos-based university during the second semester of academic year 2023-2024, * played in at least one (1) official university-wide game, * are physically prepared for the training, which is identified using the Physical Activity Readiness Questionnare for Everyone (PAR-Q+), and * have provided informed consent. Exclusion Criteria: Volleyball and basketball players who: * sustained injuries within 6 weeks before the start of the study, * have uncontrolled angina, uncontrolled hypertension, uncontrolled dysrhythmias, recent history of congestive heart failure, and/or severe aortic valve disease, * has condition/s that is/are contraindicated for pool therapy such as open wounds, skin infections, high fever, incontinence, fear of water, etc., * answered "Yes" to at least one question from the PAR-Q+; and * declined to participate. **Healthy Volunteers:** True **Maximum Age:** 24 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Batac **Country:** Philippines **Facility:** Mariano Marcos State University **State:** Il **Zip:** 2906 #### Overall Officials **Official 1:** **Affiliation:** Mariano Marcos State University **Name:** Mary Audrey D Viloria **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Based on the approved ethical considerations of the study by the ethics review board, the raw data will be kept with utmost confidentiality for at most five years. It can be viewed if required by the public, but with limitations, such as the provision of code names of participants to abide with data privacy. **IPD Sharing:** NO ### References Module #### References **Citation:** Gabbett TJ. The development of a test of repeated-sprint ability for elite women's soccer players. J Strength Cond Res. 2010 May;24(5):1191-4. doi: 10.1519/JSC.0b013e3181d1568c. **PMID:** 20386127 **Citation:** Wirth K, Keiner M, Fuhrmann S, Nimmerichter A, Haff GG. Strength Training in Swimming. Int J Environ Res Public Health. 2022 Apr 28;19(9):5369. doi: 10.3390/ijerph19095369. **PMID:** 35564764 **Citation:** Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2. **PMID:** 25555023 **Citation:** Seo DI, Kim E, Fahs CA, Rossow L, Young K, Ferguson SL, Thiebaud R, Sherk VD, Loenneke JP, Kim D, Lee MK, Choi KH, Bemben DA, Bemben MG, So WY. Reliability of the one-repetition maximum test based on muscle group and gender. J Sports Sci Med. 2012 Jun 1;11(2):221-5. eCollection 2012. **PMID:** 24149193 **Citation:** Bishop C, Jarvis P, Turner A, Balsalobre-Fernandez C. Validity and Reliability of Strategy Metrics to Assess Countermovement Jump Performance using the Newly Developed My Jump Lab Smartphone Application. J Hum Kinet. 2022 Sep 8;83:185-195. doi: 10.2478/hukin-2022-0098. eCollection 2022 Aug. **PMID:** 36157951 **Citation:** Gencoglu C, Ulupinar S, Ozbay S, Turan M, Savas BC, Asan S, Ince I. Validity and reliability of "My Jump app" to assess vertical jump performance: a meta-analytic review. Sci Rep. 2023 Nov 17;13(1):20137. doi: 10.1038/s41598-023-46935-x. **PMID:** 37978338 **Citation:** Hetzler RK, Stickley CD, Lundquist KM, Kimura IF. Reliability and accuracy of handheld stopwatches compared with electronic timing in measuring sprint performance. J Strength Cond Res. 2008 Nov;22(6):1969-76. doi: 10.1519/JSC.0b013e318185f36c. **PMID:** 18978613 **Citation:** TY - JOUR AU - Selvakumar, Kiruthika AU - Manoharlal, Manoj AU - Rusli, Nadia AU - Jing, Low AU - Thirruvevenkadam, Ilayaraja PY - 2021/06/01 SP - 04 EP - 10 T1 - Effectiveness of Modified Plank vs Conventional Plank on Core Muscle Endurance and Stability in Recreational Athletes: A Quasi-Experimental study VL - 15 DO - 10.7860/JCDR/2021/48224.15043 JO - Journal of Clinical and Diagnostic Research ER - **Citation:** TY - JOUR AU - Keiner, Michael AU - Kadlubowski, Björn AU - Hartmann, Hagen AU - Stefer, Tobias AU - Wirth, Klaus PY - 2021/05/05 SP - T1 - The Influence of Maximum Strength Performance in Squats and Standing Calf Raises on Squat Jumps, Drop Jumps, and Linear as well as Change of Direction Sprint Performance in Youth Soccer Players VL - DO - 10.23937/2469-5718/1510190 JO - ER - **Citation:** Cuthbert M, Ripley N, McMahon JJ, Evans M, Haff GG, Comfort P. The Effect of Nordic Hamstring Exercise Intervention Volume on Eccentric Strength and Muscle Architecture Adaptations: A Systematic Review and Meta-analyses. Sports Med. 2020 Jan;50(1):83-99. doi: 10.1007/s40279-019-01178-7. Erratum In: Sports Med. 2019 Nov 7;: **PMID:** 31502142 **Citation:** Jonhagen S, Ackermann P, Saartok T. Forward lunge: a training study of eccentric exercises of the lower limbs. J Strength Cond Res. 2009 May;23(3):972-8. doi: 10.1519/JSC.0b013e3181a00d98. **PMID:** 19387378 **Citation:** Collins KS, Klawitter LA, Waldera RW, Mahoney SJ, Christensen BK. Differences in Muscle Activity and Kinetics Between the Goblet Squat and Landmine Squat in Men and Women. J Strength Cond Res. 2021 Oct 1;35(10):2661-2668. doi: 10.1519/JSC.0000000000004094. **PMID:** 34341315 **Citation:** Lake JP, Lauder MA. Kettlebell swing training improves maximal and explosive strength. J Strength Cond Res. 2012 Aug;26(8):2228-33. doi: 10.1519/JSC.0b013e31825c2c9b. **PMID:** 22580981 **Citation:** Dell'Antonio E, Ruschel C, Hubert M, Lucas RD, Haupenthal A, Roesler H. The Effect of Aquatic Plyometric Training on Jump Performance Including a Four-week Follow-up in Youth Female Volleyball Players. J Hum Kinet. 2022 Sep 8;83:197-205. doi: 10.2478/hukin-2022-0058. eCollection 2022 Aug. **PMID:** 36157943 **Citation:** TY - JOUR AU - Roush, James AU - Heick, John AU - Genovese, Joseph AU - Kurashima, Kyle AU - Yarrington, Dallin PY - 2020/01/01 SP - T1 - Using Kinetic Energy with Potential Energy When Determining Power During the Stair Climbing Test VL - DO - 10.46743/1540-580X/2020.1928 JO - Internet Journal of Allied Health Sciences and Practice ER - ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412796 **Brief Title:** Postoperative Analgesic Effects of Subcostal Transversus Abdominis Plane Block Versus External Oblique Intercostal Block on Patients Undergoing Gastrectomy **Official Title:** Comparison of Postoperative Analgesic Effectiveness of Subcostal Transversus Abdominis Plane Block Versus External Oblique Intercostal Block on Patients With Gastric Cancer Undergoing Gastrectomy #### Organization Study ID Info **ID:** 2023/600 #### Organization **Class:** OTHER **Full Name:** TC Erciyes University ### Status Module #### Completion Date **Date:** 2025-03-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-26 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TC Erciyes University #### Responsible Party **Investigator Affiliation:** TC Erciyes University **Investigator Full Name:** Ayse Ulgey **Investigator Title:** Professor Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Open Gastrectomy surgery is a big surgery with upper umbilical median incision where the postoperative pain is occur frequently. pain managements of this surgery with intravenous opioid analgesics are currently standard approach. but its side effects as sedation, decreased bowel movement and respiratory depression are limiting its use. so local anesthesia done with regional block methods provides good analgesia after surgery that decrease use of opioid analgesics. in this study we intend to compare subcostal TAP block with external oblique intercostal block **Detailed Description:** in our study, we include the patients who has diagnosed Gastric Cancer and going to open gastrectomy surgery. this surgery performing with initial upper umbilical median incision of abdomen and then removing part or all of the stomach organ, which is cause postoperative pain on all abdominal area and affect the patient's recovery and morbidity. perioperative pain management is also important part of recovery after surgery. intravenous morphine using is part of protocols in analgesics. lately opioid free analgesia is aimed because of opioids side effects such as sedation, respiratory depression and decrease in bowel movement affect patients' recovery and duration in hospital. in this way regional and local anesthetics methods are getting more interested in pain management. To ensure the analgesic effects of the upper umbilical median incision area we planned to perform External Oblique Intercostal (EOI) block and Subcostal Transversus Abdominis Plane (SCTAP) block. To get better results we performed both blocks with Ultrasound Guided Imaging and injected bilateral with 15-20 ml of diluted local anesthetics on each side before the surgery. We divide patients into two groups: Group 1: the patients who get SCTAP block and Group 2: the patients who get EOI block. After the general anesthesia and intubation of patient we clean the abdominal area within antiseptic to perform injection before the surgery is began. In Group 1, SCTAP Block is performing by USG probe positioned on the anterior abdominal wall immediately inferior to the costal margin and then needle advanced to 2 to 3 cm lateral to the aponeurosis of the external oblique muscles, internal oblique muscles, and transversus abdominis in the TAP. Saline 0.5mL was injected to determine the position of the transverse fascia and 15-20 ml local anesthetics injected both in right and left sides of abdomen. In Group 2, EOI block is performed by placing the US probe in paramedian sagittal orientation at the T6-7 level and visualizing the external oblique and intercostal muscles. Local anesthetics inject the under the external oblique muscle. After the surgery patient controlled analgesia (PCA) is given to patients if there will not enough analgesic management confirmed. Pain assessment will be evaluated with the visual pain scale at 2/6/12/24 hours after surgery completed. ### Conditions Module **Conditions:** - Postoperative Pain - Analgesia **Keywords:** - SCTAP - External Oblique Intercostal block - postoperative analgesia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SCTAP Block is performing by USG probe positioned on the anterior abdominal wall immediately inferior to the costal margin and then needle advanced to 2 to 3 cm lateral to the aponeurosis of the external oblique muscles, internal oblique muscles, and transversus abdominis in the TAP. Saline 0.5mL was injected to determine the position of the transverse fascia and 15-20 ml local anesthetics injected both in right and left sides of abdomen. **Label:** Subcostal Transversus Abdominis Plane (SCTAP) block. #### Arm Group 2 **Description:** EOI block is performed by placing the US probe in paramedian sagittal orientation at the T6-7 level and visualizing the external oblique and intercostal muscles. Local anesthetics inject the under the external oblique muscle. **Label:** External Oblique Intercostal (EOI) block ### Outcomes Module #### Primary Outcomes **Description:** postoperatively monitoring of patients that need analgesics by morphine consumption using a patient contral analgesics device that record amount of used and wanted analgesics by patients themselves **Measure:** Need of morphine analgesia **Time Frame:** 24 hours **Description:** asking patients for pain at postoperative period by visual analog scale and score accordingly **Measure:** patients pain scales **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who have diagnosed Gastric Cancer and undergoing Gastric resection * patients accepted to participate for study Exclusion Criteria: * parients that not agreed for the study * patients who undergoing for second operation at the same surgery incision * patient that have chronic pains and multiple drugs using * patients that have psychiatric disorders * bariatric surgery * patients with allergics for local anaesthetics **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** all adult patients with gastric cancer who are undergoing gastrectomy and agreed for a study are accepted ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aulgey@erciyes.edu.tr **Name:** Ayşe Ülgey, MD **Phone:** 5378201751 **Phone Ext:** +90 **Role:** CONTACT #### Locations **Location 1:** **City:** Kayseri **Country:** Turkey **Facility:** University of Erciyes **State:** Talas **Zip:** 38100 ## 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: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - 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 - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - 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: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412783 **Brief Title:** Population-based Investigation of Aneurysm Incidence **Official Title:** Population-based Investigation of Aneurysm Incidence #### Organization Study ID Info **ID:** 2021YFC2501103 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-30 **Type:** ACTUAL #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2023-11-12 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Wang Shuo **Investigator Title:** Director of Department of Cerebrovascular Neurosurgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Most intracranial aneurysms are found accidentally in neurovascular imaging. And these inspection methods are limited by the problems of instrument fixation, radiation, time-consuming, contrast agent toxicity and so on. At present, blood test is an ideal alternative method for early diagnosis. Compared with imaging examination, it is economical, general screening and convenient. Blood test is simple to operate, easy to be accepted by patients, and less invasive. Early screening of aneurysms can be performed. ### Conditions Module **Conditions:** - Intracranial Aneurysm **Keywords:** - Intracranial Aneurysms - Screening - Blood test ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 1500 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: blood test **Label:** blood test group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - blood test group **Description:** performing blood tests on the participants for specific markers. **Name:** blood test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** oleic acid, arachidonic acid, docasa-hexaenoic acid, interleukin 1β， interleukin 1ra, tumor necrosis factors, SOD3, PPIA, S100A8, S100A9, MPO, APOA4, THBS1. **Measure:** Specific markers are detected **Time Frame:** 1hours after blood collection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 35-75 * Individuals with normal cognitive and communication abilities * No serious complications, such as uncontrolled hypertension, diabetes or other chronic diseases that may affect the test results. * Basic blood test is normal or close to normal range. Exclusion Criteria: * Pregnancy * Severe heart disease, renal insufficiency, liver dysfunction and other major diseases. * In the past 6 months, there were strokes, or other types of intracranial tumors, infections and other diseases that may affect the screening results. * There are metal implants, including dentures, pacemakers, etc. * Using or recently used drugs that may affect blood biomarkers ( such as anticoagulant drugs, immunosuppressive agents, etc. ). * There are serious mental illness or cognitive dysfunction, such as claustrophobia, unable to cooperate with the completion of the test. * It is currently participating in other clinical trials or has participated in other clinical trials in the past 3 months. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Capital Medical University Affiliated Beijing Tiantan Hospital **State:** Beijing ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020765 - Term: Intracranial Arterial Diseases - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4113 - Name: Aneurysm - Relevance: HIGH - As Found: Aneurysm - ID: M5781 - Name: Intracranial Aneurysm - Relevance: HIGH - As Found: Intracranial Aneurysm - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22521 - Name: Intracranial Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002532 - Term: Intracranial Aneurysm - ID: D000000783 - Term: Aneurysm ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412770 **Brief Title:** Effect of Tai Chi on Symptoms in Hemodialysis Patients **Official Title:** Director, World Health Organization (WHO) #### Organization Study ID Info **ID:** chengduTCM20240314 #### Organization **Class:** OTHER **Full Name:** Chengdu University of Traditional Chinese Medicine ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chengdu University of Traditional Chinese Medicine #### Responsible Party **Investigator Affiliation:** Chengdu University of Traditional Chinese Medicine **Investigator Full Name:** qinxiu zhang **Investigator Title:** professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn about the effect of Tai Chi on symptoms in hemodialysis patients.The main question\[s\] it aims to answer are: the effect of Tai Chi on symptoms or the quality of life in hemodialysis patients .Participants will be divided into three groups, one group will be asked to do Tai Chi for 30 minutes three times a week, and the other group will be asked to do Tai Chi imagery for 30 minutes three times a week. The comparison group will be given usual care. Researchers will compare the efficacy of symptoms and quality of life in dialysis patients in each group. ### Conditions Module **Conditions:** - Dialysis; Complications - Chinese Medicine - Quality of Life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tai Chi intervention group **Intervention Names:** - Behavioral: Tai chi **Label:** Tai Chi intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Tai Chi Imagery Intervention Group **Intervention Names:** - Behavioral: Tai Chi imagery **Label:** Tai Chi Imagery Intervention Group **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** no intervention **Intervention Names:** - Other: no-intervention **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Tai Chi intervention group **Description:** Participants will be asked to do Tai Chi for 30 minutes three times a week **Name:** Tai chi **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Tai Chi Imagery Intervention Group **Description:** Participants will be asked to do Tai Chi imagery for 30 minutes three times a week **Name:** Tai Chi imagery **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Control group **Description:** The comparison group will be given usual care **Name:** no-intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The effects of tai Chi on symptoms (fatigue, pain, depression, sleep) of hemodialysis patients were assessed by scale **Measure:** Evaluation of life quality after treatment **Time Frame:** Assessment was performed at 4, 8, and 12 weeks after treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age≥ 18; * Dialysis age≥ 3 months; * Survival≥ 12 months; * The patient has the ability to move independently, can learn independently, and has no reading and comprehension disabilities; * Informed consent Exclusion Criteria: * Inability to move autonomously; * Have a mental disorder; * Other serious complications occur **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412757 **Acronym:** STOP **Brief Title:** Silexan in the Treatment Of Posttraumatic Stress Disorder Trial **Official Title:** Silexan in the Treatment Of Posttraumatic Stress Disorder (STOP) Trial #### Organization Study ID Info **ID:** 29307 #### Organization **Class:** OTHER **Full Name:** Deakin University #### Secondary ID Infos **Domain:** US Department of Defense CDMRP Contract Number **ID:** HT9425-23-1-0885 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Melbourne #### Lead Sponsor **Class:** OTHER **Name:** Deakin University #### Responsible Party **Investigator Affiliation:** Deakin University **Investigator Full Name:** Gregory Roebuck **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 224 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment. **Detailed Description:** Background: Posttraumatic stress disorder (PTSD) is a common and debilitating psychiatric disorder. Existing PTSD treatments have very significant limitations. Current evidence-based treatments for PTSD include trauma-focussed psychotherapy and antidepressant medications, including selective serotonin reuptake inhibitors and the serotonin noradrenaline reuptake inhibitor venlafaxine. Many patients are unable to tolerate trauma-focussed psychotherapy. Uptake is relatively low and dropout rates are high. In addition, up to 50% of patients fail to respond to this therapy. Antidepressant medications have small clinical effects and are associated with unpleasant side effects that can lead to non-adherence. There is an urgent need for new treatments for PTSD that are effective and well-tolerated. Silexan has the potential to provide a transformative alternative to these treatments. It is an orally administered lavender oil preparation whose main constituents are the monoterpenoids linalool and linalyl acetate. It is available over-the-counter in 14 countries, including Australia and the United States. It has a novel pharmacodynamic profile that includes potent inhibition of voltage-gated calcium channels and reduction of serotonin 1A receptor binding potential. Silexan is an effective treatment for Generalized Anxiety Disorder (GAD) and other anxiety disorders. A 2019 independent meta-analysis of data from five randomized controlled trials involving 1,320 participants with anxiety disorders found that Silexan 160 mg out-performed paroxetine and lorazepam in reducing anxiety symptoms. Silexan is also well-tolerated. The only adverse effects that have been identified so far are mild gastrointestinal symptoms and these are uncommon. Promising pilot data suggest that Silexan may also be effective and well-tolerated in PTSD. Hypothesis: The primary hypothesis is that Silexan, as an adjunct to treatment-as-usual, over 12 weeks will be superior to placebo in improving PTSD symptoms in adults with PTSD. Specific aims: The trial aims to investigate the effectiveness of adjunctive Silexan, compared with placebo, over 12 weeks in improving PTSD symptoms. The primary outcome measure will be the between-group change from baseline in the total symptom severity score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Study design: The trial is a phase 3, 12-week, multi-site, parallel-arm, randomized, placebo-controlled, double-blind trial. Participants will be adults with PTSD without comorbid psychosis, bipolar disorder, severe depression, moderate or severe substance use disorder or Borderline Personality Disorder. Participants randomized to the Silexan arm will receive Silexan 160 mg daily for 12 weeks in addition to their usual prescribed medications. Participants randomized to the placebo arm will receive capsules containing an inert placebo. The target sample size will be 156 participants, or 78 per arm. The study will recruit 224 participants to account for a 30% drop-out rate. Clinical impact: There is an urgent need to develop new treatments for PTSD that are effective and well-tolerated. This trial has the potential to provide definitive evidence of the efficacy of Silexan in adult PTSD. Silexan is safe, well-tolerated, currently available and affordable, facilitating a rapid translation into clinical care. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. ### Conditions Module **Conditions:** - Post Traumatic Stress Disorder **Keywords:** - posttraumatic stress disorder - adjunctive treatment - Silexan - phytoceutical - pharmacotherapy - randomized controlled trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The trial is a phase 3, 12-week, parallel-arm, randomized, placebo-controlled, double-blind trial. Participants will be randomly allocated to receive either (a) Silexan 160 mg or (b) an identical appearing inert placebo, daily for 12 weeks in addition to their usual prescribed medications. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** All study team members will be blinded to allocation. Blinding will be maintained by ensuring that the packaging, appearance and color of the Silexan (treatment) and placebo capsules are identical. Placebo capsules will also include a sub-therapeutic amount of lavender oil to match the odour of the Silexan capsules. In addition, blinding will be maintained by identifying participants using anonymous participant identifier numbers; an independent statistician will coordinate randomization and an independent pharmacist will store and provide blinded batches to study team members for dispensing. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 224 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the Silexan arm will take Silexan 160 mg daily in the morning for 12 weeks in addition to their usual prescribed psychoactive medications. Participants will be followed up at 2, 4, 6, 8 and 12 weeks of the intervention period, as well as at 4 weeks post-treatment (off-treatment follow-up period). **Intervention Names:** - Drug: Silexan **Label:** Silexan 160 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this arm will take two placebo capsules daily in the morning for 12 weeks in addition to their usual medications. Participants will be followed up at 2, 4, 6, 8 and 12 weeks of the intervention period, as well as at 4 weeks post-treatment (off-treatment follow-up period). **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Silexan 160 mg **Description:** Participants in the Silexan arm will take two over-encapsulated capsules, each containing 80 mg Silexan, daily orally in the morning in addition to their usual medications. No modifications of allocated interventions will be made for any trial participants; if appropriate (i.e following the emergence of adverse events) participants will be withdrawn from the intervention. **Name:** Silexan **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Participants in the placebo arm will take two capsules containing an inert placebo daily orally in the morning in addition to their usual medications. The placebo capsules will contain a sub-therapeutic amount of lavender oil to mimic the odor of the experimental drug (Silexan). **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Primary Outcome Measure will be the between-group difference in the change from baseline to week 12 in the total symptom severity score on the CAPS-5. The CAPS-5 has good internal consistency, inter-rater reliability, test-retest reliability and convergent validity in measuring PTSD symptom severity, and is regarded as the gold-standard for measuring PTSD symptoms in research settings **Measure:** Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) **Time Frame:** At baseline and at week 12 of the intervention period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 years or over. 2. Fluent in English. 3. Meet DSM-5 criteria for PTSD, irrespective of occupation (e.g. first responder, police officer, ex-military or civilian), determined using the Mini International Neuropsychiatric Interview 7.0.2. 4. Have a score on the PTSD Checklist for DSM-5 (PCL-5) equal to or over 33. Exclusion Criteria: 1. Lifetime history of a psychotic or bipolar disorder. 2. Moderate or severe alcohol or other substance use disorder within 3 months of screening. 3. Active suicidal or homicidal ideation. 4. Borderline Personality Disorder (BPD). 5. Acute or unstable medical illness or other significant medical condition, including cardiovascular disease, epilepsy and chronic liver or kidney disease. 6. Pregnancy, lactation or unwillingness to use an acceptable method of contraception through the duration of participants' involvement in the study up to and including week 16. Participants will also be advised not to donate eggs or sperm during the study period. 7. Commencement of a trauma-focussed psychotherapy (including Prolonged Exposure, Cognitive Processing Therapy and Eye Movement Desensitisation and Reprocessing) within 3 months of screening. 8. Commencement or change in dose of psychoactive medications within 4 weeks of screening. 9. Participants will be asked not to initiate psychotherapy or change the dose of psychoactive medications during the course of the study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating their participation. 10. Severe acquired brain injury. 11. Individual is not eligible for public mental health services due to their visa status in Australia or for any other reason. 12. Any other condition that in the opinion of the research team is likely to make completion of the trial requirements infeasible. 13. Inability to understand or speak English to the extent necessary to give informed consent and complete the trial (researcher or clinician-determined). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## 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: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Stress Disorder - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - 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 - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T141 - Name: English Lavender - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412744 **Acronym:** JOZO **Brief Title:** Determination of the Iodine Status in Pregnant Women in the Netherlands. **Official Title:** Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate? #### Organization Study ID Info **ID:** NL70677.068.19 #### Organization **Class:** OTHER **Full Name:** Maastricht University Medical Center #### Secondary ID Infos **Domain:** NL trial register (NTR) **ID:** NL8297 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2020-10-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2022-12-16 **Study First Submit QC Date:** 2024-05-08 **Why Stopped:** Difficulties finding participants ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Institute for Public Health and the Environment (RIVM) #### Lead Sponsor **Class:** OTHER **Name:** Maastricht University Medical 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:** Study to determine iodine status in dutch pregnant women **Detailed Description:** Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism (1, 2). During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications (3). Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining (4). Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d)(3). