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## Protocol Section ### Identification Module **NCT ID:** NCT06431932 **Brief Title:** Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity **Official Title:** Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study #### Organization Study ID Info **ID:** Fisetin #### Organization **Class:** OTHER **Full Name:** Hvidovre University Hospital #### Secondary ID Infos **ID:** 2023-506284-34-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2034-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Southern Denmark **Class:** OTHER **Name:** Mayo Clinic #### Lead Sponsor **Class:** OTHER **Name:** Ove Andersen #### Responsible Party **Investigator Affiliation:** Hvidovre University Hospital **Investigator Full Name:** Ove Andersen **Investigator Title:** Head of Research, Clinical Professor, Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models. We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health. **Detailed Description:** The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients. Furthermore, we aim to identify potential outcome measures and perform sample size calculations for these outcomes, with the intent to conduct a larger scale effect study, at later date, given the result from this pilot study suggests that this would be feasible and safe. The trial consists of: * a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. * a 2-arm triple-blind randomized placebo-controlled study, in which older medical patients (n=40) will receive either: * 20 mg/kg/day fisetin for two consecutive days, or * placebo for two consecutive days. Each of the studies (open-label study and randomized placebo-controlled study) consists of three sub-studies: * Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mg/kg/day in healthy volunteers and in older medical patients. * Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mg/kg/day fisetin for two consecutive days in healthy volunteers and in older medical patients. * Sub-study III aims to gather representative measurements to assess the utility of inflammation, SASP, senescence, senolysis, and aging biomarkers, as well as measures of frailty, clinical parameters, physical and cognitive function, and quality of life as potential outcomes in future clinical trials; additionally, to perform sample size calculations for future trials based on these data. ### Conditions Module **Conditions:** - Multimorbidity - Healthy **Keywords:** - Senolytic - Pharmacokinetics - Chronic inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The trial consists of: * a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. * a 2-arm triple-blind randomized placebo-controlled study, in which older patients with multimorbidity (n=40) will receive either: * 20 mg/kg/day fisetin for two consecutive days, or * placebo for two consecutive days. ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy volunteers will receive fisetin. **Intervention Names:** - Drug: Fisetin **Label:** Single-arm open-label study in healthy volunteers **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Older patients with multimorbidity will receive fisetin. **Intervention Names:** - Drug: Fisetin **Label:** RCT - Treatment group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Older patients with multimorbidity will receive placebo. **Intervention Names:** - Drug: Placebo **Label:** RCT - Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - RCT - Treatment group - Single-arm open-label study in healthy volunteers **Description:** Subjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. **Name:** Fisetin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - RCT - Placebo group **Description:** Subjects will receive a corresponding number of placebo capsules for two consecutive days. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To develop a population-based pharmacokinetic (popPK) model for fisetin and its main metabolites in healthy volunteers and older patients, covariates such as body weight, body composition, age, and CYP inducers/inhibitors will be tested for influence on interindividual variability. **Measure:** Population-based pharmacokinetic model for fisetin and metabolites **Time Frame:** 24 hours **Description:** Number of participants to experience adverse events **Measure:** Adverse events **Time Frame:** Day 1 to 3 **Description:** The change in plasma levels of suPAR and a sample size calculation based on these data. **Measure:** suPAR **Time Frame:** Day 1 to 29 #### Secondary Outcomes **Description:** Changes in any of the measured biomarkers and the relationship between the pharmacokinetics and pharmacodynamics of fisetin will be investigated using population PKPD modeling. **Measure:** Population-based PKPD model for fisetin **Time Frame:** 24 hours **Description:** Urinary levels of fisetin and its main metabolites **Measure:** Renal excretion of fisetin and its main metabolites **Time Frame:** 24 hours **Description:** Number of participants to experience symptoms and clinically significant changes in vital signs (i.e., blood pressure, pulse). **Measure:** Symptoms and adverse events **Time Frame:** Day 1 to 3 **Description:** The change in plasma levels of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors). **Measure:** SASP factors and inflammation markers **Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84. **Description:** The change in expression levels of senescence markers (e.g., p16INK4a, p21CIP1/WAF1, SA-B-gal) in immune cells and tissue biopsies (skin and adipose tissue). **Measure:** Senescence **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 8, 15, 29, 84. **Description:** The change in expression levels of senolysis markers (e.g., leukotriene B4, dihomo-15d-PGJ2 (oxylipin or 1a,1b-dihomo-15-deoxy-D12,14-prostaglandin J2), and 15-Deoxy-delta 12, 14-prostaglandin J2). **Measure:** Senolysis **Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 84. **Description:** The change in plasma levels of aging markers (e.g., α-klotho, fibroblast growth factor 21). **Measure:** Aging markers **Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84. **Description:** The change in levels of routine biochemistry markers (e.g., alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, coagulation factors II, VII and X and International Normalized Ratio, CRP, creatinine, hemoglobin, lactate dehydrogenase, mean corpuscular hemoglobin concentration, mean corpuscular volume, neutrophils, potassium, sodium, thrombocytes, white blood cell count, cholesterol (total, low-density lipoproteins, high-density lipoproteins), triglycerides, and hemoglobin A1c). **Measure:** Clinical markers **Time Frame:** Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84. **Description:** The change in frailty status calculated as Frailty Index OutREF (FI-OutRef). **Measure:** Frailty Index OutRef **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84. **Description:** The change in frailty status calculated using a modified version of Fried frailty criteria. **Measure:** Frailty Index **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84. **Description:** The change in physical function (e.g., gait speed, hand grip strength, chair stand test, balance). **Measure:** Physical function **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84. **Description:** The change in cognitive function assessed using the MoCA score (0-30 with higher scores representing better cognitive function). **Measure:** Cognitive function (Montreal Cogntive Assessment) **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84. **Description:** The change in cognitive function assessed using the Digit Symbol Substitution Test (number of correct symbols). **Measure:** Cognitive function (Digit Symbol Substitution Test) **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84. **Description:** The change in quality of life assessed using the EuroQol-5D-5L (index value and VAS scale 0-100; with higher scores representing better quality of life). **Measure:** Quality of life **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84. **Description:** The change in self-rated health (score 1-5; 1:"excellent", 2:"very good", 3:"good", 4:"fair", or 5:"bad"). **Measure:** Self-rated health **Time Frame:** Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84. ### Eligibility Module **Eligibility Criteria:** Healthy volunteers: Inclusion Criteria: * Aged 20-35 years * suPAR levels \<3.5 ng/mL (± 15% corresponding to assay variation) * Able to cooperate cognitively * Able to read and understand Danish * Women of childbearing potential must use effective contraception Exclusion Criteria: * Body weight \>100 kg * Inability to swallow pills * Pregnant and/or lactating * Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules * Presence of any condition that the investigator believes would put the subject at risk or would preclude the participant from successfully completing all aspects of the trial * Presence of known chronic diagnosis * Active acute illness * Prescribed medication, except contraceptives * Previous cancer diagnosis or treatment * Use of senolytic and other "anti-aging" supplements Older patients with multimorbidity: Inclusion Criteria: At screening #1 during hospital admission: * Acutely hospitalized medical patient * Age ≥65 years * suPAR \>5 ng/mL (± 15% corresponding to assay variation) * Multimorbidity (≥2 chronic diagnoses) * Able to cooperate cognitively * Able to read and understand Danish At screening #2 28 days after hospital discharge: * suPAR \>5 ng/mL (± 15% corresponding to assay variation) Exclusion Criteria: At screening #1 during hospital admission: * Body weight \>100 kg * Inability to swallow pills * Known human immunodeficiency virus infection, active hepatitis B or C infection, invasive fungal infection * Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites * New/active invasive cancer except non-melanoma skin cancers * Active cancer treatment or disseminated cancer * Known condition associated with major immunodeficiency * Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules * Use of senolytic and other "anti-aging" supplements At screening #2 28 days after hospital discharge: * Body weight \>100 kg * CRP \>30 mg/L (± 15% corresponding to assay variation) * Inability to swallow pills * Presence of any condition, or abnormal routine biochemistry test, that the investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial * Unstable (as per clinical judgment) major disorders, e.g., cardiovascular, renal, endocrine, immunological, hepatic disorder, or cancer * Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 or as per clinical judgment (e.g., risk of acute kidney injury) * Human immunodeficiency virus infection, known active hepatitis B or C infection, invasive fungal infection * Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites * New/active invasive cancer except non-melanoma skin cancers * Active cancer treatment or disseminated cancer * Known condition associated with major immunodeficiency * Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules * Subjects taking strong inhibitors or inducers of CYP3A4 or as per clinical judgment * Subjects taking specified substrates with a narrow therapeutic range for CYP3A4 or as per clinical judgment * Subjects taking specified inhibitors, inducers, or substrates of CYP2D6, CYP2C9, or CYP2C8, or as per clinical judgment * Subjects regularly using drug classes or specific medications or as per clinical judgment * Use of senolytic and other "anti-aging" supplements **Healthy Volunteers:** True **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Juliette Tavenier **Phone:** +4538620640 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Line Jee Hartmann Rasmussen **Phone:** +4538620640 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Copenhagen University Hospital, Amager and Hvidovre **Name:** Juliette Tavenier **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Copenhagen University Hospital, Amager and Hvidovre **Name:** Line Jee Hartmann Rasmussen **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Copenhagen University Hospital, Amager and Hvidovre **Name:** Morten B Houlind **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Copenhagen University Hospital, Amager and Hvidovre **Name:** Ove Andersen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only aggregated data can be available for other researchers due to Danish Data Protection Law. **IPD Sharing:** UNDECIDED ## 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: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Fl - Name: Flavonoid - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T28 - Name: Fisetin - Relevance: HIGH - As Found: Timolol maleate ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431919 **Acronym:** CIRROSTAT **Brief Title:** Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial **Official Title:** Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial #### Organization Study ID Info **ID:** PGI/HEP/000214 #### Organization **Class:** OTHER **Full Name:** Post Graduate Institute of Medical Education and Research, Chandigarh ### Status Module #### Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Indian Council of Medical Research #### Lead Sponsor **Class:** OTHER **Name:** Post Graduate Institute of Medical Education and Research, Chandigarh #### Responsible Party **Investigator Affiliation:** Post Graduate Institute of Medical Education and Research, Chandigarh **Investigator Full Name:** Madhumita Premkumar **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:** Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. Rationale: Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy. Novelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins. Objectives: The primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol. Methods: This is double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group. Expected Outcome: We anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI). **Detailed Description:** Cirrhotic cardiomyopathy (CCM) in chronic liver disease is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease(1, 6). Cirrhosis induces systemic inflammation, and oxidative stress leading to cardiac structural remodeling, including fibrosis, hypertrophy, and chamber dilation. CCM is associated with risk of LVDD which further lead to hepatorenal syndrome (HRS)(7), septic shock. (8) and peri transplant cardiac complications.(9) Autonomic dysfunction, and neurohormonal imbalances, cardiac arrhythmias, overt heart failure are common features of CCM in advanced liver disease. Efforts to ameliorate the abnormalities associated with CCM are crucial and necessitate a significant evidence-based therapeutic intervention. We have tested the use of carvedilol in this population and found that it causes an improvement in survival. CCM can be managed by reducing preload (though nitrates), and by ameliorating neurohormonal activation. Lowering the heart rate to 55-65 beats per minute (bpm), as done with β-blockers, is likely to help by improving myocardial oxygen demand and coronary perfusion time with independent effects on portal hypertension, and heart failure(10, 11) β-blockers may reduce myocardial contractility and patients with cirrhosis have low tolerance to β-blocker dosages required to achieve a THR of 55-65 bpm. Ivabradine is useful in a subset with baseline tachycardia but does not offer survival benefit over carvedilol alone. Therefore, there is a great need to evaluate other agents that can achieve improvement in CCM related complications in cirrhosis. * Furthermore, β-blockers might diminish myocardial contractility, and patients with cirrhosis may struggle to tolerate β-blocker doses necessary for attaining a target heart rate (THR) of 55-65 bpm. Hence, there's a critical necessity to assess alternative agents capable of ameliorating complications associated with cirrhotic cardiomyopathy (CCM). * Early interventions to avert cardiovascular morbidity will prove to be cost effective in managing outcome, as they avert high cost of managing the public health burden of all-cause mortality in cirrhosis. * Cardiovascular complications stand as the primary cause of mortality post-liver transplantation (LT), underscoring the need for thorough evaluation before LT. * This study will systematically screen participants for coronary artery disease as an integral part of its screening process. * Statins, particularly simvastatin, exert a favorable impact on vascular reactivity especially in cirrhosis. Simvastatin increases the production of nitric oxide(NO), leading to increased hepatic blood flow and reduced sinusoidal resistance, particularly upon short-term exposure. resistance (8). * Kaplan et al showed extended exposure to simvastatin (1 month regimen, comprising 20 mg/day for the initial 15 days followed by 40 mg/day for the subsequent 15 days) resulted in a significant decrease in hepatic venous portal pressure as compared to control placebo. Additionally, this prolonged regimen exhibited improvements in hepatocyte metabolic function.(9). * Simvastatin has an acceptable adverse event profile in decompensated Child B patients (10, 11). There is no high-quality evidence specifically evaluating the role of simvastatin in cirrhotic cardiomyopathy, although there are data to suggest its efficacy in portal hypertension. The proposed project covers an area of overlap between cardiovascular and liver disease outcomes, which reflect as decompensation events, worsening in liver severity scores and all-cause mortality. ### Conditions Module **Conditions:** - Decompensated Cirrhosis - Cirrhotic Cardiomyopathy - Cirrhosis, Liver - Left Ventricular Diastolic Dysfunction - Acute Kidney Injury **Keywords:** - Decompensated Cirrhosis - Cirrhotic Cardiomyopathy - Left ventricular diastolic dysfunction - Acute kidney injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blind randomized controlled trial **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 260 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Simvastatin fixed dose of 20 mg per day * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate * Standard Medical Therapy **Intervention Names:** - Drug: Simvastatin 20mg - Drug: Carvedilol 3.125 mg **Label:** Experimental: Simvastatin + Carvedilol-arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate * Standard Medical Therapy **Intervention Names:** - Drug: Carvedilol 3.125 mg **Label:** Active Comparator: Carvedilol arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: Simvastatin + Carvedilol-arm **Description:** Simvastatin fixed dose of 20 mg per day **Name:** Simvastatin 20mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Active Comparator: Carvedilol arm - Experimental: Simvastatin + Carvedilol-arm **Description:** Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate **Name:** Carvedilol 3.125 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure is defined as a composite end point of acute decompensation event (acute variceal bleeding, new ascites or recurrence of previously controlled ascites, episode of hepatic encephalopathy or acute kidney injury) OR all-cause death in patients with cirrhosis and cirrhotic cardiomyopathy **Measure:** Time to acute decompensation event **Time Frame:** 1 Year #### Secondary Outcomes **Measure:** All-cause Mortality **Time Frame:** From enrollment until 1 year of follow up **Measure:** New decompensation event **Time Frame:** 1 Year **Measure:** Improvement in CCM parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging **Time Frame:** 1 Year **Measure:** Episodes warranting hospitalization **Time Frame:** 1 Year **Description:** ELISA or autoanalyzer will be performed for qunatification **Measure:** Serum level of BNP and other cardiac and inflammatory biomarkers **Time Frame:** 1 Year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age range of 18-65 years * Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings, * CCM (with EF\>50%) on 2D echocardiography with TDI * Written informed consent. Exclusion Criteria: * Age \>65 years * Serum Creatinine\>2 mg/dl * Patient previously treated with statin (one month before the study) * Contraindications to statins * Advanced Cirrhosis (CTP score\>9) * Coronary artery disease * Sick sinus syndrome/ Pacemaker, valvular heart disease * Cardiac rhythm disorder, Peripartum cardiomyopathy * Portopulmonary hypertension/ hepatopulmonary syndrome * Transjugular intrahepatic portosystemic shunt (TIPS) insertion * Hepatocellular carcinoma * Pregnancy or lactation * Patients with HIV or retroviral therapy * Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males * Acute variceal bleeding in last 6 months. * Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.) **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dr Madhumita Premkumar, DM **Phone:** 7087003409 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** PGIMER **Name:** Dr Madhumita Premkumar, DM **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004066 - Term: Digestive System Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000051437 - Term: Renal Insufficiency - 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: D000018754 - Term: Ventricular Dysfunction ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Cirrhosis - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Injury - ID: M20591 - Name: Ventricular Dysfunction, Left - Relevance: HIGH - As Found: Left Ventricular Diastolic Dysfunction - ID: M20824 - Name: Ventricular Dysfunction - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M26718 - Name: Renal Insufficiency - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases - ID: D000008103 - Term: Liver Cirrhosis - ID: D000058186 - Term: Acute Kidney Injury - ID: D000009202 - Term: Cardiomyopathies - ID: D000018487 - Term: Ventricular Dysfunction, Left - ID: D000005355 - Term: Fibrosis ### Intervention Browse Module - Ancestors - ID: D000000924 - Term: Anticholesteremic Agents - ID: D000000960 - Term: Hypolipidemic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000057847 - Term: Lipid Regulating Agents - ID: D000019161 - Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000319 - Term: Adrenergic beta-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000959 - Term: Antihypertensive Agents - ID: D000000975 - Term: Antioxidants - ID: D000020011 - Term: Protective Agents - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000058668 - Term: Adrenergic alpha-1 Receptor Antagonists - ID: D000000317 - Term: Adrenergic alpha-Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M1718 - Name: Carvedilol - Relevance: HIGH - As Found: Day 5 - ID: M21713 - Name: Simvastatin - Relevance: HIGH - As Found: Being - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M4243 - Name: Anticholesteremic Agents - Relevance: LOW - As Found: Unknown - ID: M4278 - Name: Hypolipidemic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown - ID: M21155 - 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ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M29194 - Name: Adrenergic alpha-1 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077261 - Term: Carvedilol - ID: D000019821 - Term: Simvastatin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431906 **Acronym:** FENTRA **Brief Title:** Transdermal Fentanyl as a Form of Rebound Pain Reduction in Fast Track Programme in Primary Knee Arthroplasty. **Official Title:** TRANSDERMAL FENTANYL AS A FORM OF REBOUND PAIN REDUCTION IN FAST TRACK PROGRAMME IN PRIMARY KNEE ARTHROPLASTY. Prospective Observational Non-inferiority Study Versus Morphine PCA. #### Organization Study ID Info **ID:** FEN #### Organization **Class:** OTHER **Full Name:** Hospital Universitario La Fe ### Status Module #### Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Oscar Diaz-Cambronero #### Responsible Party **Investigator Affiliation:** Hospital Universitario La Fe **Investigator Full Name:** Oscar Diaz-Cambronero **Investigator Title:** MÉDICO ADJUNTO ANESTESIOLOGÍA **Type:** SPONSOR_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:** Total knee arthroplasty is a common surgery in routine clinical practice that, although it achieves an improvement in the functionality and quality of life of patients, it causes intense postoperative pain. In this regard, locoregional block techniques are commonly used for the immediate postoperative period. However, these techniques have the disadvantage of being of limited duration and the appearance of so-called "rebound pain" when their effect wears off. To counteract this problem and maintain adequate analgesic control over a longer period of time, the use of a transdermal fentanyl patch seems to be a good option, with advantages over the traditional approach of placing a morphine PCA. Specifically, the aims of the study are: the evaluation of the decrease in the rate of rebound pain after locoregional techniques using a transdermal fentanyl patch after primary knee arthroplasty, as well as the evaluation of non-inferiority in terms of functional recovery, analgesic efficacy and adverse effects compared to morphine PCA. Methods: This will be a prospective observational cohort study, with a total N of 106 patients undergoing total knee arthroplasty who meet the study inclusion criteria. The numerical pain rating scale score will be collected at 6,8,12,24 and 26h from which the "rebound pain score" will be calculated. The need for pharmacological rescue will be assessed as well as the appearance of adverse effects at 12, 24 and 36h and finally the QoR15 scale will be assessed at 36h. **Detailed Description:** Total knee arthroplasty (TKA from now on) is a frequent surgery in routine clinical practice in constant evolution and improvement, with the objective being the earliest possible functional recovery of these patients, the role of the anaesthesiologist being fundamental in this sense throughout the perioperative period since, as we know, it is a surgery that improves the mobility and quality of life of the patient, but causes intense postoperative pain during the first 24 to 72 hours, it is a surgery that improves the patient's mobility and quality of life, but causes intense postoperative pain during the first 24 to 72 hours, a very important factor to take into account in these patients since it is known that adequate postoperative pain control promotes ambulation and the possibility of physiotherapy for the patient, This leads to an early recovery, a lower rate of complications (such as deep vein thrombosis or nosocomial infection) and a shorter hospital stay, allowing the strategy known as "fast-track" to be carried out, which would consist of achieving functional recovery and discharge as early as possible, this being the current trend in management by most trauma teams dedicated to this field, since it results in a decrease in morbidity and greater patient satisfaction. In relation to this approach, as has been mentioned, multiple studies have shown that one of the main causes of delayed hospital discharge is poor pain control and mobilisation problems. Therefore, adequate postoperative pain control will be important in this surgery. This control could be achieved with a combination of locoregional techniques such as peripheral nerve blocks of the adductor canal (BCA) and the so-called "Infiltration between the Popliteal Artery and the Capsule of the Knee" (IPACK) together with conventional analgesia such as NSAIDs, paracetamol, metamizole and, if this is not sufficient, opioids. The locoregional techniques mentioned (BCA + IPACK) have demonstrated their efficacy in controlling immediate postoperative pain in this type of surgery in multiple studies. The first of these, BCA, provides analgesia in the anteromedial area of the knee, avoiding the femoral nerve block with the consequent weakness of the quadriceps. The second of these, IPACK, is a relatively novel technique described to achieve analgesia in the posterior capsule of the knee that is achieved by blocking the popliteal plexus formed by the articular sensory branches of the tibial and obturator nerves arranged around the popliteal artery and vein without involving the motor branches of the tibial and peroneal nerves, avoiding the motor block resulting from performing a block of the sciatic nerve at the popliteal level. From all of the above, we can deduce that both techniques are effective individually, but even more so, as is logical, in combination, allowing the entire joint territory to be covered with the least possible impairment of motor function, which will be of particular relevance in terms of starting the patient's mobilisation earlier, which is definitely an advantage over traditional femoral and sciatic nerve block techniques. However, the duration of nerve blocks is less than 24h, which is a problem, since the period of maximum incidence of postoperative pain has not yet been completed and it is possible that just at this time (12-24h after the block, when the effect of the block ends) what is known as "rebound pain" may appear, considered a possible adverse effect of peripheral nerve blocks that is becoming increasingly important, as studies dedicated to its study emerge. There are multiple definitions of rebound pain in the literature, but objectively, we can say that it is a quantifiable difference between scores on pain scales when the block works and when it stops working. Its incidence is not well established, although some studies report that it appears in up to 40% of cases receiving some type of peripheral nerve block, although its incidence in the type of patient on whom this study is to be performed has not been specifically defined in the literature available to date. As for its characteristics, we can say that it appears suddenly at 12-24h, lasting 3-6h, described by many patients as a burning sensation that worsens at night. Logically, this will have a negative impact on the patient's recovery, and will require the use of rescue drugs, mainly intravenous opioids. To date, the pathophysiological mechanisms by which it occurs continue to be the subject of debate. It is definitely a sum of mechanical and chemical factors (neurotoxicity of local anaesthetics, hyperactivity of nerve fibres, hyperexcitability of nociceptors, direct mechanical damage, etc.) in patients with predisposing factors (young people, women, orthopaedic surgery, pre-existing pain, etc.). Once its existence is known, the two most important aspects will be its proper diagnosis and definition, on the one hand, and its prevention and treatment, on the other. In terms of its detection, rebound pain will be diagnosed when a difference in pain scale scores is observed at the end of the peripheral blockade effect, which is usually 12-24 hours after it has been performed. To quantify it, most studies use serial scores on the numerical pain scale (NRS), and even the "rebound pain score" has been described, which is obtained by subtracting the lowest pain score in the first 12 hours before the end of the block action from the highest pain score in the first 12 hours after the end of the block action. In prevention and treatment, a multifactorial approach will be essential, employing pharmacological and non-pharmacological strategies (mainly patient education). Among the pharmacological strategies, there are multiple strategies that have been shown to reduce the rate of rebound pain but among which there is no clear consensus: the use of adjuvants such as dexamethasone or alpha2-agonists, which not only prolong the duration of the block but also seem to exert a neuromodulatory effect; use of continuous infusion catheters instead of a single puncture; combination of various types of peripheral blockade or intra-articular infiltration. Another option, this one highly recommended in general, is the initiation of analgesic treatment prior to the end of the blockade effect, since once it occurs, it will be very difficult to control, making it necessary to rescue with intravenous drugs, mainly major opioids such as morphine in the form of a PCA pump, an analgesic modality that has demonstrated its effectiveness but which has a number of negative aspects such as: the need for personnel capable of handling the device and a learning process on the part of the patient; the possibility of programming and medication administration errors; an increase in economic cost; in addition to the consequent limitation of mobility derived from the connection to the PCA device or the delay in discharge due to the patient being under intravenous treatment. However, a new possibility has emerged in the form of the transdermal fentanyl patch (TFP); a skin patch that constantly releases fentanyl into the bloodstream according to the dose applied, traditionally used in the control of chronic pain but whose efficacy has already been demonstrated in multiple types of surgery such as abdominal, urological and orthopaedic procedures such as hip and knee surgery. Fentanyl is a major opioid with 75-100 times the potency of morphine. Because it is highly lipid soluble and has a low molecular weight (337da), it is ideal for administration in this transdermal format; it also produces fewer cardiovascular effects than other opioids and has a lower risk of histamine release than morphine. Once applied, the patch has a slow onset of action with a plasma peak in about 12-15h and stable plasma concentrations thereafter for approximately 72h of duration. It has many advantages over other forms of analgesia, such as ease of administration, reduced possibility of dosing error, no need for venous access, low risk of infection and easier to obtain than devices such as the PCA pump. The main drawback to its use as a form of postoperative analgesia lies in its slow onset of action, since, as mentioned, its plasma peak would be reached at 15h, which makes it unsuitable for acute pain control. However, if applied at the time of surgery, it could superimpose its analgesia on the end of the analgesic effect of the peripheral nerve block, thus avoiding the appearance of rebound pain or at least reducing its rate of appearance. Therefore, several positive aspects could be derived from this alternative: convenience in its dosage, reduction of resources necessary for the adequate control and functioning of a morphine PCA and improvement in postoperative pain control, resulting in an increase in the degree of patient satisfaction and autonomy and a shorter hospital stay. With all of the above, we propose the hypothesis that the transdermal fentanyl patch is an effective postoperative analgesic strategy in primary knee arthroplasty after the disappearance of the analgesic effect of the peripheral nerve blocks Canal of the Adductors + IPACK, achieving a decrease in the rate of "rebound pain", our main objective being therefore the following: Main objective: - To evaluate the decrease in the rate of rebound pain after primary knee arthroplasty with the use of transdermal fentanyl patch versus morphine PCA. To do all this we will use objective and validated tools. For the measurement of the first objective we will use the "Rebound Pain Score", described above. As for the secondary objectives that we propose to evaluate in this work, on the one hand, we want to focus on assessing the functional recovery of patients, for which we will use the QoR 15 scale, developed from the QoR40 (27), which has proven to be a suitable tool for measuring postoperative recovery (28); and on the other hand, to compare the two pharmacological modalities under study in terms of analgesic quality and adverse effects. Therefore, the following would be our secondary objectives: Secondary objectives: * To assess the non-inferiority in terms of functional recovery after primary knee arthroplasty of the transdermal fentanyl patch versus morphine PCA. * To assess the analgesic non-inferiority in terms of postoperative analgesia after primary knee arthroplasty of the 25mcg/h transdermal fentanyl patch versus morphine PCA. * To assess the non-inferiority in terms of incidence of adverse effects in postoperative total knee arthroplasty of 25mcg/h transdermal fentanyl patch versus morphine PCA. ### Conditions Module **Conditions:** - Postoperative Pain **Keywords:** - fentanyl - morphine PCA - rebound pain ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 106 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects receiving a transdermal fentanyl patch for postoperative pain control will be included here. **Label:** transdermal fentanyl #### Arm Group 2 **Description:** Subjects receiving a morphine PCA for postoperative pain control will be included here. **Label:** morphine PCA ### Outcomes Module #### Primary Outcomes **Description:** - Rebound pain score (RPS): Defined as the result of subtracting the minimum score on the pain scale the first 12 hours before the end of action of the peripheral blockade from the maximum score on the pain scale the first 12 hours after the disappearance of the action of the peripheral blockade. To calculate this variable, the numerical pain scale score will be collected 6, 8, 12, 24 and 36 hours after the peripheral nerve block. **Measure:** - Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA: **Time Frame:** 6,8,12,24 and 36hours after the lock #### Secondary Outcomes **Description:** Quality of post-surgical recovery using the QoR 15 scale at 48 hours **Measure:** non-inferiority of PFT vs PCA morphine in terms of early postoperative recovery: **Time Frame:** 48 hours in the postoperative period **Description:** * Need for prescribed pharmacological rescue at 12 hours: Yes or no * Need for pharmacological rescue at 24 hours: Yes or no * Need for pharmacological rescue at 48 hours: Yes or No **Measure:** non-inferiority of PFT vs. morphine PCA in terms of post-surgical analgesia: **Time Frame:** 48 hours in the postoperative period **Description:** Presence or not of the following adverse effects at 48 hours: pruritus, urinary retention/bladder catheterisation, constipation or abdominal distention, limited mobility, tremor. **Measure:** non-inferiority of PFT vs morphine PCA in terms of adverse effects: **Time Frame:** 48 hours in the postoperative period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy Exclusion Criteria: * Prior opioid treatment. * History of previous opioid adverse effects. * History of PONV. * History of medical history that conditions baseline alteration of the data to be collected. * Contraindication to neuroaxial techniques. * Difficulty in understanding the scales used. * Patient's refusal. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Beatriz García Rivas **Phone:** 636054510 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sathitkarnmanee T, Tribuddharat S, Noiphitak K, Theerapongpakdee S, Pongjanyakul S, Huntula Y, Thananun M. Transdermal fentanyl patch for postoperative analgesia in total knee arthroplasty: a randomized double-blind controlled trial. J Pain Res. 2014 Aug 1;7:449-54. doi: 10.2147/JPR.S66741. eCollection 2014. **PMID:** 25120375 **Citation:** Matsumoto S, Matsumoto K, Iida H. Transdermal fentanyl patch improves post-operative pain relief and promotes early functional recovery in patients undergoing primary total knee arthroplasty: a prospective, randomised, controlled trial. Arch Orthop Trauma Surg. 2015 Sep;135(9):1291-7. doi: 10.1007/s00402-015-2265-z. Epub 2015 Jun 26. **PMID:** 26112273 **Citation:** Hall MJ, Dixon SM, Bracey M, MacIntyre P, Powell RJ, Toms AD. A randomized controlled trial of postoperative analgesia following total knee replacement: transdermal Fentanyl patches versus patient controlled analgesia (PCA). Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1073-9. doi: 10.1007/s00590-015-1621-6. Epub 2015 Mar 11. **PMID:** 25753087 **Citation:** Kehlet H, Thienpont E. Fast-track knee arthroplasty -- status and future challenges. Knee. 2013 Sep;20 Suppl 1:S29-33. doi: 10.1016/S0968-0160(13)70006-1. **PMID:** 24034592 **Citation:** Lindberg-Larsen M, Petersen PB, Corap Y, Gromov K, Jorgensen CC, Kehlet H; Centre for Fast-track Hip and Knee Replacement Collaborating Group. Fast-track revision hip arthroplasty: a multicenter cohort study on 1,345 elective aseptic major component revision hip arthroplasties. Acta Orthop. 2022 Feb 23;93:341-347. doi: 10.2340/17453674.2022.2196. **PMID:** 35195270 **Citation:** Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2. **PMID:** 29721648 **Citation:** Abdullah MA, Abu Elyazed MM, Mostafa SF. The Interspace Between Popliteal Artery and Posterior Capsule of the Knee (IPACK) Block in Knee Arthroplasty: A Prospective Randomized Trial. Pain Physician. 