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women (5-11). Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here we propose to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. We hypothesize that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group. ### Conditions Module **Conditions:** - Pregnancy Related - Healthy ### Design Module #### Bio Spec **Description:** Blood (only plasma and serum is stored) Urine **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 43 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No intervention, all participants undergo the same measurements **Label:** Total cohort ### Outcomes Module #### Primary Outcomes **Description:** Median urinary iodine excretion (µg/d) **Measure:** Median urinary iodine excretion (µg/d) **Time Frame:** At baseline measurement #### Secondary Outcomes **Description:** Thyroglobulin and thyroglobulin antibody concentrations in blood serum **Measure:** Thyroglobulin and thyroglobulin antibody concentrations in blood serum **Time Frame:** At baseline measurement **Description:** Creatinin concentration in urine **Measure:** Creatinin concentration in urine **Time Frame:** At baseline measurement **Description:** Urinary volume **Measure:** Urinary volume **Time Frame:** At baseline measurement **Description:** Smoking status (smoking is interfering with iodine metabolism) Yes/no **Measure:** Smoking status (smoking is interfering with iodine metabolism) **Time Frame:** At baseline measurement **Description:** Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid) **Measure:** Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid) **Time Frame:** At baseline measurement **Description:** Nutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq **Measure:** Nutritional intake specifically related to iodine intake (questionnaire) **Time Frame:** At baseline measurement **Description:** Intake other relevant micronutrients for pregnant **Measure:** Intake other relevant micronutrients for pregnant **Time Frame:** At baseline measurement ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female * 18-45y old * in first 16 weeks of pregnancy * pregnant of singleton Exclusion Criteria: * Thyroid-disease or any other metabolic disease * kidney disease * twin-pregnancy **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands ### Contacts Locations Module #### Locations **Location 1:** **City:** Maastricht **Country:** Netherlands **Facility:** Maastricht UMC+ **State:** Limburg **Zip:** 6225 HX ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412731 **Brief Title:** Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars **Official Title:** Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars #### Organization Study ID Info **ID:** MUPRU004 #### Organization **Class:** OTHER **Full Name:** Al-Mustansiriyah University ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Mustansiriyah University #### Responsible Party **Investigator Affiliation:** Al-Mustansiriyah University **Investigator Full Name:** Alhamzah thaer hasan Ankaz **Investigator Title:** BDS **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes: 1. Arrestment of caries lesion and the emergence of a new one 2. Time required for the treatment 3. Adverse events 4. Children's anxiety **Detailed Description:** The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp. The purpose of this research was to evaluate three minimally invasive therapies via the assessment of: 1. Duration of treatment 2. (feeling of pain) and the need for anesthetic 3. Incidents with negative outcomes that have been officially documented 4. Filling material adhesiveness fellow up The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur) Setting: Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions. ### Conditions Module **Conditions:** - Dental Caries in Children **Keywords:** - CMCR - SDF - Ceramic bur ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cera bur (Ceramic Bur) Komet, Lemgo, Germany **Intervention Names:** - Other: Cera-bur **Label:** Ceramic bur (Cerabur) C **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** e-SDF (SDF 38%) E-kids, India **Intervention Names:** - Other: E-SDF **Label:** Silver Diamine Fluoride (e-SDF) S **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Brix3000 (Papain based gel) S.R.L., Argentina **Intervention Names:** - Other: Brix3000 **Label:** CMCR gel (Brix3000) B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ceramic bur (Cerabur) C **Description:** Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material **Name:** Cera-bur **Other Names:** - Ceramic bur **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - CMCR gel (Brix3000) B **Description:** Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material **Name:** Brix3000 **Other Names:** - Papain-based CMCR **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Silver Diamine Fluoride (e-SDF) S **Description:** Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling **Name:** E-SDF **Other Names:** - 38% Silver Diamine fluoride **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The following adverse events will be investigated: Pain, sensitivity, tooth discoloration, burning in the mouth, allergy altered taste of food, irritation of the gums or mucosa **Measure:** Adverse event **Time Frame:** during the first two weeks **Description:** The evaluation was done using the community periodontal index (CPI)-probe (WHO-probe) and a dental mirror. The treated lesions were classified according to the evaluation scores which were modified from those used by Francis et al.: score 1 - the restoration intact, covering all pits and fissures; score 2 - the restoration partially lost, the tooth is sound (no active/soft caries); score 3 - the restoration partially lost, the tooth is carious(active/soft caries); score 4 - the restoration completely lost, the tooth is sound; and score 5 - the restoration completely lost, the tooth is carious. The tooth was considered sound if its surface felt hard and shiny **Measure:** Filling fellow up **Time Frame:** after 3 months #### Secondary Outcomes **Description:** Anxiety level prescribed by the patient using a facial image scale to measure the children' anxiety. Each kid was instructed to indicate the facial expression that most accurately conveyed their current emotional state, which may be categorized as either (very happy; happy; neutral; unhappy; or very unhappy **Measure:** anxiety level **Time Frame:** immediately after the procedure **Description:** the time required for the treatment in each group using a digital timer A digital timer which triggers as soon as the tooth brushing starts. During the first appointment starting from dental caries removal until sound dentin reached before Glass ionomer filling placement, **Measure:** Time **Time Frame:** This will take about from 5 to 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth. * These lesions should affect the dentin but not expose the pulp. * The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization Exclusion Criteria: * Children were excluded if parents were unwilling to be assigned to any of the approaches * Children that had any abnormal medical condition or silver or papain allergy * Chose molars with clinical or radiographic signals of pulp involvement **Healthy Volunteers:** True **Maximum Age:** 8 Years **Minimum Age:** 7 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Baghdad **Country:** Iraq **Facility:** College of Dentistry, Mustansiriyah University **State:** Al-karkh **Zip:** 10011 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Satyarup D, Mohanty S, Nagarajappa R, Mahapatra I, Dalai RP. Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):217-223. doi: 10.17219/dmp/143547. **PMID:** 35506381 **Citation:** Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4. **PMID:** 31279925 #### See Also Links **Label:** Comparative Evaluation of 'Less Invasive Approach' of caries excavation and 'Only Arrest And No Excavation Approach' in dental caries management in primary molars- A Randomised Controlled Trial **URL:** https://jamdsr.com/uploadfiles/17vol9issue8pp84-92.20210815050049.pdf **Label:** Evaluation of the Efficacy of Caries Removal Using Papain Gel (Brix 3000) and Smart Preparation Bur(in vivo Comparative Study) **URL:** https://global-ie.com/wp-content/uploads/2022/02/comparativo-brix-vs-fresas-inteligentes.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M19339 - Name: Tooth Demineralization - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003731 - Term: Dental Caries ### Intervention Browse Module - Ancestors - ID: D000002327 - Term: Cariostatic Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M8587 - Name: Fluorides - Relevance: HIGH - As Found: Genetic - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T417 - Name: Papain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005459 - Term: Fluorides ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412718 **Brief Title:** Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies **Official Title:** Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies #### Organization Study ID Info **ID:** RV-WP2 #### Organization **Class:** OTHER **Full Name:** IRCCS Ospedale San Raffaele ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Ospedale San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS Ospedale San Raffaele **Investigator Full Name:** Giulio Ferrari **Investigator Title:** Professor of Ophthalmology-San Raffaele Vita Salute University, Cornea and Ocular Surface Unit; Head-Eye Repair Lab San Raffaele Scientific Institute **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The cross-sectional observational clinical study related to rare eye diseases is a multi-center study in which the hypothesis is that neurokinin 1 receptor and/or substance P expression is increased in REDs associated with inflammation/pain. Moreover, the following alternative targets are: VEGF, PAX6 and pro-inflammatory cytokine. The following procedures are performed specifically for the study: samples of blood, tear fluid and impression cytology. Precisely during the ophthalmological exam performed according to normal clinical practice (uncorrected visual acuity, best spectacle corrected visual acuity, corneal topography, corneal pachymetry and the slit lamp pictures) investigator's team collect the samples of blood, tear fluid and impression cytology to evaluate the goal of the study. ### Conditions Module **Conditions:** - Rare Diseases - Aniridia - Neurotrophic Keratopathy - Limbal Stem Cell Deficiency - Ocular Graft-versus-host Disease - Ocular Cicatricial Pemphigoid - EEC Syndrome - Corneal Neovascularization **Keywords:** - Rare Eye Diseases - Aniridia - Neurotrophic Keratopathy - Limbal Stem Cell Deficiency - Ocular Graft-versus-host Disease - Ocular Cicatricial Pemphigoid - Corneal Neovascularization - Molecular targets - Cellular targets - Genomic targets - NK1R - PBMC - Substance P - VEGF - Blood - Tear - Impression cytology - Cytokine ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 274 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Patients #### Arm Group 2 **Label:** Control group ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of NK1R transcription levels in PBMC, substance P and VEGF protein levels in the tear fluid, pro-inflammatory cytokines transcription levels in conjunctival tissue. NK1R and pro-inflammatory cytokines are expressed as fold change compared to control group. Substance P and VEGF are expressed as ng/ml. **Measure:** To quantify the expression of molecular/cellular/genomic targets in the REDs and control group to detect statistically significant and clinically relevant differences. **Time Frame:** Day 0 (enrollment day). #### Secondary Outcomes **Description:** Levels of NK1R, substance P, VEGF, and pro-inflammatory cytokines correlated with pictures, questionnaires, uncorrected visual acuity, best spectacle corrected visual acuity, corneal topography, corneal pachymetry and the slit lamp pictures acquired during the ophthalmologic exam. **Measure:** To correlate the expression of molecular/cellular genomic targets with the clinical phenotype/quality of life/pain symptoms in patients with the 7 rare diseases and in the control group so as to detect possible risk factors. **Time Frame:** Day 0 (enrollment day). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion Criteria for study group * Women and men with age equal or higher than 18 years (patients in reproductive age may be included in the study). * Willingness and ability to read and understand the informed consent. * Diagnosis (including genotype, if needed) of REDs. Inclusion Criteria for control group * Women and men with age equal or higher than 18 years (patients in reproductive age may be included in the study). * Willingness and ability to read and understand the informed consent. * Non - diagnosis of REDs. Exclusion Criteria: Exclusion Criteria for study group Patients who meet these criteria will be excluded from participation in the study: * Pregnancy, breastfeeding. * Active ocular infection. * Descemetocele/impending corneal perforation. * Recent (less than 3 months) ocular surgery. * Recent (less than 1 month) change in topical medications type and frequency. Exclusion Criteria for control group Patients who meet these criteria will be excluded from participation in the study: * Pregnancy, breastfeeding. * Active ocular infection. * Descemetocele/impending corneal perforation. * Recent (less than 3 months) ocular surgery. * Recent (less than 1 month) change in topical medications type and frequency. **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population consists of 137 patients, each of them will present with one of the 7 diseases under study (REDs). The control group will consist of 137 patients not presenting the previous reported REDs. ### References Module #### See Also Links **Label:** European Commission, ERN-EYE: a European Reference Network dedicated to Rare Eye Diseases. Accessed 29 December 2021 **URL:** https://www.ern-eye.eu/ern-eye-a-european-reference-network-dedicated-to-rare-eye-diseases/ **Label:** European Blind Union, About Blindness and Partial Sight: Facts and Figures. Accessed 26 August 2022 **URL:** https://www.euroblind.org/about-blindness-and-partial-sight/facts-and-figures **Label:** Restore Vision site **URL:** https://restorevision-project.eu/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000008679 - Term: Metaplasia - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes - ID: D000012872 - Term: Skin Diseases, Vesiculobullous - ID: D000012871 - Term: Skin Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000003316 - Term: Corneal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000005124 - Term: Eye Abnormalities - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000007499 - Term: Iris Diseases - ID: D000014603 - Term: Uveal Diseases - ID: D000000013 - Term: Congenital Abnormalities - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000003229 - Term: Conjunctival Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M24518 - Name: Rare Diseases - Relevance: HIGH - As Found: Rare disease - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M9189 - Name: Graft vs Host Disease - Relevance: HIGH - As Found: Graft Versus Host Disease - ID: M2921 - Name: Limbal Stem Cell Deficiency - Relevance: HIGH - As Found: Limbal Stem Cell Deficiency - ID: M18907 - Name: Corneal Neovascularization - Relevance: HIGH - As Found: Corneal Neovascularization - ID: M18337 - Name: Aniridia - Relevance: HIGH - As Found: Aniridia - ID: M13301 - Name: Pemphigoid, Benign Mucous Membrane - Relevance: HIGH - As Found: Ocular Cicatricial Pemphigoid - ID: M13302 - Name: Pemphigoid, Bullous - Relevance: HIGH - As Found: Pemphigoid - ID: M12334 - Name: Neovascularization, Pathologic - Relevance: HIGH - As Found: Neovascularization - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11659 - Name: Metaplasia - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15675 - Name: Skin Diseases, Vesiculobullous - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M8267 - Name: Eye Abnormalities - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M10531 - Name: Iris Diseases - Relevance: LOW - As Found: Unknown - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M6453 - Name: Conjunctival Diseases - Relevance: LOW - As Found: Unknown - ID: T2832 - Name: Homologous Wasting Disease - Relevance: HIGH - As Found: Graft Versus Host Disease - ID: T891 - Name: Bullous Pemphigoid - Relevance: HIGH - As Found: Pemphigoid - ID: T400 - Name: Aniridia - Relevance: HIGH - As Found: Aniridia - ID: T3914 - Name: Mucous Membrane Pemphigoid - Relevance: HIGH - As Found: Cicatricial Pemphigoid - ID: T4191 - Name: Ocular Cicatricial Pemphigoid - Relevance: HIGH - As Found: Ocular Cicatricial Pemphigoid - ID: T2039 - Name: EEC Syndrome - Relevance: HIGH - As Found: EEC Syndrome - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000092423 - Term: Limbal Stem Cell Deficiency - ID: D000016510 - Term: Corneal Neovascularization - ID: D000015783 - Term: Aniridia - ID: D000010390 - Term: Pemphigoid, Benign Mucous Membrane - ID: D000010391 - Term: Pemphigoid, Bullous - ID: D000006086 - Term: Graft vs Host Disease - ID: D000009389 - Term: Neovascularization, Pathologic - ID: D000035583 - Term: Rare Diseases ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16161 - Name: Substance P - Relevance: LOW - As Found: Unknown - ID: M17988 - Name: Neurokinin A - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412705 **Brief Title:** Vit D and Post-extractive Bone Turnover **Official Title:** The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial #### Organization Study ID Info **ID:** VITD-01 #### Organization **Class:** OTHER **Full Name:** Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Start Date **Date:** 2023-10-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo #### 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 aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels. **Detailed Description:** The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT). ### Conditions Module **Conditions:** - Vitamin D Deficiency - Alveolar Bone Loss - Alveolar Bone Resorption **Keywords:** - Dental Implants, Alveolar Bone Loss, Alveolar Process ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted. **Intervention Names:** - Procedure: Tooth extraction, guided bone regeneration and dental implant **Label:** Tooth extraction and bone regeneration **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tooth extraction and bone regeneration **Description:** The arm received tooth extraction and contextual guided bone regeneration. After 4 months, a dental implant was inserted. **Name:** Tooth extraction, guided bone regeneration and dental implant **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3. **Measure:** Dimensional alveolar bone changes **Time Frame:** From extraction to implant insertion (4 months) **Description:** Evaluation of new formed bone tissue performed by histomorphometric methods. **Measure:** Evaluation of new formed bone tissue **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods. **Measure:** Evaluation of Total Calcified Tissue (TCT) **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. **Measure:** Expression of Collagen A1 **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. **Measure:** Expression of Osteocalcin **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. **Measure:** Expression of Osteopontin **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. **Measure:** Expression of Runx-2 **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W\&H) **Measure:** Evaluation of Implant Stability Quotient (ISQ) **Time Frame:** Time of implant insertion: 4 months after extraction **Description:** Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device. **Measure:** Evaluation of Implant Torque Value (ITV) **Time Frame:** Time of implant insertion: 4 months after extraction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female adult (≥ 18 years old) * Patients willing to participate and to attend the planned follow-up visits Exclusion Criteria: * Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism * History of leukocyte dysfunction and deficiencies * History of neoplastic disease requiring the use of radiation or chemotherapy * History of renal failure * Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * History of uncontrolled endocrine disorders * Alcoholism or any drug abuse * History of immunodeficiency syndromes * Smoker of 10 cig per day, cigar equivalents or tobacco chewers * Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability * Mucosa disease such as erosive lichen planus * Residual post-extraction site with intact bone walls * History of local irradiation therapy * Persistent intraoral infection **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Roma **Country:** Italy **Facility:** Studi Odontoiatrici Luigi Canullo **State:** RM **Zip:** 00100 #### Overall Officials **Official 1:** **Affiliation:** Studi Odontoiatrici Luigi Canullo **Name:** Luigi Canullo **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001361 - Term: Avitaminosis - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000055093 - Term: Periodontal Atrophy - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5141 - Name: Bone Resorption - Relevance: HIGH - As Found: Bone Resorption - ID: M18747 - Name: Alveolar Bone Loss - Relevance: HIGH - As Found: Alveolar Bone Loss - ID: M17551 - Name: Vitamin D Deficiency - Relevance: HIGH - As Found: Vitamin D Deficiency - ID: M4660 - Name: Avitaminosis - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001862 - Term: Bone Resorption - ID: D000016301 - Term: Alveolar Bone Loss - ID: D000014808 - Term: Vitamin D Deficiency ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: LOW - As Found: Unknown - ID: T440 - Name: Calciferol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412692 **Brief Title:** Motivational Interviewing in Adolescents With Epilepsy **Official Title:** The Effect of Motivational Interviewıng Technique on Social Anxiety and Quality of Life of Adolescents With Epilepsy #### Organization Study ID Info **ID:** İzmirKCU-GECTAN-001 #### Organization **Class:** OTHER **Full Name:** Izmir Katip Celebi University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Izmir Katip Celebi University #### Responsible Party **Investigator Affiliation:** Izmir Katip Celebi University **Investigator Full Name:** ELİZ GECTAN **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:** Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change. **Detailed Description:** Adolescence period; It is an important stage of development in which the self-concept develops, self-related schemas are created and carried into adulthood. During this formative period of life; Adolescents experience increasing levels of uncertainty and self-consciousness as they progress through the task of identity formation. It is greatly influenced by social interactions, especially interactions with peers.Children and adolescents with epilepsy are at increased risk for social problems, reduced social competence, poor social skills, and deficits in social communication compared to healthy children. Compared to youth with other chronic diseases, youth with epilepsy have higher rates of comorbid neurological disorders, academic failure, poor social skills, stigma, poor quality of life, and behavioral health problems (e.g., anxiety, depression). They often experience low quality of life because they feel unsafe and fear having a seizure in public. In a study aiming to investigate the factors affecting the level of social anxiety in epilepsy, it was concluded that social anxiety is independently associated with low quality of life. In a meta-analysis study; It was concluded that the motivational interviewing method applied by nurses increased the quality of life of individuals with chronic diseases. When the literature was examined, no study was found that addressed the motivational interviewing technique applied to the social anxiety and quality of life of adolescents with epilepsy. Motivational Interviewing Technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life by enabling adolescents to become aware of their situation, get rid of the ambivalent (opposite emotional state) they experience, and take action to change. ### Conditions Module **Conditions:** - Pediatric ALL **Keywords:** - Epilepsy - Adolescent - Motivational Interviewing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In our study; The motivational interview technique will be applied to the intervention group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions. ##### Masking Info **Masking:** SINGLE **Masking Description:** Randomized **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 72 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Motivational Interviewing Technique Group (n=36) An equal number of patients will be classified by gender. Before the interview, each adolescent: Informed Consent Form, Personal Information Form, Social Anxiety Scale for Adolescents, Children's General Quality of Life Scale, and KINDL Epilepsy Quality of Life Module for Children will be applied. Interviews will be held in the training room next to the Child Neurology Polyclinic. In our study; The motivational interviewing technique will be applied to the experimental group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions. Each motivational interview will last approximately 40-50 minutes. One day before the motivational interview day, the experimental group will be informed by calling their registered phone numbers. The surveys will be re-administered after the end of the interview sessions. Surveys will be administered again after 1 month. **Intervention Names:** - Other: The Motivational Interviewing Technique **Label:** The Motivational Interviewing Technique **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No Intervention Group (n=36) Equal numbers of patients will be stratified according to gender. Adolescents without intervention; Patient Consent Form, Personal Information Form, Social Anxiety Scale in Adolescents, Child's General Quality of Life Scale, KINDL Epilepsy Quality of Life Module in Children will be applied. Routine follow-up and treatment will continue. The duration of the pre-interview and 6 motivational interviews will be calculated and the scales will be applied again.The surveys will be administered again after 1 month. **Label:** No Intervention **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - The Motivational Interviewing Technique **Description:** Motivational interviewing technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life of adolesce. **Name:** The Motivational Interviewing Technique **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A high score on the Social Anxiety Scale for Adolescents indicates high anxiety. **Measure:** "Social Anxiety Scale for Adolescents" [Time Frame: After the motivational interviewing technique] **Time Frame:** 3 months **Description:** A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life. **Measure:** ''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: After the motivational interviewing technique] **Time Frame:** 3 months **Description:** A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life. **Measure:** "Children's General Quality of Life Scale'' [Time Frame: After the motivational interviewing technique] **Time Frame:** 3 months **Description:** A high score on the Social Anxiety Scale for Adolescents indicates high anxiety. **Measure:** "Social Anxiety Scale for Adolescents" [Time Frame: 1 month after the Motivational Interviewing Technique] **Time Frame:** 1 months **Description:** A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life. **Measure:** ''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: 1 month after the Motivational Interviewing Technique] **Time Frame:** 1 months **Description:** A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life. **Measure:** "Children's General Quality of Life Scale" [Time Frame: 1 month after the Motivational Interviewing Technique] **Time Frame:** 1 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be between the ages of 12-15 * Having epilepsy for at least six months * Having a high score on the Social Anxiety Scale for Adolescents * Having a low score on the General Child Life Quality Scale * Low scores on the KINDL Epilepsy Quality of Life Module for Children * No mental disability * Able to communicate (can speak and understand Turkish, has no speech disorder) * Being literate * Not having any other chronic disease * Being willing to participate in the study Exclusion Criteria: -Not attending at least one of the interviewing **Gender Based:** True **Gender Description:** Experimental and control groups were selected based on randomization gender. **Healthy Volunteers:** True **Maximum Age:** 15 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** İzmir **Country:** Turkey **Facility:** İzmirKCU **State:** Çigli **Zip:** 35620 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Clifford LM, Brothers SL, Lang A. Self-Disclosure Patterns Among Children and Youth with Epilepsy: Impact of Perceived-Stigma. Adolesc Health Med Ther. 2023 Feb 5;14:27-43. doi: 10.2147/AHMT.S336124. eCollection 2023. **PMID:** 36776152 **Citation:** Tolchin B, Baslet G, Martino S, Suzuki J, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Motivational Interviewing Techniques to Improve Psychotherapy Adherence and Outcomes for Patients With Psychogenic Nonepileptic Seizures. J Neuropsychiatry Clin Neurosci. 2020 Spring;32(2):125-131. doi: 10.1176/appi.neuropsych.19020045. Epub 2019 Aug 30. **PMID:** 31466516 **Citation:** Tolchin B, Baslet G, Suzuki J, Martino S, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Randomized controlled trial of motivational interviewing for psychogenic nonepileptic seizures. Epilepsia. 2019 May;60(5):986-995. doi: 10.1111/epi.14728. Epub 2019 Apr 13. **PMID:** 30980679 **Citation:** Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22. **PMID:** 30348753 **Citation:** Aburahma SK, Hammouri H, Hazaimeh E, Jbarah O, Nassar A, Almasri A, Al Momani M, Bashtawi M. Social impairment in children with epilepsy assessed by the social responsiveness scale. Clin Child Psychol Psychiatry. 2021 Oct;26(4):1170-1181. doi: 10.1177/13591045211033176. Epub 2021 Jul 16. **PMID:** 34271834 **Citation:** Hosseini N, Mokhtari S, Momeni E, Vossoughi M, Barekatian M. Effect of motivational interviewing on quality of life in patients with epilepsy. Epilepsy Behav. 2016 Feb;55:70-4. doi: 10.1016/j.yebeh.2015.10.012. Epub 2016 Jan 12. **PMID:** 26773672 **Citation:** Lu Y, Zhong R, Li M, Zhao Q, Zhang X, Hu B, Lin W. Social anxiety is associated with poor quality of life in adults with epilepsy in Northeast China: A cross-sectional study. Epilepsy Behav. 2021 Apr;117:107866. doi: 10.1016/j.yebeh.2021.107866. Epub 2021 Mar 5. **PMID:** 33684784 **Citation:** Uzun S, Ozmaya E. The effect of motivational interview conducted by nurses on quality of life: Meta-analysis. Perspect Psychiatr Care. 2022 Oct;58(4):2449-2459. doi: 10.1111/ppc.13080. Epub 2022 Apr 5. **PMID:** 35383938 ## 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: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T1134 - Name: Childhood Acute Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412679 **Acronym:** RESETTLE-IDPs **Brief Title:** RESETTLE-IDPs: Life-Skills Education and Psychosocial Resilience Building for Displaced Nigerians **Official Title:** Rebuilding Emotional Stability and Strength Through Therapeutic and Life-Skills Education for Internally Displaced Persons in Nigeria (RESETTLE-IDPs): A Hybrid Type II Effectiveness-implementation Study #### Organization Study ID Info **ID:** 2024-7085 #### Organization **Class:** OTHER **Full Name:** Dalhousie University #### Secondary ID Infos **Domain:** CIHR **ID:** PAA - 192178 **Type:** OTHER_GRANT **Domain:** Grand Challenges Canada **ID:** R-HGC-POC-2408-67370 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** University of Maiduguri Teaching Hospital **Class:** UNKNOWN **Name:** Brooks Insights #### Lead Sponsor **Class:** OTHER **Name:** Dalhousie University #### Responsible Party **Investigator Affiliation:** Dalhousie University **Investigator Full Name:** Ejemai Eboreime **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 RESETTLE-IDPs study aims to address the urgent mental health needs of internally displaced youth and women in Nigeria, who face high rates of depression, anxiety, and post-traumatic stress due to exposure to conflict, violence, and loss. Despite the immense needs, there is a severe lack of culturally appropriate, evidence-based interventions to support the resilience and well-being of these vulnerable populations. To fill this gap, the study will evaluate the effectiveness and implementation of a novel life skills education (LSE) program delivered through two innovative approaches: in-person peer support groups and WhatsApp-based virtual support groups. The LSE curriculum, developed through extensive community engagement, covers topics such as stress management, communication, problem-solving, health, safety, and advocacy, all tailored to the unique challenges of displacement. In the in-person arm, trained IDP peers and local providers will facilitate weekly group sessions over 12 weeks, providing a safe space for participants to learn, practice, and apply new skills while building social connections and support networks. In the WhatsApp arm, participants will receive weekly messages with educational content, reflection prompts, and exercises, moderated by trained facilitators to foster dialogue and peer support. By comparing these two delivery methods, the study aims to identify the most feasible, acceptable, and effective strategies for rolling out psychosocial support interventions in humanitarian settings, particularly those with limited resources and access. The study will also assess the interventions' impact on key mental health outcomes, including depression, anxiety, PTSD, and well-being, as well as life skills, functioning, and implementation metrics such as reach, adoption, and sustainability. Ultimately, the RESETTLE-IDPs study seeks to generate actionable evidence to inform the development and scale-up of culturally responsive, community-driven interventions that can promote the mental health and resilience of conflict-affected populations in Nigeria and beyond. By empowering IDP youth and women with the knowledge, skills, and support to navigate the challenges of displacement, the study aims to contribute to a brighter, more hopeful future for these resilient communities **Detailed Description:** The RESETTLE-IDPs study is a cluster-randomized type II effectiveness-implementation hybrid trial that aims to evaluate the effectiveness and implementation of a life skills education (LSE) intervention delivered through two innovative approaches - in-person peer support groups and WhatsApp-based virtual support groups - to improve the mental health and well-being of internally displaced persons in Nigeria. Background and Rationale: Nigeria is facing a severe humanitarian crisis, with over 2.7 million people internally displaced due to armed conflict, communal violence, and natural disasters. Internally displaced persons (IDPs) in Nigeria, particularly youth and women, are at high risk of mental health problems such as depression, anxiety, and post-traumatic stress disorder (PTSD) due to exposure to trauma, loss, and ongoing stressors. Despite the immense needs, there is a severe lack of culturally appropriate, evidence-based interventions to support the mental health and resilience of IDP populations in Nigeria and other low-resource humanitarian settings. Life skills education (LSE) is a promising approach to promoting mental health and well-being among conflict-affected populations. LSE programs aim to equip individuals with the knowledge, attitudes, and skills needed to navigate challenges, cope with stress, and make healthy decisions. Previous studies have shown that LSE interventions can improve mental health outcomes, social-emotional learning, and positive youth development in various contexts. However, there is limited evidence on the effectiveness and implementation of LSE programs specifically tailored for IDP youth and women in Nigeria, and how different delivery methods (e.g., in-person vs. mobile-based) may impact their reach, acceptability, and sustainability. Study Objectives: The primary objective of the RESETTLE-IDPs study is to evaluate the effectiveness of a 12-week LSE intervention, delivered through either in-person peer support groups or WhatsApp-based virtual support groups, on mental health outcomes (depression, anxiety, PTSD, and well-being) among IDP youth and women in Nigeria, compared to a wait-list control group. Secondary objectives include: 1. To assess the impact of the LSE intervention on life skills acquisition, daily functioning, and social support among IDP youth and women. 2. To compare the feasibility, acceptability, fidelity, and cost-effectiveness of in-person vs. WhatsApp-based delivery methods for the LSE intervention. 3. To explore the contextual factors, implementation processes, and mechanisms of change that influence the effectiveness and sustainability of the LSE intervention in IDP settings. 4. To engage stakeholders (IDP communities, health workers, humanitarian organizations, policymakers) in the design, implementation, and evaluation of the LSE intervention to promote its cultural relevance, ownership, and scalability. Methods: The study will use a three-arm cluster-randomized controlled trial design, with IDP camps in Nigeria randomly allocated to one of two groups: (1) in-person LSE peer support groups, (2) WhatsApp-based LSE virtual support groups. The target population includes IDPs youth aged 13 years and above residing in selected camps in Borno State, the epicenter of the Boko Haram insurgency and displacement crisis in Nigeria. The intervention will consist of a culturally adapted LSE curriculum covering topics such as stress management, communication skills, problem-solving, health and hygiene, safety and protection, gender norms, and community mobilization. The curriculum will be developed through a participatory process involving IDP youth and women, community leaders, health workers, and education specialists, drawing on existing evidence-based resources and guidelines (e.g. UNICEF LSE Toolkit). In the in-person arm, trained IDP peers and local providers will facilitate weekly gender- and age-segregated support groups of 10-12 participants over a 12-week period. The groups will provide a safe space for participants to learn and practice life skills, share experiences, and provide mutual support. Sessions will use interactive, experiential learning methods such as role-plays, discussions, and group projects. In the WhatsApp arm, participants will be enrolled in moderated virtual support groups that deliver the LSE curriculum through weekly conversations, including psychoeducational content, reflection prompts, skill-building exercises, and peer discussion topics. Trained IDP facilitators will moderate the groups to ensure safe and supportive interactions, provide feedback, and encourage skill application. The study will enroll a total of 500 participants (250 per arm) across 20 IDP camps, with an estimated 25 participants per camp. Participants will be recruited through community-based mobilization strategies, with support from camp leaders, health workers, and NGO partners. Data will be collected at baseline, 3 months, 6 months, and 12 months using a combination of quantitative and qualitative methods. Quantitative data will include validated mental health scales, as well as locally adapted measures of life skills, functioning, and social support. Qualitative data will include in-depth interviews and focus group discussions with participants, facilitators, and stakeholders to explore experiences, perceptions, and contextual factors influencing the intervention. Data analysis will use an intent-to-treat approach, with mixed-effects regression models to assess intervention effects on primary and secondary outcomes, accounting for clustering at the camp level. Qualitative data will be analyzed thematically to identify barriers, facilitators, and mechanisms of change. Implementation outcomes (e.g., reach, fidelity, acceptability) will be assessed using process evaluation frameworks (e.g., RE-AIM). Expected Results and Impact: The RESETTLE-IDPs study aims to generate rigorous evidence on the effectiveness and implementation of a culturally adapted LSE intervention for improving the mental health and well-being of IDP youth and women in Nigeria. The study findings will have important implications for the design, delivery, and scale-up of psychosocial support interventions in humanitarian settings, particularly those affected by conflict and displacement. By comparing in-person and WhatsApp-based delivery methods, the study will provide valuable insights into the relative advantages, challenges, and effectiveness of different approaches to reaching and engaging IDP populations. The use of implementation science frameworks and participatory research methods will ensure that the intervention is not only effective but also feasible, acceptable, and sustainable in real-world contexts. The study will also contribute to capacity-building and empowerment of IDP communities by training and engaging youth and women as peer facilitators, researchers, and advocates. The participatory approach aims to foster local ownership, leadership, and sustainability of the intervention beyond the research period. Ultimately, the RESETTLE-IDPs study has the potential to inform policy, practice, and funding priorities for mental health and psychosocial support in humanitarian settings, both in Nigeria and globally. By advancing the evidence base on culturally relevant, community-based interventions, the study can contribute to reducing the global burden of mental health disorders and promoting the resilience and well-being of conflict-affected populations. ### Conditions Module **Conditions:** - Mental Health - Psychosocial Functioning - Implementation Science - Global Health - Conflict **Keywords:** - Conflict - Forced Displacement - Internally displaced persons - Mental health - Psychosocial support - Life skills education - Mobile health - Digital health - Humanitarian emergencies - Global mental health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Type II Hybrid Effectiveness-Implementation Design ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a culturally-adapted LSE intervention delivered through weekly in-person peer support group sessions for 12 weeks. The LSE curriculum covers topics such as stress management, communication skills, problem-solving, emotion regulation, health and hygiene, social skills, gender norms and safety, education and livelihoods, and community mobilization. Each peer support group will consist of 10-12 participants, separated by gender and age bands (12-17 and 18-24 for youth, 18+ for women), and will meet weekly for approximately 2 hours in a private, safe space within the IDP camp. Sessions will be co-facilitated by a trained IDP peer leader and a local mental health provider, following a structured format with interactive activities, discussions, and skill practice. **Intervention Names:** - Behavioral: Life Skills Education **Label:** In-Person Life Skills Education (LSE) Peer Support Groups **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants will receive the same culturally-adapted LSE curriculum as those in the In-person arm, but delivered through WhatsApp for 12 weeks. Participants will be added to a moderated WhatsApp group chat with other IDP youth or women in their camp, where they will receive three LSE-related messages per week. These messages will include brief psychoeducational content, practice exercises, reflection prompts, and reminders to engage with the virtual support group. The WhatsApp group will provide a platform for participants to discuss the LSE topics, share experiences and coping strategies, and provide emotional support to one another, with trained IDP peer facilitators moderating the chats to ensure a safe and supportive environment. Participants will also receive regular push notifications with motivational messages, links to further resources, and reminders to practice the LSE skills. **Intervention Names:** - Behavioral: Life Skills Education **Label:** WhatsApp-Enabled LSE Virtual Peer Support Groups **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - In-Person Life Skills Education (LSE) Peer Support Groups - WhatsApp-Enabled LSE Virtual Peer Support Groups **Description:** The RESETTLE-IDPs study compares two innovative delivery approaches for a culturally-adapted life skills education (LSE) intervention aimed at improving the mental health and well-being of internally displaced persons in Nigeria. The interventions are distinguished by their mode of delivery (in-person vs. WhatsApp-based), their focus on peer support and skill-building, and their tailoring to the specific needs and challenges of IDP populations. **Name:** Life Skills Education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Metric/Method of Measurement: PTSD Checklist for DSM-5 (PCL-5) The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. Participants rate how much they have been bothered by each symptom in the past month on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The total score ranges from 0 to 80, with higher scores indicating greater severity of PTSD symptoms. A score of 31-33 or higher suggests probable PTSD diagnosis. **Measure:** Change in Post-Traumatic Stress Disorder (PTSD) symptoms **Time Frame:** Baseline, 3 months, 6 months, and 12 months #### Secondary Outcomes **Description:** Metric/Method of Measurement: Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms based on the DSM-5 criteria. Participants rate how often they have been bothered by each symptom over the past 2 weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Cut-off scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. **Measure:** Change in depressive symptoms **Time Frame:** Baseline, 3 months, 6 months, and 12 months **Description:** Metric/Method of Measurement: Generalized Anxiety Disorder-7 (GAD-7) The GAD-7 is a 7-item self-report measure that assesses the presence and severity of anxiety symptoms. Participants rate how often they have been bothered by each symptom over the past 2 weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Cut-off scores of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. **Measure:** Change in anxiety symptoms **Time Frame:** Baseline, 3 months, 6 months, and 12 months **Description:** Metric/Method of Measurement: A Life Skills Assessment Tool (LSAT) The LSAT is a locally developed measure that assesses participants' knowledge, attitudes, and behaviors related to the key life skills covered in the LSE curriculum (e.g., stress management, communication, problem-solving, health and hygiene). The scale includes a mix of multiple-choice and Likert-type items, with higher scores indicating greater life skills competency. The exact number of items and scoring system will be determined through formative research and pilot testing with the target population. **Measure:** Change in life skills **Time Frame:** Baseline, 3 months, 6 months, and 12 months **Description:** Metric/Method of Measurement: World Health Organization-Five Well-Being Index (WHO-5) The WHO-5 is a 5-item self-report measure that assesses subjective psychological well-being over the past 2 weeks. Participants rate each item on a 6-point scale ranging from 0 (at no time) to 5 (all of the time). The total score ranges from 0 to 25, which is then multiplied by 4 to yield a percentage score ranging from 0 to 100. A score below 50 suggests poor well-being and a score below 28 indicates likely depression. **Measure:** Change in well-being **Time Frame:** Baseline, 3 months, 6 months, and 12 months **Description:** Metric/Method of Measurement: Intervention Appropriateness Measure (IAM) The IAM is a 4-item self-report measure that assesses the perceived appropriateness of an intervention. Participants rate each item on a 5-point scale ranging from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater appropriateness. **Measure:** Change in perceived appropriateness of the intervention **Time Frame:** Baseline, 3 months **Description:** Metric/Method of Measurement: Acceptability of Intervention Measure (AIM) The AIM is a 4-item self-report measure that assesses the perceived acceptability of an intervention. Participants rate each item on a 5-point scale ranging from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater acceptability. **Measure:** Change in acceptability of the intervention **Time Frame:** Baseline, 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 13 years and above * Ownership of smartphone * Internally displaced for at least 6 months. * Residing in select IDP camps in Abuja and Borno State, Nigeria * Fluency in English and/or Hausa languages * Willing and able to provide informed consent. Exclusion Criteria: * Active suicidal ideation or attempts (i.e having thoughts, plans, or intent to end one\&#39;s life within the past month) * Active psychosis * Cognitive impairment precluding informed consent or survey completion. * Not owning as smartphone **Healthy Volunteers:** True **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ejemai.eboreime@dal.ca **Name:** Ejemai A Eboreime, MBBS, PhD **Phone:** 902-473-2479 **Role:** CONTACT **Contact 2:** **Email:** chisom.obijeff@brooksinsights.org **Name:** Chisom Obi-Jeff **Phone:** +2348038878844 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Dalhousie University **Name:** Ejemai A Eboreime, MBBS, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Dalhousie University **Name:** Vincent Agyapong, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Dalhousie University **Name:** Rita Orji, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** University of Ottawa **Name:** Sanni Yaya, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data Sharing Statement We will share de-identified IPD underlying the published results of the RESETTLE-IDPs study, including the study protocol, statistical analysis plan, and analytic code. IPD will be made available upon reasonable request and after approval by the study's steering committee, subject to a data sharing agreement. Access Criteria and Procedure Researchers interested in accessing the IPD should submit a formal request to the study's principal investigator, specifying the purpose, scope, and timeline of the proposed analyses. Requests will be reviewed by the steering committee based on the scientific merit, feasibility, and alignment with the study's objectives and participants' informed consent. **Description:** We will share de-identified IPD underlying the published results of the RESETTLE-IDPs study, including the study protocol, statistical analysis plan, and analytic code. IPD will be made available upon reasonable request and after approval by the study's steering committee, subject to a data sharing agreement **Info Types:** - STUDY_PROTOCOL - SAP - ICF - ANALYTIC_CODE **IPD Sharing:** YES **URL:** ftp://NA ### References Module #### References **Citation:** Kaiser BN, Ticao C, Boglosa J, Minto J, Chikwiramadara C, Tucker M, Kohrt BA. Mental health and psychosocial support needs among people displaced by Boko Haram in Nigeria. Glob Public Health. 2020 Mar;15(3):358-371. doi: 10.1080/17441692.2019.1665082. Epub 2019 Sep 19. **PMID:** 31535595 **Citation:** Ugbe UM, Esu EB, Efut JA, Bisongedam MM, Awa TM, Ekpo OI. Sociodemographic correlates and associated factors of depression and anxiety among internally displaced adults in Ogoja, Nigeria. Gen Psychiatr. 2022 Apr 28;35(2):e100749. doi: 10.1136/gpsych-2022-100749. eCollection 2022. **PMID:** 35572773 **Citation:** Wei Y, Hayden JA, Kutcher S, Zygmunt A, McGrath P. The effectiveness of school mental health literacy programs to address knowledge, attitudes and help seeking among youth. Early Interv Psychiatry. 2013 May;7(2):109-21. doi: 10.1111/eip.12010. Epub 2013 Jan 24. **PMID:** 23343220 **Citation:** Taubner S, Ioannou Y, Saliba A, Sales CMD, Volkert J, Protic S, Adler A, Barkauskiene R, Conejo-Ceron S, Di Giacomo D, Mestre JM, Moreno-Peral P, Vieira FM, Mota CP, Henriques MIRS, Rossberg JI, Perdih TS, Schmidt SJ, Zettl M, Ulberg R, Heinonen E. Mediators of outcome in adolescent psychotherapy and their implications for theories and mechanisms of change: a systematic review. Eur Child Adolesc Psychiatry. 2023 Mar 15. doi: 10.1007/s00787-023-02186-9. Online ahead of print. **PMID:** 36918434 **Citation:** Sahebalzamani M, Farahani H, Feizi F. Efficacy of life skills training on general health in students. Iran J Nurs Midwifery Res. 2012 Nov;17(7):553-5. **PMID:** 23922605 **Citation:** Singla DR, Waqas A, Hamdani SU, Suleman N, Zafar SW, Zill-E-Huma, Saeed K, Servili C, Rahman A. Implementation and effectiveness of adolescent life skills programs in low- and middle-income countries: A critical review and meta-analysis. Behav Res Ther. 2020 Jul;130:103402. doi: 10.1016/j.brat.2019.04.010. Epub 2019 Apr 26. **PMID:** 31146889 **Citation:** Maghsoudi J, Sabour NH, Yazdani M, Mehrabi T. The effect of acquiring life skills through humor on social adjustment rate of the female students. Iran J Nurs Midwifery Res. 2010 Fall;15(4):195-201. **PMID:** 22049280 **Citation:** Magnani R, Macintyre K, Karim AM, Brown L, Hutchinson P, Kaufman C, Rutenburg N, Hallman K, May J, Dallimore A; Transitions Study Team. The impact of life skills education on adolescent sexual risk behaviors in KwaZulu-Natal, South Africa. J Adolesc Health. 2005 Apr;36(4):289-304. doi: 10.1016/j.jadohealth.2004.02.025. **PMID:** 15780784 **Citation:** undefined ## 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: M7796 - Name: Emergencies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412666 **Acronym:** CEDAR-HCM **Brief Title:** A Study to Evaluate the Effect of Aficamten in Pediatric Patients (Age 12 to <18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). **Official Title:** A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Trial to Evaluate the Efficacy and Safety of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy #### Organization Study ID Info **ID:** CY 6023 #### Organization **Class:** INDUSTRY **Full Name:** Cytokinetics #### Secondary ID Infos **ID:** 2024-511377-30-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cytokinetics #### 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 evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). **Detailed Description:** The overall objective of the trial is to determine the efficacy, safety, and tolerability of administration of aficamten in adolescents (12 to \< 18 years old) and children (6 to \< 12 years old) with symptomatic oHCM. Adolescents and children will be studied in a staged approach involving established favorable pharmacodynamic and safety profiles of aficamten in adolescents followed by further pharmacokinetic modeling to inform the dosing regimen in children. The trial will consist of 2 periods: 1. Period 1 is the randomized, double-blind, placebo-controlled treatment period that will assess the efficacy, safety and tolerability of aficamten in pediatric participants. Duration: approximately 12 weeks. 2. Period 2 is the open-label extension trial that will assess the long-term safety of aficamten in pediatric participants, and further assess efficacy and tolerability. Duration: approximately 52 weeks. ### Conditions Module **Conditions:** - Pediatric - Symptomatic Obstructive Hypertrophic Cardiomyopathy **Keywords:** - CK-3773274 - CK-274 - Aficamten - Symptomatic Obstructive Hypertrophic Cardiomyopathy - oHCM - CEDAR - CEDAR-HCM - CY 6023 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive a single daily oral dose of aficamten with dose levels (5 mg to 20 mg) guided by echocardiography assessments, for 12 weeks during the double-blinded period, and then for another 52 weeks during the open-label extension period. **Intervention Names:** - Drug: Aficamten **Label:** Aficamten **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this arm will receive placebo for 12 weeks during the double-blinded period, and then will receive aficamten for 52 weeks during the open-label extension period. **Intervention Names:** - Drug: Aficamten - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Aficamten - Placebo **Description:** Oral Tablet **Name:** Aficamten **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Oral Tablet **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from baseline in Valsalva left ventricular outflow tract gradient (LVOT-G) **Time Frame:** Baseline to week 12 #### Secondary Outcomes **Measure:** Change from baseline in resting LVOT-G **Time Frame:** Baseline to week 12 **Measure:** Change in values of NT-proBNP **Time Frame:** Baseline to week 12 **Measure:** Change in values of hs-cTnI **Time Frame:** Baseline to week 12 **Measure:** Change in New York Heart Association (NYHA) Functional Class **Time Frame:** Baseline to week 12 **Measure:** Proportion of patients with ≥1 class improvement in NYHA Functional Class **Time Frame:** Baseline to week 12 **Measure:** Trough observed plasma concentration (Ctrough) of aficamten **Time Frame:** Baseline to week 12 **Description:** A voluntary intensive PK substudy may occur at Week 8 or Week 12 **Measure:** Maximum observed concentration (Cmax) of aficamten **Time Frame:** Week 8 or Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Period 1: Treatment Period * Males and females between 12 and \< 18 years of age at screening and at Day 1. * Body weight ≥ 45 kg for the initial cohort and then body weight ≥ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to Week 4 without observed events of LVEF \< 50% at the starting dose of 5 mg qd. * Core laboratory confirmation of the following oHCM echocardiographic criteria at screening: * Left ventricular (LV) hypertrophy with nondilated LV chamber in the absence of other cardiac disease. * LV end-diastolic wall thickness that meets a threshold of: * Z-score \> 2.5 in the absence of symptoms or family history or * Z-score \> 2 in the presence of positive family history or positive genetic test. * LVEF ≥ 60% AND Valsalva LVOT-G ≥ 50 mmHg. * oHCM of sarcomeric origin confirmed by genetic testing or, if unable to confirm by genetic testing, oHCM of sarcomeric origin may be presumed in the absence of history of metabolic disorders, mitochondrial cardiomyopathies, neuromuscular disease, malformation syndromes, infiltrative diseases/inflammation, and endocrine disorders (such as Fabry's disease, Noonan syndrome with left ventricular hypertrophy, and amyloid-cardiomyopathy). * New York Heart Association (NYHA) Class ≥ II at screening. * Adequate acoustic windows for echocardiography. * Participants on beta blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for more than 4 weeks prior to randomization. Period 2: Open-Label Extension * Completed Period 1. If unable to complete Period 1 due to circumstances not related to compliance or safety, the Medical Monitor may review and determine eligibility. * LVEF ≥ 55% after washout. Exclusion Criteria: * Period 1: Treatment Period Any of the following criteria will exclude potential participants from the trial: * Significant valvular heart disease. * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction. * Mitral regurgitation that is greater than mild in severity and not due to systolic anterior motion of the mitral valve (per judgment of Principal Investigator or designee). * No evidence of fixed left-sided obstruction (eg, subaortic, aortic valve, or coarctation of the aorta). * History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy at any time during their clinical course. * History of congenital heart disease other than oHCM (may be enrolled if not hemodynamically significant in the judgement of the Principal Investigator and study Medical Monitor). * Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period. * History of paroxysmal or persistent atrial fibrillation or atrial flutter. * History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia within 3 months prior to screening. * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Principal Investigator (or designee) or the Medical Monitor, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. * Current or previous use of drugs known to cause cardiomyopathy (eg, anthracyclines, monoclonal antibodies \[trastuzumab\], alkylating agents \[cyclophosphamide\], and tyrosine kinase inhibitors \[sunitinib and imatinib\]). * Currently participating in another investigational device or drug trial or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. * Implantable cardioverter defibrillator (ICD) implantation within 6 weeks of screening or planned ICD implantation during the trial period. * Has received prior treatment with aficamten or mavacamten. Period 2: Exclusion Criteria: Had a confirmed LVEF \< 40% with an associated dose interruption during participation in Period 1. **Maximum Age:** 17 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medicalaffairs@cytokinetics.com **Name:** Cytokinetics MD **Phone:** 6506242929 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Cytokinetics **Name:** Cytokinetics MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001020 - Term: Aortic Stenosis, Subvalvular - ID: D000001024 - Term: Aortic Valve Stenosis - ID: D000082862 - Term: Aortic Valve Disease - ID: D000006349 - Term: Heart Valve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M5568 - Name: Cardiomyopathy, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Cardiomyopathy - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M4340 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: T449 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009202 - Term: Cardiomyopathies - ID: D000002312 - Term: Cardiomyopathy, Hypertrophic - ID: D000006984 - Term: Hypertrophy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412653 **Acronym:** ZINCGNAO1 **Brief Title:** Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders **Official Title:** Prospective Pilot Trial to Address the Feasibility and Safety of Treatment With Oral Zinc in GNAO1 Associated Disorders #### Organization Study ID Info **ID:** Uni-Koeln-5275 #### Organization **Class:** OTHER **Full Name:** Children's University Hospital Cologne, Germany ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-02-29 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Clinical Trials Centre Cologne **Class:** OTHER **Name:** University of Cologne **Class:** OTHER **Name:** University of Geneva, Switzerland #### Lead Sponsor **Class:** OTHER **Name:** Children's University Hospital Cologne, Germany #### Responsible Party **Investigator Affiliation:** Children's University Hospital Cologne, Germany **Investigator Full Name:** Moritz Thiel, MD **Investigator Title:** Pediatrician in pediatric neurology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. The main questions it aims to answer are: * Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy? * Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients. Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial. ### Conditions Module **Conditions:** - GNAO1 - Dystonia - Epilepsy - Development Delay - Developmental and Epileptic Encephalopathy 17 - Neurodevelopmental Disorder With Involuntary Movements - Choreoathetosis **Keywords:** - GNAO1 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Prospective single arm, open-label pilot trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Zinc acetate dihydrate in age-adapted dosage ranging from 50mg to 150mg Zn2+ per day according to the recommended dosage in Wilsons Disease. **Intervention Names:** - Drug: Zinc Acetate Dihydrate **Label:** Interventional Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional Arm **Description:** In this single arm trial, all participants will be receive the trial drug zinc acetate dihydrate orally. The Investigational medicinal product (IMP) will be given one hour after meal in a dosage which is recommended in Wilson Disease and has been given in this condition without observing severe adverse effects. If oral administration is not possible due to the disability level of the patient, the IMP can be mortared and suspended and can then be given as suspension orally or via the Percutaneous endoscopic gastrostomy. The total treatment duration in each patient is 6 months with stable dosage over the duration of the trial. If the therapy shows effects, the parents and participants may continue medication after the end of the trial. If not, they will stop the medication after the last visit at the trial site. **Name:** Zinc Acetate Dihydrate **Other Names:** - WILZIN 25mg - WILZIN 50mg - Wilzin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The feasibility is measured by the actual days that zinc was taken in the right dosage. If zinc was taken in the scheduled dosage at least on 80% of the days it is assumed to be feasible. Parents/caregivers document the daily intake into a diary. **Measure:** Feasibility of daily treatment with oral zinc in GNAO1 as assessed by diary. **Time Frame:** From first visit at Inclusion to visit after 6 month **Description:** To assess side effects: two phone calls are made and in each visit at site potential side effects are assessed. **Measure:** Safety of daily administered zinc in GNAO1 as assessed by regular evaluation of the side effects **Time Frame:** From first visit at inclusion until last phone call after 7 month **Description:** Serum ferritin and copper detect potential deficiencies, caused by regular zinc administration and therefore reduced uptake. Liver enzymes, alkaline phosphates, lipase and amylase are assessed 3 times, since these parameters can be elevated as side effect. **Measure:** Safety of daily administered zinc in GNAO1 as assessed by regular blood tests **Time Frame:** Blood analysis at baseline, after 3 and 6 month #### Secondary Outcomes **Description:** The Gross-motor function measure(GMFM-66) is a standardized test for gross motor function, carried out by a physiotherapist. Minimum value 0, maximum value 100; a higher score is a better outcome. **Measure:** Level of motor-skills assessed by Gross-motor function measure **Time Frame:** Compare measure at baseline to visit after 3 and 6 month **Description:** The CPCHILD questionnaire is a validated measure of health-related quality of life for children with severe disabilities and is evaluated 3 times in this trial. Parents/caregivers are asked to fill out the questionnaire. The CPCHILD currently consists of 37 items distributed among six sections representing the following domains: 1. Activities of daily living/personal care (nine items) 2. Positioning, transferring and mobility (eight items) 3. Comfort and emotions (nine items) 4. Communication and social interaction (seven items) 5. Health (three items) 6. Overall quality of life (one item) In Section 7, caregivers rate the importance of each of these items' contribution to their child's quality of life.Scores for each domain and for the total survey are standardized and range from a minimum: 0 (worse) to a maximum 100 (best). A higher score is a better outcome. **Measure:** Change in quality of life score assessed by Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire for caregivers **Time Frame:** Compare measure at baseline to visit after 3 and 6 month **Description:** The Burke-Fahn-Marsden Dystonia Rating Scale is a universally applied instrument for the quantitative assessment of dystonia in both children and adults. It is divided into movement score and disability score. Movement score minimum value 0, maximum value 120; a higher score is a worse outcome with more dystonia present. Disability score minimum value 0; maximum value 30; a higher score is a worse outcome with more disabilities due to dystonia. **Measure:** Level of Dystonia assessed by the Burke-Fahn-Marsden Dystonia Rating scale **Time Frame:** Compare measure at baseline to visit after 3 and 6 month **Description:** The AIMS is a 12-item clinician-rated scale to assess severity of dyskinesias (specifically, orofacial movements and extremity and truncal movements) and will be assessed 3 times at each visit at site. The minimum score is 0 and the maximum score is 4 (severe). A higher score is a worse outcome showing higher level of dyskinesia. **Measure:** Level of dyskinesia assessed by the Abnormal involuntary movement scale (AIMS) **Time Frame:** Compare measure at baseline to visit after 3 and 6 month **Description:** Parents/caregivers are given a diary in which they are asked to document the hours per day which are disturbed by movement disorder and involuntary movements. **Measure:** Level of dyskinesia assessed by a movement log for parents/caregivers **Time Frame:** Compare first two weeks of treatment to two weeks before the end of the trial **Description:** Parents/Caregivers are asked to fill out a diary addressing time of sleep per day and sleep disturbances. **Measure:** Changes in sleep assessed by diary for parents/caregivers **Time Frame:** Compare first two weeks of treatment to two weeks before the end of the trial **Description:** Parents/Caregivers are asked to fill out a diary addressing the general behaviour with two questions. **Measure:** Changes in general behaviour assessed by diary. **Time Frame:** Compare answers of diary of first two weeks of treatment to two weeks before the end of the trial **Description:** Parents/Caregivers are requested to document frequency in a seizure log which is part of the diary **Measure:** Changes in seizure frequency assessed by seizure log. **Time Frame:** Compare first two weeks of treatment to two weeks before the end of the trial **Description:** Parents/Caregivers are requested to document duration of seizures in a seizure log which is part of the diary **Measure:** Changes in seizure duration assessed by seizure log. **Time Frame:** Compare first two weeks of treatment to two weeks before the end of the trial **Description:** Serum controls of zinc are assessed three times to measure the changes in serum levels of zinc before and while zinc administration **Measure:** Changes in serum level of zinc assessed by regular blood analysis **Time Frame:** Serum controls at baseline, after 3 and 6 month **Description:** Analyze of the microbiome in stool to detect changes under therapy with oral zinc.The stool samples should be collected at home in the three days before visit 2 and 3 in special sample tubes that are handed out to the patient at visit 0. The first stool samples should be collected at visit 0 or on the first three days thereafter. **Measure:** Microbiome of stool assessed by regular analysis **Time Frame:** Samples compared from baseline to samples collected after 3 and 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * GNAO1 associated neurological disorder, documented by either * Proven pathogenic or likely pathogenic mutation in GNAO1 or * a variant of unknown significance in GNAO1 and clinical symptoms likely to be consistent with GNAO1 as determined by the investigators and * at least one of the common symptoms of GNAO1: Movement disorder (Dystonia, Chorea, Ataxia, clonic), central muscular hypotonia, epilepsy, global developmental delay * Age: 6 month - 30 years * GMFM ≤ 75 * written informed consent prior to any trial-related procedure (according to age and status of psycho-intellectual development) * of parents or legal guardian * of parents or legal guardian and patient * of the patient * stable on following concomitant treatments for at least 3 months prior to trial inclusion: anti-seizure drugs (ASD); baclofen, Deep brain stimulation settings Exclusion Criteria: * Treatment of Zinc in the last 4 months before inclusion * known other genetic variants that are known to cause symptoms like observed in GNAO1-related disorders, additional to the proven GNAO1 mutation * implantation of Deep brain stimulation planned during the duration of the trial, i.e. in the six months after inclusion * start of intrathecal baclofen therapy planned during the duration of the trial, i.e. in the six months after inclusion * Known allergy/hypersensitivity to the scheduled trial drug * Concomitant participation in other clinical drugs with investigational drugs or with competing interventions * sexually active patients who are not willing to use/ not using a highly effective contraception method with a pearl-index \< 1. Sexually active patients, unless surgically sterile, must be using a highly effective contraception method (including oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), using a condom of the sexual partner or sterile sexual partner) and must agree to continue using such precautions during the whole study period. * Pregnant women and nursing mothers **Maximum Age:** 30 Years **Minimum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** moritz.thiel@uk-koeln.de **Name:** Moritz Thiel, MD **Phone:** +49 221-478-6850 **Role:** CONTACT **Contact 2:** **Email:** kyriakos.martakis@uk-koeln.de **Name:** Kyriakos Matakis, MSc,PhD,MD **Phone:** +49 221-478-6853 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital, University Hospital Cologne, University of Cologne **Name:** Moritz Thiel, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Trial results will be published in a scientific journal and presented at national or international congresses. Publication of the results of the trial as a whole is intended. Anonymized individual patient data (IPD) can be made available on reasonable request to the PI after the results are published. **IPD Sharing:** NO ### References Module #### References **Citation:** Larasati YA, Savitsky M, Koval A, Solis GP, Valnohova J, Katanaev VL. Restoration of the GTPase activity and cellular interactions of Galphao mutants by Zn2+ in GNAO1 encephalopathy models. Sci Adv. 2022 Oct 7;8(40):eabn9350. doi: 10.1126/sciadv.abn9350. Epub 2022 Oct 7. **PMID:** 36206333 **Citation:** Thiel M, Bamborschke D, Janzarik WG, Assmann B, Zittel S, Patzer S, Auhuber A, Opp J, Matzker E, Bevot A, Seeger J, van Baalen A, Stuve B, Brockmann K, Cirak S, Koy A. Genotype-phenotype correlation and treatment effects in young patients with GNAO1-associated disorders. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):806-815. doi: 10.1136/jnnp-2022-330261. Epub 2023 May 24. **PMID:** 37225406 **Citation:** Briere L, Thiel M, Sweetser DA, Koy A, Axeen E. GNAO1-Related Disorder. 2023 Nov 9. In: Adam MP, Feldman J, Mirzaa GM, Pagon RA, Wallace SE, Bean LJH, Gripp KW, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024. Available from http://www.ncbi.nlm.nih.gov/books/NBK597155/ **PMID:** 37956232 **Citation:** Savitsky M, Solis GP, Kryuchkov M, Katanaev VL. Humanization of Drosophila Galphao to Model GNAO1 Paediatric Encephalopathies. Biomedicines. 2020 Oct 6;8(10):395. doi: 10.3390/biomedicines8100395. **PMID:** 33036271 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009069 - Term: Movement Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: HIGH - As Found: Neurodevelopmental Disorders - ID: M7595 - Name: Dystonia - Relevance: HIGH - As Found: Dystonia - ID: M22575 - Name: Dystonic Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: HIGH - As Found: Encephalopathy - ID: M22574 - Name: Dyskinesias - Relevance: HIGH - As Found: Involuntary Movements - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001927 - Term: Brain Diseases - ID: D000004421 - Term: Dystonia - ID: D000020820 - Term: Dyskinesias - ID: D000065886 - Term: Neurodevelopmental Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412640 **Brief Title:** Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori **Official Title:** Eradication of Helicobacter Pylori by 14-day Dual Therapy of Keverprazan in Combination With Low-dose and High-dose Amoxicillin: a Prospective, Single-center, Developmental-label, Randomized Controlled Study #### Organization Study ID Info **ID:** KY20240419-15 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_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:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing First Hospital, Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University **Investigator Full Name:** Zhenyu Zhang **Investigator Title:** Director of Gastroenterology **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 was to evaluate the efficacy and safety of keverprazan with different doses of amoxicillin for Helicobacter Pylori. **Detailed Description:** This study is a prospective, single-center, open-label, randomized, parallel-controlled trial. A total of 268 H. pylori positive patients needed to be recruited and were randomized into 2 groups in 1:1 ratio, Group A was the control group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. Group B was the experimental group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. All the above regimens were used for eradication of H. pylori. During the 14-day eradication treatment, all subjects were instructed and asked to record their adverse drug reactions and compliance. On days 7 and 14 of treatment, researchers followed up with patients via WeChat or phone to determine adverse reactions and compliance, and observed and recorded whether subjects experienced any adverse reactions such as nausea, diarrhea, dizziness, bitter taste in the mouth, rash, and constipation. Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT. Patients were encouraged, but not required, to undergo tongue and fecal flora testing before and after H. pylori eradication to determine the short-term effects of different doses of amoxicillin in combination with keverprazan for 14 days on the patient's tongue and intestinal flora. ### Conditions Module **Conditions:** - H. Pylori Infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 268 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients need to take keverprazan 20mg bid and amoxicillin 1000mg tid for 14 days. **Intervention Names:** - Drug: Keverprazan - Drug: Amoxicillin **Label:** high dose amoxicillin with keverprazan group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients need to take keverprazan 20mg bid and amoxicillin 1000mg bid for 14 days. **Intervention Names:** - Drug: Keverprazan - Drug: Amoxicillin **Label:** low dose amoxicillin with keverprazan group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - high dose amoxicillin with keverprazan group - low dose amoxicillin with keverprazan group **Description:** Potassium-competitive acid blocker **Name:** Keverprazan **Other Names:** - Potassium-competitive acid blocker **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - high dose amoxicillin with keverprazan group - low dose amoxicillin with keverprazan group **Description:** Antibiotic for H. pylori eradication **Name:** Amoxicillin **Other Names:** - Antibiotic for H. pylori eradication **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT. **Measure:** Helicobacter pylori eradication rate **Time Frame:** at least four weeks after completion of the medication #### Secondary Outcomes **Description:** Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy. **Measure:** Adverse even **Time Frame:** Within 7 days after completion of therapy **Description:** Compliance was defined as poor when they had taken less than 80% of the total medication **Measure:** Compliance Rate **Time Frame:** Within 7 days after completion of therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients diagnosed with Helicobacter pylori positivity through 13C-UBT or 14C-UBT 2. Patients who have not received eradication treatment for Helicobacter pylori in the past, or who have failed eradication in the early stage but have not received eradication treatment within six months 3. Voluntarily participate in this experiment and sign an informed consent form Exclusion Criteria: 1. Allergies to research drugs (such as those allergic to penicillin, amoxicillin, keverprazan) 2. Patients with peptic ulcer 3. Patients who have received Helicobacter pylori eradication treatment within six months 4. Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study 5. Using corticosteroids, non steroidal anti-inflammatory drugs, or anticoagulants 6. Those who are using atazanavir, nelfinavir, rilpivirine, itraconazole, tyrosine kinase inhibitors (imatinib, gefitinib, etc.), digoxin, and methyl digoxin 7. History of esophageal or gastric surgery 8. Pregnant or lactating women 9. Suffering from serious concomitant diseases such as liver disease, cardiovascular disease, lung disease, or kidney disease 10. Excessive drinking 11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant neoplastic diseases **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zzy6565@sina.com **Name:** Zhenyu Zhang **Phone:** +86 025-87726248 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Nanjing First Hospital, Nanjing Medical University **Name:** Zhenyu Zhang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20. **PMID:** 37086739 **Citation:** Zhou XZ, Lyu NH, Zhu HY, Cai QC, Kong XY, Xie P, Zhou LY, Ding SZ, Li ZS, Du YQ; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology and Chinese Alliance for Helicobacter pylori Study.. Large-scale, national, family-based epidemiological study on Helicobacter pylori infection in China: the time to change practice for related disease prevention. Gut. 2023 May;72(5):855-869. doi: 10.1136/gutjnl-2022-328965. Epub 2023 Jan 23. **PMID:** 36690433 **Citation:** Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print. **PMID:** 35944925 **Citation:** Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Xie Y, Shu X, Lu NH, Zhu Y. Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study. Helicobacter. 2022 Aug;27(4):e12896. doi: 10.1111/hel.12896. Epub 2022 Apr 25. **PMID:** 35466521 **Citation:** Zhou S, Xie L, Zhou C, Wang L, Chen J, Ding S, Zhu B, Su M, Shao F. Keverprazan, a novel potassium-competitive acid blocker: Multiple oral doses safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. Clin Transl Sci. 2023 Oct;16(10):1911-1922. doi: 10.1111/cts.13598. Epub 2023 Aug 2. **PMID:** 37533172 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: HIGH - As Found: Initial - ID: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Colorectal - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000658 - Term: Amoxicillin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412627 **Brief Title:** The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube **Official Title:** The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube #### Organization Study ID Info **ID:** 231234 #### Organization **Class:** OTHER **Full Name:** Changhua Christian Hospital ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Changhua Christian Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an experimental study aimed at exploring the effectiveness of using 4°C frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes. **Detailed Description:** Long-term placement of endotracheal tubes often causes discomfort, including lip ulcers, laryngeal pain, and dry oral mucosa, leading to frequent complaints of dry mouth and thirst among conscious patients. However, these symptoms are commonly overlooked in the nursing process, resulting in emotional distress and irritability in patients. Although healthcare providers recognize the issue of dry mouth and thirst in patients with endotracheal tubes, effective management is challenging due to concerns about treatment limitations, aspiration pneumonia, and the risk of coughing or vomiting. This experimental study aims to explore the effectiveness of using 4°C frozen gauze soaked in normal saline to relieve dry mouth and thirst in patients with endotracheal tubes. ### Conditions Module **Conditions:** - Endotracheal Tube - Thirst - Dry Mouth **Keywords:** - dry mouth - thirst - endotracheal tube ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group received only usual care, while the Oral moisture checker (Mucus, Life Co., Ltd.), the Oral Health Assessment Tool, and the Bedside Oral Exam were used to assess oral mucosal moisture and oral health status before (day 0) and after 7 days. **Label:** control group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The experimental group had 4°C saline-soaked gauze applied to the oral cavity for 15 minutes at 06:00 AM and 06:00 PM daily for one week, while the Oral moisture checker (Mucus, Life Co., Ltd.), the Oral Health Assessment Tool, and the Bedside Oral Exam were used to assess oral mucosal moisture and oral health status before (day 0) and after 7 days. **Intervention Names:** - Procedure: 4°C frozen normal saline gauze **Label:** experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental group **Description:** Soak two 4x4 gauze pads in 15 ml of normal saline, refrigerate at 4°C, and then apply in the oral cavity for 15 minutes before removal. **Name:** 4°C frozen normal saline gauze **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The oral moisture checking device was utilized to assess symptoms of dry mouth in participants. This study utilized an oral moisture checking device produced by Life Co., Ltd. of Japan, which measures the moisture content within the oral cavity using the principle of bioelectrical impedance analysis (BIA). The measurement method involves placing a specialized plastic sleeve over the tongue approximately one centimeter from the tip and applying a force of 200 grams. A measurement is obtained after about 2 seconds. A reading below 27.9 indicates dryness, a reading between 28 and 29.5 is considered borderline, and readings of 29.6 and above are normal. Both the sensitivity and specificity of this method are 0.8. **Measure:** Oral moisture checking device **Time Frame:** Change from baseline dry mouth at Day 3, and Day 7 #### Secondary Outcomes **Description:** The Oral health assessment Tool consists of 8 categories: lips, tongue, gum and tissues, saliva, natural teeth, dentures, oral cleanliness, and dental pain. The scoring is as follows: 0 points for "healthy," 1 point for "beginning changes in the mouth," and 2 points for "unhealthy." The maximum score is 16, with higher scores indicating poorer oral health. **Measure:** Oral health assessment Tool **Time Frame:** Change from baseline oral health status at Day 3, and Day 7 **Description:** The bedside oral examination scale comprises 8 categories: swallow, lips, tongue, mucous membranes, saliva, gingiva, teeth or dentures, and odor. Each category is scored as follows: 1 point for "severe dysfunction," 2 points for "moderate dysfunction," and 3 points for "normal." A total score of 24 indicates a normal oral health status, while a score of 8 indicates severe oral health dysfunction. **Measure:** Bedside oral examination scale **Time Frame:** Change from baseline oral health function at Day 3, and Day 7 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Endotracheal intubation. * Aged 18 years or older. * Patient or family members are willing to sign the consent form. Exclusion Criteria: * History of head and neck cancer. * Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** luke801458@gmail.com **Name:** Kuan Wen Lai **Phone:** +88647238595 **Phone Ext:** 5901 **Role:** CONTACT #### Locations **Location 1:** **City:** Changhua **Country:** Taiwan **Facility:** Changhua Christian Hospital **Zip:** 50006 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17724 - Name: Xerostomia - Relevance: HIGH - As Found: Dry Mouth - 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 ### Condition Browse Module - Meshes - ID: D000014987 - Term: Xerostomia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412614 **Acronym:** SCLERONAB **Brief Title:** Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies **Official Title:** Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies #### Organization Study ID Info **ID:** 2024PI015 #### Organization **Class:** OTHER **Full Name:** Central Hospital, Nancy, France ### Status Module #### Completion Date **Date:** 2025-06-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-02 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Central Hospital, Nancy, France #### Responsible Party **Investigator Affiliation:** Central Hospital, Nancy, France **Investigator Full Name:** Paul DECKER, MD **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:** Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes. Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies). "Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease. Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies. Secondary objectives are: * to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies * to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status ### Conditions Module **Conditions:** - Systemic Sclerosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: disease phenotype **Label:** SSc patients without specific or associated autoantibodies ("seronegative" patients) #### Arm Group 2 **Intervention Names:** - Other: disease phenotype **Label:** SSc patients with specific or associated autoantibodies ### Interventions #### Intervention 1 **Arm Group Labels:** - SSc patients with specific or associated autoantibodies - SSc patients without specific or associated autoantibodies ("seronegative" patients) **Description:** evaluation of SSc phenotypes **Name:** disease phenotype **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis **Measure:** diagnosis time **Time Frame:** baseline (J0) #### Secondary Outcomes **Description:** sine scleroderma (no scleroderma), limited scleroderma or diffuse scleroderma **Measure:** number of patients with scleroderma **Time Frame:** baseline (J0) **Measure:** number of patients with raynaud's phenomenon **Time Frame:** baseline (J0) **Measure:** number of patients with digital ulcers **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with calcinosis **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with telangiectases **Time Frame:** baseline (J0) **Measure:** number of patients with articular involvement **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with muscular involvement **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with cardiac involvement **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with interstitial lung disease **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with pulmonary arterial hypertension **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with scleroderma renal crisis **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** number of patients with gastrointestinal involvement **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** modified Rodnan skin score **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Description:** %predicted FVC values **Measure:** forced vital capacity (FVC) **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Description:** %predicted DLCO values **Measure:** diffusing capacity for carbon monoxide (DLCO) **Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years) **Measure:** rate of patients without death **Time Frame:** 3 years and 5 years of follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient with systemic sclerosis defined according to ACR/EULAR 2013 classification criteria * Patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis * Patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase I, anti-centromere, anti-RNA polymerase III (RP155 and RP11), anti-Th/To antibodies , anti-fibrillarin, anti-NOR90, anti-PM/Scl, anti-KU, anti-U1RNP and anti-SSA antibodies (independently of antinuclear antibodies status) Exclusion Criteria: * Patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies * Patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients followed in internal medicine or rheumatology units until December 2021 ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** p.decker@chru-nancy.fr **Name:** Paul Decker, MD **Phone:** +33383157240 **Role:** CONTACT #### Locations **Location 1:** **City:** Angers **Contacts:** ***Contact 1:*** - **Name:** Christian Lavigne - **Role:** CONTACT **Country:** France **Facility:** CHU Angers **Location 2:** **City:** Brest **Contacts:** ***Contact 1:*** - **Name:** Claire De Moreuil - **Role:** CONTACT **Country:** France **Facility:** CHU Brest **Location 3:** **City:** Dunkerque **Contacts:** ***Contact 1:*** - **Name:** Amélie Leurs - **Role:** CONTACT **Country:** France **Facility:** CH Dunkerque **Location 4:** **City:** Grenoble **Contacts:** ***Contact 1:*** - **Name:** Alban Deroux - **Role:** CONTACT **Country:** France **Facility:** CHU Grenoble **Location 5:** **City:** Lille **Contacts:** ***Contact 1:*** - **Name:** David Launay - **Role:** CONTACT **Country:** France **Facility:** CHU Lille **Location 6:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Name:** Claire Grange - **Role:** CONTACT **Country:** France **Facility:** Hospices Civils de Lyon **Location 7:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Name:** Brigitte Granel - **Role:** CONTACT **Country:** France **Facility:** AP-HM **Location 8:** **City:** Nice **Contacts:** ***Contact 1:*** - **Name:** Viviane Queyrel - **Role:** CONTACT **Country:** France **Facility:** CHU Nice **Location 9:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Benjamin Chaigne - **Role:** CONTACT **Country:** France **Facility:** APHP **Location 10:** **City:** Poitiers **Contacts:** ***Contact 1:*** - **Name:** Mickaël Martin - **Role:** CONTACT **Country:** France **Facility:** CHU Poitiers **Location 11:** **City:** Reims **Contacts:** ***Contact 1:*** - **Name:** Amélie Servettaz - **Role:** CONTACT **Country:** France **Facility:** CHU Reims **Location 12:** **City:** Rennes **Contacts:** ***Contact 1:*** - **Name:** Alain Lescoat - **Role:** CONTACT **Country:** France **Facility:** CHU Rennes **Location 13:** **City:** Strasbourg **Country:** France **Facility:** Hôpitaux Universitaires de Strasbourg **Location 14:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Name:** Emmanuel Chatelus - **Role:** CONTACT **Country:** France **Facility:** Hôpitaux Universitaires de Strasbourg ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Systemic Sclerosis ### Condition Browse Module - Meshes - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4625 - Name: Autoantibodies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412601 **Brief Title:** Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes **Official Title:** Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes #### Organization Study ID Info **ID:** STUDY00002907 #### Organization **Class:** OTHER **Full Name:** Children's Mercy Hospital Kansas City ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-18 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Mercy Hospital Kansas City #### Responsible Party **Investigator Affiliation:** Children's Mercy Hospital Kansas City **Investigator Full Name:** Mark Clements **Investigator Title:** Medical Director, Pediatric Clinical Research Unit, Children's Mercy Hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the impact of peer support via the Happy Bob phone app in youth with Type 1 Diabetes. The main questions it aims to answer are: What is the usability and acceptability of the app? What is the app's efficacy on measures such as treatment adherence and social support? And how are these effects impacted by remote patient monitoring by clinic staff? Participants will use the Happy Bob app for 6 months and will complete a series of surveys at the start, middle, and end of their use of the app. Some participants will participate in 2 remote patient monitoring sessions when beginning their use of the app. ### Conditions Module **Conditions:** - Type 1 Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: RPM - Behavioral: app **Label:** RPM (remote patient monitoring) **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: app **Label:** Non-RPM **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - RPM (remote patient monitoring) **Description:** remote patient monitoring by clinic staff **Name:** RPM **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Non-RPM - RPM (remote patient monitoring) **Description:** use of Happy Bob phone app **Name:** app **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** time spent in Happy Bob, **Measure:** Happy Bob App User Metrics **Time Frame:** 6 months **Description:** quality of life scale **Measure:** Type 1 Diabetes and Life (T1DAL) Measure **Time Frame:** 0,3,6 months **Description:** mood scale **Measure:** Positive and Negative Affect Schedule (PANAS) **Time Frame:** 0,3,6 months **Description:** intervention satisfaction **Measure:** Diabetes Treatment Satisfaction Questionnaire **Time Frame:** 0,3,6 months **Description:** social quality of life **Measure:** Social Support Questionnaire for Children (SSQC) **Time Frame:** 0,3,6 months **Description:** usability scale **Measure:** Health Information Technology Usability Evaluation Scale (Health-ITUES) **Time Frame:** 0,3,6 months #### Secondary Outcomes **Description:** efficacy scale **Measure:** Self Efficacy for Diabetes (SED) Scale **Time Frame:** 0,3,6 months **Description:** TIR, **Measure:** Diabetes Treatment Outcomes **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone Exclusion Criteria: Non-English Speaking **Healthy Volunteers:** True **Maximum Age:** 215 Months **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** snmaccoll@cmh.edu **Name:** Sophie MacColl **Phone:** 8166011485 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: 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 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412588 **Brief Title:** Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study. **Official Title:** Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study #### Organization Study ID Info **ID:** KY20240123-18 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing First Hospital, Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University **Investigator Full Name:** Zhenyu Zhang **Investigator Title:** Director of Gastroenterology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications. **Detailed Description:** It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications. ### Conditions Module **Conditions:** - Helicobacter Pylori Infection **Keywords:** - Helicobacter Pylori Infection - Dual therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 810 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days **Intervention Names:** - Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days **Label:** Group A Bismuth quadruple **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days **Intervention Names:** - Drug: Vonoprazan+Amoxicillin **Label:** Group B Amoxicillin Dual therapy **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days **Intervention Names:** - Drug: Vonoprazan+doxycycline **Label:** Group C doxycycline Dual therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A Bismuth quadruple **Description:** Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days. **Name:** Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days **Other Names:** - Doxycycline-based Bismuth Quadruple Therapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group B Amoxicillin Dual therapy **Description:** Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days. **Name:** Vonoprazan+Amoxicillin **Other Names:** - Vonoprazan+Amoxicillin Dual therapy **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group C doxycycline Dual therapy **Description:** Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days. **Name:** Vonoprazan+doxycycline **Other Names:** - Vonoprazan+doxycycline Dual therapy **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Adverse drug reactions **Measure:** Security observations **Time Frame:** Within 3 days after the end of treatment #### Primary Outcomes **Description:** The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT **Measure:** HP eradication rate **Time Frame:** 4-6 weeks after the end of the last dose #### Secondary Outcomes **Description:** Rate of drug consumption during the treatment period of the subjects **Measure:** Patient compliance **Time Frame:** Within 3 days after the end of treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-65 years old; 2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT; 3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year; 4. Voluntarily join this trial and sign the informed consent form. Exclusion Criteria: 1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.); 2. Patients with confirmed active peptic ulcer; 3. Patients who have received Helicobacter pylori eradication therapy within half a year; 4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment; 5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs; 6. History of esophageal or gastric surgery; 7. Pregnant or lactating women; 8. Alcoholism 9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease; 10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons; 11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhangzhenyu808@126.com **Name:** Zhenyu Zhang **Phone:** 18951670222 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M18886 - Name: Helicobacter Infections - Relevance: HIGH - As Found: Helicobacter Pylori Infection - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000016481 - Term: Helicobacter Infections ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000863 - Term: Antacids - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005765 - Term: Gastrointestinal Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Colorectal - ID: M7493 - Name: Doxycycline - Relevance: HIGH - As Found: Open-Label Study - ID: M5011 - Name: Bismuth - Relevance: HIGH - As Found: Initially - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000658 - Term: Amoxicillin - ID: D000004318 - Term: Doxycycline - ID: D000001729 - Term: Bismuth ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412575 **Brief Title:** JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy **Official Title:** Joint Nasogastric Tube (JNT) Versus Traditional Decompression Nasogastric Tube (TNT) to Guided OGT-overlap Oesophagojejunostomy in Laparoscopic Total Gastrectomy: A Randomized Controlled Trial #### Organization Study ID Info **ID:** NFEC-2024-142 #### Organization **Class:** OTHER **Full Name:** Nanfang Hospital, Southern Medical University ### Status Module #### Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-31 **Type:** ACTUAL #### Start Date **Date:** 2023-01-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanfang Hospital, Southern Medical 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:** Gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent laparoscopic total gastrectomy (LTG) were eligible for this study **Detailed Description:** All patients enrolled in our study underwent standard laparoscopic total gastrectomy (LTG) with D2 lymphadenectomy and OGT-overlap oesophagojejunostomy according to the Japanese Gastric Cancer Association treatment guidelines and our previous reports. When the surgeons decided to perform OGT-overlap oesophagojejunostomy after gastrectomy, we randomised the patients into the Traditional Decompression Nasogastric Tube (TNT) group or Joint Nasogastric Tube (JNT) group by simple randomization operatively. In the TNT group, the TNT was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophagealstump . While in the JNT group, the JNT was used to substitute the TNT. After the anastomosis was completed, the team of surgeons performed an intraoperative gastroscopy to check for defects, bleeding, and stenosis in the anastomosis, and esophageal pseudocanals, and also to confirm whether the esophageal mucosa was damaged by TNT or JNT. ### Conditions Module **Conditions:** - Gastric/Gastroesophageal Junction (g/Gej) Cancer **Keywords:** - Gastric tumor - Gastric/gastroesophageal junction (G/GEJ) - Laparoscopic total gastrectomy - Overlap anastomosis - Joint nasogastric tube ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study was a parallel, open-label randomized trial that aimed to assess safety and efficiency of JNT and TNT to guided OGT-overlap oesophagojejunostomy. Gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent LTG with OGT-overlap oesophagojejunostomy ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the JNT group, the Joint Nasogastric Tube (JNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump. **Intervention Names:** - Procedure: JNT Guided OGT-overlap Oesophagojejunostomy **Label:** JNT group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the TNT group, the traditional decompression nasogastric tube (TNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump. **Intervention Names:** - Procedure: TNT Guided OGT-overlap Oesophagojejunostomy **Label:** TNT group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - JNT group **Description:** In the JNT group, the Joint Nasogastric Tube (JNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump. **Name:** JNT Guided OGT-overlap Oesophagojejunostomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - TNT group **Description:** In the TNT group, the Traditional Decompression Nasogastric Tube (TNT) was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophageal stump. **Name:** TNT Guided OGT-overlap Oesophagojejunostomy **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** the oesophagealmucosa is observed endoscopically after the common hole is closed. Patients with esophageal mucosal injury can be shown as esophageal mucosal surface with mucosal injury caused by nasogastric tube (NT) . **Measure:** Oesophageal mucosal injury **Time Frame:** Surgery **Description:** when inserting the anvil fork into the oesophagealhole, the anvil fork can be correctly placed in a satisfactory position and at a satisfactory angle into the oesophagealmucosa canal to be fired for oesophagojejunostomy by inserting it only once. **Measure:** )Inserting anvil fork into oesophageallumen at first attempt **Time Frame:** Surgery **Description:** when inserting the NT from nose to the oesophagealstump only once without pulling out and reinserting. **Measure:** Inserting NT to oesophagealstump at first attempt **Time Frame:** Surgery **Description:** postoperative complications were assessed within 30 days after the surgery and rated following Clavien-Dindo classification (CDC) system **Measure:** Early postoperative complications **Time Frame:** Within 30 days after the surgery #### Primary Outcomes **Description:** Time starts from insertion of the NT through the nose, to the end of the NT docking with the OGT and successfully implanted into the esophageal cavity. **Measure:** Time of OGT and nasogastric tube (NT) connection **Time Frame:** Surgery #### Secondary Outcomes **Description:** Time starts from insertion of the NT through the nose, to the front end of the NT reaching the esophageal stump. **Measure:** Time of nasogastric tube (NT) insertion **Time Frame:** Surgery **Description:** Time starts from making the entry hole for the anastomosis on the oesophagealstump, to the end of the common entry hole was closed using barbed threads. **Measure:** Time of oesophagojejunostomy **Time Frame:** Surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: (1) Age 18-75 years; (2) Physical status score (ECOG) 0-2 points; (3) Preoperative pathological examination to diagnose gastric/gastroesophageal junction (G/GEJ) cancer; (4)No obvious contraindications for surgery; (5)Did not found metastasis preoperatively and intraoperatively; (6)Confirmed tumours invade oesophagus no more than 3cm intraoperatively; (7) Expected to perform OGT-overlap oesophagojejunostomy after lymphadenectomy and gastrectomy in the operation of laparoscopic total gastrectomy. Exclusion Criteria: (1)Underwent radiotherapy for G/GEJ cancer preoperatively; (2) continuous HIPEC after operation. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Nanfang Hospital, Southern Medical University **State:** Guangdong **Zip:** 510515 #### Overall Officials **Official 1:** **Affiliation:** Nanfang Hospital, Southern Medical University **Name:** Xinhua Chen, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** If other researchers are interest in the IPD, please contact Xinhua Chen(xinhuachen03@163.com）. **IPD Sharing:** NO ## Derived Section ### 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: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412562 **Brief Title:** M3VAS Validation in Polish Population **Official Title:** The Maudsley 3-item Visual Analogue Scale (M3VAS) Validation in Polish Population Diagnosed With Major Depressive Episode #### Organization Study ID Info **ID:** M3VAS_PL #### Organization **Class:** OTHER **Full Name:** Medical University of Gdansk ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** King's College London #### Lead Sponsor **Class:** OTHER **Name:** Medical University of Gdansk #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD). Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently. The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality. Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety. Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line. A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100. The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum). The M3VAS exhibited good psychometric properties in British population. In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder. ### Conditions Module **Conditions:** - Depressive Disorder **Keywords:** - anhedonia; low mood; suicidality; depression; m3vas ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), as determined by a psychiatrist. **Intervention Names:** - Diagnostic Test: The Maudsley 3-item Visual Analogue Scale (M3VAS) **Label:** Major Depressive Episode ### Interventions #### Intervention 1 **Arm Group Labels:** - Major Depressive Episode **Description:** Patients will be asked to complete The Maudsley 3-item Visual Analogue Scale (M3VAS) and 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16). **Name:** The Maudsley 3-item Visual Analogue Scale (M3VAS) **Other Names:** - 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** To analyze internal consistency and factor analysis **Measure:** The Maudsley 3-item Visual Analogue Scale (M3VAS) **Time Frame:** Baseline #### Secondary Outcomes **Description:** To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS) **Measure:** 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosis as provided by DSM-5 criteria: Major depressive disorder (MDD) Bipolar disorder (BD) Exclusion Criteria: Diagnosis as provided by DSM-5 criteria: Psychotic disorders Current Mania or hypomania within bipolar disorder (BD) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Inpatients referred to the tertiary-reference unit for mood disorders with MDD or BD diagnosis, currently either with current depression or euthymic ### Contacts Locations Module #### Locations **Location 1:** **City:** Gdańsk **Contacts:** ***Contact 1:*** - **Email:** alina.wilkowska@gumed.edu.pl - **Name:** Alina Wilkowska, MD, PhD - **Phone:** +48 58 584 46 50 - **Role:** CONTACT ***Contact 2:*** - **Name:** Aleksander Kwaśny, MD - **Phone:** +48 58 584 46 50 - **Role:** CONTACT ***Contact 3:*** - **Name:** Alina Wilkowska, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Aleksander Kwaśny, MD - **Role:** SUB_INVESTIGATOR **Country:** Poland **Facility:** Medical University of Gdańsk **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Moulton CD, Strawbridge R, Tsapekos D, Oprea E, Carter B, Hayes C, Cleare AJ, Marwood L, Mantingh T, Young AH. The Maudsley 3-item Visual Analogue Scale (M3VAS): Validation of a scale measuring core symptoms of depression. J Affect Disord. 2021 Mar 1;282:280-283. doi: 10.1016/j.jad.2020.12.185. Epub 2020 Dec 31. **PMID:** 33418379 ## Derived Section ### Condition Browse Module - Ancestors - 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 ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M29364 - Name: Suicidal Ideation - Relevance: LOW - As Found: Unknown - ID: M29467 - Name: Anhedonia - 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: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412549 **Brief Title:** Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD) **Official Title:** IMPACTO MR: Effect of a Bundle of Interventions on Patients With Central Nervous System Devices - Project Platform Supporting the National Action Plan for Prevention and Control of Antimicrobial Resistance #### Organization Study ID Info **ID:** 6. NUP25000.1672362023-51 #### Organization **Class:** OTHER **Full Name:** Beneficência Portuguesa de São Paulo ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-16 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Ministry of Health, Brazil #### Lead Sponsor **Class:** OTHER **Name:** Beneficência Portuguesa de São Paulo #### Responsible Party **Investigator Affiliation:** Beneficência Portuguesa de São Paulo **Investigator Full Name:** Viviane Cordeiro Veiga, MD, 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:** Non-randomized clinical trial conducted in the adult ICUs of Brazilian hospitals participating in the IMPACTO MR Platform, involving adult patients using an intracranial pressure monitoring catheter device or external ventricular drain. The study will test the hypothesis that the intervention bundle, following ANVISA recommendations for care practices, will reduce the rates of central nervous system infections associated with ICP and EVD devices. This reduction is expected to lead to more accurate diagnoses, decreased antibiotic usage, shortened ICU and hospital stays, and reduced hospital costs. **Detailed Description:** IMPACTO MR is a research platform that originated as a prospective and collaborative observational study collecting clinical, microbiological, and cost data from patients admitted to Brazilian adult ICUs during the three-year periods 2018-2020 and 2021-2023. Data were collected from all adult patients admitted to the ICUs of at least 61 hospitals selected for the platform. This project aims to collect data from approximately 20 participating hospitals that perform neurosurgical procedures involving external ventricular drain catheter implantation and intracranial pressure monitoring, with the goal of establishing national data on the prevalence of these conditions. The first phase of the study will involve completing data collection for the prospective cohort conducted between 2022 and 2023. This cohort is part of the IMPACTO MR: Device-related central nervous system infections in adult intensive care units in Brazil - Action Plan Support Project Platform National Prevention and Control of Antimicrobial Resistance) with the same hospitals. This will represent the baseline incidence of central nervous system infections related to devices and care practices for patients with intracranial pressure monitoring catheters and external ventricular drains. The data will include information on risk factors, care processes, and clinical management in suspected central nervous system infections related to these devices. In the second phase of the study, an intervention bundle will be implemented to prevent infections and improve care processes in these ICUs progressively. Diagnostic site visits will be conducted at hospitals to support the construction of this intervention bundle, and all participating hospitals will receive continuous training to facilitate measurement of results. The intervention bundle will be based on ANVISA recommendations for controlling healthcare-associated infections. Currently, the recommendations are based on the care to be followed from pre-operative to post-operative stages, including the use of checklists with daily goals, recommendations for dressing care, catheter handling, and treatment in the presence of infection. The intervention bundle will be developed by a minimum team of doctors and nurses from the coordinating hospital. After conducting a situational diagnosis, this team will develop care protocols, checklists with daily goals, and training materials for the participating centers. Throughout the project, systematic feedback meetings will be held to monitor action plans, both remotely and, if necessary, in person. The intervention will be implemented within each hospital until the proposed sample size is attained. ### Conditions Module **Conditions:** - Central Nervous System Infections **Keywords:** - Bacterial resistance - Health care - Central nervous systen infection - Multi-resistant microorganism ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** The first phase of the project included 554 participants (baseline sample) and the second phase included 746 participants (intervention sample). Totaling 1,300 patients with external ventricular drain and/or intracranial pressure monitoring catheter. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 1300 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular drain. Baseline database obtained from the study "Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil (IMPACTO-SNC)", Carried out during the period from 2022 to 2023. **Label:** Baseline **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants over 18 years old admitted to the ICU in the selected hospitals and trained in the intervention bundle during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. Participants included in the period from 2024 to 2026 **Intervention Names:** - Behavioral: Health care practices and routines **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The scope of the project includes a diagnostic visit to participating hospitals, conducted by the coordinating center team, to understand existing protocols related to the management of invasive central nervous system devices (such as intracranial pressure monitoring catheters or external ventricular drains), as well as the physical infrastructure, human resources, and other precautions taken for the prevention and treatment of central nervous system infections. All recommendations in the intervention bundle for patient care will align with the guidelines of the National Health Surveillance Agency (ANVISA) and the best available scientific evidence for preventing infections associated with central nervous system devices. * Provide the best care for patients with ICP and/or EVD, based on the best available evidence, with regard to the insertion and maintenance of catheters, as well as diagnosis and treatment in the presence of infection. * Training of the multidisciplinary team. **Name:** Health care practices and routines **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** To compare the incidence of device-related central nervous system infections at baseline and after the implementation of the intervention bundle. The percentage of suspected infection cases and those confirmed by ANVISA criteria will be compared at both study timepoints. **Measure:** To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices. **Time Frame:** 30 days after study inclusion #### Secondary Outcomes **Description:** Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not) at baseline versus the group included after the intervention bundle. The outcome will be measured based on the positive liquor culture and antibiogram. **Measure:** Microbiological profile identified in CSF culture results. **Time Frame:** 30 days after study inclusion **Description:** To compare microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not). **Measure:** Risk factors **Time Frame:** 30 days after study inclusion **Description:** To compare treatment practices for device-related central nervous system infections at baseline versus the group included after the intervention bundle. The outcome will be measured based on the antibiotic classes used to treat CNS infection, dose and time of use of antibiotics. The treatment data will be collected from the medical prescription during the hospital stay. **Measure:** Drug treatment during hospital stay **Time Frame:** 30 days after study inclusion **Description:** The difference between the percentages of suspected and confirmed infection cases at baseline will be evaluated, compared to the group included after the intervention bundle. **Measure:** Diagnostic accuracy **Time Frame:** 30 days after study inclusion **Description:** Compare costs associated with the duration of infection at baseline versus the group included after the intervention bundle. The outcome will be measured based on the demographic characteristics, Saps3, infection (yes or no), use of antibiotics and time of permanence on ICU. **Measure:** Cost of hospital admission in dollars, comparing patients with and without infection **Time Frame:** 30 days after study inclusion **Description:** The outcome will be measured based on the vital status on the hospital discharge, follow-up in 30 days, 6 months and 1 year. **Measure:** Death rate **Time Frame:** 30 days, 6 months and 1 year after study inclusion **Description:** Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The patient is classified as follows: * No symptoms at all; * No significant disability despite symptoms; able to carry out all usual duties and activities * Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance * Moderate disability; requiring some help, but able to walk without assistance * Moderately severe disability; unable to walk and attend to bodily needs without assistance * Severe disability; bedridden, incontinent and requiring constant nursing care and attention * Dead Compare rankin scale score before and after the intervention bundle. **Measure:** Rankin scale **Time Frame:** 30 days, 6 months and 1 year after study inclusion **Description:** From the first patient enrollment at participating centers to the last hospital discharge of the recruited sample. **Measure:** Adherence of the study site to the intervention bundle **Time Frame:** Monthly ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients with intracranial pressure monitoring catheters (intraventricular or intraparenchymal) and/or external ventricular drain. * The patient can be included from the moment the catheter is implanted, without there being a minimum time for inclusion. Exclusion Criteria: * Suspected or confirmed brain death. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** viviane.veiga@bp.org.br **Name:** Viviane Veiga, Phd **Phone:** +55 11 99942-1721 **Role:** CONTACT **Contact 2:** **Email:** juliana.coelho@bp.org.br **Name:** Juliana Coelho, Phd **Phone:** +55 11 98971-5801 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** BP - A Beneficência Portuguesa de São Paulo **Name:** Viviane Veiga, Phd **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Hospital Geral Clériston Andrade **Name:** Renata Oliveira **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Instituto Estadual do Cérebro Paulo Niemeyer **Name:** Cássia Shinotsuka **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Hospital de Clinicas de Porto Alegre **Name:** Thiago Lisboa **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Hospital do Amor de Barretos **Name:** Luciana Sanches **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Hospital Pelópidas Silveira **Name:** Lívia Medeiros **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Hospital Getúlio Vargas **Name:** Tássio Lavor **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** Hospital da Restauração **Name:** Débora Pinho **Role:** PRINCIPAL_INVESTIGATOR **Official 9:** **Affiliation:** Hospital de Pronto Socorro de Porto Alegre **Name:** Cristiano Franke **Role:** PRINCIPAL_INVESTIGATOR **Official 10:** **Affiliation:** Hospital Universitário Cajuru **Name:** Gabriela Teixeira **Role:** PRINCIPAL_INVESTIGATOR **Official 11:** **Affiliation:** Hospital Universitário Onofre Lopes **Name:** Eliane Silva **Role:** PRINCIPAL_INVESTIGATOR **Official 12:** **Affiliation:** Hcor - Associação Beneficente Síria **Name:** Marcelo Romano **Role:** PRINCIPAL_INVESTIGATOR **Official 13:** **Affiliation:** Hospital das Clínicas de Ribeirão Preto **Name:** Wilson Lovato **Role:** PRINCIPAL_INVESTIGATOR **Official 14:** **Affiliation:** Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck **Name:** Israel Maia **Role:** PRINCIPAL_INVESTIGATOR **Official 15:** **Affiliation:** Santa Casa de Misericordia de Passos **Name:** Priscila Gonçalves **Role:** PRINCIPAL_INVESTIGATOR **Official 16:** **Affiliation:** Hospital São Paulo **Name:** Flávia Machado **Role:** PRINCIPAL_INVESTIGATOR **Official 17:** **Affiliation:** Instituto Hospital de Base do Distrito Federal - IGESDF **Name:** Glécia Rocha **Role:** PRINCIPAL_INVESTIGATOR **Official 18:** **Affiliation:** Hospital das Clínicas FMUSP **Name:** Roberta Roepek **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Champey J, Mourey C, Francony G, Pavese P, Gay E, Gergele L, Manet R, Velly L, Bruder N, Payen JF. Strategies to reduce external ventricular drain-related infections: a multicenter retrospective study. J Neurosurg. 2018 Jun 1:1-6. doi: 10.3171/2018.1.JNS172486. Online ahead of print. **PMID:** 29932377 **Citation:** Ramanan M, Lipman J, Shorr A, Shankar A. A meta-analysis of ventriculostomy-associated cerebrospinal fluid infections. BMC Infect Dis. 2015 Jan 8;15:3. doi: 10.1186/s12879-014-0712-z. **PMID:** 25567583 **Citation:** Jin J, Akau Ola S, Yip CH, Nthumba P, Ameh EA, de Jonge S, Mehes M, Waiqanabete HI, Henry J, Hill A; International Society of Surgery (ISS) and the G4 Alliance International Standards and Guidelines for Quality Safe Surgery and Anesthesia (ISG-QSSA) Group. The Impact of Quality Improvement Interventions in Improving Surgical Infections and Mortality in Low and Middle-Income Countries: A Systematic Review and Meta-Analysis. World J Surg. 2021 Oct;45(10):2993-3006. doi: 10.1007/s00268-021-06208-y. Epub 2021 Jul 3. Erratum In: World J Surg. 2022 Jan;46(1):294. **PMID:** 34218314 **Citation:** Lord AS, Nicholson J, Lewis A. Infection Prevention in the Neurointensive Care Unit: A Systematic Review. Neurocrit Care. 2019 Aug;31(1):196-210. doi: 10.1007/s12028-018-0568-y. **PMID:** 29998427 **Citation:** Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022. **PMID:** 35250284 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous 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: M5743 - Name: Central Nervous System Infections - Relevance: HIGH - As Found: Central Nervous System Infections - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002494 - Term: Central Nervous System 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: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412536 **Acronym:** SWIFT-CORE-101 **Brief Title:** Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility **Official Title:** Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility (SWIFT-CORE-101) #### Organization Study ID Info **ID:** CORE042024 #### Organization **Class:** NETWORK **Full Name:** Brooklyn Clinical Research ### Status Module #### Completion Date **Date:** 2029-04-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-04-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Brooklyn Clinical Research #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** SWIFT-CORE-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. Site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. A doctor will review medical history with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials. ### Conditions Module **Conditions:** - Cardiovascular Diseases - Obesity - PreDiabetes - Diabetes Type 2 - Metabolic Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Blood work on some participants to review eligibility for future clinical trials **Name:** Blood work **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of participants who are interested in industry-sponsored clinical research in each of the following therapeutic areas: cardiovascular, obesity, and endocrine. **Measure:** Number of participants who are interested in industry-sponsored clinical research **Time Frame:** 5 years #### Secondary Outcomes **Description:** Characteristics associated with patient populations interested in clinical trials stratified by demographics and therapeutic areas **Measure:** Characteristics associated with patient populations interested in clinical trials **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed. 2. Participant is at least 18 years old. Exclusion Criteria: 1. Participant is pregnant, breast-feeding, or planning to become pregnant. 2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results. 3. Moderate or severe substance use disorder within 90 days prior to screen 4. Any condition that in the investigator's opinion makes a participant unsuitable for the study. 5. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** In year one of the program, we anticipate 4000 participants of any sex, age 18+, who have expressed interest in participating in an industry-sponsored clinical trial of an investigational product for indications in cardiovascular, obesity, and endocrine-related therapeutic areas will be screened for clinical appropriateness for a study trial. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** amushtaq@brooklynclinicalresearch.com **Name:** Ammara Mushtaq, MD **Phone:** 929-203-5879 **Role:** CONTACT **Contact 2:** **Email:** kazer@brooklynclinicalresearch.com **Name:** Katherine Azer, MS **Phone:** 929-332-7848 **Role:** CONTACT #### Locations **Location 1:** **City:** Brooklyn **Contacts:** ***Contact 1:*** - **Email:** amushtaq@brooklynclinicalresearch.com - **Name:** Ammara Mushtaq, MD - **Phone:** 929-203-5879 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ammara Mushtaq, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Brooklyn Clinical Research **State:** New York **Zip:** 11226 #### Overall Officials **Official 1:** **Affiliation:** Brooklyn Clinical Research **Name:** Ammara Mushtaq, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-30 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 281532 - Type Abbrev: ICF - Upload Date: 2024-05-06T11:52 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M14117 - Name: Prediabetic State - Relevance: LOW - As Found: Unknown - ID: M20295 - Name: Glucose Intolerance - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Syndrome - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Type 2 - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - 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: D000002318 - Term: Cardiovascular Diseases - ID: D000009765 - Term: Obesity - ID: D000024821 - Term: Metabolic Syndrome - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412523 **Acronym:** IMPACTO-SNC **Brief Title:** Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil **Official Title:** Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil #### Organization Study ID Info **ID:** 17558 #### Organization **Class:** OTHER **Full Name:** Beneficência Portuguesa de São Paulo ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2022-08-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2022-08-11 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beneficência Portuguesa de São Paulo #### Responsible Party **Investigator Affiliation:** Beneficência Portuguesa de São Paulo **Investigator Full Name:** Viviane Cordeiro Veiga, MD, PhD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies. **Detailed Description:** Neurosurgical procedures with placement of devices are related to increased morbidity and mortality. A study shows that the incidence of device-related central nervous system infection can reach 27%. A meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day. This is a prospective cohort study, including adult patients, in the ICUs of hospitals participating in the IMPACTO MR Platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes ### Conditions Module **Conditions:** - Central Nervous System Infections **Keywords:** - Central Nervous System Infections - Catheters ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 554 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported. **Measure:** Incidence density of central nervous system infection **Time Frame:** 30 days after study inclusion #### Secondary Outcomes **Description:** Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not) **Measure:** Microbiological characteristics **Time Frame:** 30 days after study inclusion **Description:** Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated **Measure:** Risk factors **Time Frame:** 30 days after study inclusion **Description:** Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance) **Measure:** Treatment **Time Frame:** 30 days after study inclusion **Description:** Costs associated with the duration of infection **Measure:** Costs **Time Frame:** 30 days after study inclusion **Description:** Deaths during hospital stay and long-term (6 months) **Measure:** Deaths **Time Frame:** 30 days and 6 months after study inclusion **Description:** Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The patient is classified as follows: * No symptoms at all; * No significant disability despite symptoms; able to carry out all usual duties and activities * Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance * Moderate disability; requiring some help, but able to walk without assistance * Moderately severe disability; unable to walk and attend to bodily needs without assistance * Severe disability; bedridden, incontinent and requiring constant nursing care and attention * Dead **Measure:** Rankin scale **Time Frame:** 30 days and 6 months after study inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. Exclusion Criteria: * Diagnosis of brain death. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults admitted to Intensive Care Units. ### Contacts Locations Module #### Locations **Location 1:** **City:** Feira De Santana **Country:** Brazil **Facility:** Hospital Geral Cleriston Andrade **State:** BA **Location 2:** **City:** Salvador **Country:** Brazil **Facility:** Hospital da Cidade **State:** BA **Location 3:** **City:** Vitória **Country:** Brazil **Facility:** Unimed Vitória **State:** ES **Location 4:** **City:** Belo Horizonte **Country:** Brazil **Facility:** Santa Casa de Belo Horizonte **State:** MG **Location 5:** **City:** Passos **Country:** Brazil **Facility:** Santa Casa de Misericórdia de Passos **State:** MG **Location 6:** **City:** São João Del Rei **Country:** Brazil **Facility:** Santa Casa de Misericórdia de São João del Rei **State:** MG **Location 7:** **City:** Rio De Janeiro **Country:** Brazil **Facility:** Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar) **State:** RJ **Location 8:** **City:** Natal **Country:** Brazil **Facility:** Hospital Universitário Onofre Lopes **State:** RN **Location 9:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital de Clinicas de Porto Alegre **State:** RS **Location 10:** **City:** Florianópolis **Country:** Brazil **Facility:** Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck **State:** SC **Location 11:** **City:** Barretos **Country:** Brazil **Facility:** Hospital de Amor (Fundação PIO XII - Barretos) **State:** SP **Location 12:** **City:** Limeira **Country:** Brazil **Facility:** Hospital Unimed Limeira **State:** SP **Location 13:** **City:** Ribeirão Preto **Country:** Brazil **Facility:** Hospital das Clínicas - FMUSP Ribeirão Preto **State:** SP **Location 14:** **City:** Santo André **Country:** Brazil **Facility:** Hospital e Maternidade Brasil (Rede D´or São Luis) **State:** SP **Location 15:** **City:** São Paulo **Country:** Brazil **Facility:** Beneficência Portuguesa de São Paulo **State:** SP **Location 16:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital do Coração **State:** SP **Location 17:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital São Luiz Itaim **State:** SP **Location 18:** **City:** São Paulo **Country:** Brazil **Facility:** Hospital São Paulo **State:** SP #### Overall Officials **Official 1:** **Affiliation:** Beneficencia Portuguesa Sao Paulo **Name:** Viviane Veiga, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M5743 - Name: Central Nervous System Infections - Relevance: HIGH - As Found: Central Nervous System Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000002494 - Term: Central Nervous System Infections ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412510 **Brief Title:** Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT **Official Title:** Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy #### Organization Study ID Info **ID:** CASE3824 #### Organization **Class:** OTHER **Full Name:** Case Comprehensive Cancer Center ### Status Module #### Completion Date **Date:** 2025-02-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **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:** Case Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery. **Detailed Description:** Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care. ### Conditions Module **Conditions:** - Ovarian Cancer - Epithelial Ovarian Cancer - Pancreatic Adenocarcinoma **Keywords:** - Ovarian Cancer - Neoadjuvant chemotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free. **Intervention Names:** - Other: Prehabilitation **Label:** Intervention - Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program. **Label:** Control - Arm 2 **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention - Arm 1 **Description:** Exercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training. Nutrition Intervention: 30 gm protein supplement Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and music therapy **Name:** Prehabilitation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study. **Measure:** Rate of adherence as calculated by the compliance percentage **Time Frame:** 6 weeks post intervention #### Secondary Outcomes **Description:** Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength **Measure:** Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test **Time Frame:** Baseline, 6 weeks post intervention **Description:** At baseline, and within the immediate post-exercise recovery, rating of perceived exertion (RPE; Borg scale, 6-20) will be assessed. Peak exercise exhaustion was verified if two or more of the following criteria were met: 1)96 HR within 10 bpm of age-predicted maximum HR (220-age), 2) RPE \> 17, and/or 3) a plateau in HR (\<3 bpm change over the last two intensity stages). VO2 max will be calculated by ACSM's Treadmill Walking Equation: VO2 \[ml/kg/min\] = (0.1 x speed) + (1.8 x Speed x Grade) 3.5 ml/kg/min **Measure:** Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test. **Time Frame:** Baseline, 6 weeks post intervention **Description:** Timed up and go test is one unit of time to measure how fast patients can move **Measure:** Change in effectiveness of prehabilitation as assessed by timed up and go test **Time Frame:** Baseline, 6 weeks post intervention **Description:** The 6-minute walk test is measured by the distance walked in 6 minutes **Measure:** Change in effectiveness of prehabilitation as assessed by 6-minute walk test **Time Frame:** Baseline, 6 weeks post intervention **Description:** Grip strength test measured by handheld dynamometer **Measure:** Change in effectiveness of prehabilitation as assessed by grip strength test **Time Frame:** Baseline, 6 weeks post intervention **Description:** The number of times a patient can rise to a standing position from a seated position without the use of their upper extremities is counted in a thirty second period. **Measure:** Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test **Time Frame:** Baseline, 6 weeks post intervention **Description:** This is a measure of balance and is assessed by asking the participant to stand on one foot (of their choice) with the lifted foot remaining close to their opposite ankle, first with eyes open and then with eyes closed.The amount of time a participant can stand on one foot is recorded. **Measure:** Change in measure of balance as assessed by unipedal stance test **Time Frame:** Baseline, 6 weeks post intervention **Description:** Body composition measured using contrast-enhanced CT scan **Measure:** Effectiveness of prehabilitation as assessed by measuring the change in body mass composition **Time Frame:** Baseline, 6 weeks post-intervention **Description:** Assessed for the presence of malnutrition per the Cleveland Clinic organization's standard of care based on American Society for Parenteral and Enteral Nutrition (ASPEN) and the Academy of Nutrition and Dietetics (AND) (ASPEN/AND) guidelines, and by assessing changes in the degree of malnutrition throughout the study period **Measure:** Effectiveness of prehabilitation as assessed by the change in nutritional status **Time Frame:** Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention **Description:** Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' **Measure:** Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) **Time Frame:** At baseline **Description:** Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' **Measure:** Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) **Time Frame:** Upto 6 weeks post intervention **Description:** FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' **Measure:** Quality of life as assessed by FACT-O **Time Frame:** At baseline **Description:** FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much' **Measure:** Quality of life as assessed by FACT-O **Time Frame:** Upto 6 weeks post intervention **Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system **Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity **Time Frame:** At cycle 2, day 1(each cycle is 21 days) **Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system **Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity **Time Frame:** At cycle 3, day 1(each cycle is 21 days) **Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system **Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity **Time Frame:** At cycle 4, day 1(each cycle is 21 days) **Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system **Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity **Time Frame:** Upto 6 weeks post intervention **Description:** IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree. **Measure:** Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure) **Time Frame:** Upto 6 weeks post intervention **Description:** FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree. **Measure:** Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure) **Time Frame:** Upto 6 weeks post surgery **Description:** Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal **Measure:** Effectiveness of prehabilitation as assessed by participant acceptability scale **Time Frame:** Baseline **Description:** Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal **Measure:** Effectiveness of prehabilitation as assessed by participant acceptability scale **Time Frame:** Upto 6 weeks post surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 65 and older * Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC) undergoing neoadjuvant chemotherapy; OR Patients with diagnosis of pancreatic adenocarcinoma undergoing neoadjuvant chemotherapy Exclusion Criteria: * Life expectancy less than 3 months in the opinion of the treating physician * Patients unable to provide informed consent. * Wheelchair bound patients/ physical immobility. * Severe cardiopulmonary disease defined as NYHA class III or IV * Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded. * Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** alhillm@ccf.org **Name:** Mariam AlHilli, MD **Phone:** 216-644-0418 **Role:** CONTACT #### Locations **Location 1:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Name:** Mariam AlHilli, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Mariam AlHilli, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center **State:** Ohio **Zip:** 44195 #### Overall Officials **Official 1:** **Affiliation:** Cleveland Clinic Foundation, Case Comprehensive Cancer Center **Name:** Mariam AlHilli, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The data will be available as it pertains to journal publication to the scientific/medical community. This study has no intellectual property data that would require a CDA be in place. **Description:** All IPD that underlie results in publication will be shared with scientific journals during peer-review or at scientific/medical conferences/meetings. All IDP will be anonymized. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** The data will become available during the course of the study and indefinitely thereafter. ## 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 - ID: D000009371 - Term: Neoplasms by Site - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004700 - Term: Endocrine System Diseases - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000006058 - Term: Gonadal Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Cancer - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Ovarian Cancer - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - 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: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412497 **Brief Title:** MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure. **Official Title:** MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure. #### Organization Study ID Info **ID:** 2023LS101 #### Organization **Class:** OTHER **Full Name:** Masonic Cancer Center, University of Minnesota ### Status Module #### Completion Date **Date:** 2036-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2035-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Masonic Cancer Center, University of Minnesota #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and/or clonal hematopoiesis. ### Conditions Module **Conditions:** - Severe Aplastic Anemia - Acquired Amegakaryocytic Thrombocytopenia - Acquired Pure Red Cell Aplasia - Paroxysmal Nocturnal Hemoglobinuria **Keywords:** - HCT - RIC - SAA - PTCy - aAT - aPRCA ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants 25 years of age and younger with no clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. **Intervention Names:** - Drug: Rituximab - Drug: Rabbit ATG - Drug: Cyclophosphamide - Drug: Fludarabine - Radiation: Total Body Irradiation - Biological: Cell Infusion - Drug: Post-Transplant G-CSF - Drug: Tacrolimus - Drug: Mycophenolate Mofetil **Label:** Arm A: No clonal hematopoiesis **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants 25-75 years old and/or with clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. **Intervention Names:** - Drug: Rituximab - Drug: Rabbit ATG - Drug: Cyclophosphamide - Drug: Fludarabine - Radiation: Total Body Irradiation - Biological: Cell Infusion - Drug: Post-Transplant G-CSF - Drug: Tacrolimus - Drug: Mycophenolate Mofetil **Label:** Arm B: Clonal hematopoiesis **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** For patients with EBV IgG seropositivity or EBV PCR positivity on pre-transplant evaluations, Rituximab 375 mg/m2 is given IV once on day -14 (+/-2 day) in the outpatient setting. Pre-medicate 30 minutes prior to rituximab with methylprednisolone (1 mg/kg) IV, acetaminophen 15 mg/kg (maximum 650mg) IV or PO and diphenhydramine 1 mg/kg (maximum 50mg) IV or PO. **Name:** Rituximab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** Rabbit ATG will be administered at doses and days indicated above, infused through a 0.22 micrometer filter over 4-6 hours. Pre-medicate 30 minutes prior to ATG infusion with methylprednisolone 1 mg/kg IV, (max dose = 125 mg), acetaminophen 15 mg/kg dose (max dose = 650 mg) enterally and diphenhydramine 1 mg/kg/dose (max dose = 50 mg) enterally or IV. **Name:** Rabbit ATG **Other Names:** - Thymoglobulin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** Cyclophosphamide 14.5 mg/kg is be given as a 2-hour infusion on day -6. If the patient is obese (actual body weight (ABW) \>/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (14.5 mg/kg/day) in IV continuous infusion will be provided per institutional guidelines. Hyperhydration is not required for 14.5 mg/kg cyclophosphamide doses. Cyclophosphamide will be administered at 50 mg/kg using ABW over 2 hours on days +3 and +4. If the patient is obese (ABW \>/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (50 mg/kg/day) in IV continuous infusion as well as hyperhydration will be provided per institutional guidelines. **Name:** Cyclophosphamide **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** For all patients, fludarabine dosing will be model-based using Bayesian methodology IV every 24 hours on days -6 to -3 with a cumulative area under the curve (cAUC) of 20 mg\*hr/L. **Name:** Fludarabine **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** For patients age \>/= 25 years, with myelodysplasia, or clonal hematopoiesis, total body irradiation will be 4 Gy, provided in two fractions on day -1. For all other patients, total body irradiation will be 2 Gy provided in a single fraction on day -1. Each dose of 2 Gy will be given at a dose rate between 1 and 1.9 Gy/minute prescribed to the midplane of the patient at the level of the umbilicus. **Name:** Total Body Irradiation **Other Names:** - TBI **Type:** RADIATION #### Intervention 6 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** On day 0 the cells will be infused per cell source specific institutional guidelines. **Name:** Cell Infusion **Type:** BIOLOGICAL #### Intervention 7 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** Beginning on day +5, patients will receive G-CSF SQ or IV 5 micrograms/kg once daily until post-nadir ANC \> 1500/μL for 3 consecutive days or \>3000/μL for 1 day. **Name:** Post-Transplant G-CSF **Other Names:** - Filgrastim **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** Tacrolimus will begin on day +5 at an initial dose of 0.03 mg/kg/day IV via continuous infusion. Goal trough levels will be 10-15 ug/mL until day +14 posttransplant, then decreased to a goal of 5-10 ng/mL thereafter. In the absence of GvHD, tacrolimus will discontinue at day +180 without a taper. **Name:** Tacrolimus **Type:** DRUG #### Intervention 9 **Arm Group Labels:** - Arm A: No clonal hematopoiesis - Arm B: Clonal hematopoiesis **Description:** Mycophenolate mofetil (MMF) therapy will begin on day +5. For pediatric service patients dosing of MMF will be 15 mg/kg/dose (max = 1000 mg) three times daily. For adult service patients dosing of MMF will be 15 mg/kg/dose (max = 1500 mg) twice daily. The same dosage is used orally or intravenously. Consider dose modification and/or pharmacokinetic measurements if renal and/or hepatic impairment (GFR\<25 mL/minute corrected). Stop MMF at Day +35 or 7 days after engraftment achieved (ANC\>500 x 106 neutrophils/L x 3 days) if later than day +35. If sufficient acute GvHD is observed to require systemic therapy, MMF should be continued for 7 days after initiation of systemic therapy. Afterward, use of MMF is at the discretion of the treating physician. **Name:** Mycophenolate Mofetil **Other Names:** - MMF **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence of grade 3-4 acute graft-versus host disease (GvHD) at 1 year post HCT. **Measure:** Incidence of grade 3-4 acute GvHD **Time Frame:** 1 year post HCT **Description:** Incidence of chronic GvHD-free, failure-free survival (GFFS) 1 year post HCT **Measure:** Incidence of chronic GvHD-free, failure-free survival (GFFS) **Time Frame:** 1 year post HCT **Description:** Incidence of chronic GvHD-free survival at 1 year post HCT **Measure:** Incidence of chronic GvHD-free survival **Time Frame:** 1 year post HCT #### Secondary Outcomes **Description:** Incidence of chronic GvHD-free, failure-free survival (GFFS) 2 years post HC **Measure:** Incidence of failure-free survival (GFFS) **Time Frame:** 2 years post HCT **Description:** Incidence of neutrophil recovery at day 42 post HCT **Measure:** Incidence of neutrophil recovery **Time Frame:** Day 42 post HCT **Description:** Incidence of platelet recovery at 6 months post HCT **Measure:** Incidence of platelet recovery **Time Frame:** 6 months post HCT **Description:** Incidence of grade 3-4 acute GvHD at 100 days post HCT **Measure:** Incidence of grade 3-4 acute GvHD **Time Frame:** 100 days post HCT **Description:** Incidence of any chronic GvHD at 1 year post HCT **Measure:** Incidence of any chronic GvHD **Time Frame:** 1 year post HCT **Description:** Overall survival at 1 and 2 years **Measure:** Overall survival **Time Frame:** 1 and 2 years post HCT **Description:** Incidence of chronic GvHD-free survival at 2 years post HCT **Measure:** Incidence of chronic GvHD-free survival **Time Frame:** 2 years post HCT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Idiopathic Severe Aplastic Anemia (SAA), characterized by one of the following: 1. Refractory cytopenia(s), with 1+ of the following: 1. Platelets \<20,000/uL or transfusion dependent 2. Absolute neutrophil count \<500/uL without hematopoietic growth factor support 3. Absolute reticulocyte count \<60,000/uL AND bone marrow cellularity \<50% (with \< 30% residual hematopoietic cells) 2. Early myelodysplastic features (bone marrow (BM) blasts \<5%), without history of MDS/AML pre-treatment. 3. Idiopathic SAA with post-HCT graft failure (blood/marrow donor chimerism \<5%) requiring a 2nd allogeneic HCT * Paroxysmal Nocturnal Hemoglobinuria (PNH), including AA-PNH overlap syndrome, acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT), characterized by one of the following: 1. Refractory cytopenia(s), with 1+ of the following: 1. Platelets \<20,000/uL or transfusion dependent 2. Absolute neutrophil count \<500/uL without hematopoietic growth factor support 3. Absolute reticulocyte count \<60,000/uL or red cell transfusion dependent AND Bone marrow evidence of 1 to 3-lineage aplasia OR peripheral blood PNH clone \>/= 10% 2. Early myelodysplastic features (bone marrow (BM) blasts \<5%) without history of MDS/AML pre-treatment. 3. Idiopathic PNH, aPRCA, or aAT with post-HCT graft failure (blood/marrow donor chimerism \<5%) requiring a 2nd allogeneic HCT * Adequate organ function within 30 days of conditioning regimen Exclusion Criteria: * Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment * Uncontrolled infection * Evidence of moderate or severe portal fibrosis or cirrhosis on biopsy * Known allergy to any of the study components * Prior radiation therapy deemed excessive by radiation therapist for proposed low dose TBI exposure on this protocol * Diagnosis of an inherited bone marrow failure disorder such as Fanconi anemia, Telomere biology disorder, or Schwachman-Diamond syndrome, unless reviewed by the principal investigator and deemed appropriate for this approach (e.g. GATA2 deficiency) * Advanced myelodysplastic syndrome (MDS; BM blasts \>5%) or acute myeloid leukemia * Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements * Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study **Maximum Age:** 75 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ebens012@umn.edu **Name:** Christen Ebens, MD, MPH **Phone:** 612-624-1791 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000095542 - Term: Cytopenia - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000011507 - Term: Proteinuria - 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: D000020924 - Term: Urological Manifestations - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000009190 - Term: Myelodysplastic Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M16680 - Name: Thrombocytopenia - Relevance: HIGH - As Found: Thrombocytopenia - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M9542 - Name: Hemoglobinuria - Relevance: HIGH - As Found: Hemoglobinuria - ID: M13118 - Name: Pancytopenia - Relevance: HIGH - As Found: Bone Marrow Failure - ID: M14852 - Name: Red-Cell Aplasia, Pure - Relevance: HIGH - As Found: Pure Red Cell Aplasia - ID: M9543 - Name: Hemoglobinuria, Paroxysmal - Relevance: HIGH - As Found: Paroxysmal Nocturnal Hemoglobinuria - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: HIGH - As Found: Bone Marrow Failure - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M14368 - Name: Proteinuria - 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: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14164 - Name: Preleukemia - Relevance: LOW - As Found: Unknown - ID: M12145 - Name: Myelodysplastic Syndromes - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia - ID: T4436 - Name: Paroxysmal Nocturnal Hemoglobinuria - Relevance: HIGH - As Found: Paroxysmal Nocturnal Hemoglobinuria - ID: T4833 - Name: Pure Red Cell Aplasia - Relevance: HIGH - As Found: Pure Red Cell Aplasia - ID: T114 - Name: Acquired Pure Red Cell Aplasia - Relevance: HIGH - As Found: Acquired Pure Red Cell Aplasia - ID: T109 - Name: Acquired Amegakaryocytic Thrombocytopenia - Relevance: HIGH - As Found: Acquired Amegakaryocytic Thrombocytopenia - ID: T3993 - Name: Myelodysplastic Syndromes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006456 - Term: Hemoglobinuria - ID: D000000740 - Term: Anemia - ID: D000013921 - Term: Thrombocytopenia - ID: D000000741 - Term: Anemia, Aplastic - ID: D000006457 - Term: Hemoglobinuria, Paroxysmal - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000010198 - Term: Pancytopenia - ID: D000012010 - Term: Red-Cell Aplasia, Pure ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000065095 - Term: Calcineurin Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Combined - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M14120 - Name: Prednisolone - Relevance: LOW - As Found: Unknown - ID: M1945 - Name: Lenograstim - Relevance: LOW - As Found: Unknown - ID: M12128 - Name: Mycophenolic Acid - Relevance: HIGH - As Found: Lifestyle - ID: M18950 - Name: Tacrolimus - Relevance: HIGH - As Found: 3 weeks - ID: M255823 - Name: Thymoglobulin - Relevance: HIGH - As Found: Doctor - ID: M11749 - Name: Methylprednisolone - Relevance: LOW - As Found: Unknown - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: LOW - As Found: Unknown - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M229449 - Name: Prednisolone acetate - Relevance: LOW - As Found: Unknown - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M248881 - Name: Prednisolone phosphate - Relevance: LOW - As Found: Unknown - ID: M7338 - Name: Diphenhydramine - Relevance: LOW - As Found: Unknown - ID: M14268 - Name: Promethazine - Relevance: LOW - As Found: Unknown - ID: M17811 - Name: Mesna - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M30452 - Name: Calcineurin Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009173 - Term: Mycophenolic Acid - ID: D000003520 - Term: Cyclophosphamide - ID: D000069283 - Term: Rituximab - ID: C000024352 - Term: Fludarabine - ID: D000016559 - Term: Tacrolimus - ID: C000512542 - Term: Thymoglobulin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412484 **Brief Title:** State vs. Trait Alterations in Low Back Pain **Official Title:** Low Back Pain - Disentangling Trait-Like and State-Like Alterations #### Organization Study ID Info **ID:** CRPP Renewal #### Organization **Class:** OTHER **Full Name:** Balgrist University Hospital ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-01-22 **Study First Submit QC Date:** 2024-05-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Schweinhardt Petra #### Responsible Party **Investigator Affiliation:** Balgrist University Hospital **Investigator Full Name:** Schweinhardt Petra **Investigator Title:** Prof. Dr. Med. PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation. **Detailed Description:** The study consists of three visits (healthy volunteers will only have one pain-free visit), in which patients will be tested in a different "pain state" at each visit: 1. Pain-free visit: will be carried out when the patients have no or little (Numerical Pain Rating Scale (NPRS) \</= 2/10) clinical pain. 2. Clinically relevant Low Back Pain visit: will be carried out with patients experiencing a low back pain episode with an intensity of 3/10 or more on the NPRS. 3. Experimental pain / Clinically irrelevant pain visit: will be carried out with the application of a high concentration (8%) Qutenza® capsaicin patch at the arm. Each of the visits will consist of psychophysical testing, neurophysiological assessement of sweat activity in response to pain, brain resting state magnetic resonance imaging and magnetic resonance spectroscopy. Additionally, and depending on the type of session, a lumbar spine magnetic resonance image (only pain-free session, as characterization) and a blood sample (only pain free and low back pain visit) will be performed. ### Conditions Module **Conditions:** - Low Back Pain **Keywords:** - Trait vs. State Alterations ### Design Module #### Bio Spec **Description:** Blood serum **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** LBP patients will undergo three study visits, at moments at which their pain status is different: a) "pain-free", b) low back pain (clinically relevant), c) experimental pain (clinically irrelevant). Measures will be repeated in each visit, to understand the influence / relationship of pain state on possible mechanistic alterations observed in LBP compared to HCs. **Intervention Names:** - Behavioral: Pain Free Session - Behavioral: Low Back Pain Session (= clinically relevant pain) - Behavioral: Experimental Pain Session (= clinically irrelevant pain) **Label:** Low Back Pain (LBP) Patients #### Arm Group 2 **Description:** HCs will undergo one single visit, equivalent to patients' "pain-free" visit. **Intervention Names:** - Behavioral: Pain Free Session **Label:** Healthy Controls (HCs) ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy Controls (HCs) - Low Back Pain (LBP) Patients **Description:** On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail): clinical exam, QST, SSRs, CPM, rsMRI, lumbar MRI, MRS, and blood sample. **Name:** Pain Free Session **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Low Back Pain (LBP) Patients **Description:** On a day in which patients have an ongoing typical low back pain episode of an intensity of 3 or more (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail), except the lumbar MRI: clinical exam, QST, SSRs, CPM, rsMRI, MRS, and blood sample. **Name:** Low Back Pain Session (= clinically relevant pain) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Low Back Pain (LBP) Patients **Description:** On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), an experimental pain state will be induced using a high concentration (8%) Qutenza patch, containing capsaicin. All the study measures will be performed (see primary outcome measures for detail), except the lumbar MRI and blood sample: clinical exam, QST, SSRs, CPM, rsMRI, MRS. **Name:** Experimental Pain Session (= clinically irrelevant pain) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MDT will be assessed with Von Frey filaments applied to the skin (mN). Subject reports when tactile input is detected. **Measure:** Mechanical Detection Threshold (MDT) **Time Frame:** 1 - 6 months **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MPT will be assessed with pin-pricks (mN) applied to the skin. Subject reports when the stimulus feels sharp or blunt. **Measure:** Mechanical Pain Threshold (MPT) **Time Frame:** 1 - 6 months **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MPS will be assessed with pin-pricks and Q-tip, cotton swab, and brush applied to the skin. Subjects rate stimuli on scale of 0-100. In our protocol only 3 blocks. **Measure:** Mechanical Pain Sensitivity (MPS) **Time Frame:** 1 - 6 months **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. WUR will be assessed with a pin-prick, which is applied 10 times in 10 seconds. Subjects rate the series on scale of 0-100. In our protocol, only 3 series. **Measure:** Wind-Up Ratio (WUR) **Time Frame:** 1 - 6 months **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. VDT will be assessed with a tuning fork applied to a bony prominence. Subject reports when the vibration can't be felt anymore. **Measure:** Vibration Detection Threshold (VDT) **Time Frame:** 1 - 6 months **Description:** A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. PPT will be assessed with an algometer (kg), applied to a muscle. Subject reports when pressure becomes painful. **Measure:** Pressure Pain Threshold (PPT): **Time Frame:** 1 - 6 months **Description:** Neurophysiological assessement of sweat activity in response to pain will be recorded with cap electrodes located at the hand. Painful heat stimulation will be applied with a thermode of the Pathway Medoc System. A train of 15 heat stimuli, with an inter-stimulus interval of 13-17 seconds, will be applied. The thermode baseline temperature will be 42ºC and during the stimulation the temperature will quickly ramp up to 52 ºC. Subjects are asked to rate the perception of the stimulus using a pain scale of 0-100. This procedure will be done two times: one at the most painful area of the patients, and the corresponding body area in the matched healthy volunteer, and at the volar forearm as a control pain-free area. This readout is a proxy for sympathetic nervous system activity. **Measure:** Sympathetic Skin Responses (SSRs) **Time Frame:** 1 - 6 months **Description:** CPM measures the modulation of a noxious test stimulus by another noxious conditioning stimulus applied at a remote body region. In this study, test stimuli of different modalities (pressure, superficial mechanical, heat or electrical stimuli) will be applied at different body regions before and after or before, during and after a cold water bath or neutral water bath (hand immersion) as conditioning stimulus. Changes in test stimuli read-outs (during-before or after-before) will serve as CPM measure. Negative changes represent inhibitory, positive changes facilitatory CPM effects. For all test stimuli read-outs, CPM effects will be expressed as percentage changes. Test stimuli read-outs include: pain ratings on a scale of 0: no pain, to 100: most intense pain; perception thresholds and pain thresholds (in kg for pressure). **Measure:** Conditioned Pain Modulation (CPM) **Time Frame:** 1 - 6 months **Description:** Measure of the brain's spontaneous activity acquired during resting state using a 7T Siemens scanner. **Measure:** Brain resting state Magnetic Resonance Imaging (rsMRI) **Time Frame:** 1 - 6 months **Description:** Structural resonance image of lumbar spine section acquired using a 3T Siemens scanner. **Measure:** Lumbar Magnetic Resonance Imaging **Time Frame:** 1 - 6 months **Description:** Imaging method that allows the detection of concentration of certain metabolites in the brain. This data will be acquired using a 3T Phillips scanner. **Measure:** Brain Magnetic Resonance Spectroscopy (MRS) **Time Frame:** 1 - 6 months **Description:** Blood sample of approximately 14 ml will be drawn, in a total of 3 tubes: PAXGene blood RNA tube, Serum tube, and K2 EDTA tube. This will allow analysis of inflammatory molecules (i.e. cytokines) and cell concentrations (i.e. immune cells). **Measure:** Blood Sample **Time Frame:** 1 - 6 months #### Secondary Outcomes **Description:** Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3), with 7 items for each subscale (anxiety and depression). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher score means more anxiety or depression. **Measure:** Anxiety and Depression **Time Frame:** 1 - 6 months **Description:** Pain catastrophizing will be assessed using questionnaires as for example the Pain Catastrophizing Scale (0-52; higher score meaning more catastrophizing). **Measure:** Pain Catastrophizing **Time Frame:** 1 - 6 months **Description:** Pain sensitivity will be assessed using the Pain Sensitivity Questionnaire (PSQ). It consists of 17 items, with an answer range from 0 (not at all painful) to 10 (most severe pain imaginable). The maximum score is 170, where a higher score indicates a higher pain sensitivity. **Measure:** Pain Sensitivity **Time Frame:** 1 - 6 months **Description:** Pain self efficacy will be assessed using the Pain Self Efficacy Questionnaire (PSEQ). It consists of 10 items, with an answer range from 0 (not at all confident) to 6 (completely confident). The maximum score is 60, where a higher score indicates a higher pain self efficacy / pain coping capacity. **Measure:** Pain Self Efficacy **Time Frame:** 1 - 6 months **Description:** Back awareness will be assessed using the Fremantle Back Awareness Questionnaire. It consists of 9 items, with an answer range from 0 (never) to 4 (always). The maximum score is 36, where a higher score indicates a decreased back awareness. **Measure:** Back Awareness **Time Frame:** 1 - 6 months **Description:** Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI), which consists of two parts. Part A: includes 25 questions assessing typical central sensitisation symptoms. Each answer is scored on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation. Part B: determines if the patient has been diagnosed with certain central sensitivity disorder or related disorders, such as anxiety and depression. **Measure:** Central sensitization **Time Frame:** 1 - 6 months **Description:** Presence of fibromyalgia symptoms will be assessed using the WPI. In the WPI, patients report body areas in which they have had pain in the past week. Each marked area adds one point, to reach a total score of 19. A patient would meet the criteria for fibromyalgia if: * WPI score (Part 1) is 7 or higher and SSS score (see below) (Part 2a \& b) is 5 or higher OR * WPI score (Part 1) is from 3 to 6 AND the SSS score (Part 2a \& b) is 9 or higher. **Measure:** Widespread Pain Index (WPI) **Time Frame:** 1 - 6 months **Description:** Presence of fibromyalgia symptoms will be assessed using the SSS. SSS consists of two parts. In part A patients report the severity of fatigue, waking unrefreshed, and cognitive symptoms. Each question can be answered from 0-3, for a total of 9. The higher the score, the higher the severity of these symptoms. In part B, patients report other somatic symptoms that they have experienced in the past week, reaching a total score of 3. Parts A and B, have a total score of 12 put together. A patient would meet the criteria for fibromyalgia if: * WPI score (see above) (Part 1) is 7 or higher and SSS score (Part 2a \& b) is 5 or higher OR * WPI score (Part 1) is from 3 to 6 AND the SSS score (Part 2a \& b) is 9 or higher. **Measure:** Symptom Severity Scale (SSS) **Time Frame:** 1 - 6 months **Description:** Neuropathic pain components will be assessed using PainDETECT, which consists of 9 items: 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A score of 19 or more (out of 38) indicates likely neuropathic pain. **Measure:** Neuropathic Pain **Time Frame:** 1 - 6 months **Description:** Patients' functional disability will be measured using the Oswestry Disability Index (ODI), which consists of 10 items addressing different aspects of life (i.e. walking, social life, hygiene, etc.). Each item, has a possible 5 point answer. A higher score indicates higher functional disability. **Measure:** Disability **Time Frame:** 1 - 6 months **Description:** Low back pain patients will be asked to complete pain drawings indicating painful body regions. The painful body area will be calculated as percentage of the whole body area. Higher percentages represent more widespread pain. **Measure:** Pain Extent **Time Frame:** 1 - 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * German or English proficiency * Informed consent * Low back pain for more than 3 months * Low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation) * Fluctuating course of pain (with on and off pain periods). Exclusion Criteria (applicable to both groups): * Inability to give informed consent / follow study instructions (e.g. due to language problems) * Major medical or psychiatric condition. E.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc. * Symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar MRI. * Back operation * BMI \> 30 * Pregnancy **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population consists of people that suffer from non-specific low back pain, meaning that their pain cannot reliably be attributed to a specific pathology and radiographic abnormalities correlate poorly with patients' symptoms. Participants should suffer from chronic episodic low back pain, meaning that they have had back pain pain for at least more than 3 months, with recurrent fluctuating pain episodes. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** petra.schweinhardt@balgrist.ch **Name:** Petra Schweinhardt **Phone:** +41 44 386 57 24 **Role:** CONTACT **Contact 2:** **Email:** beatriz.chozasbarrientos@balgrist.ch **Name:** Beatriz Chozas Barrientos **Phone:** +41 77 809 72 12 **Role:** CONTACT #### Locations **Location 1:** **City:** Zürich **Contacts:** ***Contact 1:*** - **Email:** petra.schweinhardt@balgrist.ch - **Name:** Petra Schweinhardt, MD, PhD - **Phone:** +41445107381 - **Role:** CONTACT **Country:** Switzerland **Facility:** Balgrist Campus **Status:** RECRUITING **Zip:** 8008 #### Overall Officials **Official 1:** **Affiliation:** University of Zurich **Name:** Petra Schweinhardt **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5471 - Name: Capsaicin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412471 **Brief Title:** A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients **Official Title:** A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients #### Organization Study ID Info **ID:** SSGJ-707-NSCLC-II-02 #### Organization **Class:** INDUSTRY **Full Name:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. **Detailed Description:** This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients. ### Conditions Module **Conditions:** - First-line Advanced NSCLC Patients ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 235 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** dose level 1 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: Pemetrexed **Label:** Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** dose level 2 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: Pemetrexed **Label:** Arm 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** dose level 3 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: Pemetrexed **Label:** Arm 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** PD-1/L1 combined with chemotherapy **Intervention Names:** - Drug: carboplatin - Drug: Pemetrexed - Drug: PD-1/L1 **Label:** Arm 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** dose level 1 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: paclitaxel **Label:** Arm 5 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** dose level 2 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: paclitaxel **Label:** Arm 6 **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** dose level 3 of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: paclitaxel **Label:** Arm 7 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** Selected dose of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: paclitaxel **Label:** Arm 8 **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** Selected dose of SSGJ-707 combined with chemotherapy **Intervention Names:** - Drug: SSGJ-707 - Drug: carboplatin - Drug: Paclitaxel-albumin **Label:** Arm 9 **Type:** EXPERIMENTAL #### Arm Group 10 **Description:** PD-1/L1 combined with chemotherapy **Intervention Names:** - Drug: carboplatin - Drug: paclitaxel - Drug: PD-1/L1 **Label:** Arm 10 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 - Arm 2 - Arm 3 - Arm 5 - Arm 6 - Arm 7 - Arm 8 - Arm 9 **Description:** bispecific antibody **Name:** SSGJ-707 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 1 - Arm 10 - Arm 2 - Arm 3 - Arm 4 - Arm 5 - Arm 6 - Arm 7 - Arm 8 - Arm 9 **Description:** chemotherapy **Name:** carboplatin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm 1 - Arm 2 - Arm 3 - Arm 4 **Description:** chemotherapy **Name:** Pemetrexed **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Arm 10 - Arm 5 - Arm 6 - Arm 7 - Arm 8 **Description:** chemotherapy **Name:** paclitaxel **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Arm 10 - Arm 4 **Description:** Immune checkpoint inhibitors **Name:** PD-1/L1 **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Arm 9 **Description:** chemotherapy **Name:** Paclitaxel-albumin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate **Measure:** ORR **Time Frame:** 12 months **Description:** Safety and tolerability assessed by incidence and severity of adverse events **Measure:** Safety and tolerability **Time Frame:** 12 months #### Secondary Outcomes **Description:** The efficacy end points **Measure:** PFS **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or metastatic NSCLC . 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>=3 months. 5. Signed informed consent form. Exclusion Criteria: 1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wulin-calf@vip.163.com **Name:** Lin Wu, MD, Ph.D **Phone:** 0731-89762302 **Role:** CONTACT #### Locations **Location 1:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** 13975895664@163.com - **Name:** Jia Li - **Phone:** 13975895664 - **Role:** CONTACT **Country:** China **Facility:** Institute of The Hunan Cancer Hospital ### 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: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: NSCLC - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung 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 ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: Strategies - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M20194 - Name: Antibodies, Bispecific - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel - ID: D000016190 - Term: Carboplatin - ID: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412458 **Brief Title:** IM83 Clinical Study of CAR-T Cell Therapy in Patients With Relapsed or Refractory Osteosarcoma **Official Title:** Phase I Clinical Study to Evaluate the Safety and Efficacy of IM83 CAR-T Cells for the Treatment of Relapsed or Refractory Osteosarcoma #### Organization Study ID Info **ID:** IM83-002 #### Organization **Class:** INDUSTRY **Full Name:** Beijing Immunochina Medical Science & Technology Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Guangdong Provincial People's Hospital #### Lead Sponsor **Class:** INDUSTRY **Name:** Beijing Immunochina Medical Science & Technology Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study, a single-center, open, single-dose clinical study, was to evaluate the safety, tolerability, and pharmacokinetic profile of IM83 CAR-T cells in the treatment of patients with relapsed or refractory osteosarcoma **Detailed Description:** This study is planned to enroll 9-18 patients with relapsed or refractory osteosarcoma in a modified "3+3" design for dose escalation, with three dose groups of 5×10\^8 cells, 1×10\^9 cells, and 2×10\^9 cells.3-6 subjects are planned to be enrolled in each dose group to assess their safety. Each dose group is planned to enroll 3-6 subjects to assess safety, and if the incidence of horizontal dose-limiting toxicity (DLT) is ≤1/6 within 28 days after transfusion in a dose group, the transfusion of cells from the next dose group can be initiated. This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group. ### Conditions Module **Conditions:** - Refractory Osteosarcoma - Recurrent Osteosarcoma **Keywords:** - IM83 CAR-T - Relapsed or refractory osteosarcoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After preconditioning with chemotherapy, IM83 CAR-T Cells will be evaluated **Intervention Names:** - Biological: IM83 CAR-T Cells **Label:** IM83 CAR-T Cells **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - IM83 CAR-T Cells **Description:** IM83 CAR-T Cells, 5×10\^8 cells, 1×10\^9 cells, and 2×10\^9 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline. **Name:** IM83 CAR-T Cells **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Incidence of Adverse Events and Abnormal Findings on Clinically Significant Laboratory Tests Associated with IM83 CAR-T Cell Therapy Within 28 Days of Infusion **Measure:** Incidence of Treatment Related adverse events (AEs) **Time Frame:** Up to 28 days after CAR-T cell infusion #### Secondary Outcomes **Description:** Objective remission rate (ORR) after infusion **Measure:** Objective response rate (ORR) **Time Frame:** At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion **Description:** Post-infusion disease control rate (DCR) **Measure:** Disease control rate (DCR) **Time Frame:** At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion **Description:** Duration of disease remission (DoR) after infusion **Measure:** Duration of response (DOR) **Time Frame:** At 28 days, 3 months and 6 months after CAR-T cell infusion **Description:** Progress free survival (PFS) after infusion **Measure:** Progress free survival (PFS) **Time Frame:** At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion **Description:** Overall Survival (OS) **Measure:** Overall Survival (OS) **Time Frame:** At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion **Description:** AUC 0-D28 of IM83 CAR-T cells in vivo (peripheral blood) after infusion **Measure:** AUC (Area Under Curve) 0-D28 **Time Frame:** Up to 28 days after CAR-T cell infusion **Description:** AUC 0-D90 of IM83 CAR-T cells in vivo (peripheral blood) after infusion **Measure:** AUC (Area Under Curve) 0-D90 **Time Frame:** Up to 90 days after CAR-T cell infusion **Description:** Peak Concentrationof IM83 CAR-T cells in vivo (peripheral blood) after infusion **Measure:** Cmax (Peak Concentration) **Time Frame:** Up to 28 days after CAR-T cell infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 16 years, both male and female; 2. Subjects with a diagnosis of osteosarcoma of the extremity confirmed by pathohistologic examination; 3. To enroll subjects with recurrent or refractory extremity osteosarcoma who have failed or are intolerant to first-line standard therapy and who are not candidates for radical surgery and/or localized therapy and who lack effective subsequent treatment. Notes: 1. Standard treatment failure was defined as disease relapse or progression during or within 6 months of completion of treatment with first-line chemotherapeutic agents (including high-dose methotrexate, doxorubicin, cisplatin, isocyclophosphamide, etc.); 2. Requirement of treatment intolerance: means that the subject is unable to continue the current effective systemic regimen due to the development of toxic side effects such as ≥ grade 3 vomiting, diarrhea, abdominal pain, myelosuppression, etc., and that refusal is not accepted for financial and personal reasons; 3. The standard treatment received by the subject must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Bone and Soft Tissue Tumors, 2023 Edition; 4. At least one measurable target lesion according to RECIST 1.1 criteria; 5. Subjects must provide a tumor tissue sample (paraffin block or number of unstained sections meeting the testing requirements specified by the Institute) within 2 years that meets the requirements to be tested by immunohistochemistry for GPC3 and CD40 and needs to be positive for GPC3 expression;; 6. Karnofsky functional status score ≥60; 7. Expected survival ≥ 12 weeks; 8. Laboratory tests should meet at least the indicators specified below: 1)Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; 2)Absolute lymphocyte cell count (LY) ≥ 0.6 x 10\^9/L; 3)Lymphocytes make up ≥10% of white blood cells; 4)Platelets ≥75 x 10\^9/L; 5)Hemoglobin ≥ 90 g/L; 6)Creatinine clearance ≥60 ml/min; 7)Serum bilirubin ≤ 1.5 times the upper limit of normal; if liver metastases are present, serum bilirubin ≤ 3.0 times the upper limit of normal; 8)Prolongation of prothrombinogen time ≤ 4s; 9)≤ 2.5 times the upper limit of normal for albumin transaminase (AST) and albumin transaminase (ALT); if liver metastases are present, ALT and/or AST ≤ 5.0 times the upper limit of normal; 9. Left ventricular ejection fraction was \>50%; 10. Oxygen saturation \>92% in the non-oxygenated state; 11. Women of childbearing potential who had a negative blood pregnancy test prior to the start of the trial and who agreed to use effective contraception for the duration of the trial up to the last follow-up visit; male subjects whose partners were of childbearing potential agreed to use effective contraception for the duration of the trial up to the last follow-up visit; 12. Vascular access is adequate for cell collection, and lines are available for subjects with existing central venous catheters; 13. I or my legal guardian/proxy agree to participate in this trial and sign the informed consent form. Exclusion Criteria: 1. Presence of brain metastases; 2. Subjects who have previously received or are awaiting an organ transplant; 3. Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant); 4. Autoimmune diseases requiring systemic immunosuppressive therapy, such as systemic lupus erythematosus, rheumatoid arthritis, and ulcerative colitis, within 2 years prior to the start of screening; 5. Use of any of the following medications or treatments during the designated time period prior to cell collection: 1. Surgical treatment, interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection; 2. Subjects who have had major surgery or significant trauma within 4 weeks prior to cell collection, or who are expected to require major surgery during the study period; 3. Immunotherapy with anti-PD1, PD-L1, etc. within 4 weeks prior to cell collection; 4. Therapeutic doses of corticosteroids have been used within 3 days prior to cell collection. However, topical and inhaled steroids are permitted; 6. Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast; 7. Previously treated with targeted GPC3 therapy (can be enrolled if still positive for GPC3 expression upon testing); 8. Those who have previously received other cellular therapy or genetically modified cellular therapy, such as TCR-T therapy, CAR-T therapy, etc; 9. Prior or clinically significant CNS disorders at screening, such as epilepsy, seizures, cerebrovascular disease (ischemia/hemorrhage/infarction), cerebral edema, reversible posterior leukoencephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders; 10. Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities; 11. Subjects assessed by the investigator as having a significant amount of plasmapheresis (e.g., pleural effusion, peritoneal effusion, pericardial effusion) that cannot be controlled with treatment; 12. Medication-uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or the presence of clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident, myocardial infarction, unstable angina pectoris, or severe cardiac arrhythmia that is uncontrolled with medication or that has a potential impact on the study treatment in the 6 months prior to the date of signing of the informed consent; 13. Subjects who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and have a peripheral blood HBV-DNA test higher than the lower limit of detection (HBsAg-positive but with a peripheral blood HBV-DNA test lower than the lower limit of detection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, Version 2022, at least at least 4 weeks of antiviral therapy is required prior to the first administration of the investigational drug, and during the course of the study Ongoing antiviral therapy for 6-12 months with monitoring of HBV DNA, HBsAg, and ALT levels every 1-3 months); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV-RNA test above the lower limit of detection; HIV antibody positive; syphilis antibody positive; 14. Active EBV and cytomegalovirus, defined as subjects with IgM antibody-positive or IgM antibody-negative EBV serum but higher-than-normal EBV-DNA; and cytomegalovirus (CMV) serum IgM antibody-positive or IgM antibody-negative cytomegalovirus but higher-than-normal CMV-DNA; 15. Abnormalities of cardiac function include: long QTc syndrome or QTc interval \>480 ms; complete left bundle branch block, degree II/III AV block; severe, uncontrolled arrhythmia requiring pharmacologic therapy; history of chronic congestive heart failure with NYHA class ≥3 (refer to Appendix 3) cardiac ejection fraction less than 50% in the 6 months prior to screening; CTCAE ≥3 grade heart valve disease; myocardial infarction, cardiac angioplasty or stenting, unstable angina, history of severe pericardial disease, or other clinically significant cardiac disease within 6 months prior to screening; 16. Subjects requiring anticoagulation therapy; 17. Subjects requiring long-term antiplatelet therapy; 18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening; 19. Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the investigator evaluates that they can be controlled by curative treatment; 20. The presence of any factors affecting compliance with the protocol, or the unwillingness or inability of the subject to comply with the procedures required in the study protocol, as judged by the investigator. **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** luck_2001@126.com **Name:** Yu Zhang, PhD **Phone:** 8620 83827812 **Role:** CONTACT **Contact 2:** **Email:** 329877102@qq.com **Name:** Junhua Nie, PhD **Phone:** 8620 83827812 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangdong **Country:** China **Facility:** Guangdong Provincial People's Hospital **State:** Guangdong **Zip:** 519041 #### Overall Officials **Official 1:** **Affiliation:** Guangdong Provincial People's Hospital **Name:** Yu Zhang, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018213 - Term: Neoplasms, Bone Tissue - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000012509 - Term: Sarcoma ### 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: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M15334 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteosarcoma - ID: M20359 - Name: Neoplasms, Bone Tissue - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: T4340 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteosarcoma - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012516 - Term: Osteosarcoma ### 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:** NCT06412445 **Brief Title:** Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair **Official Title:** Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Transabdominal Inguinal Hernia Repair: A Comparative Study #### Organization Study ID Info **ID:** Mesh Fixation Methods in TAPP #### Organization **Class:** OTHER **Full Name:** Helwan University ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-03 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Helwan University #### Responsible Party **Investigator Affiliation:** Helwan University **Investigator Full Name:** Adham Ashraf Maher Farid **Investigator Title:** General Surgery Assistant Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence. **Detailed Description:** Inguinal hernia is the most common abdominal wall hernia. It is defined as a peritoneal sac protrusion through a weak point within the groin area. It often contains abdominal contents and is traditionally treated with surgery. Repair of inguinal hernia is one of the most commonly performed surgical procedures worldwide. Males are more commonly affected by inguinal hernia than females. The male to female ratio is approximately 9 to 1. Whether to perform an open or a laparoscopic approach for inguinal hernia repair has always been a controversial issue. However, recent improvement in laparoscopic techniques has made it the procedure of choice in the opinion of most surgeons. Laparoscopic approach includes two main techniques, namely the total extra-peritoneal approach (TEP) and the trans abdominal pre-peritoneal approach (TAPP). However, TAPP has gained more popularity owing to its relative simplicity and easier reproducibility. TAPP involves standard laparoscopic approach with access into the peritoneal cavity and placement of a mesh along the anterior abdominal wall, thereby, repairing the hernia posterior to the defect. During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs, the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment. Intraoperative strategies to reduce pain entail the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative pain. By far, guidelines of the European Association for Endoscopic Surgery (EAES) and the European Hernia Society (EHS) reported no general evidence based consensus on the ideal tool for mesh fixation. Therefore, the choice often depends on surgeons personal preference, market availability and cost/benefit ratio. Recent advances in the biotechnology of mesh and mesh fixation industry lead to the production of innovative self-fixating meshes and alternatively meshes that are fixed with variable types of biomaterials and glue. Eventually, such tack free meshes are intended to reduce the rate of complications that might be attributed to tack bearing meshes. However, studies to evaluate the different tools of tack free mesh fixation techniques are still lacking. ### Conditions Module **Conditions:** - Inguinal Hernia **Keywords:** - TAPP - Self-Fixating Mesh - Mesh Fixation - Tissue Glue - Laparoscopic Transabdominal Inguinal Hernia Repair - Inguinal Hernia Repair ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair having there mesh fixated with tissue glue. Glubran 2® surgical glue is a medical device Class III CE marked for internal and external use. It is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer synthesized by the manufacturer GEM. It is ready for use. It has high adhesive and haemostatic properties and once it is polymerised it creates an efficient antiseptic barrier against the most diffused infective or pathogenic agents during the surgical intervention. It polymerizes quickly in contact with live tissue and wet environment creating a thin and elastic film having high tensile properties which guarantee strong adhesion to the tissues. This film naturally conforms with the tissues on which it is applied; it is not permeable to liquids and is not altered by blood or organic liquids **Intervention Names:** - Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation **Label:** Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair with self fixating mesh. Covidien ProGrip mesh is a self-gripping polyester mesh, 15x15 cm in size, it is equipped with resorbable microgrip technology which provides immediate fixation of the entire mesh surface for a secure repair and even distribution of tension for patient comfort. The resorbable polylactic acid (PLA) microgrips enable surgeons to position and place the mesh in under 60 seconds, without the use of additional fixation. Surgeons and patients can depend on a secure repair with the potential for greater patient comfort. According to the manufacturer, the time for degradation of the quickly absorbing layer is \< 1 day and that for the layer with microgrips \> 18 months **Intervention Names:** - Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh **Label:** Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue **Description:** The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving applying tissue glue for mesh fixation. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures. **Name:** Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh **Description:** The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving the adherence of grips to tissue using self-fixating mesh. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures. **Name:** Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh **Other Names:** - TAPP procedure **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** clinical or radiological at any time point **Measure:** Hernia recurrence **Time Frame:** Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months **Description:** pain persisting beyond three months postoperatively. Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain **Measure:** Chronic pain **Time Frame:** Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months #### Secondary Outcomes **Description:** in minutes **Measure:** Length of surgery **Time Frame:** 1 to 3 hours **Description:** Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain **Measure:** Immediate postoperative pain **Time Frame:** 1 to 3 days **Description:** Any visualized or reported vascular or visceral injury during the operation **Measure:** Vascular/visceral injury **Time Frame:** 1 to 3 hours **Description:** Haematoma or seroma development in postoperative period (Clinical or radiological) **Measure:** Haematoma/seroma development **Time Frame:** 1 to 7 days **Description:** in days **Measure:** Length of hospital stay **Time Frame:** 1 to 7 days **Description:** in immediate postoperative period **Measure:** Urinary retention **Time Frame:** 1 to 2 days **Description:** at any time point **Measure:** Wound infection/mesh infection **Time Frame:** 1 to 30 days **Description:** in days **Measure:** Recovery time to normal activity **Time Frame:** 1 to 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Unilateral direct or indirect inguinal hernia Exclusion Criteria: * Bilateral hernia. * Femoral hernia. * Inguinoscrotal hernia. * Complicated inguinal hernias. * Recurrent inguinal hernias. * Morbid obesity. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Helwan University Hospitals **Zip:** 11795 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000046449 - Term: Hernia, Abdominal ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Hernia - ID: M9630 - Name: Hernia, Inguinal - Relevance: HIGH - As Found: Inguinal Hernia - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M25675 - Name: Hernia, Abdominal - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006547 - Term: Hernia - ID: D000006552 - Term: Hernia, Inguinal ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06412432 **Acronym:** ERICA **Brief Title:** Exercise Training and Rehabilitation In Cardiac Amyloidosis **Official Title:** Exercise Training and Rehabilitation In Cardiac Amyloidosis: ERICA-Study #### Organization Study ID Info **ID:** ERICA562023CRCA #### Organization **Class:** OTHER **Full Name:** Federico II University ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Start Date **Date:** 2024-01-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Federico II University #### Responsible Party **Investigator Affiliation:** Federico II University **Investigator Full Name:** Alberto Maria Marra **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Notwithstanding the dramatic improvement associated with Tafamidis in Heart Failure (HF) due to wild-type transthyretin cardiac amyloidosis (ATTRwt-CA), remarkable morbidity and mortality still burden this disease. Exercise training (ET) is a first-line recommended treatment for unselected HF patients, whose effects on ATTRwt-CA form remain however unexplored. The investigators hereby present rationale and design of the Exercise training and Rehabilitation in Cardiac Amyloidosis (ERICA) study, whose aim is to determine whether a tailored, supervised ET program might improve exercise capacity in HF due to ATTRwt-CA. This interventional, controlled study will randomize ATTRwt-CA patients into a control group (C) and a primary training group (ET-1). After 12 weeks, patients in group C will be offered to undergo the same ET program (ET-2) for further 12 weeks, considering the last observation as baseline. Primary endpoint will be the distance obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment in pooled ET-1 and ET-2 groups compared to C. Quality of life, peak oxygen consumption, left and right heart architecture and function, natriuretic peptides will be secondary endpoints. This study will be the first testing the effects of ET in patients with ATTRwt-CA. **Detailed Description:** Among Systemic amyloidosis, the peculiar deposition of beta-amyloid fibrils agglomerates localized in the interstitial space between the cardiomyocytes characterizes the spectrum of cardiac amyloidosis (AC). All AC phenotypes culminate in a progressive deterioration of cardiac compliance up to a true infiltrative cardiomyopathy with restrictive physiology. Clinical presentation may vary from mildly symptomatic Heart Failure (HF), usually labeled, and mistakenly confused as a classic Heart Failure with preserved ejection fraction (HFpEF) up to a severe scenario of severe cardiac decompensation with fluid overload, marked shortness of breath, fatigue and orthostatic hypotension. Syncope may also appear due to infiltration in the conduction system leading to sinoatrial disease and atrioventricular block. To date, more than 30 proteins responsible for the deposition of fibrils have been identified and of these 9 have been identified as responsible for the cardiac involvement of the disease. AC is determined in 98% of cases by the accumulation of monoclonal light chains of immunoglobulins (AL) or transthyretin (ATTR); the latter can occur either in its hereditary form (ATTRv) or in the wild-type variant (ATTRwt). Although AC is perceived as a rare disease, standing a reported prevalence of around 1/100,000 inhabitants, a recent metanalysis reported AC as underlying HF cause in 13.7% of cases, varying from 15.1% of Heart Failure (HF) with preserved ejection fraction (HFpEF) and 11.3% in reduced fraction phenotype (HFrEF). This mismatch begets the hypothesis that AC is often underdiagnosed, probably due to its challenging diagnosis, the diverse spectrum of clinical presentation ranging from severely compromised clinical cases to rather silent manifestations, and the absence of specific therapies for this condition making until a few years ago AC a true orphan disease. This paradigm has been subverted in recent years, by the emergence of tafamidis, a targeted drug from amyloidosis that binds transthyretin, preventing tetramer dissociation and production of amyloid. Tafamidis has been successfully tested for ATTRwt-AC in a relatively large multicenter, international, double-blind, placebo-controlled, phase 3 trial, the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), showing a remarkable improvement of the composite outcome of all-cause mortality and hospitalizations due to cardiovascular causes. Apart from Tafamidis, there are no evidence supporting the use of guideline-directed medical therapy (GDMT) used in classical forms of HF in ATTR-ACT. On top of GDMT, exercise training (ET) remains largely uninvestigated in AC. ET consists of a multidisciplinary approach, including a medical evaluation with modification of cardiovascular risk factors, prescription of a physical exercise program and psychosocial evaluation and is currently recommended with the highest degree of recommendation (in class I, type A level) in current guidelines on HF. To date, there are no data about the efficacy and safety of ET in AC, specifically in the ATTRwt-AC. We hereby present the outlines and the study protocol of the Exercise Rehabilitation and training in Cardiac Amyloidosis (ERICA) study, whose aim is to investigate and analyze the safety and the efficacy of cardiac rehabilitation on patients with AC, specifically those affected by the ATTR-wt form. The present study aims to investigate and analyze, through an interventional longitudinal, controlled, randomized, design, the effects of a structured program of Exercise training in patients with ATTRwt-AC. ### Conditions Module **Conditions:** - Cardiac Amyloidosis **Keywords:** - Cardiac Amyloidosis - wild-type transthyretin - Exercise Training - Rehabilitation - Cardiomyopathies - Heart Failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients enrolled will be handled in the outpatient's clinic of Cardiometabolic Rehabilitation Program of the Federico II University Hospital of Naples for exercise training and cardiac rehabilitation intervention. Patients will be randomized in blocks to two groups. Specifically, the primary intervention (ET-1) and the control group who won't undergo exercise training (No-ET). Following baseline assessments of both groups at baseline, the ET-1 group will be subjected to exercise training program of 2 weekly sessions for 12 weeks. After 12 weeks, both groups will be reassessed and patients belonging to group No-ET will be offered to undergo the same ET program for further 12 weeks. Those who will accept will join the secondary training group (ET-2). Primary endpoint will be the distance obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment in pooled ET-1 and ET-2 groups compared to No-ET. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will undergo exercise training, nutritional advice, smoking cessation, lipid profile evaluation, control and management of body weight and abdominal circumference; evaluation of the drug therapy in progress; psycho-social evaluation. **Intervention Names:** - Other: Exercise training (ET1+ET2) **Label:** Exercise training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** control group who won't undergo exercise training and will be managed with optimal medical therapy **Intervention Names:** - Behavioral: Optimal Medical Therapy (No-ET) **Label:** Controls **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise training **Description:** Exercise training will consist of continuous aerobic training of moderate intensity on cycle ergometer/treadmill, with a frequency of 2-3 weekly sessions lasting 12 weeks, with exercise intensity of VO2 peak of 40% gradually increasing up to 50-60% of VO2 peak based on individual tolerability and improvement; 55-65% of heart rate at peak; 40-59% of heart rate reserve; 4-6 Metabolic equivalents (METS); the duration of the session will gradually increase from 15-30 min to 45-60 min. **Name:** Exercise training (ET1+ET2) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Controls **Description:** Patients will be handled according to optimal medical therapy **Name:** Optimal Medical Therapy (No-ET) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** distance (meters) obtained at the 6-minute walk test (6MWD) performed at baseline and after 12-weeks of treatment treatment in pooled ET-1 and ET-2 groups compared to No-ET. **Measure:** distance obtained at the 6-minute walk test (6MWD) **Time Frame:** Baseline and after 12-weeks of treatment #### Secondary Outcomes **Description:** serum levels (ng/ml) **Measure:** N terminal pro brain natriuretic peptide (NT-pro BNP) serum levels **Time Frame:** Baseline and after 12-weeks of treatment **Description:** serum levels (ng/ml) **Measure:** Troponin serum levels **Time Frame:** Baseline and after 12-weeks of treatment **Description:** serum levels (ng/ml) **Measure:** Galectin-3 serum levels **Time Frame:** Baseline and after 12-weeks of treatment **Description:** serum levels (ng/ml) **Measure:** Transthyretin serum levels **Time Frame:** Baseline and after 12-weeks of treatment **Description:** Kansas City Questionnaire (ranges 0 to 100 where 100 is the better quality of life score ) **Measure:** Quality of life assessment **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography (%) **Measure:** Left ventricular ejection fraction (LVEF) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in ml **Measure:** Left atrial (LA,ml) volume **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in % **Measure:** global longitudinal strain (GLS) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in mm **Measure:** Tricuspid Annular Plane Systolic Excursion (TAPSE) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in mmHg **Measure:** estimated systolic Pulmonary arterial pressure **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in % **Measure:** Right Ventricular Free-wall Strain (RVFWS) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed at echocardiography in mm Hg% **Measure:** Myocardial work **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed during Cardiopulmonary exercise test in mL/(kg·min) **Measure:** Peak oxygen consumption (VO2 peak) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** assessed during Cardiopulmonary exercise test in watt **Measure:** Work (Watt) **Time Frame:** Baseline and after 12-weeks of treatment **Description:** minute ventilation (VE)/ carbon dioxide (VCO2) slope assessed during Cardiopulmonary exercise test in watt **Measure:** Respiratory efficiency **Time Frame:** Baseline and after 12-weeks of treatment **Description:** Any adverse Event with special focus on Serious Adverse event **Measure:** Adverse Events **Time Frame:** Baseline and after 12-weeks of treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18 or older * Established ATTRwt diagnosis * Heart Failure diagnosis * Informed consent according to Italian regulations Exclusion Criteria: * Unstable Angina * Acutely decompensated Heart Failure within 1 month before enrollment * Occurrence of complex ventricular arrhythmias * Presence of intracavitary thrombus * recent (\< 1 year) thrombophlebitis with or without pulmonary embolism * Severe obstructive cardiomyopathies * Severe or symptomatic aortic stenosis * Uncontrolled inflammatory or infectious diseases * Any musculoskeletal conditions preventing physical exercise **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Naples **Country:** Italy **Facility:** Department of Translational Medical Sciences **Zip:** 80131 #### Overall Officials **Official 1:** **Affiliation:** Department of Translational Medical Sciences **Name:** Alberto M. Marrra, Md,PhD **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 ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: LOW - As Found: Unknown - ID: M12154 - Name: Cardiomyopathies - Relevance: LOW - As Found: Unknown - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloidosis - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000686 - Term: Amyloidosis ### Misc Info Module - Version Holder: 2024-05-31