2022 May;25(3):E427-E433. **PMID:** 35652772 **Citation:** Tang X, Jiang X, Lei L, Zhu W, Fu Z, Wang D, Chen J, Ning N, Zhou Z. IPACK (Interspace between the Popliteal Artery and the Capsule of the Posterior Knee) Block Combined with SACB (Single Adductor Canal Block) Versus SACB for Analgesia after Total Knee Arthroplasty. Orthop Surg. 2022 Nov;14(11):2809-2821. doi: 10.1111/os.13263. Epub 2022 Sep 20. **PMID:** 36125191 **Citation:** Ochroch J, Qi V, Badiola I, Grosh T, Cai L, Graff V, Nelson C, Israelite C, Elkassabany NM. Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty. Reg Anesth Pain Med. 2020 Oct;45(10):799-804. doi: 10.1136/rapm-2020-101558. Epub 2020 Aug 31. **PMID:** 32868483 **Citation:** Kampitak W, Tanavalee A, Ngarmukos S, Tantavisut S. Motor-sparing effect of iPACK (interspace between the popliteal artery and capsule of the posterior knee) block versus tibial nerve block after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):267-276. doi: 10.1136/rapm-2019-100895. Epub 2020 Feb 4. **PMID:** 32024676 **Citation:** Guo J, Hou M, Shi G, Bai N, Huo M. iPACK block (local anesthetic infiltration of the interspace between the popliteal artery and the posterior knee capsule) added to the adductor canal blocks versus the adductor canal blocks in the pain management after total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Aug 12;17(1):387. doi: 10.1186/s13018-022-03272-5. **PMID:** 35962410 **Citation:** Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26. **PMID:** 33915199 **Citation:** Nobre LV, Cunha GP, Sousa PCCB, Takeda A, Cunha Ferraro LH. [Peripheral nerve block and rebound pain: literature review]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):587-593. doi: 10.1016/j.bjan.2019.05.001. Epub 2019 Nov 2. **PMID:** 31690509 **Citation:** Admassie BM, Tegegne BA, Alemu WM, Getahun AB. Magnitude and severity of rebound pain after resolution of peripheral nerve block and associated factors among patients undergoes surgery at university of gondar comprehensive specialized hospital northwest, Ethiopia, 2022. Longitudinal cross-sectional study. Ann Med Surg (Lond). 2022 Nov 18;84:104915. doi: 10.1016/j.amsu.2022.104915. eCollection 2022 Dec. **PMID:** 36536717 **Citation:** Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651. **PMID:** 30124544 **Citation:** Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011. **PMID:** 17543812 **Citation:** Munoz-Leyva F, Cubillos J, Chin KJ. Managing rebound pain after regional anesthesia. Korean J Anesthesiol. 2020 Oct;73(5):372-383. doi: 10.4097/kja.20436. Epub 2020 Aug 10. **PMID:** 32773724 **Citation:** Hade AD, Okano S, Pelecanos A, Chin A. Factors associated with low levels of patient satisfaction following peripheral nerve block. Anaesth Intensive Care. 2021 Mar;49(2):125-132. doi: 10.1177/0310057X20972404. Epub 2021 Mar 30. **PMID:** 33784851 **Citation:** Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257. **PMID:** 31491863 **Citation:** Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31. **PMID:** 33390261 **Citation:** Fang J, Shi Y, Du F, Xue Z, Cang J, Miao C, Zhang X. The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 12;21(1):47. doi: 10.1186/s12871-021-01267-z. **PMID:** 33579199 **Citation:** Abrisham SM, Ghahramani R, Heiranizadeh N, Kermani-Alghoraishi M, Ayatollahi V, Pahlavanhosseini H. Reduced morphine consumption and pain severity with transdermal fentanyl patches following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1580-4. doi: 10.1007/s00167-012-2287-9. Epub 2012 Dec 2. **PMID:** 23212185 **Citation:** van Bastelaere M, Rolly G, Abdullah NM. Postoperative analgesia and plasma levels after transdermal fentanyl for orthopedic surgery: double-blind comparison with placebo. J Clin Anesth. 1995 Feb;7(1):26-30. doi: 10.1016/0952-8180(94)00000-t. **PMID:** 7772354 **Citation:** Minville V, Lubrano V, Bounes V, Pianezza A, Rabinowitz A, Gris C, Samii K, Fourcade O. Postoperative analgesia after total hip arthroplasty: patient-controlled analgesia versus transdermal fentanyl patch. J Clin Anesth. 2008 Jun;20(4):280-3. doi: 10.1016/j.jclinane.2007.12.013. **PMID:** 18617126 **Citation:** Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol. 2009 Dec;5(4):230-41. doi: 10.1007/BF03178274. **PMID:** 19876859 **Citation:** Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet. 2000 Jan;38(1):59-89. doi: 10.2165/00003088-200038010-00004. **PMID:** 10668859 **Citation:** Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. **PMID:** 23411725 **Citation:** Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. **PMID:** 29397134 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### 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: LOW - As Found: Unknown - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431893 **Acronym:** ENSEMBLE **Brief Title:** A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU) **Official Title:** An Open-Label, Phase 3 Long-Term Extension (LTE) Study To Assess The Safety, Tolerability, And Efficacy Of Treatment With Pegtibatinase In Participants With Classical Homocystinuria (HCU) Due To Cystathionine Beta Synthase Deficiency (ENSEMBLE) #### Organization Study ID Info **ID:** TVTX-TVT058-302 #### Organization **Class:** INDUSTRY **Full Name:** Travere Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Travere Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this long-term extension (LTE) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (HCU). Patients who are active in the Phase 1/2 COMPOSE study or those who complete the 24 weeks of treatment in the Phase 3 HARMONY are eligible to participate. Participants will be in this clinical study for up to about 13 months including: * a treatment period of up to 52 weeks * a 4-week safety follow-up period **Detailed Description:** Overall Design: This is a global, multicenter, single-arm, open-label study. Participants who meet all eligibility criteria may transition from other pegtibatinase studies and enroll into this LTE study for long-term safety, efficacy, and clinical assessments of pegtibatinase treatment. All participants will follow a protocol of self-administration of pegtibatinase unless exempted. During the ENSEMBLE study, an optional protein tolerance modification (PTM) sub-study will also be conducted for eligible participants. ### Conditions Module **Conditions:** - Homocystinuria **Keywords:** - Classical homocystinuria - HCU - Cystathionine Beta Synthase Deficiency ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Pegtibatinase **Label:** pegtibatinase **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - pegtibatinase **Description:** Full Target Dose of pegtibatinase BIW **Name:** Pegtibatinase **Other Names:** - OT-58 - TVT-058 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence of treatment-emergent AEs **Measure:** Treatment-emergent AEs **Time Frame:** Week 1 - Week 56 **Description:** Incidence of hypermethioninemia **Measure:** Hypermethioninemia **Time Frame:** Week 1 - Week 56 **Description:** Incidence of hypomethioninemia **Measure:** Hypomethioninemia **Time Frame:** Week 1 - Week 56 **Description:** Incidence of dietary protein rescue **Measure:** Dietary Protein Rescue **Time Frame:** Week 1 - Week 56 #### Secondary Outcomes **Description:** Relative and absolute changes from baseline in tHcy levels **Measure:** Total Homocysteine (tHcy) Levels **Time Frame:** Week 1 - Week 56 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants active in the Phase 1/2 COMPOSE study or who completed the 24-week blinded period in the Phase 3 HARMONY study Exclusion Criteria: * Participant permanently discontinued from study intervention treatment in a previous pegtibatinase study due to serious AE (SAE) or intolerance **Maximum Age:** 65 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Culver City **Country:** United States **Facility:** Travere Investigational Site - Virtual Site **State:** California **Zip:** 90230 #### Overall Officials **Official 1:** **Affiliation:** Travere Therapeutics, Inc. **Name:** Sagar A Vaidya, MD, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020739 - Term: Brain Diseases, Metabolic, Inborn - ID: D000001928 - Term: Brain Diseases, Metabolic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020138 - Term: Hyperhomocysteinemia - ID: D000000592 - Term: Amino Acid Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - 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: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9774 - Name: Homocystinuria - Relevance: HIGH - As Found: Homocystinuria - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5205 - Name: Brain Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M22498 - Name: Brain Diseases, Metabolic, Inborn - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M21974 - Name: Hyperhomocysteinemia - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M3932 - Name: Amino Acid Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T2827 - Name: Homocystinuria - Relevance: HIGH - As Found: Homocystinuria - ID: T2828 - Name: Homocystinuria Due to CBS Deficiency - Relevance: LOW - As Found: Unknown - ID: T3036 - Name: Inborn Amino Acid Metabolism Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006712 - Term: Homocystinuria ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431880 **Brief Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain **Official Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial #### Organization Study ID Info **ID:** 36246PR638/4/24 #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Mohammed Said ElSharkawy **Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy. **Detailed Description:** Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder. ### Conditions Module **Conditions:** - External Oblique Intercostal Plane Block - Thoracic Paravertebral Block - Post Thoracotomy Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive external oblique intercostal plane block. **Intervention Names:** - Other: External oblique intercostal plane block **Label:** External oblique intercostal plane block **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive thoracic paravertebral block. **Intervention Names:** - Other: Thoracic paravertebral block **Label:** Thoracic paravertebral block **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - External oblique intercostal plane block **Description:** Patients will receive external oblique intercostal plane block **Name:** External oblique intercostal plane block **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Thoracic paravertebral block **Description:** Patients will receive thoracic paravertebral block **Name:** Thoracic paravertebral block **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively. **Measure:** Total morphine consumption **Time Frame:** 24 hours postoperatively #### Secondary Outcomes **Description:** Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). **Measure:** Intraoperative fentanyl consumption **Time Frame:** Intraoperative **Description:** Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery. **Measure:** Mean arterial pressure **Time Frame:** Till the end of surgery **Description:** Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery. **Measure:** Heart rate **Time Frame:** Till the end of surgery **Description:** All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively **Measure:** Time to the 1st rescue analgesia **Time Frame:** 24 hours postoperatively **Description:** Degree of pain will be measured using numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively. **Measure:** Degree of pain **Time Frame:** 24 hours postoperatively **Description:** Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded. **Measure:** Complications **Time Frame:** 24 hour postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-III. * Scheduled for open thoracotomy Exclusion Criteria: * Patients with neurological or intellectual disability. * Infection at the injection site. * Opioid addiction. * Allergic reaction to local anesthetics. * Coagulation abnormalities. * Drug abuse. * Pregnancy. * Severe liver and/or renal failure. * Uncontrolled hypertension. * Severe cardiovascular problems. * Diabetes mellitus. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohammed S Elsharkawy, MD **Phone:** 00201148207870 **Role:** CONTACT #### Locations **Location 1:** **City:** Tanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mohammed S Elsharkawy, MD - **Phone:** 00201148207870 - **Role:** CONTACT ***Contact 2:*** - **Name:** Saad A Moharam, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Ahmed E Abo ElKheir, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Tanta University Hospitals **State:** El-Gharbia Governorate, Egypt **Zip:** 31527 ### IPD Sharing Statement Module **Access Criteria:** The data will be available upon a reasonable request from the corresponding author. **Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After the end of study for one year. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Thoracic - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431867 **Brief Title:** Primary Care Management of Osteoporosis in Older Women **Official Title:** A Qualitative Exploration of Older Women and Primary Healthcare Professional Experiences to Guide Improvements in Osteoporosis Care #### Organization Study ID Info **ID:** BTHFT2918 #### Organization **Class:** OTHER **Full Name:** Bradford Institute for Health Research #### Secondary ID Infos **Domain:** National Institute for Health and Care Research (NIHR) **ID:** NIHR205378 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Institute for Health Research, United Kingdom #### Lead Sponsor **Class:** OTHER **Name:** Bradford Institute for Health Research #### Responsible Party **Investigator Affiliation:** Bradford Institute for Health Research **Investigator Full Name:** Anne Heaven **Investigator Title:** Research Programme Manager **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Investigators aim to improve primary-care for older women with osteoporosis. Older women they spoke with previously felt unseen, unimportant, unheard and uninformed. These women felt that bone/joint health was an important issue for women aged 70+. Osteoporosis is a disease that makes bones more breakable and can lead to significant pain, disability and death, costing approximately £4.4 billion a year in the United Kingdom. Women are four times more likely to have osteoporosis than men and suffer fractures earlier. Osteoporosis care is poor in primary care even though good guidelines are available. The Investigators will work with older women and healthcare professionals to help guide the research. They have already looked at published research and will build on this. They will identify what is important for both older women and professionals to inform the first interview questions. The Investigators will ask older women and healthcare professionals about the diagnosis and treatment of osteoporosis. They will also ask them how they manage osteoporosis as a patient or care provider. At regular intervals, the Investigators will look at the interview findings first and then share their thoughts with older women and professionals. Together they will explore what the interviews mean. These discussions may change the questions asked and who is interviewed next. The Investigators will combine all the information from interviews to identify what works well and less well in osteoporosis care. They will check these findings against the guidelines. They will continue to work with older women and healthcare professionals to develop recommendations for improving care. The Investigators will also identify areas of further work. They will share recommendations with healthcare commissioners and produce a summary for a variety of professional networks. They will also publish papers in journals aimed at healthcare professionals and produce a summary document and advice for older women to use. **Detailed Description:** RESEARCH QUESTION How can older women and primary healthcare professionals be empowered to improve osteoporosis care? BACKGROUND The Women's Health Strategy for England highlights the lack of focus on older women's needs and experiences. The Investigators talked to 32 older women across five public engagement workshops. These women felt unseen, unimportant, unheard and uninformed. They also felt bone/joint health and osteoporosis were important issues for older women (aged 70+). Osteoporosis leads to around 180,000 fractures per year causing significant pain, disability and death. The related cost, in the United Kingdom, is estimated at £4.4 billion a year. Women are four times more likely to suffer with osteoporosis than men and tend to suffer fractures earlier. Despite comprehensive guidelines being available, evidence suggests that osteoporosis care is lacking in primary care. AIMS AND OBJECTIVES To develop strategies to improve osteoporosis care using insights from the experience of primary healthcare professionals and older women. METHODS Ethnographic meta-analysis literature review, in-depth interviews and co-production workshops. An information specialist will update the preliminary literature review. The Investigators will synthesise evidence from older women and healthcare professionals to identify new theoretical constructs. Findings will be reviewed in co-production workshops and used to focus initial lines of enquiry. The Investigators will purposively sample 30 older women, from across England, aged 70+ to interview. They will also elicit the views of healthcare professionals in primary care. Interviews will explore the process of diagnosis, treatment and management of osteoporosis. Information from interviews will initially be reviewed by the Investigators. Following a Constructivist Grounded Theory approach, the Investigators will take initial findings to co-production workshops on a regular basis throughout fieldwork. Workshops will facilitate iterative analysis and identify theoretical sampling gaps. This process may change the types of questions asked or who is interviewed. The Investigators will combine information from all interviews to identify barriers and facilitators for older women's osteoporosis care, and cross-reference this with existing guidelines. Professional 'expert witnesses' will join the workshops when required. Finally, recommendations for improving osteoporosis care will be co-produced . Areas of further work that would improve osteoporosis care in the future will also be identified. PATIENT AND PUBLIC INVOLVEMENT Lay members will be involved in co-production workshops throughout the research. The Investigators will also work with an expert patient co-applicant in overall management of the project. TIMELINES FOR DELIVERY Following 3 months of pre-award set-up, the Investigators will conduct the literature review and develop the interview schedule in months 1-3. Interviews and workshops will happen in months 4-11. A final analysis and report will be available in month 18. IMPACT AND DISSEMINATION Findings will be sent to Integrated Care Boards responsible for local commissioning to facilitate 'better fit' services. The Investigators will also produce dissemination products for wide distribution through a variety of professional networks. Academic papers will be published in journals targeted at healthcare professionals. Summary information and advice, for older women, will be disseminated via national and community networks and presentations nationwide. These outputs will be aimed at supporting successful implementation of the All Party Parliamentary Group recommendations for better diagnosis, treatment and management. ### Conditions Module **Conditions:** - Osteoporosis **Keywords:** - women - older - primary-care ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Women aged 70 years and older with a diagnosis of osteoporosis **Intervention Names:** - Other: Guidelines for primary care management of osteoporosis **Label:** Older women #### Arm Group 2 **Description:** Any healthcare professional working in a primary care setting e.g. general practitioner, pharmacist, physiotherapist **Intervention Names:** - Other: Guidelines for primary care management of osteoporosis **Label:** Primary healthcare professionals ### Interventions #### Intervention 1 **Arm Group Labels:** - Older women - Primary healthcare professionals **Description:** All usual care of osteoporosis in primary care **Name:** Guidelines for primary care management of osteoporosis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Constructivist grounded theory about how osteoporosis in older women is treated and managed in primary care **Measure:** Questionnaire **Time Frame:** September 2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria Older women: * Osteoporosis diagnosis - either self-reported following a clinical diagnosis or taken from the patient's medical record in the case of the Community Ageing Research 75+ (CARE75+) cohort and Fracture Liaison Service (FLS) patients. * Aged 70 years or older to align with the recommendation from our preliminary engagement work. * Community dwelling. Healthcare professionals: • Working in the National Health Service (NHS) in England to align with the participant sample. Exclusion criteria Older women: * Aged under 70 years. * Lacks capacity to consent to participate in research. * Resident in a care home - care home residents are likely to need different types of interventions than community dwelling older women as there are organisational considerations. * Member of the co-production workshop. Healthcare professionals: * Not performing any NHS work. * \< 12 months in NHS practice. **Minimum Age:** 70 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Thirty women with a diagnosis of osteoporosis aged 70 years and older. The Investigators will purposively sample for maximum variation to ensure inclusion of people from a range of living circumstances, from a mixture of urban and rural locations and spanning the least deprived and most deprived locations (identified from Index of Multiple Deprivation (IMD) deciles based on postcode areas). Interview findings will be reviewed on a regular basis during the co-production workshops and adjusted as necessary to follow emergent leads. Thirty healthcare professionals using a purposive sample based on gender, number of years qualified and IMD score of practice catchment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anne Heaven, MPhil **Phone:** +44 1274382815 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicol Kime, PhD **Phone:** +44 1274383441 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Bradford Institute for Health Research **Name:** Anne Heaven, MPhil **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All external data requests will be reviewed by the Project Management Group. Permission to access anonymised data will be subject to a data sharing agreement. Participants will be asked to explicitly consent to secondary data analysis - this will be optional. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Organisational website **URL:** http://ageingstrokeresearch.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001851 - Term: Bone Diseases, Metabolic - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12947 - Name: Osteoporosis - Relevance: HIGH - As Found: Osteoporosis - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5130 - Name: Bone Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010024 - Term: Osteoporosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431854 **Brief Title:** Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program **Official Title:** The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA #### Organization Study ID Info **ID:** MINERVA #### Organization **Class:** OTHER **Full Name:** Fundació Sant Joan de Déu ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-12 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Ramon Llull #### Lead Sponsor **Class:** OTHER **Name:** Fundació Sant Joan de Déu #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to investigate the efficacy, efficiency, and patient experience of a new intervention program on adolescents with high-complexity eating disorders (ED). A prospective group of adolescents with ED (N=60) will follow this treatment program including four different phases: 1) Inpatient treatment; 2) Family Treatment Apartment; 3) Home Treatment; 4) Recovery within the community. The investigators will use a retrospective, control group (N=60) that matched the prospective group in age, sex, ED diagnosis, and severe symptomatology. Primary variables regarding Body Mass Index (BMI), ED symptomatology, functionality, recovery (yes/no), type of outpatient services (low/mid/high intensity), number of readmissions, and patient experience will be assessed at discharge, and after 6 and 12 months. Secondary variables include anxiety, depression, readiness to recover, quality of life symptoms, caregiver skills, and functionality of the family **Detailed Description:** The goal of this single-center, longitudinal study is to test the efficacy, efficiency, and patient experience of a new intensive treatment program in adolescents with high-complex eating disorders. The main questions it aims to answer are: * What are the efficacy, efficiency, and patient experiences (families and patients) of the new treatment program in adolescents with high-complex eating disorders? * What are the long-term effects of efficacy and efficiency (after 6 and after 12 months) of the new treatment program in adolescents with high-complex eating disorders? Participants will receive this new treatment program in four different phases between 16 and 20 weeks approximately. * 1st: inpatient treatment (4 weeks): Set-up: inpatient ED unit at the hospital (without the family). Objectives: maintenance of physical stabilization; ensuring adequate food intake while preventing compensatory behaviors; addressing ED-related problems; improving nutritional administration; enhancing awareness of the disorder and motivating the patient to change. * 2nd: family treatment apartment (2-3 weeks): Set-up: apartments where patients and their families live together that is owned by the healthcare system provider. Family treatment apartments are within a hospital context to facilitate a good transition to home treatment. Objectives: intensifying the treatment within a hospital setting that targets the difficulties the family encounter in managing ED symptoms; intervening from a systemic perspective; involving other family members in the treatment; collaborating with the family in developing skills to cope with the disorder; working on more autonomy and improved ED decision-making; facilitating the transition from hospitalization to home; facilitate access to the hospital staff and leads to a high frequency treatment. * 3rd: home treatment (8-9 weeks): Set-up: Patients live in their own home. Objectives: facilitating a good transition from hospitalization and family treatment apartments to home; generalize psychological skills and learnings; assisting in the progress that began in the hospital environment; providing treatment in a more family and social context; empowering families in their natural setting; promoting integration of the patient into their family, social, and school environments. * 4th: Recovery within the community (2-4 weeks): Set-up: transferring to the patients' specialized ED reference center. Objectives: gradually reducing the intervention from MINERVA; promoting autonomy and emotional management within their family and school environment; ensuring continued care with their ED reference unit; monitoring the implemented intervention. The current model will provide different treatment models during these phases. * family-based treatment * cognitive behavioural therapy * dialectical behavioural therapy * systemic family therapy ### Conditions Module **Conditions:** - Eating Disorders in Adolescence - Anorexia Nervosa - Bulimia Nervosa - Binge-Eating Disorder - Other Specified Feeding or Eating Disorder **Keywords:** - Eating Disorders - Adolescence - Inpatient treatment - Home treatment - Cognitive Behaviorial Therapy - Family-Based Treatment - Dialectical Behavioral Therapy - Systemic Family Treatment ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This study will compare prospective data with retrospective data of patients that followed Treatment As Usual (TAU). Treatment As Usual (TAU) involves arranging visits for external consultations, partial hospitalization, and inpatient admissions as necessary, by following clinical guidelines. The retrospective control group consists of 60 patients, matched in age, sex, Body Mass Index (BMI), and diagnosis of eating disorder (ED) with the prospective group. Subjects are identified by reviewing medical records of patients treated at the ED unit of Hospital Sant Joan de Déu before the initiation of the MINERVA program. The temporal reference is the first day of admission to acute total hospitalization. Subjects present the same criteria of poor treatment response as the prospective group, ensuring severity comparability with the prospective group. Exclusion occurs if there is ≥20% missing data. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group comprises 60 patients aged 12 to 17 diagnosed with an eating disorder. They must have shown poor response to treatment, defined as having one of the two conditions: 1) undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations); 2) having more than three admissions without symptom stabilization in less than one year. They will be recruited from child/adolescent ED units in Catalonia. Exclusions will be acute ED pathology requiring urgent pediatric attention or admission to an acute psychiatric ward. **Intervention Names:** - Behavioral: ED-MINERVA Program **Label:** Patient group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patient group **Description:** ED-MINERVA Program aims to improve ED symptoms and related difficulties of the patient and provide tools to enhance the family's management (nutritionally, emotionally, and behaviorally) in their natural environment. The treatment consists of four phases with a gradually decreasing therapeutic intensity, ranging from total hospitalization, family treatment apartment, to home treatment and subsequent linkage with specialized local facilities. The ED-MINERVA program uses various aspects of family-based treatment, cognitive behavioral therapy, dialectical behavioral therapy, and systemic family therapy. **Name:** ED-MINERVA Program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the change in BMI between the beginning and the end of the intervention of the patients included in the MINERVA program. Furthermore, BMI changes of the MINERVA group will be compared with retrospective data. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. **Measure:** O1: Changes in BMI (efficacy) **Time Frame:** Up to 20 weeks **Description:** Evaluate the changes in clinical eating symptomatology between the beginning and the end of the intervention of patients included in the MINERVA program. The Eating Disorder Inventory 3 (EDI-3) will be used to assess clinical eating symptomatology. It comprises 91 items where responses are given on a Likert scale (0-4). The subscales regarding 'drive for thinness' and 'body dissatisfaction' will be used for the main objective, where improvements in both subscales need to be detected. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. **Measure:** O2: Changes in clinical eating symptomatology (efficacy) **Time Frame:** Up to 20 weeks **Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. **Measure:** O3: Changes in functionality of the patient (efficacy) **Time Frame:** Up to 20 weeks **Description:** Evaluate the percentage of patients who do no longer meet diagnostics criteria for a primary eating disorder. Furthermore, data will be compared with retrospective data. Improvements in O1 and O2 need to be detected to consider the MINERVA program effective. Additionally, improvements in at least one of the other two outcomes (O3 and/or O4) need to be detected to conclude that the MINERVA program is effective at clinical and functional levels, in comparison to previous treatment programs. **Measure:** O4: Changes in recovery rates (efficacy) **Time Frame:** 6 months after treatment completion **Description:** Determine the percentage of patients in low-intensity care settings after 6 months of completing the program (including day hospital and specific outpatient consultations). The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units or community resources. **Measure:** O5: Percentage of patients in low-intensity care settings (efficiency) **Time Frame:** 6 months after treatment completion **Description:** Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected. **Measure:** Percentages of readmissions (efficiency) **Time Frame:** 6 months after treatment completion **Description:** Determine the percentage of readmissions at 6 and 12 months after completing the program. Furthermore, this data will be compared with retrospective data. The MINERVA program will be considered efficient if more than 60% of the patients will be able to continue treatment at low-intensity outpatient services (including day hospitals and specific external consultations) in ED units. Furthermore, the program will be considered more efficient than TAU if significant lower readmission percentages in O6 and O7 will be detected. **Measure:** Percentages of readmissions (efficiency) **Time Frame:** 12 months after treatment completion **Description:** Evaluate the level of satisfaction with the received intervention, adherence, and the rate of patient and family dropout (less than 20%). Patient Experience will be assessed through individual interviews with the patient and their family, and Patient-Reported Experience Measures (PREMs) surveys. PREM is a systematic online survey that assesses and describes the experience regarding healthcare services. The survey consists of Likert-scale and open-ended questions to gather narrative information that enriches qualitative data with more details and context. **Measure:** Patient experience **Time Frame:** Up to 20 weeks #### Secondary Outcomes **Description:** Evaluate changes in symptoms of anxiety between the beginning and the end of the intervention of the patients included in the MINERVA program. The State-Trait Anxiety Inventory (STAI) will be used to assess anxiety. STAI is scored on a range from 20 to 80, whereby a higher score indicates a worse outcome. **Measure:** Changes in symptoms of anxiety **Time Frame:** Up to 20 weeks **Description:** Evaluate changes in symptoms of depression between the beginning and the end of the intervention of the patients included in the MINERVA program. The Beck Depression Inventory (BDI) will be used to assess depression. It consists of 21 Likert-scale items, ranging from 0 to 3, with a cutoff point of 13 or higher that indicates the presence of depressive symptoms. **Measure:** Changes in symptoms of depression **Time Frame:** Up to 20 weeks **Description:** Evaluate changes in readiness to recover between the beginning and the end of the intervention of the patients included in the MINERVA program. The Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) will be used to assess motivation of recovering. It consist of 20 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome. **Measure:** Changes in readiness to recover **Time Frame:** Up to 20 weeks **Description:** Assess caregiver skill changes in the families of the included patients. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher outcome indicates a better outcome. **Measure:** Changes in caregiver skills **Time Frame:** Up to 20 weeks **Description:** Examine changes in the quality of life of the patients and their families. The Kidscreen-27: Quality of Life Inventory will be used to assess the quality of life. It consists of 27 Likert-scale items, ranging from 1 to 5, whereby a higher score indicates a better outcome. **Measure:** Changes in quality of life **Time Frame:** Up to 20 weeks **Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. **Measure:** Functionality of the patient **Time Frame:** 6 months after treatment completion **Description:** Evaluate the functionality of the patient between the beginning and the end of the intervention in patients included in the MINERVA program. Functionally will also be assessed at 6 and 12 months after completing the program. The Children's Global Assessment Scale (CGAS) will be used to assess functionality. CGAS is scored on a range from 1 to 100, whereby a higher score indicates a better outcome. **Measure:** Functionality of the patient **Time Frame:** 12 months after treatment completion **Description:** Mental illness in parents will be assessed at the beginning and the end of the intervention. The Kiddie Schedule For Affective Disorders and Schizophrenia-Present and Lifetime 5 (K-SADS-PL-5) will be used to assess mental illness in parents. The K-SADS-PL-5 is a semi-structured diagnostic interview designed to clinically diagnose ED and identify psychiatric comorbidities. It includes an introductory interview, a screening interview, and diagnostic supplements. **Measure:** Mental illness in parents **Time Frame:** Up to 20 weeks **Description:** Skills in managing eating disorders of the parents will be assessed at the beginning and the end of the intervention. The Caregiver Skills (CASK) will be used to assess caregiver skills. CASK is scored on a range from 0 to 100, whereby a higher score indicates a better outcome. **Measure:** Parental skills in managing eating disorders **Time Frame:** Up to 20 weeks **Description:** The functionality and dynamics of the family will be assessed at the beginning and the end of the intervention. The SCORE-15 will be used to assess changes in functionality and dynamics. SCORE-15 is a self-administered questionnaire that consists of 15 Likert-type items (1-5) and is divided into three scales: strengths and adaptability, concerns or distress, and communication difficulties. The total score can be on a range from 15 to 75, whereby a higher score indicates a worse outcome **Measure:** Functionality and dynamics of the family **Time Frame:** Up to 20 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria for the prospective experimental group: * Patient diagnosed with an Eating Disorder (according to the DSM-5) through a semi-structured interview (K-SADS PL-5) * Aged between 12 and 17 years old * Both patients and parents are willing to participate in the study and sign the informed consent to accept participation * Patient with a poor response to treatment, defined as having one of the following two conditions: 1. undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization, experiencing severe psychological distress, eating symptomatology, comorbidities, or family dysfunction during this period (clinical improvement of at least 50 on the CGAS functioning scale) OR 2. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale). Exclusion criteria for the prospective group: * Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward. Inclusion criteria for the retrospective control group: * Aged between 12 and 17 years old * Diagnosed with an Eating Disorder (according to the DSM-5) * Received treatment in Sant Joan de Déu between 2012 and 2022 * Patient with a poor response to treatment, defined as having one of the following two conditions: 1. undergoing over a year of treatment, including partial or total hospitalization, without achieving stabilization of ED symptomatology (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations) OR 2. undergoing more than three admissions without symptom stabilization once referred to partial hospitalization in less than one year, including a similar psychological state and characteristics as the first condition Exclusion criteria for the retrospective control group: * Missingness of 20% or more of the required data **Maximum Age:** 17 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eduardo Serrano-Troncoso, Dr. **Phone:** 0034673837093 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eduardo Serrano-Troncoso, Dr. - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Sant Joan de Déu **Status:** RECRUITING **Zip:** 08950 #### Overall Officials **Official 1:** **Affiliation:** Hospital Sant Joan de Deu **Name:** Eduardo Serrano-Troncoso, Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Proposals should be directed to the Principal Investigator. To obtain access, data requestors will need to sign a data agreement with our institution, to comply with legal requirements and data protection rights. The study protocol and/or amendment to the protocol will be reviewed by the corresponding Ethics Committees. **Description:** Data obtained through the current study may be provided to qualified researchers with academic interest in eating disorders. Data shared will be encoded, with no Protected Health Information (PHI) included. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Data requests can be submitted immediately following publication. There will be no end date. ## Document Section ### Large Document Module #### Large Docs - Date: 2023-08-31 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 321352 - Type Abbrev: Prot_SAP - Upload Date: 2024-01-09T05:54 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000006963 - Term: Hyperphagia ### 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: M4181 - Name: Anorexia - Relevance: HIGH - As Found: Anorexia - ID: M5304 - Name: Bulimia - Relevance: HIGH - As Found: Bulimia - ID: M4182 - Name: Anorexia Nervosa - Relevance: HIGH - As Found: Anorexia Nervosa - ID: M26956 - Name: Bulimia Nervosa - Relevance: HIGH - As Found: Bulimia Nervosa - ID: M28641 - Name: Binge-Eating Disorder - Relevance: HIGH - As Found: Binge Eating Disorder - 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: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M10014 - Name: Hyperphagia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000855 - Term: Anorexia - ID: D000002032 - Term: Bulimia - ID: D000001068 - Term: Feeding and Eating Disorders - ID: D000000856 - Term: Anorexia Nervosa - ID: D000056912 - Term: Binge-Eating Disorder - ID: D000052018 - Term: Bulimia Nervosa ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431841 **Acronym:** DIMS **Brief Title:** Efficacy and Safety of Atropine and DIMS Lenses in Controlling Myopia in Children: A Randomized Clinical Trial. **Official Title:** Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population. #### Organization Study ID Info **ID:** 21/522-EC_M #### Organization **Class:** OTHER **Full Name:** Hospital San Carlos, Madrid ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-02-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-03-13 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital San Carlos, Madrid #### Responsible Party **Investigator Affiliation:** Hospital San Carlos, Madrid **Investigator Full Name:** Noemi Guemes **Investigator Title:** Principal Investigator and sponsor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial involving 50 subjects in each treatment arm (100 patients in total). The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values. ### Conditions Module **Conditions:** - Myopia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Atropine 0,025% + DIMS Lenses **Intervention Names:** - Drug: Atropine 0,025% + DIMS/monofocal Lenses **Label:** DIMS Lenses **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Atropine 0,025% + monofocal (single vision) Lenses **Intervention Names:** - Drug: Atropine 0,025% + DIMS/monofocal Lenses **Label:** Monofocal Lenses **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - DIMS Lenses - Monofocal Lenses **Description:** Atropine 0,025% (1 drop per day) + DIMS/monofocal Lenses **Name:** Atropine 0,025% + DIMS/monofocal Lenses **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cycloplegic spherical equivalent refraction (SER) change **Measure:** Cycloplegic spherical equivalent refraction (SER) change **Time Frame:** 2 years (24 months) **Description:** Axial length (AL) change **Measure:** Axial length (AL) change **Time Frame:** 2 years (24 months) ### Eligibility Module **Eligibility Criteria:** Inclusion criteria * Age between 4-16 years. * Signing of informed consent. * Refractive error: myopia greater than -1.00 diopters (D). * Myopia progression of at least -0.50 D in the last 12 months. * Astigmatism of 2 D or less and anisometropia of 1.50 D or less. * Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better. Exclusion criteria * Children under 4 years old and over 16 years old * Strabismus and binocular vision anomalies. * Alterations in eye fundus that the researcher consider necessary the patient exclution. * Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision * Amblyopia * Previous eye surgery * Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation) * Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study. **Maximum Age:** 16 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Noemi Guemes, PHD **Phone:** 913303000 **Role:** CONTACT #### Locations **Location 1:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Noemi Guemes - **Phone:** +34913303000 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** uicec - **Phone:** +34913303000 - **Role:** CONTACT ***Contact 3:*** - **Name:** Noemi Guemes - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Noemi Guemes **Status:** RECRUITING **Zip:** 28040 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012030 - Term: Refractive Errors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12168 - Name: Myopia - Relevance: HIGH - As Found: Myopia - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009216 - Term: Myopia ### Intervention Browse Module - Ancestors - ID: D000000759 - Term: Adjuvants, Anesthesia - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000009184 - Term: Mydriatics - ID: D000010276 - Term: Parasympatholytics - ID: D000018727 - Term: Muscarinic Antagonists - ID: D000018680 - Term: Cholinergic Antagonists - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M4590 - Name: Atropine - Relevance: HIGH - As Found: Young Adults - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: M12139 - Name: Mydriatics - Relevance: LOW - As Found: Unknown - ID: M13189 - Name: Parasympatholytics - Relevance: LOW - As Found: Unknown - ID: M20801 - Name: Muscarinic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20760 - Name: Cholinergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001285 - Term: Atropine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431828 **Acronym:** BIOMONI-DIG **Brief Title:** Remote Symptom Review in Patients With Implantable Diagnostic Holter **Official Title:** Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter. #### Organization Study ID Info **ID:** FF088 #### Organization **Class:** OTHER **Full Name:** Fundacin Biomedica Galicia Sur ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fundacin Biomedica Galicia Sur **Class:** OTHER **Name:** Fundacion Investigacion Interhospitalaria Cardiovascular #### Lead Sponsor **Class:** OTHER **Name:** Andres Iñiguez Romo #### Responsible Party **Investigator Affiliation:** Fundacin Biomedica Galicia Sur **Investigator Full Name:** Andres Iñiguez Romo **Investigator Title:** Head of Cardiology **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital. **Detailed Description:** Population of patients: Patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period. Design: Clinical, randomized, prospective, single-center study. Investigational Device: BIOMONITOR III implantable cardiac holter and successive models with HOMEMONITORING remote monitoring system for constant monitoring of patient's cardiac signals. Installation of the Patient APP on the patient's phone for symptom transmission. Overall Objective: To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital. ### Conditions Module **Conditions:** - Atrial Fibrillation - Syncope - Bradycardia - Arrythmia **Keywords:** - Implantable loop recorder - Arrythmia - Atrial Fibrillation - Home Monitoring ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events. **Intervention Names:** - Other: APP **Label:** Homemonitoring + APP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patients receive the usual standard treatment with remote holter monitoring **Label:** Homemonitoring **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Homemonitoring + APP **Description:** The patients will download an app through which they will be able to report adverse events related to their cardiovascular health. **Name:** APP **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication. **Measure:** TIME FRAME **Time Frame:** one year #### Secondary Outcomes **Description:** Number of in-person visits in each group **Measure:** Number of in-person visits in each group **Time Frame:** one year **Description:** Number of remote transmissions activated by patient indication **Measure:** Incidence remote transmissions activated by patient indication **Time Frame:** one year **Description:** Number of false positives, according to physician's diagnosis. **Measure:** Rate of false positives **Time Frame:** one year **Description:** Number of false positives (according to physician's diagnosis) **Measure:** Rate of symptoms sent by the patient **Time Frame:** one year **Description:** Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient (e.g., the symptom corresponds to a detected arrhythmia) **Measure:** Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient **Time Frame:** one year **Description:** Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia) **Measure:** Rate of symptoms not corresponding to detected arrhythmias **Time Frame:** one year **Description:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia **Measure:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient. **Time Frame:** one year **Description:** Change in patient interaction with the physician - fewer calls/visits to the hospital. **Measure:** Efficacy of implementing a clinical process based on remote monitoring of patient symptoms **Time Frame:** one year **Description:** Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms **Measure:** Qualitative Patient Objectives **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection) * Patients over 18 years old. * Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms. * Patients capable of using the patient application. Exclusion Criteria: * Patients over 80 years of age or, failing that, not able to use an application to send their symptoms. * Life expectancy of less than 12 months for any reason. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andrés Iñiguez Romo, MD, PhD **Phone:** +34986825564 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Elvis Teijeira Fernández, MD, PhD **Phone:** +34986825564 **Role:** CONTACT #### Locations **Location 1:** **City:** Vigo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pablo Juan Salvadores, MPH,PhD - **Phone:** +34986825564 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Álvaro Cunqueiro **Status:** RECRUITING **Zip:** 36211 #### Overall Officials **Official 1:** **Affiliation:** Servicio Galego de Saude **Name:** Andrés Iñiguez Romo, MD, phD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gupta N, Yang J, Reynolds K, Lenane J, Garcia E, Sung SH, Harrison TN, Solomon MD, Go AS; KP-RHYTHM Study Group. Diagnostic Yield, Outcomes, and Resource Utilization With Different Ambulatory Electrocardiographic Monitoring Strategies. Am J Cardiol. 2022 Mar 1;166:38-44. doi: 10.1016/j.amjcard.2021.11.027. Epub 2021 Dec 23. **PMID:** 34953575 **Citation:** Sharma AN, Baranchuk A. Ambulatory External Electrocardiography Monitoring: Holter, Extended Holter, Mobile Cardiac Telemetry Monitoring. Card Electrophysiol Clin. 2021 Sep;13(3):427-438. doi: 10.1016/j.ccep.2021.04.003. Epub 2021 Jul 8. **PMID:** 34330370 **Citation:** Varma N, Epstein AE, Schweikert R, Michalski J, Love CJ; TRUST Investigators. Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial. J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27. **PMID:** 26661687 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000014474 - Term: Unconsciousness - ID: D000003244 - Term: Consciousness Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood 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: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M16353 - Name: Syncope - Relevance: HIGH - As Found: Syncope - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: HIGH - As Found: Arrhythmia - ID: M5196 - Name: Bradycardia - Relevance: HIGH - As Found: Bradycardia - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17224 - Name: Unconsciousness - Relevance: LOW - As Found: Unknown - ID: M6468 - Name: Consciousness Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013575 - Term: Syncope - ID: D000001281 - Term: Atrial Fibrillation - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000001919 - Term: Bradycardia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431815 **Acronym:** ADVENT PAS **Brief Title:** ADVENT Post-Approval Study **Official Title:** Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation #### Organization Study ID Info **ID:** PF304 #### Organization **Class:** INDUSTRY **Full Name:** Boston Scientific Corporation ### Status Module #### Completion Date **Date:** 2029-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Boston Scientific Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study. **Detailed Description:** The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF). ### Conditions Module **Conditions:** - Paroxysmal Atrial Fibrillation **Keywords:** - Pulsed Field Ablation - PFA - Pulmonary Vein Isolation - PVI - Ablation - Atrial Fibrillation - AF ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System. **Name:** FARAPULSE™ Pulsed Field Ablation System **Other Names:** - FARAWAVE™ Pulsed Field Ablation Catheter **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary safety endpoint is defined as the primary safety event rate at 12 months post-Index Procedure. Primary safety events will consist of a composite of the following serious procedure-related and device-related adverse events: * Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later. * Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure: * Atrial esophageal fistula * Pulmonary vein stenosis (≥ 70% reduction of diameter) **Measure:** Primary Safety Endpoint **Time Frame:** 12 Months **Description:** The primary effectiveness endpoint is treatment success in treated subjects, defined as: * Acute Procedural Success AND * Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit: * Occurrence of any Detectable AF, AFL, AT * ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG * Following interventions: * Any cardioversion for AF, AFL or AT * Prescribed a higher dose of any failed Class I or III AAD documented at baseline or any new Class I or III AAD * Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter only) **Measure:** Primary Effectiveness Endpoint **Time Frame:** 12 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; * Subjects who are willing and capable of providing informed consent; * Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site; * Subjects who are of legal age to give informed consent specific to the national law. * Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications. For the LUX-Dx Sub-Study: * Subjects with an existing LUX-Dx, inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure. Exclusion Criteria: * Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU); * Subjects with any prior LA ablation; * Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL); * Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion); * Life expectancy of \< 1 year, per investigator's medical judgement. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Erin L Feddema, MPH **Phone:** +1 651-582-5077 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Paroxysmal Atrial Fibrillation - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431802 **Brief Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children **Official Title:** Construction and Application of the Visualization Training Platform Based on a Multimodal Standardized Dataset for Pain Assessment in Critically Ill Children #### Organization Study ID Info **ID:** FNF20231219 #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Fudan University ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital of Fudan University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children is applicable for pain assessment training. The main questions it aims to answer are: 1. Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' knowledge level of pain assessment? 2. Does pain assessment training with a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children improve participants' skill level of pain assessment? Researchers will compare a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children to on-site lesson to see how well the platform intervention can be applied to pain assessment training. Participants will: 1. Use the visualisation platform or receive on-site lesson for pain assessment training every week for 1 month 2. Test before and 1 month after the start of the study **Detailed Description:** In pediatric intensive care units, children are often faced with complex and critical conditions that require frequent pain-causing operations and experience varying degrees of pain. Pain has serious negative physiological, psychological, and social effects on critically ill children, and may even cause long-term distress, hindering individual growth and long-term health. Reliable pain assessment can help healthcare professionals to better understand the type and extent of pain in children, so that appropriate interventions can be taken to better manage the child's pain and thereby improve the child's health outcomes. However, pediatric nurses face challenges from the child, observational indicators, and the individual themselves during pain assessment in the clinic. Training in pain assessment can effectively improve nurses' knowledge, skills and attitudes towards pain assessment, enabling them to better cope with the difficulties associated with pain assessment, thereby improving the quality of pain management and providing optimal pain care for children. Traditional training has many drawbacks, and there are various difficulties in pain assessment training for critically ill children, which brings various challenges to pain assessment training for pediatric ICU nurses. Visualization training is intuitive, interactive and personalized, showing unique advantages different from traditional training. The union of deliberate practice with visualization training can further enhance the training effect, and help pediatric ICU nurses' pain assessment ability to be comprehensively improved through purposeful practice, timely feedback, and repeated training and challenges, so that they can more accurately identify and assess children's pain. Therefore, a visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children will be constructed for pain assessment training to promote better improvement of pain assessment ability of pediatric ICU nurses, so that pain in critically ill children can be better managed. ### Conditions Module **Conditions:** - Pediatrics - Critical Illness - Pain Measurement ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** On-site course training in pain assessment **Intervention Names:** - Other: Conventional intervention **Label:** Conventional intervention group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pain assessment training using the visualization training platform based on a multimodal standardized dataset for pain assessment in critically ill children **Intervention Names:** - Behavioral: Platform intervention **Label:** Platform intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional intervention group **Description:** A nursing specialist with extensive clinical and teaching experience will provide on-site course training. The training will cover topics related to pain and pain assessment, such as: pain definition, types, physiological mechanisms, performance, pain assessment tools, and frequency of pain assessment. Interventions will be provided once a week for 4 weeks. **Name:** Conventional intervention **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Platform intervention group **Description:** Using a pre-assigned account to log in to the platform, read the guidance instructions and enter the platform to start training. Basic knowledge of pain and pain assessment can be learnt through the Learning Resources module on the platform, and pain assessment training can be conducted through the Pain Assessment Exercise module. During pain assessment training the platform provides instant feedback based on the participant's exercises. Interventions will be completed in 4 weeks. **Name:** Platform intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Use the Pediatric ICU Nurses' Pain Assessment Knowledge Test，which is measured on a scale from 0 to 100 points. The higher the total score, the higher the level of knowledge. **Measure:** Knowledge level of pain assessment **Time Frame:** before and 1 month after the start of the study **Description:** The pediatric pain assessment cases developed by the research team will be utilized for evaluation. The correct percentage range is from 0% to 100%, with higher percentages indicating a higher skill level in pain assessment. **Measure:** Skill level of pain assessment **Time Frame:** before and 1 month after the start of the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Obtain a Nurse Practitioner's Certificate; 2. Nurses working in critical care; 3. Voluntarily participate in this study. Exclusion Criteria: 1. Nurses in the neonatal unit (due to the specificity of pain assessment in neonates); 2. Not on duty during the survey period due to further training, rotations, sick leave, maternity leave, etc.; 3. Nurses who travel to our hospital for further training, rotations, or clinical placements during the survey period; 4. Those who fail to complete the full intervention or withdrew from the study midway. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ying Gu, Doctor **Phone:** +86 13816881726 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Children's Hospital of Fudan University #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital of Fudan University **Name:** Ying Gu, Doctor **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431789 **Brief Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency **Official Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency #### Organization Study ID Info **ID:** SLCO1B1 #### Organization **Class:** OTHER **Full Name:** Qianfoshan Hospital ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Qianfoshan Hospital #### Lead Sponsor **Class:** OTHER **Name:** Yi Han #### Responsible Party **Investigator Affiliation:** Qianfoshan Hospital **Investigator Full Name:** Yi Han **Investigator Title:** Associate professor of pharmacy **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** 1. To provide reference for clinical rational use of edoxaban; 2. Optimize the individualized dosing regimen of edoxaban. **Detailed Description:** In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban. ### Conditions Module **Conditions:** - Gene Polymorphism - Edoxaban - Renal Insufficiency **Keywords:** - Anti-factor Xa activity - Edoxaban - Moderate to severe renal insufficiency - Solute carrier organic anion transporter family member 1B1 ### Design Module #### Bio Spec **Description:** blood **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** Thrombotic and bleeding events. **Measure:** Safety index:Thrombotic and bleeding events. **Time Frame:** six months #### Primary Outcomes **Description:** Anti-factor Xa activity **Measure:** Anti-factor Xa activity **Time Frame:** six months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula * Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment * Patients voluntarily participate and sign informed consent Exclusion Criteria: * Age \< 18 years old * Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease * The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients treated with edoxaban at the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Hospital). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yi Han, doctorate **Phone:** 15552565120 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yi Han, doctorate - **Phone:** 15552565120 - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) **State:** Shandong **Status:** RECRUITING **Zip:** 250014 #### Overall Officials **Official 1:** **Affiliation:** Qianfoshan Hospital **Name:** Yi Han, doctorate **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### 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: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Renal Insufficiency - 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 ### Condition Browse Module - Meshes - ID: D000051437 - Term: Renal Insufficiency ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M261011 - Name: Edoxaban - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431776 **Brief Title:** Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). **Official Title:** An Open-label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). #### Organization Study ID Info **ID:** SAV006-04 #### Organization **Class:** INDUSTRY **Full Name:** Savara Inc. ### Status Module #### Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Savara Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are: The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP. This is an open-label study: all participants will receive treatment with molgramostim. Patients will: * Take molgramostim once daily via nebulizer every day for 12 months. * Visit the clinic approximately every 12 weeks for checkups and tests. * Keep a diary of any oxygen use. **Detailed Description:** This is an interventional open-label, single arm, multi-center study in pediatric subjects, age 6 through 18 years, who are diagnosed with autoimmune pulmonary alveolar proteinosis (aPAP). The diagnosis of aPAP should be confirmed by an anti-GM-CSF antibody test and a history compatible with PAP based on patient symptoms, high resolution computed tomography of the lung, lung biopsy or bronchoalveolar lavage cytology. The study consists of a 4-week screening period followed by a 48-week open-label treatment period. After completing the 48-week treatment or early withdrawal, subjects will enter a 4-week safety follow up period. The maximum treatment duration is 48-weeks, and the maximum study period will be 56 weeks. During the trial, lung lavage will be allowed as a rescue treatment in case of worsening of aPAP. ### Conditions Module **Conditions:** - Autoimmune Pulmonary Alveolar Proteinosis **Keywords:** - alveolar proteinosis - autoimmune - lung lavage - GM-CSF - children ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Open-label study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Molgramostim 300 mcg administered once daily via nebulizer for 48 weeks. **Intervention Names:** - Drug: Molgramostim **Label:** molgramostim **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - molgramostim **Description:** Molgramostim nebulizer solution will be administered once daily using a proprietary nebulizer optimized for the delivery of high molecular weight biologic compounds. **Name:** Molgramostim **Other Names:** - Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF). **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Adverse events (AEs), including clinically significant findings on pulmonary function tests and safety laboratory assessments and adverse events of special interest (AESIs; hypersensitivity and chest pain). **Measure:** Adverse Events **Time Frame:** 48 weeks **Description:** Titers of anti-GM-CSF antibodies **Measure:** Anti-GM-CSF Ab titer **Time Frame:** 0, 4, 12,24,48 and 52 weeks **Description:** Change from Baseline in forced expiratory volume in one second (FEV1) (% predicted) **Measure:** FEV1 **Time Frame:** 24 and 48-weeks **Description:** Change from Baseline in Forced vital capacity (FVC) (% predicted) **Measure:** FVC **Time Frame:** 24 and 48-weeks #### Primary Outcomes **Description:** Change in Hb-adjusted % predicted DLCO from Baseline. **Measure:** DLCO **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** Change in Hb-adjusted % predicted DLCO from Baseline . **Measure:** DLCO **Time Frame:** 48-weeks **Description:** Absolute change from Baseline in 6-minute walk distance (6MWD) **Measure:** 6-minute walk distance **Time Frame:** 24-weeks **Description:** Absolute change from Baseline in 6-minute walk distance (6MWD). **Measure:** 6-minute walk distance **Time Frame:** 48-weeks **Description:** Change from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score. **Measure:** PedsQL **Time Frame:** 24-weeks **Description:** Change from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score. **Measure:** PedsQL **Time Frame:** 48-weeks **Description:** Absolute change from Baseline in oxygen saturation (SpO2) **Measure:** Oxygen Saturation (SpO2) **Time Frame:** 24 weeks **Description:** Absolute change from Baseline in oxygen saturation (SpO2) **Measure:** Oxygen Saturation (SpO2) **Time Frame:** 48 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be ≥6 and \<18 years of age, at the time of signing the informed consent and informed assent (if applicable). * Have a history of pulmonary alveolar proteinosis, based on examination of a lung biopsy, bronchoalveolar lavage cytology, or a high-resolution computed tomogram of the chest. * Have a positive serum anti-GM-CSF autoantibody test result confirming aPAP. * Have a hemoglobin (Hb)-adjusted diffusing capacity of the lung for carbon monoxide (DLCO) ≤70% predicted at Screening. Exclusion Criteria: * Have a diagnosis of hereditary (congenital) or secondary PAP, or a metabolic disorder of surfactant production. * Have undergone treatment with Lung Lavage (WLL) within 1 month of Baseline **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yasmine Wasfi, MD, PhD, **Phone:** 1 512 851 1364 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Raymond D Pratt, MD **Phone:** 1 240 899 7058 **Role:** CONTACT #### Locations **Location 1:** **City:** Cincinnati **Country:** United States **Facility:** Cincinnati Children's Hospital Medical Center **State:** Ohio **Zip:** 45229-3039 #### Overall Officials **Official 1:** **Affiliation:** Savara Inc. **Name:** Yasmine Wasfi, MD, Ph.D. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000007154 - Term: Immune 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: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M14503 - Name: Pulmonary Alveolar Proteinosis - Relevance: HIGH - As Found: Pulmonary Alveolar Proteinosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Pulmonary Alveolar Proteinosis - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T568 - Name: Autoimmune Pulmonary Alveolar Proteinosis - Relevance: HIGH - As Found: Autoimmune Pulmonary Alveolar Proteinosis ### Condition Browse Module - Meshes - ID: D000011649 - Term: Pulmonary Alveolar Proteinosis - ID: D000001327 - Term: Autoimmune Diseases ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M257633 - Name: Molgramostim - Relevance: HIGH - As Found: Desmoid - ID: M219218 - Name: Sargramostim - Relevance: HIGH - As Found: Dihydroxyphenylalanine - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000082430 - Term: Molgramostim - ID: C000081222 - Term: Sargramostim ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431763 **Brief Title:** A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease. **Official Title:** A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of Inclisiran to Bempedoic Acid on LDL Cholesterol (LDL-C) Lowering in Participants With Atherosclerotic Cardiovascular Disease (VICTORION-CHALLENGE) #### Organization Study ID Info **ID:** CKJX839A1DE02 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran. **Detailed Description:** During the screening period study eligibility will be assessed and the participants' individual LDL-C target according to guideline (Mach et al., 2020) will be determined. Among other criteria, at screening, a participant must be on a stable maximally tolerated dose of a HI statin with either atorvastatin ≥40 mg once a day (QD) or rosuvastatin ≥20 mg QD (+/- Ezetimibe \[10mg\]) for ≥ 4 weeks with which, however, a target LDL-C of \< 70 mg/dL is not reached. During the open-label treatment period, all participants, who fulfill the inclusion/exclusion criteria, will be randomized at V1 (Day 1) in a 1:1 open-label fashion to either Inclisiran sodium 300 mg s.c. (administered at Day 1 and Day 90) or to BPA tablets 180 mg p.o. (given once daily). Participants will be required to maintain their background lipid-lowering treatment (maximally tolerated statin dose +/- Ezetimibe) unchanged for the duration of the study. The end of treatment (EOT) is reached at day 150. A Safety-Follow-up call will be conducted 30 days after EOT visit (Day 180). The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS visit. ### Conditions Module **Conditions:** - Hypercholesterolemia **Keywords:** - LDL-cholesterol - atherosclerotic cardiovascular disease - Inclisiran - bempedoic acid - BPA - PCSK9 inhibitor - head-to-head comparison ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Inclisiran treatment on top of background treatment (high intensity statin with/without ezetimibe) **Intervention Names:** - Drug: Inclisiran sodium **Label:** Inclisiran **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** BPA treatment on top of background treatment (high intensity statin with/without ezetimibe) **Intervention Names:** - Drug: BPA **Label:** Bempedoic acid (BPA) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Inclisiran **Description:** 300 mg s.c. administered at day 1 and day 90 **Name:** Inclisiran sodium **Other Names:** - PCSK9 inhibitor, siRNA **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Bempedoic acid (BPA) **Description:** 180 mg daily per oral **Name:** BPA **Other Names:** - small molecule, ACL inhibitor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To demonstrate superiority of Inclisiran compared to BPA, in combination with standard of care (maximally tolerated HI statin dose +/- Ezetimibe) in reducing relative LDL-C levels at Day 150. **Measure:** Percent change from baseline in LDL-C levels **Time Frame:** Baseline, Day 150 #### Secondary Outcomes **Description:** To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose without Ezetimibe in relative reduction of LDL-C levels at Day 150. **Measure:** Percent change from baseline in LDL-C levels in patients without Ezetimibe **Time Frame:** Baseline, Day 150 **Description:** To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose with Ezetimibe in reducing relative LDL-C levels at Day 150. **Measure:** Percent change from baseline in LDL-C levels in patients with Ezetimibe **Time Frame:** Baseline, Day 150 **Description:** Number of patients who qualify for 'sufficient response' based on their individual risk class, defined through on treatment LDL-C levels. For patients classified as 'very high risk', responsiveness is 'achieved' once the LDL-C drops below 55mg/dL, and for patients classified as 'high risk' responsiveness is 'achieved' once the LDL-C \< 70 mg/dL at Day 150. **Measure:** Number of participants by individual responsiveness **Time Frame:** Day 150 **Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C (absolute reduction). **Measure:** Absolute change from Baseline in LDL-C **Time Frame:** Day 150 **Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C \[time-adjusted percent change\] starting Day 30 and up to Day 150. **Measure:** Percent change from Baseline in LDL-C levels **Time Frame:** Baseline, from Day 30 up to Day 150 **Description:** Assess efficacy of Inclisiran compared to BPA in reducing LDL-C \[time-adjusted percent change\] between Day 90 and Day 150. **Measure:** Percent change from Baseline in LDL-C levels **Time Frame:** Between Day 90 and Day 150 **Description:** Assess adherence to lipid-lowering therapy over time in participants receiving Inclisiran compared to BPA on top of maximally tolerated HI statins (+/- Ezetimibe) using the Morisky 8-Item Medication Adherence Scale (MMAS-8). The Morisky Medication Adherence Scale is an assessment tool used to measure non-adherence in patient populations. It consists of seven yes/no questions and one 5-point Likert scale with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence. **Measure:** Mean change from baseline in MMAS-8 over time **Time Frame:** From Baseline up to Day 150 **Description:** Assess effect of Inclisiran compared to BPA regarding treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM v. II). The TSQM (version II) comprises 11 items across four domains focusing on effectiveness (two items), side effects (four items), convenience (three items), and global satisfaction (two item) of the medication over the previous weeks, or since the patient's last use. With the exception of item 3 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales had a nonneutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Higher scores indicating higher patient satisfaction with medication. **Measure:** Mean change from Baseline in TSQM over time **Time Frame:** From Baseline up to Day 150 **Description:** Assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI). The SF-BPI is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The SF-BPI includes two main scores: a pain severity score and a pain interference score. The pain severity score combines the information of the four items about pain intensity, which are rated from 0, no pain, to 10, pain as bad as you can imagine. To derive the pain severity score the average of the four items will be taken. The pain interference is calculated similarly using the seven items regarding pain interference, which are rated from 0, does not interfere, to 10, completely interferes. The pain interference score will be the average of these seven items. Both scores will be between 0 and 10. Higher scores correspond to a poorer condition of the participant. **Measure:** Mean change from Baseline in SF-BPI over time **Time Frame:** From Baseline up to Day 150 **Description:** Proportion of participants with clinically significant change from Baseline \[Minimal clinically important difference of 2 points\] in SF-BPI, to assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI). **Measure:** Proportion of participants with clinically significant change from Baseline in SF-BPI **Time Frame:** At day 150 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Fasting LDL-C ≥ 70 mg/dL at screening 2. Participants must be on a stable (≥ 4 weeks) and well-tolerated lipid-lowering regimen (with or without Ezetimibe \[10mg\]) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD in a maximally tolerated or maximally approved dose at screening 3. Participants categorized as very high or high CV risk, as defined below: * Very high risk participants with at least one of the following: * Documented ASCVD: ACS: Unstable angina or myocardial infarction, Stable angina, Coronary revascularization, Unequivocally documented ASCVD upon prior imaging Stroke and Transient Ischaemic Attack (TIA) * Peripheral artery disease (PAD) * Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (\< 20 years) * A calculated SCORE2 ≥ 7.5 % for age \< 50 years; SCORE2 ≥ 10 % for age 50-69 years; SCORE2-OP ≥ 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD * Pre-existing diagnosis of heterozygous familial hyper-cholesterolemia (HeFH) with ASCVD or with another major risk factor OR * High risk participants with at least one of the following: * Markedly elevated single risk factors, in particular total cholesterol \> 310 mg/dL, LDL-C \> 190 mg/dL, or blood pressure ≥ 180/110 mmHg * Pre-existing diagnosis of HeFH without other major risk factors * DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor * Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2) * A calculated SCORE2 2.5 to \< 7.5 % for age \< 50 years; SCORE2 5 to \< 10 % for age 50-69 years; SCORE2-OP 7.5 to \< 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020), and updated SCORE2 and SCORE2-OP (Hageman et al 2021, de Vries et al 2021, Visseren et al 2021). Further details for documented ASCVD will be provided in the protocol. 4. Fasting triglyceride \< 400 mg/dL at screening Exclusion Criteria: 1. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks prior to screening visit. 2. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within 6 months after screening visit. 3. Heart failure NYHA class IV at screening or baseline visit. 4. Participants on more than one other lipid-lowering drug on top of statin at screening visit. 5. Previous treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab) or planned use after screening visit. 6. Previous treatment prior to screening with BPA within 90 days 7. Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug. **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Novartis Pharmaceuticals **Phone:** +41613241111 **Role:** CONTACT **Contact 2:** **Name:** Novartis Pharmaceuticals **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Novartis Pharmaceuticals **Name:** Novartis Pharmaceuticals **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006949 - Term: Hyperlipidemias - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic 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 ### Condition Browse Module - Browse Leaves - ID: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerotic Cardiovascular Disease - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Hypercholesterolemia - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - 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: D000002318 - Term: Cardiovascular Diseases - ID: D000050197 - Term: Atherosclerosis - ID: D000006937 - Term: Hypercholesterolemia ### Intervention Browse Module - Ancestors - ID: D000000924 - Term: Anticholesteremic Agents - ID: D000000960 - Term: Hypolipidemic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000015842 - Term: Serine Proteinase Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000057847 - Term: Lipid Regulating Agents ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M2849 - Name: PCSK9 Inhibitors - Relevance: HIGH - As Found: C-section - ID: M409 - Name: Ezetimibe - Relevance: LOW - As Found: Unknown - ID: M21155 - Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4243 - Name: Anticholesteremic Agents - Relevance: LOW - As Found: Unknown - ID: M4278 - Name: Hypolipidemic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M18391 - Name: Serine Proteinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown - ID: T18 - Name: Serine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000091362 - Term: PCSK9 Inhibitors ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431750 **Acronym:** Toddler **Brief Title:** Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis **Official Title:** Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler) #### Organization Study ID Info **ID:** CAIN457FRU02 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Completion Date **Date:** 2028-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-04-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis **Detailed Description:** Rheumatologists and pediatricians actively managing pediatric Enthesitis-related Arthritis (ERA) and Juvenile Psoriatic Arthritis (jPsA) in different regions of Russia are planned to participate in the study. To be include in this study, physicians must consult more than 10 pediatric patients with ERA/jPsA in a typical month. Any pediatric patients with active ERA/jPsA who started secukinumab treatment (index date) within 4-8 weeks prior to inclusion can be enrolled. At the inclusion retrospective data collection is planned, then data will be collected 3 months of treatment), 6, 12, 18, and 24 months after index date. Therefore, maximum duration of prospective observation is expected to be 23 months. Data collection schedule fits routine (Juvenile Idiopathic Arthritis) JIA management guidelines for patients receiving biologics stating that treatment effectiveness should be evaluated at 3 and 6 months after biologic initiation and every 6 months thereafter. At each visit effectiveness and tolerability parameters, as well as the patients' Quality of life (QoL) will be documented. Retrospective data will be collected for medical history and JIA treatment, including secukinumab before inclusion, as well to describe all necessary parameters since the Index date. Expected look-back period is 12 months. Initiation of secukinumab treatment will be considered the index date. ### Conditions Module **Conditions:** - Juvenile Idiopathic Arthritis **Keywords:** - Juvenile Idiopathic Arthritis - JIA - Secukinumab - Cosentyx ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** pediatric patients with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment **Intervention Names:** - Other: Secukinumab **Label:** Secukinumab ### Interventions #### Intervention 1 **Arm Group Labels:** - Secukinumab **Description:** This is an observational study, there is no treatment allocation. **Name:** Secukinumab **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab **Measure:** Drug survival rate **Time Frame:** 24 months **Description:** The ACR Pedi 30/50/70/90 is defined as a minimum of 30/50/70/90 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30/50/70/90 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]). **Measure:** American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates **Time Frame:** Month 3, Month 6, Month 12, Month 18, and Month 24 **Description:** To state the absence of disease activity (inactive phase of the disease), the patient must meet all of the listed criteria. * absence of joints with active arthritis, * absence of fever, rash, serositis, splenomegaly or generalized lymphadenopathy typical of juvenile arthritis; * absence of active uveitis, * normal ESR and (or) CRP, * absence of disease activity according to the doctor's general assessment (VAS), * morning stiffness less than 15 minutes. **Measure:** Clinical remission/inactive disease rates by Wallace criteria **Time Frame:** Month 3, Month 6, Month 12, Month 18, and Month 24 #### Secondary Outcomes **Description:** Describes the child's usual activities in eight domains over the past week. It include dressing, getting up, eating, walking, hygiene, reaching overhead objects, grip and activities. Each question is scored from 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do). The score for each of the eight functional areas will be averaged to calculate the disability index. **Measure:** Childhood Health Assessment Questionnaire (CHAQ) score **Time Frame:** Up to 24 months **Description:** Physician global assessment of disease activity assessed on a VAS scale of 0 \[no activity\] to 10 \[extreme activity\] **Measure:** Physician global assessment of disease activity **Time Frame:** Up to 24 months **Description:** Patient/legal representative global assessment of disease activity assessed on a VAS scale of 0 \[no activity\] to 10 \[extreme activity\] **Measure:** Patient/legal representative global assessment of disease activity **Time Frame:** Up to 24 months **Description:** Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response. **Measure:** Time to treatment failure **Time Frame:** Up to 24 months **Description:** The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]). **Measure:** Proportion of patients not achieving ACR Pedi 30 response **Time Frame:** Month 3 **Description:** Score to evaluate the number of joints inflamed. A joint is considered to be inflamed when at leats two of the following criteria are present: * pain * Swelling * limited motion. The score range (total) is from 0-101, where higher scores indicate worse outcome. **Measure:** Disease activity index in 71 joints Juvenile Arthritis Disease Activity Score (JADAS71) **Time Frame:** Up to 24 months **Description:** The JSpADA score is a comprehensive clinical assessment tool designed to measure the impact of juvenile spondyloarthritis on the patient. The JSpADA scale includes 8 indicators that assess the signs and symptoms of spondyloarthritis. Patients receive an overall score based on scores on each of 8 indicators. There are two options for assessing morning stiffness, clinical sacroiliitis, uveitis and back mobility: presence or absence. Number of joints with active arthritis: 0 joints = 0; 1-2 joints = 0.5; \> 2 joints = 1; Number of active enthesites: 0 = 0; 1-2 = 0.5; \> 2 = 1; Patient-Reported Pain Score (VAS 0-10): 0 = 0; 1-4 = 0.5; 5-10 = 1; Assessment of ESR or CRP level: normal = 0; 1-2x = 0.5; \> 2x = 1. As a result, we add up the scores for the obtained indicators and get an overall score, and the higher it is, the higher the disease activity. **Measure:** Juvenile Spondyloarthritis (JSpA) Disease Activity - JSpADA **Time Frame:** Up to 24 months **Description:** Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA) to be provided. Score can range from 0 (no disease) to 72 (maximal disease). **Measure:** Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA) **Time Frame:** Up to 24 months **Description:** Reasons for discontinuation: * lack of efficacy, * adverse events * administrative reasons (no medication available in the hospital, etc.) * lack of patient's adherence * patient's or legal representative's wish * other. **Measure:** Number of participants by reasons of secukinumab discontinuation **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study. 2. Age ≥6 to \<18 years old. 3. Recognized physician diagnosis of active ERA or jPsA: * ERA per ILAR criteria: * Peripheral arthritis and enthesitis, or * Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or * Arthritis or enthesitis plus 2 of the following: sacroiliac joint tenderness; inflammatory back pain; presence of HLA-B27 antigen; acute (symptomatic) anterior uveitis; and history of a spondyloarthritis in a first-degree relative. * jPsA per ILAR criteria * Arthritis and psoriasis, or * arthritis and at least 2 of the following: * Dactylitis * Nail pitting or onycholysis * Psoriasis in a first-degree relative. 4. Patient was prescribed with secukinumab within 4-8 weeks before inclusion. 5. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct. 6. The Purified Protein Derivative (PPD) Skin Test for Tuberculosis and/or Negative T-SPOT test and/or TB-feron test before secukinumab treatment and every 6 months. Exclusion Criteria: 1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex). 2. Chronic recurrent infections. 3. Clinically significant infection exacerbation, including active tuberculosis. 4. Age \<6 years or ≥18 years. 5. Pregnancy and breastfeeding. 6. Patients participating in parallel in an interventional clinical trial. 7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab. 8. Patients within the safety follow-up phase of interventional study. 9. Active inflammatory bowel disease at inclusion. 10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation. 11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation. 12. Concomitant conditions (Candida infections, other infections, inflammatory bowel disease \[IBD\], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis). **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Pediatric patients with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Novartis Pharmaceuticals **Phone:** +41613241111 **Role:** CONTACT **Contact 2:** **Name:** Novartis Pharmaceuticals **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Novartis Pharmaceuticals **Name:** Novartis Pharmaceuticals **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000025242 - Term: Spondylarthropathies - ID: D000025241 - Term: Spondylarthritis - ID: D000013166 - Term: Spondylitis - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000011565 - Term: Psoriasis - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin 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 - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M18178 - Name: Arthritis, Psoriatic - Relevance: HIGH - As Found: Psoriatic 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: M23036 - Name: Spondylarthropathies - Relevance: LOW - As Found: Unknown - ID: M15961 - Name: Spondylitis - Relevance: LOW - As Found: Unknown - ID: M23035 - Name: Spondylarthritis - 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: M14422 - Name: Psoriasis - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - 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 - ID: T5412 - Name: Spondylarthropathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000015535 - Term: Arthritis, Psoriatic - ID: D000001171 - Term: Arthritis, Juvenile ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431737 **Brief Title:** Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication **Official Title:** Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis #### Organization Study ID Info **ID:** SCH-HP-2024 #### Organization **Class:** OTHER **Full Name:** Soonchunhyang University Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Soonchunhyang University Hospital #### Responsible Party **Investigator Affiliation:** Soonchunhyang University Hospital **Investigator Full Name:** Jun-Hyung Cho **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking. **Detailed Description:** The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates. ### Conditions Module **Conditions:** - H.Pylori Infection ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days **Intervention Names:** - Drug: Amoxicillin **Label:** BID group #### Arm Group 2 **Description:** Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid for 14 days **Intervention Names:** - Drug: Amoxicillin **Label:** QID group ### Interventions #### Intervention 1 **Arm Group Labels:** - BID group - QID group **Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid or 500 mg qid, clarithromycin 500 mg bid for 14 days **Name:** Amoxicillin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Urea breath test after completing H. pylori eradication regimen **Measure:** H. pylori eradication rates **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Assessment of patients' numbers completing H. pylori eradication regimen **Measure:** Treatment compliance **Time Frame:** 6 weeks **Description:** Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment **Measure:** Drug-related adverse event rate **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Gastroscopy can be performed * H. pylori test and pathological analysis can be performed Exclusion Criteria: * Age \< 20 or \> 80 years * Anemia (serum hemoglobin level \< 10 g/dL) * Severe systemic disease * Advanced chronic liver disease * Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics * History of H. pylori eradication * Drug allergy to antibiotics * History of gastric surgery * Recent history of upper gastrointestinal bleeding **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** H. pylori-infected patients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jun-Hyung Cho, M.D. **Phone:** +82-2-709-9202 **Phone Ext:** 9581 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jun-Hyung Cho, M.D. - **Phone:** +82-2-709-9581 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jun-Hyung Cho, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Korea, Republic of **Facility:** Soonchunhyang University Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Soonchunhyang University Hospital **Name:** Jun-Hyung Cho, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: D000000900 - Term: Anti-Bacterial Agents - 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: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Colorectal - ID: M19585 - Name: Clarithromycin - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000658 - Term: Amoxicillin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431724 **Brief Title:** A Review of Cervical Cancer Screening Practices in Women Age >65 **Official Title:** A Prospective Analysis of Adherence to National Cervical Cancer Screening Recommendations in Women Age >65 #### Organization Study ID Info **ID:** 23-ONC-34 #### Organization **Class:** OTHER **Full Name:** Sarasota Memorial Health Care System ### Status Module #### Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sarasota Memorial Health Care System #### Responsible Party **Investigator Affiliation:** Sarasota Memorial Health Care System **Investigator Full Name:** Tamela Fonseca **Investigator Title:** Director of Research **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this research study is to examine adherence to national guidelines for cervical cancer screening in women age \>65. Patient surveys will provide information about women age \>65 current cervical screening practices and allow researchers to compare that information to national recommended guidelines regarding cervical screenings. Provider surveys will provide information from surveyed providers about screening knowledge and current provider practices for women patients \> 65 for cervical cancer. The results may be used to make future recommendations for improving gynecological care and to help develop effective strategies for ensuring guideline adherence. **Detailed Description:** This prospective study will be conducted to determine adherence to the national guidelines for cervical cancer screening in women \>65. A nonpaired patient and provider survey will be utilized to assess both provider and patient adherence to the national cervical cancer screening guidelines. Providers who meet study eligibility will be asked to complete a survey containing questions regarding their current practice for cervical cancer screening, the guidelines they follow, and their decision-making process when deciding who to screen. Patients who meet study eligibility will be asked to complete a survey detailing the frequency and types of cervical cancer screenings they have had and any relevant outcomes. The aims of the study are to assess cervical cancer screening practices among at risk women age \>65 years and describe adherence to nationally recommended cervical cancer screening guidelines for this same patient group and among primary care providers (PCPs) and gynecologists. To assess adherence, the Sarasota Memorial Research Institute (SMRI) will conduct a research study which includes patients age \>65 from the Sarasota Memorial Health Care System (SMHCS) and their First Physician's Group (FPG) affiliates and providers. Patients who agree to participle will be surveyed to determine their behaviors surrounding cervical cancer screenings. Primary care physicians and gynecologists who are either members of the American Academy of Family Physicians (AAFP), ACOG, or practice within SMHCS or FPG providers who agree to participate will also receive a separate one-time survey to assess adherence to the ACOG, ACS, and USPSTF guidelines for conducting cervical cancer screenings. The target survey sample size for this study will be 200 patients, women \>65 years who are considered at risk of developing cervical cancer (women with a history of a hysterectomy will be excluded) and receive gynecological services at SMHCS. In addition, 100 primary care physicians (PCPs) and gynecologists will be targeted. ### Conditions Module **Conditions:** - Cervical Cancer **Keywords:** - cervical cancer screening - cervical cancer - geriatric cancer ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 200 women \>65 years who are considered at risk of developing cervical cancer. **Intervention Names:** - Other: Patient Survey **Label:** Women >65 years who are considered at risk of developing cervical cancer #### Arm Group 2 **Description:** 100 Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians. **Intervention Names:** - Other: Provider Survey **Label:** Primary care providers and gynecologic providers ### Interventions #### Intervention 1 **Arm Group Labels:** - Women >65 years who are considered at risk of developing cervical cancer **Description:** A simple data intake collection from the patients regarding their medical history that will allow the researchers to assess if recommended guidelines were followed. **Name:** Patient Survey **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Primary care providers and gynecologic providers **Description:** A survey will be used to evaluate providers' practices, knowledge and adherence to guidelines, and decision making related to current practice for cervical screening in women \>65. **Name:** Provider Survey **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To report adherence to national guidelines within each group, exact binomial 95% confidence intervals will be used. A multi-variant analysis will be conducted to determine the frequency, types, and outcomes of cervical cancer screening/s performed and patient and provider characteristics associated with guideline adherence. **Measure:** Exact binomial 95% confidence intervals will be used. **Time Frame:** Both patient and provider surveys are one-time only events. Their participation is limited to only the single time they take the survey which is estimated to take approximately 15 minutes. ### Eligibility Module **Eligibility Criteria:** For participants: Inclusion Criteria: * Women age \>65 who have not had a hysterectomy. * Women who received gynecological services within the SMHCS/FPG network FPG physician offices -Primary Care or Gynecologic Care)) Exclusion Criteria: * Woman has a history of prior hysterectomy. * Woman is age 65 years and under * Woman does not receive gynecologic services within SMHCS/FPG network. For providers: Inclusion Criteria: * Licensed Primary Care and Gynecologic Providers which includes APRNs, PAs, and Physicians. * Provider practices in the U.S. * Provider performs gynecological screenings as part of their current practice. Exclusion Criteria: * Provider does not practice in the United States. * Provider does not provide gynecological screenings. * Provider does not have an active license as a Primary Care Provider or Gynecologic Provider (APRNs, PAs, or Physicians). **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The sample size for this study will consist of 200 patients and 100 providers who are comprised of PCPs and gynecologists affiliated with the American Academy of Family Physicians (AAFP) or the American College of Obstetricians and Gynecologists (ACOG) or who are practitioners within SMHCS/FPG locations. ### Contacts Locations Module #### Locations **Location 1:** **City:** Sarasota **Country:** United States **Facility:** Sarasota Memorial Health Care System **State:** Florida **Zip:** 34239 #### Overall Officials **Official 1:** **Affiliation:** Sarasota Memorial Health Care System Research Institute **Name:** Tamela Fonseca, PhD, RN, CCRC **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. Erratum In: Lancet Glob Health. 2022 Jan;10(1):e41. **PMID:** 31812369 **Citation:** Bujang MA, Omar ED, Baharum NA. A Review on Sample Size Determination for Cronbach's Alpha Test: A Simple Guide for Researchers. Malays J Med Sci. 2018 Nov;25(6):85-99. doi: 10.21315/mjms2018.25.6.9. Epub 2018 Dec 28. **PMID:** 30914882 **Citation:** Dilley S, Huh W, Blechter B, Rositch AF. It's time to re-evaluate cervical Cancer screening after age 65. Gynecol Oncol. 2021 Jul;162(1):200-202. doi: 10.1016/j.ygyno.2021.04.027. Epub 2021 Apr 26. **PMID:** 33926748 **Citation:** Feldman S, Cook E, Davis M, Gershman ST, Hanchate A, Haas JS, Perkins RB. Cervical Cancer Incidence Among Elderly Women in Massachusetts Compared With Younger Women. J Low Genit Tract Dis. 2018 Oct;22(4):314-317. doi: 10.1097/LGT.0000000000000435. **PMID:** 30256336 **Citation:** Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. **PMID:** 18929686 **Citation:** Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9. **PMID:** 31078660 **Citation:** Mills JM, Morgan JR, Dhaliwal A, Perkins RB. Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort. Gynecol Oncol. 2021 Aug;162(2):308-314. doi: 10.1016/j.ygyno.2021.05.035. Epub 2021 Jun 3. **PMID:** 34090706 **Citation:** Qin J, Shahangian S, Saraiya M, Holt H, Gagnon M, Sawaya GF. Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019. Gynecol Oncol. 2021 Nov;163(2):378-384. doi: 10.1016/j.ygyno.2021.08.023. Epub 2021 Sep 8. **PMID:** 34507826 **Citation:** Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; American Cancer Society; American Society for Colposcopy and Cervical Pathology; American Society for Clinical Pathology. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012 Apr;137(4):516-42. doi: 10.1309/AJCPTGD94EVRSJCG. **PMID:** 22431528 **Citation:** Surveillance, Epidemiology, and End Results (SEER) Cancer Stat Facts: Cervix uteri Cancer, n.d. **Citation:** Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17. **PMID:** 28616007 **Citation:** Yost S, Hoekstra A. Cervical cancer in women over 65: An analysis of screening. Gynecol Oncol Rep. 2018 May 22;25:48-51. doi: 10.1016/j.gore.2018.05.010. eCollection 2018 Aug. **PMID:** 30023421 #### See Also Links **Label:** ACOG Updated Cervical Cancer Screening Guidelines **URL:** https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines **Label:** Centers for Disease Control and Prevention (CDC), 2019 **URL:** http://www.cdc.gov/cancer/uscs/about/data-briefs/no11-gynecologic-cancer-incidence-UnitedStates-2012-2016.htm **Label:** U.S. Census Bureau (2022). QuickFacts **URL:** http://www.census.gov/quickfacts/sarasotacountyflorida. **Label:** United States Preventative Task Force (USPTF). Cervical Cancer Screening. August 21, 2018. **URL:** http://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431711 **Acronym:** FRESH-CSVD **Brief Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease **Official Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease #### Organization Study ID Info **ID:** KY2024050 #### Organization **Class:** OTHER **Full Name:** Zhejiang Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2034-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Provincial People's Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal/choroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA. ### Conditions Module **Conditions:** - Cerebral Small Vessel Diseases - Retinal Ischemia - Choroid; Injury ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This does not entail the application of interventions. **Label:** Individuals with CSVD ### Outcomes Module #### Primary Outcomes **Description:** Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCTA for CSVD: area under the receiver operating characteristic curve (AUROC) **Measure:** Diagnostic accuracy of fundus OCTA-derived parameters for CSVD **Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years #### Secondary Outcomes **Description:** Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points **Measure:** The development of total CSVD burden in MRI **Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years **Description:** Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Using the Chinese version of the MMSE scale, dementia is defined based on different levels of education (≤ 22, ≤ 23, ≤ 24, ≤ 26 points for illiteracy, primary school, junior high school, and university). Death included any reason caused death. **Measure:** Number of Patients with cerebrovascular events, cardiovascular events, dementia or death **Time Frame:** baseline ,6-month, and every 1 year, follow-up time up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Older than 35 years old; 2. Patients who underwent Multimodal MRI with any CSVD imaging marker; 3. Subjects who have signed informed consent. Exclusion Criteria: 1. Patient who was unable to cooperate with examinations; 2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.); 3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment; 4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses; 5. Contraindications for imaging examinations Exit Criteria: 1. Not meet the inclusion criteria. 2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator. 3. Any adverse or serious adverse events during the study period judged by investigator **Minimum Age:** 35 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The research population for this study consists of patients who have been diagnosed with non-acute ischemic symptoms of Cerebral Small Vessel Disease. Inclusion criteria: Patients with any of the CSVD-related MRI imaging markers; Patients aged old than 35 years; Sign informed consent. Exclusion criteria: Unable to cooperate with examinations; Known dementia; Serious systemic illness; Contraindications for imaging examination; Known retinal diseases. Exit criteria: not meet the inclusion criteria; For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator; Any adverse or serious adverse events during the study period judged by investigator. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sheng Zhang **Phone:** +8618758188313 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sheng Zhang, M.D. - **Phone:** +8618758188313 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sheng Zhang, M.D. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Weitao Yu, B.S.Med - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Zhejiang Provincial People's Hospital **State:** Zhejiang **Status:** RECRUITING **Zip:** 310000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M29437 - Name: Cerebral Small Vessel Diseases - Relevance: HIGH - As Found: Cerebral Small Vessel Disease - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059345 - Term: Cerebral Small Vessel Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431698 **Acronym:** MOLDEAR **Brief Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS **Official Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS #### Organization Study ID Info **ID:** 21-0023 #### Organization **Class:** OTHER **Full Name:** University Hospital, Caen ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-31 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Caen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group ### Conditions Module **Conditions:** - Ear Malformation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 134 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Correction of deformation using the adjustable Earwell device **Intervention Names:** - Device: adjustable Earwell device **Label:** Control group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Correction of deformation using the custom-made silicone device **Intervention Names:** - Device: Custom-made silicone device **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Correction of deformation using the custom-made silicone device **Name:** Custom-made silicone device **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Correction of deformation using the adjustable Earwell device **Name:** adjustable Earwell device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group. **Measure:** Subjective ear deformation score **Time Frame:** baseline and 1 year after ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Newborn, age between 8 days and 1 month * newborn with ear malformation Exclusion Criteria: * Total chondrocutaneous agenesis of the ear * polymalformative syndrome * age greater than 4 weeks * parental refusal **Maximum Age:** 1 Month **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexis VEYSSIERE **Phone:** +33231063106 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** VEYSSIERE **Role:** CONTACT #### Locations **Location 1:** **City:** Caen **Contacts:** ***Contact 1:*** - **Name:** Alexis VEYSSIERE, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Alexis VEYSSIERE - **Phone:** +33231063106 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 3:*** - **Name:** Alexis VEYSSIERE, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Caen University Hospital **State:** N **Status:** RECRUITING **Zip:** 14000 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Deformity ### Condition Browse Module - Meshes - ID: D000000013 - Term: Congenital Abnormalities ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431685 **Brief Title:** Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer **Official Title:** Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer #### Organization Study ID Info **ID:** LM-001 #### Organization **Class:** OTHER **Full Name:** Sichuan University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sichuan University #### Responsible Party **Investigator Affiliation:** Sichuan University **Investigator Full Name:** You Lu **Investigator Title:** Chair of Department of Thoracic Cancer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer. **Detailed Description:** This exploratory phase I study will be conducted in West China Hospital, Sichuan University. Three cohorts of whole brain low dose radiotherapy (3 patients per cohort) will be enrolled to determine the safety and efficacy of whole brain low dose radiotherapy combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with WB-LDRT at same dose (4 Gy/2f) with diffent cycles (decried as below), PD-1 inhibitor, pemetrexed chemotherapy, and intrathecal pemetrexed every 3 weeks (Q3w) for 4 cycles. Patients will receive WB-LDRT at 3 cohorts with increasing dose fractions: 4 Gy/2f of one cycle in group 1; 4 Gy/2f of two cycles in group 2; 4 Gy/2f of four cycles in group 3. ### Conditions Module **Conditions:** - NSCLC - Low Dose Radiotherapy - PD-1 Inhibitor - Leptomeningeal Metastasis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The treatment regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 30 mg, once per three weeks, 4 cycles in total), PD-1 inhibitor (Sintilimab, via intravenous infusion, once per three weeks, 4 cycles in total)), pemetrexed chemotherapy (via intravenous infusion, once per three weeks, 4 cycles in total) and radiotherapy. Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: 4 Gy/2f of 2 fraction (administered a daily dose of 2 Gy for two days) in group 1; 4 Gy/2f of 4 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 2 cycles in total) in group 2; 4 Gy/2f of 8 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 4 cycles in total) in group 3. **Intervention Names:** - Radiation: Whole Brain Low Dose Radiotherapy - Drug: Pemetrexed - Drug: Sintilimab - Drug: Chemotherapy **Label:** whole brain LDRT + ICI + intrathecal chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - whole brain LDRT + ICI + intrathecal chemotherapy **Description:** Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy/2f of one cycle; Group 2: 4 Gy/2f of two cycles (Q3w); Group 3: 4 Gy/2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy/2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total). **Name:** Whole Brain Low Dose Radiotherapy **Other Names:** - WB-LDRT **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - whole brain LDRT + ICI + intrathecal chemotherapy **Description:** Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total **Name:** Pemetrexed **Other Names:** - Intrathecal Chemotherapy **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - whole brain LDRT + ICI + intrathecal chemotherapy **Description:** PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total **Name:** Sintilimab **Other Names:** - PD-1 Inhibitor **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - whole brain LDRT + ICI + intrathecal chemotherapy **Description:** Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total **Name:** Chemotherapy **Other Names:** - One of the standard chemotherapy regimens **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study. **Measure:** Clinical response rate **Time Frame:** 48 months **Description:** The incidence of treatment-related adverse events were measured for determing tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events. **Measure:** Incidence of treatment-related adverse events **Time Frame:** 48 months #### Secondary Outcomes **Description:** NPFS was defined as time from the start of treatment until neurological progression or death. The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol. **Measure:** Neurological progression-free survival (NPFS) **Time Frame:** 48 months **Description:** Survival time was recorded since the date of patient enrollment. All patients were followed up until death or the end of the study. **Measure:** Overall survival **Time Frame:** 48 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥ 18 years old and ≤ 75 years old; 2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.; 3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment; 4. Efficacy of extracranial lesions SD; 5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy; 6. Expected survival ≥3 months, PS score ≤3; 7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing; 8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases; 9. One week before enrollment, bone marrow and liver and kidney function met the following criteria: ① Hemoglobin ≥80 g/L, neutrophils ≥1.5×10\^9/L and platelets ≥70×10\^9/L; ② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml/min; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit); 10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended Exclusion Criteria: 1. Active autoimmune disease or history of autoimmune diseases; 2. Congenital or acquired immunodeficiency; 3. Uncontrolled cardiac clinical symptoms or diseases; 4. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes; 5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Other systemic malignancies within the last 5 years; 7. Allergy to any test drug; 8. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator; 9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** You Lu, MD **Phone:** 18980601763 **Phone Ext:** +86 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lisha Xiang, MD **Phone:** 13320943069 **Phone Ext:** +86 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lisha Xiang, MD - **Phone:** 13320943069 - **Phone Ext:** +86 - **Role:** CONTACT **Country:** China **Facility:** West China Hospital, Sichuan University **State:** Sichuan **Status:** RECRUITING **Zip:** 610041 #### Overall Officials **Official 1:** **Affiliation:** West China Hospital **Name:** You Lu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cao M, Chen W. Epidemiology of lung cancer in China. Thorac Cancer. 2019 Jan;10(1):3-7. doi: 10.1111/1759-7714.12916. Epub 2018 Nov 28. **PMID:** 30485694 **Citation:** Clarke JL, Perez HR, Jacks LM, Panageas KS, Deangelis LM. Leptomeningeal metastases in the MRI era. Neurology. 2010 May 4;74(18):1449-54. doi: 10.1212/WNL.0b013e3181dc1a69. **PMID:** 20439847 **Citation:** Remon J, Le Rhun E, Besse B. Leptomeningeal carcinomatosis in non-small cell lung cancer patients: A continuing challenge in the personalized treatment era. Cancer Treat Rev. 2017 Feb;53:128-137. doi: 10.1016/j.ctrv.2016.12.006. Epub 2016 Dec 30. **PMID:** 28110254 **Citation:** Gleissner B, Chamberlain MC. Neoplastic meningitis. Lancet Neurol. 2006 May;5(5):443-52. doi: 10.1016/S1474-4422(06)70443-4. **PMID:** 16632315 **Citation:** Cheng H, Perez-Soler R. Leptomeningeal metastases in non-small-cell lung cancer. Lancet Oncol. 2018 Jan;19(1):e43-e55. doi: 10.1016/S1470-2045(17)30689-7. **PMID:** 29304362 **Citation:** Le Rhun E, Weller M, van den Bent M, Brandsma D, Furtner J, Ruda R, Schadendorf D, Seoane J, Tonn JC, Wesseling P, Wick W, Minniti G, Peters S, Curigliano G, Preusser M; EANO Guidelines Committee and ESMO Guidelines Committee. Electronic address: [email protected]. Leptomeningeal metastasis from solid tumours: EANO-ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. ESMO Open. 2023 Oct;8(5):101624. doi: 10.1016/j.esmoop.2023.101624. Epub 2023 Sep 19. **PMID:** 37863528 **Citation:** Chamberlain M, Junck L, Brandsma D, Soffietti R, Ruda R, Raizer J, Boogerd W, Taillibert S, Groves MD, Le Rhun E, Walker J, van den Bent M, Wen PY, Jaeckle KA. Leptomeningeal metastases: a RANO proposal for response criteria. Neuro Oncol. 2017 Apr 1;19(4):484-492. doi: 10.1093/neuonc/now183. **PMID:** 28039364 **Citation:** Yin K, Li YS, Zheng MM, Jiang BY, Li WF, Yang JJ, Tu HY, Zhou Q, Zhong WZ, Yang XN, Chen HJ, Yan HH, Li LL, Wu YL, Zhang XC. A molecular graded prognostic assessment (molGPA) model specific for estimating survival in lung cancer patients with leptomeningeal metastases. Lung Cancer. 2019 May;131:134-138. doi: 10.1016/j.lungcan.2019.03.015. Epub 2019 Mar 18. **PMID:** 31027690 **Citation:** Wang Y, Yang X, Li NJ, Xue JX. Leptomeningeal metastases in non-small cell lung cancer: Diagnosis and treatment. Lung Cancer. 2022 Dec;174:1-13. doi: 10.1016/j.lungcan.2022.09.013. Epub 2022 Oct 1. **PMID:** 36206679 **Citation:** Thai K, Prat A. CNS therapeutics: Immune cells break the barriers. Sci Transl Med. 2023 Nov 8;15(721):eadh1150. doi: 10.1126/scitranslmed.adh1150. Epub 2023 Nov 8. **PMID:** 37939159 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: Strategies - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: HIGH - As Found: Obstruction - 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: M1346 - Name: Antineoplastic Agents, Immunological - 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: D000068437 - Term: Pemetrexed - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431672 **Brief Title:** Perinatal Interpersonal Psychotherapy Group for Distressed Women **Official Title:** The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women #### Organization Study ID Info **ID:** MOST 106-2410-H-040-004 -SSS #### Organization **Class:** OTHER **Full Name:** Chung Shan Medical University #### Secondary ID Infos **Domain:** Ministry of Science and Technology, Taiwan **ID:** MOST 107-2410-H-040-005 -SSS **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Start Date **Date:** 2018-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chung Shan Medical University #### Responsible Party **Investigator Affiliation:** Chung Shan Medical University **Investigator Full Name:** Peyling Shieh **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:** This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. **Detailed Description:** This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design. ### Conditions Module **Conditions:** - Depression, Postpartum - Social Adjustment **Keywords:** - feasibility - group psychotherapy - interpersonal psychotherapy - maternal depression - perinatal adjustment ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 258 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention was an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. All participants replied to the measures at four waves from baseline to one year postpartum. The outcome variables were within-group and between-group changes in depression, social support, dyadic adjustment, interpersonal relationship satisfaction, and mother-infant bonding. **Intervention Names:** - Other: interpersonal group psychotherapy **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants of control group reply questionnaires for four times. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group **Description:** Interpersonal psychotherapy (IPT) was developed by Stuart and O'Hara (1995). It addresses four domains of conflict. The intervention is an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. **Name:** interpersonal group psychotherapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Edinburgh Postnatal Depression Scale (EPDS, Cox et al., 1987) was used to assess depressive symptoms. It consists of ten Likert-type items with 0 to 3 points, with higher scores indicating more depressive symptoms over the past week. Following the previous study (Su et al., 2007), we used higher than 12 to define participants with significant depressive tendencies. **Measure:** Edinburgh Postnatal Depression Scale **Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum **Description:** The Dyadic Adjustment Scale (DAS, Spanier, 1976) assessed women's perceived quality of either married or unmarried couple relationship. The scale consists of 32 items, primarily scored in a 6-point scale (27 items). It measures four factors: dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectionate expression. Higher scores indicate better dyadic adjustment in respective aspects. **Measure:** Dyadic Adjustment Scale **Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum **Description:** The Social Network Interaction System Questionnaire (SNISQ, Lay \& Liu, 1996) was used to evaluate perceptions of social support from partners, original families, and in-laws. The SNISQ consists of nine Likert-type items with 1 to 4 points, with higher scores indicating better- perceived support from specific individuals. **Measure:** Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996) **Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum **Description:** Chan et al. (2002) used the Satisfaction with Interpersonal Relationships Scale (SWIRS,) to assess women's satisfaction with their relationships with partners and mothers-in-law over the past few weeks. We expanded the scale to include ratings of relationships with fathers, mothers, and fathers-in-law, resulting in five items. The SWIRS is a Likert-type item with 1 to 7 points, with higher scores indicating greater satisfaction with the relationship. **Measure:** Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002) **Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum **Description:** The Mother-Infant Bonding Inventory (MIBI, Shieh et al., 2015) assessed mothers' thoughts, feelings, and commitment toward their infants. The MIBI consists of 25 items scored on 1 to 6 points. Its four factors are proximity, parental adjustment, commitment, and confidence of reciprocity. Higher scores indicate good mother-infant bonding in specific aspects. **Measure:** Mother-Infant Bonding Inventory (Shieh et al., 2015) **Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships." Exclusion Criteria: * women with schizophrenia, substance use, or suicide risk. **Gender Based:** True **Gender Description:** women in pregnancy and postpartum **Healthy Volunteers:** True **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taichung **Country:** Taiwan **Facility:** Chung Shan Medical University **Zip:** 402 #### Overall Officials **Official 1:** **Affiliation:** Chung Shan Medical University, Taiwan **Name:** Peyling Shieh, Ph. D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** For confidentiality, we plan to share IPD with other researchers by contact. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000003866 - Term: Depressive Disorder - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000011644 - Term: Puerperal Disorders - 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: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M21076 - Name: Depression, Postpartum - Relevance: HIGH - As Found: Depression, Postpartum - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M14499 - Name: Puerperal Disorders - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019052 - Term: Depression, Postpartum - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431659 **Brief Title:** Swedish Palliative Care Guide (S-PCG) at Residential Facilities **Official Title:** Swedish Palliative Care Guide (S-PCG) at Residential Facilities #### Organization Study ID Info **ID:** 2023-02274-01-1 #### Organization **Class:** OTHER **Full Name:** Region Skane ### Status Module #### Completion Date **Date:** 2027-05-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-05-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Region Skane #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. The Institute for Palliative Care, Lund, has developed the Swedish Palliative Care Guide (S-PCG) which support for a person-centred approach throughout the palliative care process. The aim of this study is to implement the Swedish Palliative Care Guide (S-PCG) part 2 at Residential Facilities and evaluate functionality, effect and patient benefit in clinical use. **Detailed Description:** The concept of palliative care has changed over time and is not longer reserved for patients in the dying phase, on the contrary more and more studies show that early integration of palliative care and disease-specific care produce positive results. Specifically, palliative care is about prevent and alleviate suffering by early detection of symptoms and treatment of physical, psychological, social and existential problems. In order to provide the best care, a holistic approach is required that takes up what is important right now and not focus on individual diagnoses. The Swedish Palliative Care Guide (S-PCG) aims to support for a person-centred approach throughout the palliative care process. The purpose of S-PCG is to provide increased security and quality of life for patients and their relatives by identifying needs, make sure that these are addressed and followed up. S-PCG can be used cross-professionally and provides support for coordination and communication in care transitions, regardless of diagnosis or form of care. The research questions for this study are: 1. Has people living at Residential Facilities to a greater extent treatment restrictions, a stated plan in case of deterioration and information to relatives documented in the medical record after S-PCG was implemented compared to people who were cared for, at the same Residential Facilities, before S-PCG was implemented? 2. Do patients cared for after S-PCG was implemented feel more involved in decisions about their care and do they feel more safe to discuss their thoughts about the end of life (if they so wish)? ### Conditions Module **Conditions:** - Age Problem - Old Age; Debility - Death **Keywords:** - Palliative care - Elderly - Residential Facilities ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Measured by likert scale, 1-5. Higher number indicate higher experience of security **Measure:** Experience of security **Time Frame:** baseline and 12 weeks after implementation of S-PCG **Description:** Measured by likert scale, 1-5. Higher number indicate higher experience of participation **Measure:** Experience of participation **Time Frame:** baseline and 12 weeks after implementation of S-PCG #### Secondary Outcomes **Description:** Presence of documented break point conversations in medical records. **Measure:** Breakpoint conversation **Time Frame:** baseline and 12 weeks after implementation of S-PCG **Description:** Presence of documented treatment limitations in medical records. **Measure:** Treatment limitations **Time Frame:** baseline and 12 weeks after implementation of S-PCG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients living in residential facilities. * Ability to answer a short survey in Swedish. Exclusion Criteria: - Patients with dementia or other Cognitive Dysfunction. **Maximum Age:** 130 Years **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Patients living at included recidental facilities. ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Valgossens äldreboende **State:** Region Stockholm **Zip:** 11219 #### Overall Officials **Official 1:** **Affiliation:** Region Skåne **Name:** Maria Schelin, ass. prof. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6845 - Name: Death - Relevance: LOW - As Found: Unknown - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Debility ### Condition Browse Module - Meshes - ID: D000073496 - Term: Frailty ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431646 **Brief Title:** Effectiveness of Web-Based Education on Symptoms and Quality of Life in University Students With Premenstrual Syndrome **Official Title:** Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life #### Organization Study ID Info **ID:** 60116787-020/31827 #### Organization **Class:** OTHER **Full Name:** Pamukkale University #### Secondary ID Infos **Domain:** PamukkaleU Scientific Research Projects Coordination Unit **ID:** 2020SABE021 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2022-06-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-31 **Type:** ACTUAL #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pamukkale University #### Responsible Party **Investigator Affiliation:** Pamukkale University **Investigator Full Name:** Sevgi Özkan **Investigator Title:** Dean of Health Sciences Faculty, Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Digital solutions are becoming increasingly prevalent, addressing health concerns through innovative means has become imperative. Among these concerns, Premenstrual Syndrome (PMS) stands out as a significant challenge that affecting the physical and emotional well-being of women of reproductive age. Despite previous studies demonstrating the effectiveness of health education for PMS, there remains a gap in providing accessible and cost-effective evidence-based interventions. The present study seeks to address this gap by using technology to provide targeted information and support to women. For this reason, the purpose of this randomized controlled study is to evaluate the effectiveness of a web-based health education in university students with PMS. The main questions it aims to answer are: * Does web-based education lower the premenstrual symptoms in university students with PMS? * Does web-based education improve the quality of life in university students with PMS? Researchers compared web-based education to a control (no special intervention) to see if intervention works to management PMS. Intervention group participants received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management strategies for 4 weeks. **Detailed Description:** The study was planned as a parallel, single-blind, randomized, controlled experimental study with a pretest-posttest design. The sample group of the research was the nursing department of a Faculty of Health Sciences in Pamukkale University. Eligibility was determined by the Premenstrual Syndrome Scale and personal information form. The sample size was calculated in the PS Power and Sample Size Calculations 3.1.6 program by using data from a previous study with a large effect size (α =0.05, d=0.86). Accordingly, it was found that at least 32 participants should be taken for each group to sampling for 80% power. To avoid possible data loss, all participants (n=74) determined to be eligible were included in the study. A simple randomization method was used in this study. Outcomes were measured at baseline, 4 weeks, and 12 weeks after the intervention began. Data were collected using the Premenstrual Syndrome Scale, Premenstrual Symptoms Impact Scale, System Usability Scale, and personal information form. ### Conditions Module **Conditions:** - Premenstrual Syndrome - Quality of Life **Keywords:** - Premenstrual Syndrome - Web-Based - Nurse-Led - Health Education - Quality of Life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized controlled study with a pretest-posttest design ##### Masking Info **Masking:** SINGLE **Masking Description:** Student **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 67 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management (especially, non-pharmacologic strategies) for 4 weeks. **Intervention Names:** - Behavioral: A web-based education intervention developed for university students with PMS **Label:** Intervention Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group received no special intervention. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group **Description:** The content of the web-based education program includes the definition, prevalence, importance, causes, symptoms, diagnosis, risk factors, management strategies and treatment options of PMS. The education emphasizes non-pharmacological strategies for managing PMS, including diet, exercise and body mass index (BMI), sleep hygiene, smoking cessation, stress management, as well as vitamin and mineral supplements, herbal therapy, acupuncture, acupressure and reflexology. **Name:** A web-based education intervention developed for university students with PMS **Other Names:** - Premenstrual Syndrome Education Program **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The form was designed by researchers to collect students' socio-demographic characteristics and factors related to PMS, including menstrual characteristics and associated risk factors. **Measure:** Personal Information Form **Time Frame:** Baseline #### Primary Outcomes **Description:** The scale consists of 44 questions about to experiences in the week before the menstrual period. The total score ranges from 44 to 220, and above the 132 points indicates the presence of PMS. The nine subscales are as follows: (1) depressive affect, (2) anxiety, (3) fatigue, (4) irritability, (5) depressive thoughts, (6) pain, (7) appetite changes, (8) sleep changes, and (9) swelling. **Measure:** Premenstrual Syndrome Scale (PMSS) **Time Frame:** Change from baseline score at 4 and 12 weeks **Description:** The scale consists of six question to evaluate the impact of premenstrual symptoms on health-related quality-of-life. Each question measures the intensity of symptoms ranging from 1 (no influence) to 5 (severe influence), concerning the "last premenstrual period". The total score ranges from 6 to 30, with higher scores indicating worsening quality of life. **Measure:** Premenstrual Symptoms Impact Scale (PMSIS) **Time Frame:** Change from baseline score at 4 and 12 weeks #### Secondary Outcomes **Description:** The scale consists of 10 questions to evaluate user satisfaction with the usability of products and systems, including websites. Each question scored between 0 (strongly disagree) and 4 (strongly agree) and the total score obtained is multiplied by 2.5 to obtain a score between 0 and 100. A score of 68 or higher is considered above average and indicates the system is usable. **Measure:** System Usability Scale (SUS) **Time Frame:** At the end of the 4-week intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Presence of PMS, defined as a score of 132 and above on the PMSS * Menstrual cycle within the normal range (21-35 days) * Not using oral contraceptives * Not having any psychiatric- related problems or treatment * Actively using the Internet * Be over 18 years old * Volunteering to participate in research Exclusion Criteria: * Problems accessing the Internet * Inability to log into the website * Non-response to the survey questions **Gender Based:** True **Gender Description:** Female students with PMS **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Denizli **Country:** Turkey **Facility:** Pamukkale University **Zip:** 20160 #### Overall Officials **Official 1:** **Affiliation:** Pamukkale University **Name:** Ece Özkaradiğin, RN, MSc **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Pamukkale University **Name:** Sevgi Özkan, RN, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Management of Premenstrual Syndrome: Green-top Guideline No. 48. BJOG. 2017 Feb;124(3):e73-e105. doi: 10.1111/1471-0528.14260. Epub 2016 Nov 30. No abstract available. **PMID:** 27900828 **Citation:** Taghizadeh Z, Shirmohammadi M, Feizi A, Arbabi M. The effect of cognitive behavioural psycho-education on premenstrual syndrome and related symptoms. J Psychiatr Ment Health Nurs. 2013 Oct;20(8):705-13. doi: 10.1111/j.1365-2850.2012.01965.x. Epub 2012 Sep 10. **PMID:** 22957993 **Citation:** Ayaz-Alkaya S, Yaman-Sozbir S, Terzi H. The effect of Health Belief Model-based health education programme on coping with premenstrual syndrome: a randomised controlled trial. Int J Nurs Pract. 2020 Apr;26(2):e12816. doi: 10.1111/ijn.12816. Epub 2020 Jan 27. **PMID:** 31985138 **Citation:** Simsek Kucukkelepce D, Timur Tashan S. The effects of health belief model-based education and acupressure for coping with premenstrual syndrome on premenstrual symptoms and quality of life: A randomized-controlled trial. Perspect Psychiatr Care. 2021 Jan;57(1):189-197. doi: 10.1111/ppc.12546. Epub 2020 May 29. **PMID:** 32468669 **Citation:** Borji-Navan S, Mohammad-Alizadeh-Charandabi S, Esmaeilpour K, Mirghafourvand M, Ahmadian-Khooinarood A. Internet-based cognitive-behavioral therapy for premenstrual syndrome: a randomized controlled trial. BMC Womens Health. 2022 Jan 8;22(1):5. doi: 10.1186/s12905-021-01589-7. **PMID:** 34996424 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000008599 - Term: Menstruation Disturbances ### 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: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M14167 - Name: Premenstrual Syndrome - Relevance: HIGH - As Found: Premenstrual Syndrome - ID: M11582 - Name: Menstruation Disturbances - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000013577 - Term: Syndrome - ID: D000011293 - Term: Premenstrual Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431633 **Acronym:** ARIAN **Brief Title:** Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free. **Official Title:** A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN #### Organization Study ID Info **ID:** GECP 23/03_ARIAN #### Organization **Class:** OTHER **Full Name:** Fundación GECP ### Status Module #### Completion Date **Date:** 2031-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2031-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-16 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fundación GECP #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. 129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment. This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded. **Detailed Description:** This is an open-label, phase II, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to: * ARM 1: Observational Arm for 10 months * ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W * ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause. Secondary objectives: * Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment * Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0. Exploratory objectives - To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS. The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded ### Conditions Module **Conditions:** - Lung Diseases - Carcinoma, Non-Small-Cell Lung - Resectable Lung Non-Small Cell Carcinoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 129 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients randomized in this arm will be in observation for 10 months. It is allowed to administer adjuvant treatment according to investigator criteria. Immunotherapy is not allowed in this arm, only chemotherapy treatment is allowed. **Intervention Names:** - Drug: Cisplatin - Drug: Carboplatin **Label:** ARM 1: Observation-investigator decision **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Adjuvant treatment with Zimberelimab will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W). Zimberelimab: day 1 360 mg IV Q3W (13 cycles) **Intervention Names:** - Drug: Zimberelimab **Label:** ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Sacituzumab Govitecan: day 1 and 8; 10mg/Kg IV Q3W Zimberelimab: day 1 360 mg IV Q3W Treatment sequence: Adjuvant treatment will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W). Patients will receive 8 cycles of Sacituzumab Govitecan + Zimberelimab and 5 cycles of Zimberelimab monotherapy. **Intervention Names:** - Drug: Zimberelimab - Drug: Sacituzumab govitecan **Label:** ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles - ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles **Description:** Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells. Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL. No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle. **Name:** Zimberelimab **Other Names:** - anti-PD-1 monoclonal antibody AB122 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles **Description:** Sacituzumab govitecan (SG) is an ADC composed of the following 3 components: o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers. o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38. Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer. **Name:** Sacituzumab govitecan **Other Names:** - Trodelvy **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - ARM 1: Observation-investigator decision **Description:** Cisplatin-based adjuvant chemotherapy Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation. **Name:** Cisplatin **Other Names:** - Platinol **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - ARM 1: Observation-investigator decision **Description:** Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02 **Name:** Carboplatin **Other Names:** - Paraplatin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Analyze plasma samples and quantifying the amount of circulating tumor DNA (ctDNA) by NGS. **Measure:** Change in levels of ctDNA during treatment **Time Frame:** To analyze at pretreatment, after 6 months of treatment, and at disease relapse, assessed up to 36 months #### Primary Outcomes **Description:** Defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. **Measure:** Disease free survival **Time Frame:** The time from random assignment to cancer recurrence or death from any cause, assessed up to 36 months #### Secondary Outcomes **Description:** defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive. **Measure:** Overall survival **Time Frame:** To evaluate at 12, 24 and 36 months after the start of adjuvant treatment **Description:** Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria. **Measure:** Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) **Time Frame:** From the subject's written consent to participate in the study through 180 days after the final administration of the drug ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed. * 2. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology * 3. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide. Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station * 4. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study except if R0 resection can be confirmed. * 5. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible. * 6. Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory. * 7. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible. * 8. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery. * 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * 10. Patients aged ≥ 18 years. * 11. PDL1 value analysed locally (hospital must be able to provide this value before randomization) * 12. PET-CT and brain CT before randomization to confirm the absence of distant disease. * 13. Adequate hematologic and organ function * 14.All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention. * 15.For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception * 16. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception * 17. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. * 18.Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. * 19.Patient capable of proper therapeutic compliance and accessible for correct follow-up * 20. Patients with a life expectancy of at least more than 12 weeks Exclusion Criteria: * 1. Patients with a history of other malignant diseases, with the exception of the following: * properly treated non-melanotic skin cancer * cancer in situ treated with curative intent or other malignancies treated with curative intent and without signs of disease for a period of\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease. * 2.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus or spine * 3. Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusion in this trial. * 4. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study. * 5. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma * 6. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of randomization. * 7. Patients that received live attenuated vaccines within 30 days prior to randomization * 8. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments * 9. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol. * 10. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction * 11. Pregnant or breastfeeding women * 12. Patients in whom R0 resection cannot be confirmed. * 13. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * 14.Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * 15. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded. * 16. History of allergy or hypersensitivity to any of the study drug components * 17. Pleural or pericardial effusion, both will be considered indicative of metastatic disease unless proven otherwise. Patients with pleural effusion not visible on chest-X-ray or too small to perform diagnostic puncture safely may be included. * 18. Have known history of HIV-1 or 2 with detectable viral load OR taking medications that may interfere with SN-38 metabolism. * 19.Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. * 20.Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures. * 21. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder; any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement; or prior pneumonectomy. * 22. Treatment with systemic immunosuppressive medications * 23.Patients with uncontrolled comorbidities that may affect the clinical trial compliance. * 24.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eva Pereira **Phone:** +34 934302006 **Role:** CONTACT #### Locations **Location 1:** **City:** Elche **Contacts:** ***Contact 1:*** - **Name:** Miguel Borregón Rivilla, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Miguel Borregón Rivilla, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital General de Elche **State:** Alicante **Zip:** 03203 **Location 2:** **City:** Badalona **Contacts:** ***Contact 1:*** - **Name:** Marta Domenech, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Marta Domenech, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** ICO Badalona, Hospital Germans Trias i Pujol **State:** Barcelona **Zip:** 08916 **Location 3:** **City:** Hospitalet de Llobregat **Contacts:** ***Contact 1:*** - **Name:** Ernest Nadal, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Ernest Nadal, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** ICO Hospitalet **State:** Barcelona **Zip:** 08908 **Location 4:** **City:** Jerez De La Frontera **Contacts:** ***Contact 1:*** - **Name:** Mª Ángeles Moreno, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Mª Ángeles Moreno, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Jerez De La Frontera **State:** Cádiz **Zip:** 11407 **Location 5:** **City:** A Coruña **Contacts:** ***Contact 1:*** - **Name:** Rosario García Campelo, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Rosario García Campelo, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospitalario Universitario A Coruña **State:** La Coruña **Zip:** 15006 **Location 6:** **City:** Las Palmas De Gran Canaria **Contacts:** ***Contact 1:*** - **Name:** David Aguiar Bujanda, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** David Aguiar Bujanda - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari de Gran Canària Doctor Negrín **State:** Las Palmas **Zip:** 35010 **Location 7:** **City:** Majadahonda **Contacts:** ***Contact 1:*** - **Name:** Mariano Provencio, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Mariano Provencio, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Puerta de Hierro **State:** Madrid **Zip:** 28222 **Location 8:** **City:** Palma De Mallorca **Contacts:** ***Contact 1:*** - **Name:** Aitor Azkárate Martínez, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Aitor Azkárate Martínez, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital de Son Espases **State:** Mallorca **Zip:** 07120 **Location 9:** **City:** Vigo **Contacts:** ***Contact 1:*** - **Name:** Gerardo Huidobro, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Gerardo Huidobro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Complejo Hospitalario Universitario de Vigo **State:** Pontevedra **Zip:** 36036 **Location 10:** **City:** Reus **Contacts:** ***Contact 1:*** - **Name:** Clara Lucía Gozálvez, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Clara Lucía Gozálvez, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari Sant Joan de Reus **State:** Tarragona **Zip:** 43204 **Location 11:** **City:** Alicante **Contacts:** ***Contact 1:*** - **Name:** Bartomeu Massuti, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Bartomeu Massuti, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital General Universitario de Alicante **Zip:** 03010 **Location 12:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Alex Martínez, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Alex Martínez, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari Vall d' Hebron **Zip:** 08035 **Location 13:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Noemí Reguart - **Role:** CONTACT ***Contact 2:*** - **Name:** Noemí Reguart, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Clínic De Barcelona **Zip:** 08036 **Location 14:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Andres Barba, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Andres Barba, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital de la Santa Creu i Sant Pau **Zip:** 08041 **Location 15:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Laia Vilà, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Laia Vilà, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Parc Taulí **Zip:** 08208 **Location 16:** **City:** Bilbao **Contacts:** ***Contact 1:*** - **Name:** Mª Ángeles Sala, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Mª Ángeles Sala, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital De Basurto **Zip:** 48013 **Location 17:** **City:** León **Contacts:** ***Contact 1:*** - **Name:** Blanca Távara, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Blanca Távara, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario de León **Zip:** 24071 **Location 18:** **City:** Lugo **Contacts:** ***Contact 1:*** - **Name:** Begoña Campos, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Begoña Campos, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Lucus Augusti **Zip:** 27003 **Location 19:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Monica Antoñanzas, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Monica Antoñanzas, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Clínico San Carlos **Zip:** 28040 **Location 20:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Manuel Dómine, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Manuel Dómine, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Fundación Jiménez Díaz **Zip:** 28040 **Location 21:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Javier De Castro, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Javier De Castro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario la Paz **Zip:** 28046 **Location 22:** **City:** Ourense **Contacts:** ***Contact 1:*** - **Name:** Karmele Areses, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Karmele Areses - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Santa María Nai **Zip:** 32005 **Location 23:** **City:** Palma De Mallorca **Contacts:** ***Contact 1:*** - **Name:** Juan Coves Sarto, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Juan Coves Sarto, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari Son Llatzer **Zip:** 07198 **Location 24:** **City:** Salamanca **Contacts:** ***Contact 1:*** - **Name:** Alejandro Olivares Hernández, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Alejandro Olivares Hernández, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Salamanca **Zip:** 37007 **Location 25:** **City:** Santa Cruz De Tenerife **Contacts:** ***Contact 1:*** - **Name:** Karla Mercedes Medina, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Karla Mercedes Medina, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Nuestra Señora La Candelaria **Zip:** 38009 **Location 26:** **City:** Sevilla **Contacts:** ***Contact 1:*** - **Name:** Reyes Bernabé, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Reyes Bernabé, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Virgen del Rocío **Zip:** 41013 **Location 27:** **City:** Terrassa **Contacts:** ***Contact 1:*** - **Name:** Remei Blanco, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Remei Blanco, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Consorci Sanitari de Terrassa **Zip:** 08227 **Location 28:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Amelia Insa, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Amelia Insa, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Clínico de Valencia **Zip:** 46010 **Location 29:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Oscar Juan-Vidal, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Oscar Juan-Vidal, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario La Fe **Zip:** 46026 **Location 30:** **City:** Valladolid **Contacts:** ***Contact 1:*** - **Name:** Rafael López, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Rafael López, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Clínico Universitario de Valladolid **Zip:** 47003 #### Overall Officials **Official 1:** **Affiliation:** President of Fundacion GECP **Name:** Mariano Provencio, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Web page of the sponsor where users can find more information about Fundación GECP studies **URL:** http://www.gecp.org ## 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: D000012140 - Term: Respiratory Tract Diseases - 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 ### 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: Carcinoma, Non-Small-Cell Lung - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - 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: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung - ID: D000008171 - Term: Lung Diseases ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000018796 - Term: Immunoconjugates - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: AA - Name: Amino Acids - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M287620 - Name: Sacituzumab govitecan - Relevance: HIGH - As Found: Major Depression - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5426 - Name: Camptothecin - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20855 - Name: Immunoconjugates - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: T8 - Name: Histidine - Relevance: LOW - As Found: Unknown - ID: T395 - Name: Glucosamine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin - ID: C000608132 - Term: Sacituzumab govitecan ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431620 **Brief Title:** Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer **Official Title:** Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer #### Organization Study ID Info **ID:** KY20240514-03 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-27 ### 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:** Feng Wang **Investigator Title:** Director of nuclear medicine department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Exogenous injection of recombinant human thyroid stimulating hormone (rhTSH) can elevate TSH in the short term (2 days) to meet the requirements of diagnostic 131I SPECT/CT whole-body scans. Antiangiogenic tyrosine kinase inhibitors (TKI) couuld alter the uptake of radioactive 131I in locally advanced or metastatic differentiated thyroid cancer. rhTSH can help to perform the diagnostic 131I SPECT/CT whole-body scans before and after the TKI usage. rhTSH can reduce the risk of tumor progression caused by thyroid hormone withdrawal period and the side effects of hypothyroidism also caused by thyroid hormone withdrawal, and clarify the 131I uptake change after TKI treatment. ### Conditions Module **Conditions:** - Recombinant Human Thyroid Stimulating Hormone ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** rhTSH is used to raise blood TSH levels to meet the requirements of diagnostic 131I SPECT/CT whole-body scans before and after TKI medication. **Intervention Names:** - Drug: Recombinant Human Thyroid Stimulating Hormone **Label:** rhTSH group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - rhTSH group **Description:** recombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. **Name:** Recombinant Human Thyroid Stimulating Hormone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients with thyroid stimulating hormone\>30 mIU/L **Measure:** TSH **Time Frame:** 24 hours after the second TSH injection #### Secondary Outcomes **Description:** Positive diagnosis rate of lesions in diagnostic 131I SPECT/CT whole-body scans **Measure:** Positive diagnosis rate of lesions **Time Frame:** 72 hours after 131I treatment until progression or death, whichever came first ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 18\~75 years old (including 18 and 75 years old); * ECOG: 0-2 points; * Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker (tg), biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1. * Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L; * Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men); * Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up; * Patients diagnosed with iodine-refractory/potentially iodine-refractory DTC after multidisciplinary team discussion. Exclusion Criteria: * Accompanied by pleural effusion or ascites, causing respiratory distress; * Symptoms of brain metastasis cannot be controlled and treated in less than 2 months; there is a risk of suffocation due to excessively large neck metastatic masses; patients with spinal bone metastases have a risk of spinal cord compression paralysis; cardiac metastasis, heart failure, and patients at risk of acute cardiovascular events; * Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval (QTc) male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association (NYHA) classification); 3) Poorly controlled diabetes (fasting blood sugar \&gt;10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus (HCV) RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment. * Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization; * Unable to quit or with a history of psychiatric medication abuse; * Allergic to the investigational drug (rhTSH or 131I) or its excipients; * Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening; * Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening; * Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening; * Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study; * Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Feng Wang **Phone:** 02552271455 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liang Shi **Phone:** 02552271491 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Wang - **Phone:** 02552271455 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Liang Shi - **Phone:** 02552271491 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Nanjing Medical Univerity **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 #### Overall Officials **Official 1:** **Affiliation:** Nanjing First Hospital, Nanjing Medical University **Name:** Feng Wang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - 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: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431607 **Brief Title:** A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults **Official Title:** A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older #### Organization Study ID Info **ID:** 222853 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### 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 **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA). ### Conditions Module **Conditions:** - Influenza, Human **Keywords:** - Influenza - Safety - Reactogenicity - Immunogenicity - mRNA vaccine - Healthy younger adults - Healthy older adults ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** This is an observer blind study. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 1 **Label:** Flu mRNA_YA_Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 2 **Label:** Flu mRNA_YA_Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 3 **Label:** Flu mRNA_YA_Group 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 4 **Label:** Flu mRNA_YA_Group 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly. **Intervention Names:** - Combination Product: Active Comparator 1 **Label:** YA_Active Comparator Group 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 6 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 5 **Label:** Flu mRNA_OA_Group 1 **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 6 **Label:** Flu mRNA_OA_Group 2 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 7 **Label:** Flu mRNA_OA_Group 3 **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly. **Intervention Names:** - Biological: Flu Seasonal mRNA Formulation 8 **Label:** Flu mRNA_OA_Group 4 **Type:** EXPERIMENTAL #### Arm Group 10 **Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly. **Intervention Names:** - Combination Product: Active Comparator 2 **Label:** OA_Active Comparator Group 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Flu mRNA_YA_Group 1 **Description:** 1 dose of Flu mRNA Formulation 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 1 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Flu mRNA_YA_Group 2 **Description:** 1 dose of Flu mRNA Formulation 2 is administered intramuscularly in the non-dominant upper deltoid to YA at Day 1. **Name:** Flu Seasonal mRNA Formulation 2 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - Flu mRNA_YA_Group 3 **Description:** 1 dose of Flu mRNA Formulation 3 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 3 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - Flu mRNA_YA_Group 4 **Description:** 1 dose of Flu mRNA Formulation 4 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 4 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 5 **Arm Group Labels:** - Flu mRNA_OA_Group 1 **Description:** 1 dose of Flu mRNA Formulation 5 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 5 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 6 **Arm Group Labels:** - Flu mRNA_OA_Group 2 **Description:** 1 dose of Flu mRNA Formulation 6 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 6 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 7 **Arm Group Labels:** - Flu mRNA_OA_Group 3 **Description:** 1 dose of Flu mRNA Formulation 7 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 7 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 8 **Arm Group Labels:** - Flu mRNA_OA_Group 4 **Description:** 1 dose of Flu mRNA Formulation 8 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1. **Name:** Flu Seasonal mRNA Formulation 8 **Other Names:** - GSK4382276A **Type:** BIOLOGICAL #### Intervention 9 **Arm Group Labels:** - YA_Active Comparator Group 1 **Description:** 1 dose of active comparator 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1. **Name:** Active Comparator 1 **Type:** COMBINATION_PRODUCT #### Intervention 10 **Arm Group Labels:** - OA_Active Comparator Group 2 **Description:** 1 dose of active comparator 2 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1. **Name:** Active Comparator 2 **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Measure:** Geometric mean titer (GMT) of antigen 1 antibody **Time Frame:** At Day 29 **Measure:** Geometric mean increase (GMI) of Antigen 1 antibody titer **Time Frame:** From Day 1 to Day 29 **Measure:** Percentage of participants with antigen 1 seroconversion rate (SCR) **Time Frame:** From Day 1 to Day 29 **Measure:** Percentage of participants with antigen 1 titer greater than or equal to (>=) the cut off value at Day 1 **Time Frame:** At Day 1 **Measure:** Percentage of participants with antigen 1 titer >= the cut off value at Day 29 **Time Frame:** At Day 29 #### Secondary Outcomes **Measure:** GMT of antigen 2 antibody **Time Frame:** At Day 29 **Measure:** GMI of antigen 2 antibody titer **Time Frame:** From Day 1 to Day 29 **Measure:** Percentage of participants with Antigen 2 SCR **Time Frame:** From Day 1 to Day 29 **Description:** The following administration site events are solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). **Measure:** Percentage of participants reporting each solicited administration site event **Time Frame:** Day 1 to Day 7 **Description:** The following systemic events are solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature \>=38 °C/100.4°F regardless the location of measurement. The route for measuring temperature is oral. **Measure:** Percentage of participants reporting each solicited systemic event **Time Frame:** Day 1 to Day 7 **Description:** An unsolicited AE is defined as an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. **Measure:** Percentage of participants reporting unsolicited adverse events (AEs) **Time Frame:** Day 1 to Day 28 **Description:** An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. **Measure:** Percentage of participants reporting serious adverse events (SAEs) **Time Frame:** Day 1 to Day 183 **Description:** The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). **Measure:** Percentage of participants reporting adverse events of special interest (AESIs) **Time Frame:** Day 1 to Day 183 **Description:** A MAAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physicians office visits, emergency room visits or hospitalization). **Measure:** Percentage of participants reporting medically attended adverse events (MAAEs) **Time Frame:** Day 1 to Day 183 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration. 2. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment. 3. Body mass index (BMI) \>=18 Kilograms per meter square (kg/m²) and less than or equal to (\<=) 35kg/m2. 4. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver. 5. Written informed consent obtained from the participant prior to performance of any study-specific procedure. 6. Female participants of non-childbearing potential may be enrolled in the clinical study. 7. Female participants of childbearing potential may be enrolled in the clinical study, if the participant: * Has practiced adequate contraception for 1 month prior to the study intervention administration, and * Has a negative pregnancy test within 24 hours prior to the study intervention administration, and * Has agreed to continue adequate contraception for at least 1 month after study intervention administration. Exclusion Criteria: 1. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1. 2. Current or past malignancy, unless completely resolved without sequelae for greater than (\>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer). 3. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is \>= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (\<) 50 copies/milliliter \[mL\]) (based on medical records, no laboratory testing required). 4. Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study. 5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics). 6. Hypersensitivity to latex. 7. Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood. 8. Any history of dementia or any medical condition that moderately or severely impairs cognition. 9. Any condition that in the judgment of the investigator would make intramuscular injection unsafe. 10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. 11. Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration. 12. Previous vaccination with a mRNA influenza vaccine. 13. Administration of a vaccine not foreseen by the study protocol in the period starting 30 days (Day -30) before the study intervention administration, or planned administration within 28 days (Visit 2 \[Day 29\]) after the study intervention administration\*. * If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified. 14. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period. 15. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period. 16. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Up to 3 months prior to the study intervention administration: For corticosteroids, this will mean prednisone equivalent \>=20 mg/day. Inhaled, intraarticular and topical steroids are allowed. * Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. 17. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). 18. Pregnant or lactating female participant. 19. Bedridden participants. 20. Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period. 21. History of chronic alcohol consumption and/or drug abuse in the past 5 years as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. 22. Any study personnel or their immediate dependents, family, or household members. 23. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Hialeah **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jose Cardona - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Florida **Status:** RECRUITING **Zip:** 33012 **Location 2:** **City:** Miami **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Kimberly S Cruz - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33147 **Location 3:** **City:** Miami **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Rafael Ubeda - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Florida **Status:** RECRUITING **Zip:** 33186 **Location 4:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Rupal Trivedi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60640 **Location 5:** **City:** Valparaiso **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Robert J. Buynak - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Indiana **Status:** NOT_YET_RECRUITING **Zip:** 46383 **Location 6:** **City:** El Dorado **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Michael Rausch - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Kansas **Status:** RECRUITING **Zip:** 67042 **Location 7:** **City:** Lenexa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Carlos A Fierro - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Kansas **Status:** RECRUITING **Zip:** 66219 **Location 8:** **City:** Newton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Troy Holdeman - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Kansas **Status:** RECRUITING **Zip:** 67114 **Location 9:** **City:** Wichita **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Terry D Klein - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Kansas **Status:** RECRUITING **Zip:** 67207 **Location 10:** **City:** Lexington **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mark S Adams - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Kentucky **Status:** RECRUITING **Zip:** 40509 **Location 11:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Patrick Connors - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** New York **Status:** RECRUITING **Zip:** 14609 **Location 12:** **City:** Greensboro **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Alexander Vance Murray - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** North Carolina **Status:** RECRUITING **Zip:** 27408 **Location 13:** **City:** East Greenwich **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** David L Fried - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Rhode Island **Status:** NOT_YET_RECRUITING **Zip:** 02818 **Location 14:** **City:** Knoxville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** William Smith - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Tennessee **Status:** RECRUITING **Zip:** 37909 **Location 15:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Laurence Chu - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 78705 **Location 16:** **City:** Fort Worth **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** William M Seger - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Status:** RECRUITING **Zip:** 76135 **Location 17:** **City:** Tomball **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Vicki Miller - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Status:** RECRUITING **Zip:** 77375 **Location 18:** **City:** Newport News **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** George H Freeman - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Virginia **Status:** RECRUITING **Zip:** 23606 **Location 19:** **City:** Norfolk **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mary Bailey - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 23502 ### 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: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009976 - Term: Orthomyxoviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: HIGH - As Found: Influenza - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12902 - Name: Orthomyxoviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007251 - Term: Influenza, Human ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431594 **Brief Title:** A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors **Official Title:** A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors #### Organization Study ID Info **ID:** 222730 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline #### Secondary ID Infos **Domain:** EU CT Number **ID:** 2024-513860-25 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-01-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-22 ### 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 **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount. ### Conditions Module **Conditions:** - Solid Tumors **Keywords:** - Solid Tumors - GSK5733584 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: GSK5733584 **Label:** Part 1: Dose Escalation **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: GSK5733584 **Label:** Part 2: Dose Expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1: Dose Escalation - Part 2: Dose Expansion **Description:** GSK5733584 will be administered **Name:** GSK5733584 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Part 1: Number of participants with dose limiting toxicity (DLT) **Time Frame:** Up to 21 days **Description:** ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) **Measure:** Part 2: Objective Response Rate (ORR) **Time Frame:** Up to approximately 28 months #### Secondary Outcomes **Measure:** Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584 **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584 **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584 **Time Frame:** Up to approximately 31 months **Description:** ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1 **Measure:** Part 1: Objective Response Rate (ORR) **Time Frame:** Up to approximately 31 months **Description:** DCR is defined as the percentage of subjects whose best overall response is Complete Response (CR), Partial Response (PR) or Stable Disease (SD) **Measure:** Part 1 and 2: Disease control rate (DCR) **Time Frame:** Up to approximately 31 months **Description:** DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause **Measure:** Part 1 and 2: Duration of response (DoR) **Time Frame:** Up to approximately 31 months **Description:** PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first). **Measure:** Part 1 and 2: Progression-free survival (PFS) **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2:Number of participants with treatment-emergent Anti-drug antibodies (ADA) **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2: Titers of ADA to GSK5733584 **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 31 months **Measure:** Part 1 and 2: Number of participants with clinically significant changes in physical examination **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in body temperature (degree Celsius) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in respiratory rate (breaths per minute) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in pulse rate (beats per minute) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)] **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in weight [kilogram (kg)] **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in white blood cell count (cells per microliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from Baseline in Platelet count (cells per microliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Description:** Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed **Measure:** Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Creatinine clearance (milliliter per minute) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) and Thrombin time (seconds) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in fibrinogen (milligrams per deciliter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Description:** Leukocyte esterase measured as negative or positive **Measure:** Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio) **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in CA-125 tumor marker [units per milliliter (U/mL)] **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)] **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Measure:** Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage] **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Description:** ECOG PS is used for measuring how the disease impacts a patient's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity. **Measure:** Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score **Time Frame:** Baseline (Day -1) and up to approximately 31 months **Description:** OS is defined as the time interval between the date of randomization (or from the first dose of the investigational product) and the date of death due to any cause **Measure:** Part 2: Overall Survival (OS) **Time Frame:** Up to approximately 31 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males or females aged 18 years or older (≥18 years). * Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care). * Participants have at least one target lesion as assessed per the RECIST 1.1 * Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose. * Have a life expectancy of at least 12 weeks. Exclusion Criteria: * Have received any of B7-H4-targeted therapies. * Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study. * Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment. * Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion * Major surgery within 4 weeks prior to the first dose of study treatment. * Evidence of brain metastasis unless asymptomatic. * Has inadequate bone marrow reserve or hepatic/renal functions. * Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG. * Evidence of current clinically significant arrhythmias or ECG abnormalities * Risk factors of prolonged QTc or arrhythmia events, * Left ventricular ejection fraction (LVEF) \< 50%. * Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events * Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Lake Mary **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Alexander Philipovskiy - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Florida **Zip:** 32746 **Location 2:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Sara Bouberhan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Massachusetts **Zip:** 02114 **Location 3:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Antonio Giordano - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Massachusetts **Zip:** 02215 **Location 4:** **City:** Detroit **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ira Winer - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Michigan **Zip:** 48201 **Location 5:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Minal Barve - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Zip:** 75230 **Location 6:** **City:** West Valley City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** William McKean - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Utah **Zip:** 84119 **Location 7:** **City:** Sydney **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Dhanusha Sabanathan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** GSK Investigational Site **State:** New South Wales **Zip:** 2109 **Location 8:** **City:** Ottawa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Moira Katherine Rushton-Marovac - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** GSK Investigational Site **State:** Ontario **Zip:** K1H 8L6 **Location 9:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Philippe Bedard - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** GSK Investigational Site **State:** Ontario **Zip:** M5G 2M9 ### 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 - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431581 **Brief Title:** Effect of a Mobile Health Intervention on Birth Outcome and Infant Health **Official Title:** Effect of a Mobile Health Intervention on Birth Outcome and Infant Health in a Tertiary Healthcare Facility in Nepal #### Organization Study ID Info **ID:** NHRC 42-2042 #### Organization **Class:** OTHER **Full Name:** Kathmandu University School of Medical Sciences ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kathmandu University School of Medical Sciences #### Responsible Party **Investigator Affiliation:** Kathmandu University School of Medical Sciences **Investigator Full Name:** Bhawana Shrestha **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight, preterm birth, and challenges in child growth and development. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviors for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery. Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal. In the initial phase, a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions. These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the m-Health intervention's effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital. The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up). Follow-up will be done from enrollment until the child reaches one year of age, with a focus on evaluating effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery) and infant health (growth and development of the infant). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health. **Detailed Description:** To evaluate the effect of mobile health intervention on birth outcome and infant health, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher and the research assistant will employ purposive sampling to select pregnant women visiting Dhulikhel Hospital in the out patient department (OPD) of the Obstetric department. Written informed consent will be obtained from research participants by either the researcher or research assistant. A focus group discussion will be conducted with pregnant women regarding enablers, barriers, and preferences in perinatal care for improving birth outcomes and infant health. A topic guide will be used for data collection. Subsequently, another focus group discussion will be done with the same participants after developing the educational video to assess the satisfaction and acceptability of the video within the targeted group. The goal of these focus group discussions are to understand the user's needs in educational video. The investigators will ensure that the educational video is user-centered by involving end users (pregnant women) throughout the design and development process. Then after, the content of educational video will be subjected to content validity assessments by subject matter experts to ascertain its accuracy and suitability. After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD. Phase 1: Recruitment, baseline data collection and randomization: The head of the obstetrics and pediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinic and immunization clinic, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 14 to 22 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at Dhulikhel Hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "perinatal care for a healthy birth and a healthy infant" from the participants in both the intervention and control groups. Phase 2: Delivery of the intervention: Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed. Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events: * During the baseline data collection phase, the initial educational video addressing "perinatal care for a healthy birth and healthy infant" will be viewed by participants via a tablet in a separate designated setting. * Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy. * Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic. * To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrollment until delivery and till the child reaches 1 year of age as per the reminder schedule. * Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others. Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit. Phase 3: Follow up Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits. • Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of perinatal care for birth outcome and infant health will be assessed approximately one month following the participants' initial viewing of the videos. • Birth outcome assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes. • Infant health assessment: In the subsequent phase of the study, which aims to evaluate the impact of the intervention on infant health, the growth and development of infant will be assessed. Both groups will be informed of the necessity of follow-up visits at the immunization clinic through phone calls. Following the notification, the growth and developmental assessments of the infants will be conducted at the immunization clinic on the day of their scheduled immunization visit (at 6 weeks, 14 weeks, 9 months, and 12 months of life). For those participants who are unable to visit immunization clinic of Dhulikhel Hospital, they will be followed up at their nearby health post or within their homes. This follow-up process will be conducted by the researcher, along with the assistance of a research assistant. ### Conditions Module **Conditions:** - Birth Outcomes - Infant Health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 494 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** An intervention group will receive standard care along with m-health intervention that includes tailored educational video, SMS and reminder phone call for follow up **Intervention Names:** - Behavioral: m-Health intervention (educational video, SMS and reminder phone call) **Label:** Intervention group (educational video, SMS and reminder phone call) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A control group will receive standard care along with a control video and reminder phone call for follow-up **Label:** Control Group (standard care, control video and reminder phone call for follow up) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group (educational video, SMS and reminder phone call) **Description:** Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive m-health intervention that includes a tailored educational video regarding perinatal care targeting positive birth outcomes and infant health, SMS messages, and reminder phone calls for follow-up **Name:** m-Health intervention (educational video, SMS and reminder phone call) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared. **Measure:** Birth weight **Time Frame:** 1-1.5 years **Description:** The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group. **Measure:** Gestational age at delivery **Time Frame:** 1-1.5 years #### Secondary Outcomes **Description:** Knowledge on perinatal care for healthy birth and healthy infant will be assessed through validated knowledge related questionnaire. The mean score will be be calculated for both the intervention and the control group and then will be compared. **Measure:** Knowledge on perinatal care **Time Frame:** 6 months **Description:** The weight of the infant will be measured in grams and compared to the World Health Organization(WHO) standard for weight-for-age of the infant. **Measure:** Weight of the infant **Time Frame:** 2-2.5 years **Description:** The height/length of the infant will be measured in centimeters and compared to the WHO standard for height-for-age of the infant. **Measure:** Height/Length of the infant **Time Frame:** 2-2.5 years **Description:** The development of an infant will be evaluated using the Ages and Stages Questionnaire (ASQ) and average ASQ score will be determined **Measure:** Development of an infant **Time Frame:** 2-2.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women of age 18 years and above; * Pregnant with 14 to 22 weeks of gestation; * Planned to deliver a child and come for infant's vaccination at Dhulikhel hospital; * Pregnant women who use smart phone; * Pregnant women who have plan to stay in Dhulikhel thorough out this study period; * Can read and understand Nepali language Exclusion Criteria: * Vision impairment and diagnosed learning difficulties **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bhawana Shrestha, M.Sc. Nursing **Phone:** 977-9841748266 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kunta Devi Pun, PhD **Phone:** 977-9841239826 **Role:** CONTACT #### Locations **Location 1:** **City:** Dhulikhel **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bhawana Shrestha, M.Sc. Nursing - **Phone:** 977-9841748266 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Kunta Devi Pun, PhD - **Phone:** 977-9841239826 - **Role:** CONTACT ***Contact 3:*** - **Name:** Anjana Dongol, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Archana Shrestha, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Srijana Dongol, MD - **Role:** SUB_INVESTIGATOR **Country:** Nepal **Facility:** Bhawana Shrestha **State:** Bagmati **Zip:** 45210 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug. **PMID:** 26425706 **Citation:** Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8. **PMID:** 36151526 **Citation:** Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21. **PMID:** 25178042 **Citation:** Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z. **PMID:** 32005294 **Citation:** Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019. **PMID:** 35252905 **Citation:** Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019. **PMID:** 33134854 #### See Also Links **Label:** Effectiveness of Theory of Planned Behavior-Based Educational Intervention on Newborn Care in Pregnant Mothers: A Quasi-experimental Study. Jundishapur J Health Sci. 2021;13(4) **URL:** https://brieflands.com/articles/jjhs-117452.html **Label:** Early Childhood Development (ECD) \| UNICEF India **URL:** https://www.unicef.org/india/what-we-do/early-childhood-development **Label:** Effect of parenting intervention through "Care for Child Development Guideline" on early child development and behaviors: a randomized controlled trial. BMC Pediatr.2022;22(1):690 **URL:** https://doi.org/10.1186/s12887-022-03752-x **Label:** Health Behaviors and Behavior Change during Pregnancy: Theory-Based Investigation of Predictors and Interrelations. Sexes. 2022 Sep;3(3):351-66. **URL:** https://doi.org/10.3390/sexes3030027 **Label:** Pregnancy and Childbirth - Healthy People 2030 \| health.gov **URL:** https://health.gov/healthypeople/objectives-and-data/browse-objectives/pregnancy-and-childbirth **Label:** Lessons from digital technology-enabled health interventions implemented during the coronavirus pandemic to improve maternal and birth outcomes: a global scoping review. BMC Pregnancy Childbirth. 2023 Mar 20;23(1):195. **URL:** https://doi.org/10.1186/s12884-023-05454-3 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431568 **Acronym:** Ondansetron **Brief Title:** Ondansetron Prior Spinal Anaesthesia **Official Title:** Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study) #### Organization Study ID Info **ID:** IRB0000871252 #### Organization **Class:** OTHER **Full Name:** Assiut University #### Secondary ID Infos **Domain:** Maternity Hospital **ID:** Kuwait MOH **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-02 **Type:** ACTUAL #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Kuwait Institute for Medical Specialization #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Abdelrady S Ibrahim, MD **Investigator Title:** Professor of Anesthesia and ICU **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration. **Detailed Description:** Hypothesis: Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia. Aim: Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration. Objectives: * Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not * Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia. ### Conditions Module **Conditions:** - Cesarean Section **Keywords:** - Spinal anesthesia, Cesarean section, Ondansetron ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 400 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron **Label:** Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia ### Outcomes Module #### Primary Outcomes **Description:** incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron **Measure:** Blood Pressure **Time Frame:** one hour #### Secondary Outcomes **Description:** Incidence of bradycardia after ondansetron **Measure:** Heart rate **Time Frame:** One hour **Description:** Incidence of use of ephedrine or phenylpherine **Measure:** Vasopressor **Time Frame:** One hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant patients undergoing elective caesarean section Exclusion Criteria: * Preeclampsia * Eclampsia * Hypertension * Diabetes **Gender Based:** True **Gender Description:** Pregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants ### Contacts Locations Module #### Locations **Location 1:** **City:** Assiut **Country:** Egypt **Facility:** Assiut university faculty of medicine #### Overall Officials **Official 1:** **Affiliation:** Assiut University Faculty Of Medicine **Name:** Abdelrady S Ibrahim, .M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019. **PMID:** 30881108 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5196 - Name: Bradycardia - Relevance: LOW - As Found: Unknown - ID: M10072 - Name: Hypotension - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: AnEm - Name: Antiemetics - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M19588 - Name: Ondansetron - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431555 **Brief Title:** Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome **Official Title:** Magnetic Resonance Lung Function Imaging Study of Pulmonary Fibrosis Combined With Emphysema Syndrome #### Organization Study ID Info **ID:** 2024-ke-107 #### Organization **Class:** OTHER **Full Name:** Beijing Chao Yang Hospital ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-10 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Chao Yang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study intends to use magnetic resonance pulmonary function imaging technology to explore imaging markers for early diagnosis of patients with CPFE. Through baseline, 6-month and 12-month follow-up examinations, the changes in magnetic resonance pulmonary function in patients with CPFE and their correlation with disease progression were explored. ### Conditions Module **Conditions:** - Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 55 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Non-contrast, free-breathing MRI scan **Name:** MRI **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Calculate MRI lung perfusion defect as a percentage of the whole lung **Measure:** perfusion defect percentage **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \<1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter \> 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities. Exclusion Criteria: * (1) Refusal to sign the informed consent form; (2) MRI contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer MRI examinations). **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** (1) Chest HRCT shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \<1 mm) low-transmittance areas with clear boundaries with normal tissue, or multiple bullae (diameter \> 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tao Ouyang, PhD **Phone:** +86 18720931226 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tao Ouyang, PhD - **Phone:** +86 18720931226 - **Role:** CONTACT **Country:** China **Facility:** Beijing Chaoyang Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100020 #### Overall Officials **Official 1:** **Affiliation:** Beijing Chao Yang Hospital **Name:** Shumin Wang, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000017563 - Term: Lung Diseases, Interstitial - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M14512 - Name: Pulmonary Fibrosis - Relevance: HIGH - As Found: Pulmonary Fibrosis - ID: M14510 - Name: Pulmonary Emphysema - Relevance: HIGH - As Found: Emphysema - ID: M7812 - Name: Emphysema - Relevance: HIGH - As Found: Emphysema - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011658 - Term: Pulmonary Fibrosis - ID: D000011656 - Term: Pulmonary Emphysema - ID: D000013577 - Term: Syndrome - ID: D000005355 - Term: Fibrosis - ID: D000004646 - Term: Emphysema ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431542 **Brief Title:** Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis **Official Title:** Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis #### Organization Study ID Info **ID:** XMZSYYKY2024-047 #### Organization **Class:** OTHER **Full Name:** Zhongshan Hospital Xiamen University ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhongshan Hospital Xiamen University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment. **Detailed Description:** The study analyzes the clinical characteristics, including symptoms and physical examinations, as well as the types of fungal infections. It compares the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in treating otomycosis two weeks after starting treatment. Furthermore, the study also compares the recurrence rates six months after treatment. ### Conditions Module **Conditions:** - Otomycosis **Keywords:** - triamcinolone acetonide econazole cream - otomycosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The doctor provided detailed instructions for the patient to self-apply Triamcinolone Acetonide Econazole Cream to the external auditory canal once daily for two weeks. **Intervention Names:** - Procedure: patient-applied Triamcinolone Acetonide Econazole Cream **Label:** patient-applied medication group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications. **Intervention Names:** - Procedure: physician-applied Triamcinolone Acetonide Econazole Cream **Label:** physician-applied medication group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - physician-applied medication group **Description:** The doctor applies the Triamcinolone Acetonide Econazole Cream onto a thin cotton swab and gently inserts it deep into the ear canal, evenly spreading the cream around the sides of the ear canal and on the surface of the eardrum. **Name:** physician-applied Triamcinolone Acetonide Econazole Cream **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - patient-applied medication group **Description:** The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab. **Name:** patient-applied Triamcinolone Acetonide Econazole Cream **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Treatment efficacy is defined as the proportion of patients who are effective after two weeks of treatment. Effectiveness is defined by the absence of abnormalities in the external auditory canal and the alleviation of symptoms. **Measure:** treatment efficacy **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Recurrence rate is assessed six months later during a follow-up examination, where the presence of abnormal secretions in the ear canal and the recurrence of symptoms are noted. **Measure:** recurrece rate **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing; 2. Physical examination findings:presence of fungal hyphae or accumulations that appear creamy or cheese-like or resembling abnormal earwax (crusts, films) , skin redness, erosion, swelling, or granulation tissue within the ear canal; 3. Positive results in fungal culture. Exclusion Criteria: * The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy. **Maximum Age:** 100 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chunsheng Ye, MD **Phone:** +8613400661815 **Role:** CONTACT #### Locations **Location 1:** **City:** Xiamen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Chunsheng Ye, MD - **Phone:** +8613400661815 - **Role:** CONTACT **Country:** China **Facility:** Xiamen University Zhongshan Hospital **State:** Fujian **Zip:** 361000 #### Overall Officials **Official 1:** **Affiliation:** Xiamen University Zhongshan Hospital **Name:** Chunsheng Chunsheng **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009181 - Term: Mycoses - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M29414 - Name: Otomycosis - Relevance: HIGH - As Found: Otomycosis - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059249 - Term: Otomycosis ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000058888 - Term: 14-alpha Demethylase Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000006727 - Term: Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M7635 - Name: Econazole - Relevance: HIGH - As Found: Czech - ID: M16974 - Name: Triamcinolone - Relevance: HIGH - As Found: Subcutaneous injection - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: HIGH - As Found: Combination Therapy - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: HIGH - As Found: Combination Therapy - ID: M209573 - Name: Triamcinolone diacetate - Relevance: HIGH - As Found: Combination Therapy - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004464 - Term: Econazole - ID: D000014221 - Term: Triamcinolone - ID: D000014222 - Term: Triamcinolone Acetonide - ID: C000005900 - Term: Triamcinolone hexacetonide - ID: C000030262 - Term: Triamcinolone diacetate ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431529 **Acronym:** Neoantigen-T **Brief Title:** A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors **Official Title:** Exploratory Clinical Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors #### Organization Study ID Info **ID:** SWZL20231008 #### Organization **Class:** OTHER **Full Name:** Jinling Hospital, China ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Nanjing University #### Lead Sponsor **Class:** OTHER **Name:** JIANG LONGWEI #### Responsible Party **Investigator Affiliation:** Jinling Hospital, China **Investigator Full Name:** JIANG LONGWEI **Investigator Title:** Associate Researcher **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are: Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer. To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients. **Detailed Description:** In this open, single-armed study, selected patients with advanced solid tumor confirmed by Histopathology will be received tumor neoantigen specific T cells treatment. First, their tumor specimen will be collected from surgery or puncture，then their PBMC will be separated by blood cell separator. This cells will be cultured and selected in GMP laboratory to make tumor neoantigen specific T cells. The tumor neoantigen specific T cells will be infused intravenous into patients. ### Conditions Module **Conditions:** - Tumor, Solid **Keywords:** - Solid tumor; T cell; neoantigen ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tumor neoantigen specific T cells will be infused intravenously into patients. The number of T cells will be more than 1.0E9. **Intervention Names:** - Biological: tumor neoantigen specific T cell **Label:** tumor neoantigen specific T cell **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - tumor neoantigen specific T cell **Description:** Isolate the patient's autologous monocytes, induce and culture them into tumor antigen presenting cells in vitro, and then phagocytose tumor tissue cells obtained from biopsy or surgery to present tumor neoantigens to autologous T cells. The final product For tumor neoantigen specific T cells (NeoT). **Name:** tumor neoantigen specific T cell **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** The adverse events and severe adverse events will be evaluated. **Measure:** Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients **Time Frame:** 2 years #### Secondary Outcomes **Description:** The objective clinical response will be evaluated. **Measure:** Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-75 years old; 2. Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer; 3. Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months; 4. ECOG: 0-2 points; 5. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment; 6. Those who can understand this trial and have signed the informed consent form; 7. Able to follow the research protocol and follow-up procedures Exclusion Criteria: 1. Those who have received any form of immunotherapy within the past 3 months; 2. Those who need to use immunosuppressants; 3. Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month; 4. Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) ); 5. White blood cell count \<3E9/L, platelet count \<80E9/L; 6. AST and ALT\>3×the upper limit of normal (ULN), total bilirubin\>2×ULN, and AST and ALT\>6×ULN in patients with liver metastasis; 7. Creatinine clearance \<60ml/min; 8. Abnormal coagulation function; 9. The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition); 10. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA detection value is \>100 IU/mL; hepatitis C virus (HCV) antibody is positive and the peripheral blood hepatitis C Those who are positive for hepatitis virus (HCV) RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for cytomegalovirus (CMV) DNA; those who are positive for syphilis; 11. Diseases judged by the researcher to be ineligible for inclusion: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment, uncontrollable coronary artery disease or asthma, and uncontrollable cerebrovascular disease. 12. Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment; 13. Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation; 14. Those who may be allergic to study drugs; 15. Participate in other clinical trials one month before registration; 16. Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened; 17. Any uncertain factors that affect patient safety or compliance; 18. Other researchers believe that the subject is not suitable for inclusion. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jiang Longwei, Master **Phone:** +86-02580864524 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jiang Longwei, Master - **Phone:** +86-02580864524 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jia Shaochang, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Zen Ke, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Liu Yuan, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Jiang Longwei, Master - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Nanjing Jinling Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 210002 #### Overall Officials **Official 1:** **Affiliation:** Jinling Hospital, China **Name:** Jia Shaochang, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431516 **Brief Title:** LMCA Treatment Outcome **Official Title:** Clinical Outcomes of Medical Treatment for Patients With Significant Unprotected Left Main Coronary Artery Disease #### Organization Study ID Info **ID:** 2023.230 #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese University of Hong Kong #### Responsible Party **Investigator Affiliation:** Chinese University of Hong Kong **Investigator Full Name:** GuangMing Tan **Investigator Title:** Assistant professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet. **Detailed Description:** Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet. ### Conditions Module **Conditions:** - Left Main Coronary Artery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 4600 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Label:** Patients with significant LMCA disease #### Arm Group 2 **Label:** normal patient ### Outcomes Module #### Primary Outcomes **Description:** Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization **Measure:** Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization **Time Frame:** 1 year **Description:** Death of any cause. **Measure:** Death of any cause. **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with significant LMCA disease who were on the waitlist for CABG since 1st January 2000 to 31st December 2020. * The decision for CABG over PCI as a mode of revascularization for the patients on this waitlist were collectively made by the HEART team Exclusion Criteria: * patients with co-existing significant valvular heart disease requiring concomitant surgical intervention, and unstable patients in whom urgent surgical intervention was performed **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Categorical variables will be presented as numbers and percentages and continuous data as mean and standard deviation. Kaplan-Meier survival curve will be obtained using time to event analysis will be performed for this study, with the time of CABG referral counted as day 0 and the day of CABG counted as the end of follow-up. Multivariate Cox regression analysis will be conducted to delineate the predictors for primary outcomes. Potential implications of this study This study will inform us about the mid-term clinical outcomes of modern-day medical therapy in patients with significant LMCA disease. Potential predictors of adverse outcome could be identified through regression analysis. This might help us to identify and expedite CABG arrangement for patients with these risk factors. ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Prince of Wales Hospital **State:** Shatin **Zip:** 0000 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431503 **Brief Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain **Official Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain #### Organization Study ID Info **ID:** CMUH112-REC1-132 #### Organization **Class:** OTHER **Full Name:** China Medical University Hospital ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China Medical University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this clinical trial was to find out whether Tok Sen massage (a massage method with wooden instruments from northern Thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. The main questions it aims to answer are: Can Tok Sen Massage Relieve Chronic Lower Back Pain? Can Tok Sen massage improve the quality of life of patients with chronic low back pain? Researchers compared Tok Sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain. Participants will: Receive Tok Sen massage or pressure massage every week for 1 month. Questionnaires and flexion measurements before and after each massage. After the massage session, fill out the online questionnaire once a month for three months. **Detailed Description:** Low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (YLDs), with a high prevalence of 28%-42% among those aged 40 to 69 years. The prevalence of different occupations in Taiwan ranges from 35% to 90%; according to the summary of the National Health Insurance Database results report: "The annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime Suffering from low back pain. "Most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. Approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. Tok-Sen Massage is a kind of folk therapy in northern Thailand, specializing in musculoskeletal system diseases. This trial selected Pressure Massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain. This is an open-label and randomized controlled trial. Patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the Tok-Sen Massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the Pressure Massage group received a 40-minute intervention once a week for a total of 4 times. Massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs. The evaluation methods are: 1. Oswestry Disability Index (ODI) (baseline and after three interventions), 2. Visual Analogue Scale (VAS)before and after each massage, 3. Trunk flexibility test. before and after each massage. ### Conditions Module **Conditions:** - Non-specific Chronic Low Back Pain **Keywords:** - Tok-Sne massage - pressure massage - low back pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tok-Sen massage uses a mallet to hit a wooden wedge to produce impact and sound. **Intervention Names:** - Other: Tok-Sen Massage **Label:** Tok-Sen massage **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Pressure massage uses the wooden wedge to press. **Intervention Names:** - Other: Pressure Massage **Label:** Pressure massage **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tok-Sen massage **Description:** Press the wedge and tapping: the strength for pressing the wadge is 1000g±50g, the height for mallet free fall(instead of beating by arm)10cm±2cm. For Pressure massage, the strength for pressing the wadge is 1500g±50g. **Name:** Tok-Sen Massage **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Pressure massage **Description:** Press the wedge: the strength for pressing the wadge is 1500g±50g, **Name:** Pressure Massage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Improvement in ODI score **Measure:** Improve the disability of low back pain **Time Frame:** From enrollment to the end of follow up at 4 months #### Secondary Outcomes **Description:** Improvement of VAS score **Measure:** Pain relieving **Time Frame:** From enrollment to the end of 4 times treatments at 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * chronic low back pain for more than 3 months * diagnosis of non-specific low back pain Exclusion Criteria: - * Spinal surgery history * Joint disease * Pregnancy * Cancer * Systemic disease * Mental disease * Bone Mass Measurement less than **Maximum Age:** 69 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taichung City **Country:** Taiwan **Facility:** China Medical University Hospital **State:** North Dist **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** China Medical University, China **Name:** Yu-Chen Lee, M.D. & Ph.D. **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Snook SH. Self-care guidelines for the management of nonspecific low back pain. J Occup Rehabil. 2004 Dec;14(4):243-53. doi: 10.1023/b:joor.0000047427.21710.07. **PMID:** 15638255 **Citation:** Farooque M. Specific and nonspecific low back pain-mind the gap and its impact in clinical practice: opinion of a recovering interventional spine physiatrist. Spine J. 2023 Aug;23(8):1101-1107. doi: 10.1016/j.spinee.2023.04.011. Epub 2023 Apr 27. No abstract available. **PMID:** 37116719 **Citation:** Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8. **PMID:** 34115979 **Citation:** Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017. **PMID:** 11074683 **Citation:** Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. **PMID:** 27745712 **Citation:** Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6. **PMID:** 21982256 **Citation:** Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883. **PMID:** 29321099 **Citation:** Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. **PMID:** 28192789 **Citation:** GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44. **PMID:** 30496104 **Citation:** Merritt JL, McLean TJ, Erickson RP, Offord KP. Measurement of trunk flexibility in normal subjects: reproducibility of three clinical methods. Mayo Clin Proc. 1986 Mar;61(3):192-7. doi: 10.1016/s0025-6196(12)61848-5. **PMID:** 3945120 **Citation:** Chen S, Chen M, Wu X, Lin S, Tao C, Cao H, Shao Z, Xiao G. Global, regional and national burden of low back pain 1990-2019: A systematic analysis of the Global Burden of Disease study 2019. J Orthop Translat. 2021 Sep 10;32:49-58. doi: 10.1016/j.jot.2021.07.005. eCollection 2022 Jan. **PMID:** 34934626 **Citation:** Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939. **PMID:** 32694387 **Citation:** Shafshak TS, Elnemr R. The Visual Analogue Scale Versus Numerical Rating Scale in Measuring Pain Severity and Predicting Disability in Low Back Pain. J Clin Rheumatol. 2021 Oct 1;27(7):282-285. doi: 10.1097/RHU.0000000000001320. **PMID:** 31985722 **Citation:** Klineberg E, Mazanec D, Orr D, Demicco R, Bell G, McLain R. Masquerade: medical causes of back pain. Cleve Clin J Med. 2007 Dec;74(12):905-13. doi: 10.3949/ccjm.74.12.905. **PMID:** 18183841 **Citation:** Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. **PMID:** 26487293 **Citation:** Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21. **PMID:** 29573872 **Citation:** Langevin HM, Sherman KJ. Pathophysiological model for chronic low back pain integrating connective tissue and nervous system mechanisms. Med Hypotheses. 2007;68(1):74-80. doi: 10.1016/j.mehy.2006.06.033. Epub 2006 Aug 21. **PMID:** 16919887 **Citation:** Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. **PMID:** 29573870 **Citation:** Traeger AC, Buchbinder R, Elshaug AG, Croft PR, Maher CG. Care for low back pain: can health systems deliver? Bull World Health Organ. 2019 Jun 1;97(6):423-433. doi: 10.2471/BLT.18.226050. Epub 2019 Apr 30. **PMID:** 31210680 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: 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 - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431490 **Brief Title:** A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer **Official Title:** A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer #### Organization Study ID Info **ID:** TQB2102-Ib/II-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer. ### Conditions Module **Conditions:** - Biliary Tract Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 103 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles. **Intervention Names:** - Drug: TQB2102 for injection **Label:** TQB2102 for injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TQB2102 for injection **Description:** TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC) **Name:** TQB2102 for injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever came first). **Measure:** Incidence and severity of adverse events (AE) and serious adverse events (SAE) **Time Frame:** From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy **Description:** Phase II Recommended Dose (RP2D) **Measure:** Phase II Recommended Dose (RP2D) **Time Frame:** Baseline up to 24 weeks #### Secondary Outcomes **Description:** The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. **Measure:** Objective response rate (ORR) **Time Frame:** Baseline up to 36 weeks **Description:** The time between first medication and first disease progression or death from any cause. **Measure:** Progression-free survival (PFS) **Time Frame:** Baseline up to 36 weeks **Description:** The first assessment was complete response, partial response, and time to disease stabilization. **Measure:** Disease control rate (DCR) **Time Frame:** Baseline up to 36 weeks **Description:** First assessed as complete or partial response to first disease progression or time of death from all causes. **Measure:** Disease response time (DOR) **Time Frame:** Baseline up to 36 weeks **Description:** Time from first use to death from any cause **Measure:** Overall survival (OS) **Time Frame:** Baseline up to 36 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1; * Test subjects with HER2 expression or amplification or mutation require immunohistochemistry of HER2 3+ or HER2 2 and positive for in situ hybridization (ISH); * The main organs function well; * Meet the criteria for advanced biliary tract cancer: 1. Biliary tract carcinoma confirmed by histology or cytology; 2. Non-operable locally advanced, recurrent and/or metastatic disease with at least one measurable lesion according to Evaluation criteria for the efficacy of solid tumors (RECIST) 1.1 criteria; 3. Failure of previous standard treatment. * Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period; * The subjects voluntarily joined the study, signed the informed consent, and the compliance was good. Exclusion Criteria: * Complicated diseases and medical history: 1. Have had or are currently suffering from other malignant tumors within 3 years before the first medication; 2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment; 3. Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication; 4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period; 5. Active viral hepatitis with poor control; 6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms; 7. Have a history of psychotropic drug abuse and can not quit or have mental disorders; 8. People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation; 9. Have a history of hepatic encephalopathy; 10. Currently on or recently used (within 7 days before the start of study treatment) aspirin (\>325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; 11. Subjects with any severe and/or uncontrolled disease. * Tumor related and treatment: 1. For subjects who have received chemotherapy, immunotherapy within 3 weeks before the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (as the shortest time of occurrence), the washout period is calculated from the end time of the last treatment; 2. Within 2 weeks before the first use of the drug, the treatment of Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions; 3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding; 4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage; 5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage); 6. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks. * Research treatment related: 1. Known allergy to study drug excipients; 2. Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited); 3. Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids \<10 mg per day of prednisone or other therapeutic hormones). 4. Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication. 5. According to the judgment of the researcher, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Feng Shen, Doctor **Phone:** 13901651428 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jun Zhou, Doctor **Phone:** 13366152815 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuyang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hesheng Qian, Bachelor - **Phone:** 13956814015 - **Role:** CONTACT **Country:** China **Facility:** Fuyang Cancer Hospital **State:** Anhui **Zip:** 236010 **Location 2:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhanggui Wang, Doctor - **Phone:** 13637095096 - **Role:** CONTACT **Country:** China **Facility:** Anhui Second People's Hospital **State:** Anhui **Zip:** 230012 **Location 3:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yifu He, Doctor - **Phone:** 18963789042 - **Role:** CONTACT **Country:** China **Facility:** Anhui Provincial Cancer Hospital **State:** Anhui **Zip:** 230031 **Location 4:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yongkun Sun, Doctor - **Phone:** 13141276041 - **Role:** CONTACT **Country:** China **Facility:** Cancer Hospital Chinese Academy of Medical Science **State:** Beijing **Zip:** 100021 **Location 5:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jun Zhou, Doctor - **Phone:** 13366152815 - **Role:** CONTACT **Country:** China **Facility:** Beijing Cancer Hospital **State:** Beijing **Zip:** 100089 **Location 6:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ming Yang, Doctor - **Phone:** 15810092973 - **Role:** CONTACT **Country:** China **Facility:** Tsinghua Changgeng Hospital, Beijing **State:** Beijing **Zip:** 100089 **Location 7:** **City:** Guangzhou **Country:** China **Facility:** Sun Yat-sen University Cancer Center **State:** Guangdong **Zip:** 510062 **Location 8:** **City:** Jiangmen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gengsheng Yu, Doctor - **Phone:** 13828077428 - **Role:** CONTACT **Country:** China **Facility:** Jiangmen Central Hospital **State:** Guangdong **Zip:** 529000 **Location 9:** **City:** Tangshan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhiwu Wang, Doctor - **Phone:** 18931506162 - **Role:** CONTACT **Country:** China **Facility:** Tangshan People's Hospital **State:** Hebei **Zip:** 063000 **Location 10:** **City:** Harbin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhiwei Li - **Phone:** 15004683651 - **Role:** CONTACT **Country:** China **Facility:** Harbin Medical University Cancer Hospital **State:** Heilongjiang **Zip:** 150081 **Location 11:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** YanRu Qin, Doctor - **Phone:** 13676932999 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Zhengzhou University **State:** Henan **Zip:** 450000 **Location 12:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hong Ma, Doctor - **Phone:** 13377876066 - **Role:** CONTACT **Country:** China **Facility:** Huazhong University of Science and Technology **State:** Hubei **Zip:** 430023 **Location 13:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fuxiang Zhou, Doctor - **Phone:** 18971252780 - **Role:** CONTACT **Country:** China **Facility:** Wuhan University Zhongnan Hospital **State:** Hubei **Zip:** 430071 **Location 14:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jia Luo, Doctor - **Phone:** 13874994359 - **Role:** CONTACT **Country:** China **Facility:** Hunan Cancer Hospital **State:** Hunan **Zip:** 410031 **Location 15:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaofeng Chen, Doctor - **Phone:** 13585172066 - **Role:** CONTACT **Country:** China **Facility:** Jiangsu Provincial People's Hospital **State:** Jiangsu **Zip:** 210000 **Location 16:** **City:** Yancheng **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Qi Li, Doctor - **Phone:** 13818207333 - **Role:** CONTACT **Country:** China **Facility:** Dongtai People'S Hospital **State:** Jiangsu **Zip:** 224200 **Location 17:** **City:** Changchun **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ying Cheng, Doctor - **Phone:** 0431-85871902 - **Role:** CONTACT **Country:** China **Facility:** Jilin Cancer Hospital **State:** Jilin **Zip:** 130012 **Location 18:** **City:** Chifeng **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhonghua Liu, Doctor - **Phone:** 18604769266 - **Role:** CONTACT **Country:** China **Facility:** Chifeng City Hospital **State:** Neimengu **Zip:** 024000 **Location 19:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aili Suo, Doctor - **Phone:** 18991232561 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xi'an Jiaotong University **State:** Shaanxi **Zip:** 710000 **Location 20:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Shen, Doctor - **Phone:** 13901651428 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Leilei Bao, Doctor - **Phone:** 021-81875571 - **Role:** CONTACT **Country:** China **Facility:** The Third Affiliated Hospital of PLA Navy Medical University **State:** Shanghai **Zip:** 200433 **Location 21:** **City:** Taiyuan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yusheng Wang, Doctor - **Phone:** 13834646436 - **Role:** CONTACT **Country:** China **Facility:** First Hospital of Shangxi Medical University **State:** Shanxi **Zip:** 030001 **Location 22:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hongli Li, Doctor - **Phone:** 18622221233 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Cancer Hospital **State:** Tianjin **Zip:** 300000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: HIGH - As Found: Biliary Tract Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract 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: T761 - Name: Biliary Tract Cancer - Relevance: HIGH - As Found: Biliary Tract Cancer ### Condition Browse Module - Meshes - ID: D000001661 - Term: Biliary Tract 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: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431477 **Brief Title:** Efficacy and Safety of Telmisartan Compared With Losartan **Official Title:** A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension #### Organization Study ID Info **ID:** B115_02HT/DN2201 #### Organization **Class:** INDUSTRY **Full Name:** Chong Kun Dang Pharmaceutical ### Status Module #### Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chong Kun Dang Pharmaceutical #### 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 study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension **Detailed Description:** A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension ### Conditions Module **Conditions:** - Diabetic Nephropathies - Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 98 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: telmisartan **Label:** Telmisartan tablet **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Losartan **Label:** Losartan tablet **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Telmisartan tablet **Description:** QD, PO **Name:** telmisartan **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Losartan tablet **Description:** QD, PO **Name:** Losartan **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio) **Time Frame:** 24 weeks after drug administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male of Female subjects aged ≥19 or \<75 * Type II Diabetes Mellitus subjects who have been taken medicine * Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF Exclusion Criteria: * Subjects with Type I Diabetes Mellitus * Subjects with Primary hyper-aldosteronism * Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening * Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period * Subjects who received other clinical trial drugs within 28 days of screening visit * Subjects who are unable to participate in this clinical trial at the discretion of the investigator. **Maximum Age:** 75 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BeomSeok Kim, M.D, Ph.D **Phone:** +82-2-2228-5331 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** BeomSeok Kim, M.D, Ph.D - **Phone:** +02-2228-5331 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Severance Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Severance Hospital **Name:** BeomSeok Kim, M.D, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular 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: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Nephropathy - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Nephropathy - ID: M17400 - Name: Vascular 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: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000003928 - Term: Diabetic Nephropathies - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Ancestors - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000047228 - Term: Angiotensin II Type 1 Receptor Blockers - ID: D000057911 - Term: Angiotensin Receptor Antagonists - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M21701 - Name: Losartan - Relevance: HIGH - As Found: Living - ID: M1770 - Name: Telmisartan - Relevance: HIGH - As Found: Self-management - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M4132 - Name: Angiotensin II - Relevance: LOW - As Found: Unknown - ID: M289354 - Name: Giapreza - Relevance: LOW - As Found: Unknown - ID: M4135 - Name: Angiotensinogen - Relevance: LOW - As Found: Unknown - ID: M25789 - Name: Angiotensin II Type 1 Receptor Blockers - Relevance: LOW - As Found: Unknown - ID: M28916 - Name: Angiotensin Receptor Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019808 - Term: Losartan - ID: D000077333 - Term: Telmisartan ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431464 **Brief Title:** Tattoo Particles: Picosecond Laser Versus Nanosecond Laser **Official Title:** In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser #### Organization Study ID Info **ID:** 02-24 #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf **Investigator Full Name:** Lynhda Nguyen **Investigator Title:** Principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** - For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin. ### Conditions Module **Conditions:** - Tattoo; Pigmentation ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with unwanted tattoos who plan a nanosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. **Intervention Names:** - Other: nanosecond laser treatment + measurement with a multiphoton tomography system **Label:** Nanosecond laser #### Arm Group 2 **Description:** Patients with unwanted tattoos who plan a picosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. **Intervention Names:** - Other: picosecond laser treatment + measurement with a multiphoton tomography system **Label:** Picosecond laser ### Interventions #### Intervention 1 **Arm Group Labels:** - Picosecond laser **Description:** Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. **Name:** picosecond laser treatment + measurement with a multiphoton tomography system **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Nanosecond laser **Description:** Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. **Name:** nanosecond laser treatment + measurement with a multiphoton tomography system **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Size of intercellular spaces after picosecond or nanosecond laser treatment. **Measure:** Size of intercellular spaces **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Size of keratinocytes after picosecond or nanosecond laser treatment. **Measure:** Size of keratinocytes **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Size of tattoo particles after picosecond or nanosecond laser treatment. **Measure:** Size of tattoo particles **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Distribution though the epidermal and dermal layers after picosecond or nanosecond laser treatment. **Measure:** Distribution of tattoo particles **Time Frame:** 6 weeks and 12 weeks post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department Exclusion Criteria: * laser pretreatment of their tattoos to be treated * pregnancy, breast feeding * open wound on the area to be treated **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lynhda Nguyen, Dr. med. **Phone:** +49 (0) 7410-0 **Role:** CONTACT #### Locations **Location 1:** **City:** Hamburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** L Nguyen, Dr. med. - **Phone:** +49 (0)40-74100 - **Role:** CONTACT **Country:** Germany **Facility:** University Medical Center Hamburg-Eppendorf **Status:** RECRUITING **Zip:** 20251 ### References Module #### References **Citation:** Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25. **PMID:** 35837813 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431451 **Brief Title:** The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients With Advanced GISTs **Official Title:** The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients With Advanced Gastrointestinal Stromal Tumors: an Observational Study #### Organization Study ID Info **ID:** 20240102v3.0 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital, Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2023-12-24 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital, Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Investigator Full Name:** Xinhua Zhang, MD **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 prospective, single-center, observational study to explore the correlation between ripretinib exposure and the efficacy and safety in patients with advanced gastrointestinal stromal tumors **Detailed Description:** INTRODUCTION AND RATIONALE: Gastrointestinal stromal tumors (GISTs) are a rare mesenchymal sarcoma that most commonly occur in the stomach and small intestine, but can occur in any region of the entire gastrointestinal tract. For advanced GISTs that cannot be surgically removed or metastasized, imatinib, sunitinib, and regorafenib are recommended TKIs in the current clinical guidelines for the first-, second-, and third-line therapy respectively. Although imatinib has significant effect in the first-line treatment of GIST, improving the prognosis and survival outcome, GISTs often develop primary or secondary drug resistance, resulting in disease progression.Ripretinib is a broad-spectrum switch-control kinase inhibitor that specifically inhibits KIT and PDGFRA kinase signaling through dual mechanisms of action. In clinical studies of advanced GIST patients, Ripretinib has shown good safety and efficacy. In the phase III clinical study INVICTUS, Ripretinib 150 mg QD was used to treat patients with metastatic or unresectable GIST who failed to treatment with imatinib, sunitinib, and regorafenib. The median progression-free survival (mPFS) was 6.3 months in the Ripretinib group and 1.0 month in the placebo group. The phase III clinical trial INTRIGUE showed that although there was no significant advantage in progression-free survival (PFS) compared with sunitinib, Ripretinib had better safety, lower incidence of adverse events, and better patient tolerability. In May 2020, Ripretinib was approved by the US FDA for the treatment of adult patients with advanced GIST who have failed to three or more kinase inhibitors including imatinib. It is also recommended as a preferred fourth-line drug in the 2023 version of the NCCN guidelines and the 2022 version of the CSCO guidelines for GISTs. In vitro kinase and cell studies have shown that Ripretinib is effective against wild-type KIT and PDGFRA, as well as a wide range of KIT and PDGFRA mutations, including major and resistant mutations in KIT exons 9, 11, 13, 14, 17, and 18, as well as the regorafenib-resistant D816V mutation. It is more effective than other type I and type II TKI inhibitors. However, the inhibitory effect of Ripretinib varies depending on the mutation type. At the same time, in the phase III clinical study INVICTUS gene mutation analysis, it was found that patients with primary mutations in KIT exon 11 and secondary mutations in KIT exon 17 had a relatively longer PFS. The preclinical study of Ripretinib suggests that its inhibitory effect on KIT is concentration-dependent and time-dependent. With the increase of in vivo concentration, the inhibitory effect of KIT phosphorylation also increases. Increasing the dosage or dosing frequency can increase tumor regression and survival rates. In the phase I clinical study of Ripretinib, it was found that increasing the dose to 150 mg BID after oral administration of 150mg QD with disease progression (PD) can obtain a further benefit. The median progression-free survival (mPFS) of second-line, third-line, and fourth-line patients was 5.6, 3.3, and 4.6 months, respectively, indicating that the increase of Ripretinib's exposure in vivo is associated with improved efficacy. Preclinical and clinical studies have found that the main metabolic pathway of Ripretinib is N-demethylation. Ripretinib and its active metabolite DP-5439 are mainly metabolized in the liver through CYP3A4 metabolic enzymes, and DP-5439 has pharmacological activity similar to the parent drug Ripretinib. In a phase I clinical study of pharmacokinetics, there was significant inter-patient variability in PK parameters after administration of Ripretinib. The variation (CV%) of Cmax and AUC0-24h reached 35% to 60%. The AUC of DP-5439 after a single dose of 150 mg was about 49% of Ripretinib, and the AUC after 15 days of dosing at 150 mg QD was about 129% of Ripretinib. At the same time, the AUC0-24h of Ripretinib increased proportionally with dose within the range of 20-250 mg, but the Cmax increased less than dose proportionally. The Cmax and AUC0-24h of DP-5439 increased less than dose proportionally within the range of 50-250 mg.The above findings suggest that therapeutic drug monitoring (TDM) may be clinically relevant for patients receiving Ripretinib treatment, and further exploration of the relationship between blood concentration or exposure level of Ripretinib and clinical efficacy is warranted. In terms of safety, in the phase I dose-escalation trial of Ripretinib, no maximum tolerated dose (MTD) was found, and the dose-limiting toxicity (DLT) was elevation of lipase and creatine kinase, which occurred in dose groups of 100 mg BID, 200 mg BID, and 150 mg QD. The most common treatment-related adverse events included fatigue, alopecia, nausea, muscle pain, constipation, loss of appetite, palmoplantar erythrodysesthesia syndrome (PPES), diarrhea, and elevation of lipase. Most of these events were mild to moderate. The incidence of serious adverse events was 14.1%, including elevation of creatine kinase, elevation of lipase, elevation of bilirubin, myocardial infarction, and heart failure. In the phase I dose-escalation trial, it was shown that the incidence of adverse events such as muscle pain, muscle spasms, PPES, and hypertension increased with dose escalation, indicating a possible dose-related toxicity. Therefore, in order to reduce the occurrence of adverse reactions and improve medication safety, it is of great significance to find a relatively safe dose range to guide clinical safe drug use. In addition, although the results of the phase II clinical trial of Ripretinib in China suggested that the efficacy, safety, and PK characteristics of Ripretinib in Chinese patients were consistent with the global patient population, a comparison of the results between Chinese patients and global patients in the phase I clinical trial showed that the clinical efficacy of Chinese patients receiving Ripretinib as a fourth-line treatment at a dose of 150 mg QD was slightly better than that of global patients (mPFS: 7.2 vs. 6.3 months; ORR: 18.4% vs. 11.8%). Meanwhile, the overall exposure of Ripretinib and DP-5439 was slightly higher in the Chinese population compared to global data. This suggests that it is worth further exploring the relationship between the pharmacokinetics and exposure of Ripretinib in the Chinese population and its efficacy, which has implications for personalized treatment in Chinese patients. This study aims to establish a method for monitoring the blood concentrations of Ripretinib and its active metabolite DP-5439, and to monitor the blood concentrations of advanced GIST patients receiving Ripretinib treatment. The study will explore the relationship between the exposure of Ripretinib and its efficacy and safety in real-world advanced GIST patients, determine the therapeutic window of Ripretinib, and explore the effective exposure levels required for different KIT mutation types. ### Conditions Module **Conditions:** - Gastrointestinal Stromal Tumors **Keywords:** - Ripretinib - plasma drug concentration ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The concentration of ripretinib in the plasma was measured. **Measure:** Plasma Concentration of ripretinib **Time Frame:** Before Dosing and at 0.5, 1, 2, 4, 6, 8,12 and 24 Hours after Dosing **Description:** The concentration of DP-5439 in the plasma was measured. **Measure:** Plasma Concentration of DP-5439 **Time Frame:** Before Dosing and at 0.5, 1, 2, 4, 6, 8,12 and 24 Hours after Dosing **Description:** To evaluate objective response rate (ORR,CR+PR) determined by radiology assessment per mRECIST(Response Evaluation Criteriain Solid Tumours), version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with lymph nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response. **Measure:** Objective Response Rate **Time Frame:** 2 years **Description:** To evaluate disease control rate (CBR,CR+PR+\>16 weeks continuation SD) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with lymph nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease. **Measure:** Disease control rate **Time Frame:** 2 years #### Secondary Outcomes **Description:** Progression-free survival (PFS) is defined as the interval between the date of drug administration and the earliest date of disease progression or death due to any cause. **Measure:** Progression-free survival **Time Frame:** 2 years **Description:** Overall survival is defined as the time from drug administration until death. **Measure:** overall survival **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who are aged ≥ 18 years. * Gastrointestinal stromal tumors confirmed by histopathological examination, and CD117 and/or DOG-1-positive by immunohistochemistry. * patients who are currently receiving Ripretinib treatment. * Subjects must have at least one measurable lesion based on mRECIST v1.1 criteria, and have undergone at least one radiographic evaluation for efficacy analysis. * Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 4 * Patient informed consent and signed written consent form. * The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures. Exclusion Criteria: * Unable to complete at least 15 consecutive days of Ripretinib due to intolerance or disease progression. * Individuals with other serious acute or chronic physical or mental health problems, or abnormal laboratory test results that increase the risk associated with participation in the study or use of the drug, or that could interfere with the interpretation of study results, and who, in the opinion of the investigator, are not suitable for participation in the study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Gastrointestinal stromal tumor patients who are receiving treatment with Ripretinib at the research center. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** xinhua zhang, MD **Phone:** +8613828463644 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** yanzhe xia, MD **Phone:** +8618680238481 **Role:** CONTACT ### References Module #### References **Citation:** von Mehren M, Joensuu H. Gastrointestinal Stromal Tumors. J Clin Oncol. 2018 Jan 10;36(2):136-143. doi: 10.1200/JCO.2017.74.9705. Epub 2017 Dec 8. **PMID:** 29220298 **Citation:** Di Vito A, Ravegnini G, Gorini F, Aasen T, Serrano C, Benuzzi E, Coschina E, Monesmith S, Morroni F, Angelini S, Hrelia P. The multifaceted landscape behind imatinib resistance in gastrointestinal stromal tumors (GISTs): A lesson from ripretinib. Pharmacol Ther. 2023 Aug;248:108475. doi: 10.1016/j.pharmthera.2023.108475. Epub 2023 Jun 10. **PMID:** 37302758 **Citation:** Zalcberg JR. Ripretinib for the treatment of advanced gastrointestinal stromal tumor. Therap Adv Gastroenterol. 2021 Apr 15;14:17562848211008177. doi: 10.1177/17562848211008177. eCollection 2021. **PMID:** 33948116 **Citation:** Janku F, Abdul Razak AR, Chi P, Heinrich MC, von Mehren M, Jones RL, Ganjoo K, Trent J, Gelderblom H, Somaiah N, Hu S, Rosen O, Su Y, Ruiz-Soto R, Gordon M, George S. Switch Control Inhibition of KIT and PDGFRA in Patients With Advanced Gastrointestinal Stromal Tumor: A Phase I Study of Ripretinib. J Clin Oncol. 2020 Oct 1;38(28):3294-3303. doi: 10.1200/JCO.20.00522. Epub 2020 Aug 17. **PMID:** 32804590 **Citation:** Smith BD, Kaufman MD, Lu WP, Gupta A, Leary CB, Wise SC, Rutkoski TJ, Ahn YM, Al-Ani G, Bulfer SL, Caldwell TM, Chun L, Ensinger CL, Hood MM, McKinley A, Patt WC, Ruiz-Soto R, Su Y, Telikepalli H, Town A, Turner BA, Vogeti L, Vogeti S, Yates K, Janku F, Abdul Razak AR, Rosen O, Heinrich MC, Flynn DL. Ripretinib (DCC-2618) Is a Switch Control Kinase Inhibitor of a Broad Spectrum of Oncogenic and Drug-Resistant KIT and PDGFRA Variants. Cancer Cell. 2019 May 13;35(5):738-751.e9. doi: 10.1016/j.ccell.2019.04.006. **PMID:** 31085175 **Citation:** Klug LR, Khosroyani HM, Kent JD, Heinrich MC. New treatment strategies for advanced-stage gastrointestinal stromal tumours. Nat Rev Clin Oncol. 2022 May;19(5):328-341. doi: 10.1038/s41571-022-00606-4. Epub 2022 Feb 25. **PMID:** 35217782 **Citation:** Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5. Erratum In: Lancet Oncol. 2020 Jul;21(7):e341. **PMID:** 32511981 **Citation:** Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Dec 1;40(34):3918-3928. doi: 10.1200/JCO.22.00294. Epub 2022 Aug 10. **PMID:** 35947817 **Citation:** Li J, Cai S, Zhou Y, Zhang J, Zhou Y, Cao H, Wu X, Deng Y, Huang Z, Dong J, Shen L. Efficacy and Safety of Ripretinib in Chinese Patients with Advanced Gastrointestinal Stromal Tumors as a Fourth- or Later-Line Therapy: A Multicenter, Single-Arm, Open-Label Phase II Study. Clin Cancer Res. 2022 Aug 15;28(16):3425-3432. doi: 10.1158/1078-0432.CCR-22-0196. **PMID:** 35686969 **Citation:** George S, Chi P, Heinrich MC, von Mehren M, Jones RL, Ganjoo K, Trent J, Gelderblom H, Razak AA, Gordon MS, Somaiah N, Jennings J, Meade J, Shi K, Su Y, Ruiz-Soto R, Janku F. Ripretinib intrapatient dose escalation after disease progression provides clinically meaningful outcomes in advanced gastrointestinal stromal tumour. Eur J Cancer. 2021 Sep;155:236-244. doi: 10.1016/j.ejca.2021.07.010. Epub 2021 Aug 12. **PMID:** 34391056 **Citation:** Zalcberg JR, Heinrich MC, George S, Bauer S, Schoffski P, Serrano C, Gelderblom H, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Somaiah N, Meade J, Reichert V, Shi K, Sherman ML, Ruiz-Soto R, von Mehren M, Blay JY. Clinical Benefit of Ripretinib Dose Escalation After Disease Progression in Advanced Gastrointestinal Stromal Tumor: An Analysis of the INVICTUS Study. Oncologist. 2021 Nov;26(11):e2053-e2060. doi: 10.1002/onco.13917. Epub 2021 Aug 16. **PMID:** 34313371 **Citation:** Pan C, Cheng Y, He Q, Li M, Bu F, Zhu X, Li X, Xiang X. Evaluating the impact of co-administered drug and disease on ripretinib exposure: A physiologically-based pharmacokinetic modeling approach. Chem Biol Interact. 2023 Mar 1;373:110400. doi: 10.1016/j.cbi.2023.110400. Epub 2023 Feb 9. **PMID:** 36773833 **Citation:** Li X, Shelton MJ, Wang J, Meade J, Ruiz-Soto R. Effects of CYP3A Inhibition, CYP3A Induction, and Gastric Acid Reduction on the Pharmacokinetics of Ripretinib, a Switch Control KIT Tyrosine Kinase Inhibitor. Clin Pharmacol Drug Dev. 2022 Oct;11(10):1165-1176. doi: 10.1002/cpdd.1110. Epub 2022 May 13. **PMID:** 35560823 **Citation:** Demetri GD, Wang Y, Wehrle E, Racine A, Nikolova Z, Blanke CD, Joensuu H, von Mehren M. Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. J Clin Oncol. 2009 Jul 1;27(19):3141-7. doi: 10.1200/JCO.2008.20.4818. Epub 2009 May 18. **PMID:** 19451435 **Citation:** Yang W, Qian H, Yang L, Wang P, Qian H, Chu B, Liu Z, Sun J, Wu D, Sun L, Zhou W, Hu J, Chen X, Shou C, Ruan L, Zhang Y, Yu J. Efficacy and safety of ripretinib in Chinese patients with advanced gastrointestinal stromal tumors: a real-world, multicenter, observational study. Front Oncol. 2023 May 18;13:1180795. doi: 10.3389/fonc.2023.1180795. eCollection 2023. **PMID:** 37274264 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M25642 - Name: Gastrointestinal Stromal Tumors - Relevance: HIGH - As Found: Gastrointestinal Stromal Tumors - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T2444 - Name: Gastrointestinal Stromal Tumors - Relevance: HIGH - As Found: Gastrointestinal Stromal Tumors ### Condition Browse Module - Meshes - ID: D000046152 - Term: Gastrointestinal Stromal Tumors ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431438 **Brief Title:** Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets **Official Title:** A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets #### Organization Study ID Info **ID:** TQA3810-I-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Start Date **Date:** 2021-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination. ### Conditions Module **Conditions:** - Chronic Hepatitis B ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 759 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.5mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 1.0mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Sixteen subjects were enrolled and all received the trial drug. **Intervention Names:** - Drug: TQA3810 **Label:** Food impact group **Type:** OTHER #### Arm Group 4 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.1mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.3mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 6 **Description:** Sixteen subjects were enrolled and all received the trial drug. **Intervention Names:** - Drug: TQA3810 **Label:** Drug interaction group **Type:** ACTIVE_COMPARATOR #### Arm Group 7 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.1mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 8 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.3mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 9 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.5mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 10 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.2mg multiple dosing **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 0.1mg multiple dosing - 0.1mg single-dose - 0.2mg multiple dosing - 0.3mg multiple dosing - 0.3mg single-dose - 0.5mg multiple dosing - 0.5mg single-dose - 1.0mg single-dose - Drug interaction group - Food impact group **Description:** TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist **Name:** TQA3810 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded. **Measure:** Incidence of Adverse Events **Time Frame:** From the subject signed the informed consent form to 30 days after the last dose #### Secondary Outcomes **Description:** Maximum plasma drug concentration **Measure:** Cmax **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** To maximum plasma drug concentration time. **Measure:** Tmax **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Drug half-life in plasma. **Measure:** Half-life (t1/2) **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Plasma drug concentration from time 0 to the last measurable area under the drug concentration time curve. **Measure:** AUC0-t **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Area under the plasma drug concentration time curve from time 0 to infinity. **Measure:** AUC0-∞ **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; * Able to complete the study according to the requirements of the trial protocol; * The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix; * Male and female subjects aged 18-55 years old (including 18 and 55 years old); * The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value); * The physical examination and vital signs were normal or abnormal without clinical significance. Exclusion Criteria: * Smoking more than 5 cigarettes per day in the 3 months before the study; * Allergic constitution (multi-drug and food allergy); * A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine); * Donation or massive blood loss (\> 400 mL) within 3 months before screening; * Taking any drugs that alter liver enzyme activity 28 days before screening; * Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening; * Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion; * Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone, within three months before taking the study drug; * A recent major change in diet or exercise habits; * Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug; * A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease; * Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; * With severe systemic diseases and related medical history (including subjects with active or occult tuberculosis, a history of tuberculosis, or clinical manifestations suspected of tuberculosis), as well as immune system diseases and medical history; * Had systemic or local infection within 2 months prior to screening, and were hospitalized for severe infection and/or required intravenous antibiotics; * Subjects who were unable to tolerate a standard meal; * An electrocardiogram (ECG) abnormalities have clinical significance; * The female subjects were lactating or seropositive for pregnancy during the screening or test period; * Clinically significant abnormalities on clinical examination or other clinical findings within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases); * Clinically significant fundus lesions (symptomatic cotton-like fundus changes) and retinopathy; * Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive; * From the screening stage to the onset of acute illness or concomitant medication before study medication; * Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 24 hours before taking the study drug; * Have taken any alcohol-based product within 24 hours before taking the study medication; * Having a positive urine drug screen or having a history of drug abuse or drug use in the past 5 years; * Subjects with other factors considered by the investigator to be ineligible for the trial. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nanjing **Country:** China **Facility:** Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University **State:** Jiangsu **Zip:** 210008 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006505 - Term: Hepatitis - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000006521 - Term: Hepatitis, Chronic - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive 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: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: LOW - As Found: Unknown - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M21609 - Name: Hepatitis B, Chronic - Relevance: HIGH - As Found: Chronic Hepatitis B - ID: M9607 - Name: Hepatitis, Chronic - 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: 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: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006509 - Term: Hepatitis B - ID: D000019694 - Term: Hepatitis B, Chronic ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431425 **Acronym:** eCG **Brief Title:** The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling **Official Title:** The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling: Evaluation of Uptake, Psychological Impact and Satisfaction Among Users #### Organization Study ID Info **ID:** IMDI104021006 #### Organization **Class:** OTHER **Full Name:** UMC Utrecht ### Status Module #### Completion Date **Date:** 2025-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Amsterdam UMC **Class:** OTHER **Name:** University Medical Center Groningen **Class:** OTHER **Name:** Radboud University Medical Center #### Lead Sponsor **Class:** OTHER **Name:** UMC Utrecht #### Responsible Party **Investigator Affiliation:** UMC Utrecht **Investigator Full Name:** Lieke M van den Heuvel, 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:** Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern. When a mutation is detected in the proband, relatives can have predictive DNA testing, and - when they are carrier - be monitored and timely treated if needed. Currently, less than half of relatives attends genetic counselling. With the eCG Family Clinic, an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered. At the eCG Family Clinic, relatives will receive tailored information to support informed decision-making, a DNA-test at home if desired, and can be referred for local cardiac monitoring if relatives appear to be a carrier. Implementation of the eCG Family Clinic in clinical practice is compared to current practice in this clinical trial. **Detailed Description:** Background: Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern. When a mutation is detected in the proband, relatives can have predictive DNA testing, and - when they are carrier - be monitored and timely treated if needed. Currently, less than half of relatives attends genetic counselling. With the eCG Family Clinic, an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered. At the eCG Family Clinic, relatives will receive tailored information to support informed decision-making, a DNA-test at home if desired, and can be referred for local cardiac monitoring if relatives appear to be a carrier. Implementation of the eCG Family Clinic in clinical practice (intervention group) is compared to current practice (control group) in this clinical trial. Hypotheses: It is hypothesized that the eCG Family Clinic can lower practical barriers for at-risk relatives to attend genetic counselling and equally or better suit the needs of probands and relatives in this regard. A higher uptake of presymptomatic counselling in the eCG Family Clinic (intervention) group is expected. Design: A non-inferiority randomised controlled trial (RCT) design with two study arms (parallel-group, control- and intervention group) for this study was chosen. In this study, probands, at-risk relatives and genetic healthcare professionals will be recruited for this study. The Medical Ethical Committee of the University Medical Centre Utrecht (UMCU, NedMec) has approved the study design. Measures: In this RCT, the following outcome measures will be evaluated: (1) uptake of presymptomatic counselling among at-risk relatives, (2) satisfaction with provided care among healthcare professionals, probands and at-risk relatives, (3) impact on feelings of anxiety and worry among at-risk relatives, (4) time requested for care provision and administration. Uptake of presymptomatic testing will be evaluated using file research. Data on the other outcome measures will be collected using questionnaires. First, probands will be asked to fill out one questionnaire after informing at-risk relatives. In addition, at-risk relatives are asked to fill out a questionnaire twice: (a) shortly after the presymptomatic counselling (time-point 1) and, (b) after two/three months, in which at-risk relatives who chose to have DNA-testing, will have received their results. Finally, healthcare professionals involved in providing counselling will be asked to fill out one questionnaire after study completion. Questionnaires will also be used to administer sociodemographic and clinical characteristics of study participants. Sample size calculation: Assuming a two-sided 5% significance level and a power of 80%, 238 at-risk relatives ( 119 per study arm) will be included. Previous literature shows that on average four adult relatives per proband are at 50% risk of inheriting the genetic mutation. Using a conservative estimate of 3.5 relatives per proband, a total of 68 probands (34 per study arm) needs to be included in this study. Statistical analyses: Sociodemographic and clinical characteristics will be analysed using descriptive and frequency statistics. Differences in participant characteristics between study arms will assessed with chi-square tests / t-tests, as appropriate. Differences in uptake of genetic counselling will be analysed using chi-square tests; logistic regression analyses will be conducted to assess differences in uptake while controlling for the influence of coviarates. Multilevel analyses will be performed to assess whether the study group has an impact on satisfaction with the care provided and impact on psychological functioning, adjusted for coviarates. SPSS version 29.0.1 will be used to perform statistical analyses. A p-level of p\<0.05 will be used. ### Conditions Module **Conditions:** - Inherited Cardiac Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Non-inferiority randomised controlled trial with a parallel group design ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 170 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals included in the intervention group (eCG Family Clinic), will receive an invitation to the DNA-poli platform after the proband adds their email address to the digital clinic at risk relatives list. The eCG Family Clinic serves as the pre-test counseling, afterwards counseling by a healthcare professional can be requested. Subsequently the at-risk relative decides whether to get genetically tested and if the results are communicated via the DNA-poli platform or via telephone. **Intervention Names:** - Behavioral: eCG Family Clinic **Label:** Digital care path (eCG Family Clinic) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Individuals included in the control group, will receive the family letter via the proband. The relative needs to contact their general practitioner to get a referral to the genetic department. The relative sets up an appointment with a genetic counselor. The relative has a face-to-face session with a healthcare professional and will decide during this conversation whether to get genetically tested. When results are in, another face-to-face appointment is set to discuss the result and if applicable, follow-up steps will be discussed. **Label:** Current clinical practice **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital care path (eCG Family Clinic) **Description:** The DNA-poli is an online tool which is designed as an addition to the current genetic counseling method to make the process more efficient and to increase the uptake without compromising counseling quality. Probands can invite their at-risk family members by entering their email addresses. The family members are invited to the DNA-poli via which they can get all the information needed to make a well-considered decision about genetic testing. The information is provided in different formats, for example via a virtual assistant and via videos, which they can evaluate at their own pace, and which can be reread or rewatched. Afterwards they can request an appointment with a health care professional and make a definite decision about genetic testing. **Name:** eCG Family Clinic **Other Names:** - DNA poli **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Uptake of genetic counselling and predictive DNA testing: i.e., the number of family members attending genetic counselling / pursuing genetic testing, relative to the total number of family members eligible for genetic counselling / genetic testing. **Measure:** Uptake **Time Frame:** 1 year post disclosure of the proband result **Description:** Measured using a self-constructed 9-item questionnaire, with answer options ranging from 1=totally disagree to 5=totally agree (score range: 0-36). In addition, the Dutch patient Satisfaction Questionnaire (PSQ) will be administered among relatives. This questionnaire consists of 5 questions using a 10-point scale (1=not at all to 10=a lot). Scores range from 0-45. A higher score indicates higher satisfaction. **Measure:** Experience with the eCG Family Clinic **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results #### Secondary Outcomes **Description:** Measured using the genetic counseling outcome scale (GCOS). The GCOS consists of 24 questions using a 7-point likert scale (1=totally disagree to 7=totally agree). Total scores range from 0-144, with a higher score indicating higher empowerment. **Measure:** Empowerment / genetic counselling outcomes **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured the Decisional Conflict Scale (DSC). The DSC consists of 16 questions using a 5 point Likert Scale (1=totally disagree, to 5= totally agree, total score range 0-64). A higher score indicates higher certainty about the decision made. Furthermore, informed decision-making is measures by 5 self-constructed knowledge questions, which can be answered with 'yes', 'no' or 'I don't know'. **Measure:** Informed decision-making **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured using the shortened State Trait Anxiety Inventory (STAI). The shortened STAI consists of 6 questions on a 4 point Likert scale (1=not at all, 4=a lot). Total scores range from 0-18, with a higher score indicating higher levels of anxiety. **Measure:** Impact on feelings of anxiety **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured by administering time needed for counselling / administration per at-risk relative **Measure:** Efficiency **Time Frame:** Administered per genetic consultation through study completion, on average two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Probands: * \> 18 y/o * Diagnosed with inherited hypertrophic cardiomyopathy (HCM) or dialted cardiomyopathy (DCM)) * Class 4 or 5 variant identified. * Access to a working laptop or computer device. At risk relatives: * \> 18 y/o * First degree family member, or second degree in case of a deceased first degree relative * Access to a working laptop or computer device. Healthcare professionals: - Genetic counsellors of the genetics department directly involved in the care given to the family. Exclusion Criteria: - Insufficient control of the Dutch language or digital skills. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marlies van Lingen, MSc. **Phone:** +31887553745 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lieke van den Heuvel, PhD **Phone:** +31887553745 **Role:** CONTACT #### Locations **Location 1:** **City:** Utrecht **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marlies van Lingen, MSc. - **Phone:** +31887553745 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Lieke van den Heuvel, PhD - **Phone:** +31887553745 - **Role:** CONTACT **Country:** Netherlands **Facility:** University Medical Centre Utrecht **Status:** RECRUITING **Zip:** 3584 CX ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Cardiac Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431412 **Brief Title:** A Model for Drug Concentration Prediction of Vancomycin **Official Title:** A Clinical Data-Based Model for Drug Concentration Prediction of Vancomycin in Critical Patients #### Organization Study ID Info **ID:** K5927 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### 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 ### Description Module **Brief Summary:** Objective: This study aims to use machine learning methods to establish an optimal model for predicting serum vancomycin trough concentrations in critically ill patients. Methods: This is a single-center, retrospective study. Data on serum vancomycin concentration in the Critical Care Database of Peking Union Medical College Hospital were screened and extracted to construct a prediction model using machine learning methods. The MIMIC-IV (Medical Information Mart for Intensive Care) database will be further used for external verification of the constructed model. The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1161). **Detailed Description:** Background: Vancomycin is a glycopeptide antibiotic primarily used to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). As a time-dependent antibiotic, the serum concentration of vancomycin is closely related to the clinical efficacy, toxicity and emergence of drug resistance. Therefore, therapeutic drug monitoring (TDM) is considered an important component of vancomycin treatment management. According to vancomycin surveillance guidelines, It is recommended to maintain a serum vancomycin concentration of 15-20 mg/L in patients with severe infections in order to improve clinical outcomes and prevent drug resistance. However, serum vancomycin concentration testing is not widely used in clinical practices, especially in resource-constrained areas and medical institutions, so individualized monitoring remains a challenge. Currently, studies on vancomycin concentration prediction generally use the population pharmacokinetic (PPK) model. However, this model is affected by many factors such as age, weight, and creatinine clearance rate. However, since critically ill patients have complex diseases accompanied by multiple organ dysfunction, vancomycin pharmacokinetics may be altered. In such patients, the evidence for concentration prediction using PPK models is insufficient. Currently, the rapidly developing machine learning methods can help capture nonlinear variable relationships while making predictions through multiple variables to achieve a high degree of accuracy in prediction results. This study aims to use machine learning methods to establish an optimal model for predicting serum vancomycin trough concentrations in critically ill patients. Objective: This study aims to extract the serum vancomycin concentration data from the Critical Care Database of Peking Union Medical College Hospital from January 2014 to December 2023 and use machine learning methods to establish the optimal model for predicting vancomycin concentrations in critically ill patients. Methods: (1)This is a single-center, retrospective study. Data on serum vancomycin concentration in the Critical Care Database of Peking Union Medical College Hospital were screened. After meeting the eligibility criteria, the clinical data of included patients are collected through the inpatient medical record system, including demographic characteristics, severity scores, laboratory test information and treatment information. (2) After extracting the available data, five models of machine learning, including Linear Regression, Lasso Regression, Ridge Regression, Random Forest and LightGBM, are used to build prediction models. The model with the best prediction accuracy is selected based on the percent error (PE), the mean percentage error (MPE) and the mean absolute percentage error (MAPE). (3) The MIMIC-IV (Medical Information Mart for Intensive Care) database is used to conduct external validation of the model constructed by machine learning. Moreover, the investigators will compare the predictive performance of the PPK model with the constructed model. Quality control: Patients who meet the inclusion criteria are included. Patients with missing information are not enrolled in order to reduce bias. The information of included patients is recorded and registered by a dedicated research person. Ethics and patient privacy protection: Personal information in the study will be used only for the purposes described in the protocol for this study. Medical information obtained will be kept confidential. The results will also be published in academic journals without revealing any identifiable patient information. The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1161). ### Conditions Module **Conditions:** - Critical Illness - Infections - Drug Use **Keywords:** - Serum vancomycin concentration - Machine learning ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 401 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** no intervention **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The serum vancomycin concentration predicted by the constructed model **Measure:** The predicted serum vancomycin concentration **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years; * Patients admitted to ICUs; * Patients were administered intravenous vancomycin; * Vancomycin TDM was performed at least two times. Exclusion Criteria: * Vancomycin TDM was performed in a ward rather than in an ICU; * Patients with missing data. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult ICU patients who receivied intravenous vancomycin treatment ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Peking Union Medical College Hospita **State:** Beijing **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Li Weng, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ye ZK, Li C, Zhai SD. Guidelines for therapeutic drug monitoring of vancomycin: a systematic review. PLoS One. 2014 Jun 16;9(6):e99044. doi: 10.1371/journal.pone.0099044. eCollection 2014. **PMID:** 24932495 **Citation:** Ingram PR, Lye DC, Tambyah PA, Goh WP, Tam VH, Fisher DA. Risk factors for nephrotoxicity associated with continuous vancomycin infusion in outpatient parenteral antibiotic therapy. J Antimicrob Chemother. 2008 Jul;62(1):168-71. doi: 10.1093/jac/dkn080. Epub 2008 Mar 10. **PMID:** 18334494 **Citation:** Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro B. Therapeutic Monitoring of Vancomycin for Serious Methicillin-resistant Staphylococcus aureus Infections: A Revised Consensus Guideline and Review by the American Society of Health-system Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2020 Sep 12;71(6):1361-1364. doi: 10.1093/cid/ciaa303. **PMID:** 32658968 **Citation:** Yasuhara M, Iga T, Zenda H, Okumura K, Oguma T, Yano Y, Hori R. Population pharmacokinetics of vancomycin in Japanese adult patients. Ther Drug Monit. 1998 Apr;20(2):139-48. doi: 10.1097/00007691-199804000-00003. **PMID:** 9558127 **Citation:** Obermeyer Z, Emanuel EJ. Predicting the Future - Big Data, Machine Learning, and Clinical Medicine. N Engl J Med. 2016 Sep 29;375(13):1216-9. doi: 10.1056/NEJMp1606181. No abstract available. **PMID:** 27682033 **Citation:** Doupe P, Faghmous J, Basu S. Machine Learning for Health Services Researchers. Value Health. 2019 Jul;22(7):808-815. doi: 10.1016/j.jval.2019.02.012. **PMID:** 31277828 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17388 - Name: Vancomycin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431399 **Brief Title:** To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 **Official Title:** A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 in Healthy Adult Volunteers #### Organization Study ID Info **ID:** JP-2004-102 #### Organization **Class:** INDUSTRY **Full Name:** Jeil Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2024-07-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jeil 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:** To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 **Detailed Description:** A randomized, open-label, crossover phase 1 clinical trial to evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 in healthy adult volunteers ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Thin arm is JLP-2004 FAST condition **Intervention Names:** - Drug: JLP-2004 qd **Label:** JLP-2004 FAST **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Thin arm is JLP-2004 FED condition **Intervention Names:** - Drug: JLP-2004 qd **Label:** JLP-2004 FED **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - JLP-2004 FAST - JLP-2004 FED **Description:** Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST) **Name:** JLP-2004 qd **Other Names:** - painkiller **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** AUCt of JLP-2004 in FAST and FED condition **Measure:** AUCt of JLP-2004 **Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour **Description:** Cmax of JLP-2004 in FAST and FED condition **Measure:** Cmax of JLP-2004 **Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy adult volunteers aged 19 years or older at the time of screening 2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. 3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography) 4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening 5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it Exclusion Criteria: 1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. ① Renal impairment ② Liver disorder 2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother 3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction 4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs **Healthy Volunteers:** True **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** DAJIN KIM **Phone:** 043-269-6781 **Role:** CONTACT #### Locations **Location 1:** **City:** Chungju **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** DAJIN KIM - **Phone:** 043-269-6781 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Chungbuk National University Hospital **State:** Seowon-gu **Status:** RECRUITING **Zip:** 28644 #### Overall Officials **Official 1:** **Affiliation:** Chungbuk National University Hospital **Name:** Minkyu Park **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4032 - Name: Analgesics - Relevance: HIGH - As Found: Laparoscopic Splenectomy ### Intervention Browse Module - Meshes - ID: D000000700 - Term: Analgesics ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431386 **Brief Title:** Behavioural Activation Therapy and Esketamine for Resistant Depression **Official Title:** Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression #### Organization Study ID Info **ID:** REB 2024002 #### Organization **Class:** OTHER **Full Name:** The Royal's Institute of Mental Health Research ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Royal's Institute of Mental Health Research #### Responsible Party **Investigator Affiliation:** The Royal's Institute of Mental Health Research **Investigator Full Name:** Dr. Jeanne Talbot **Investigator Title:** Physician Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression. **Detailed Description:** Depression is the leading cause of disability in the world and current treatments with medication are limited. Over one-third of individuals with major depressive disorder (MDD) and one quarter of individuals with bipolar disorder (BD) do not benefit from traditional pharmacotherapies, leading to treatment-resistant depressive episodes. Individuals with treatment-resistant depressive episodes (defined as a suboptimal response to two or more appropriate trials of antidepressant medication) have a higher burden of illness, higher healthcare utilization, poorer quality of life, worse occupational and social outcomes, and are at greater risk of death. Treatment-resistance may increase an individual's likelihood of engaging in suicidal behaviours and an estimated 30 percent of individuals with treatment-resistant depressive episodes will have a suicide attempt in their lifetime. To address these gaps in treatment, there has been growing interest in the use of intravenous (IV) ketamine as well as its newly marketed stereoisomer, esketamine, which is delivered intranasally. The discovery of the rapid antidepressant effects of low doses of ketamine has been hailed as a paradigm shift in psychiatry. However, a remaining challenge to address is the temporary nature of its effects. Ketamine induces neuroplasticity-enhancing effects more than conventional medications for depression. There may be the potential to harness this window of neuroplasticity to facilitate more lasting cognitive and/or behavioural changes through psychotherapy. To date, there are no randomized clinical trials of combined treatment with esketamine and psychotherapy for treatment-resistant depressive episodes. Studies to ensure that individuals can maximally benefit from this novel treatment are needed. The overall goal of this project is to maximize and sustain the beneficial effects of esketamine through combined treatment with behavioural activation (BA) therapy. The central hypothesis is that combined esketamine and BA therapy will elicit larger and faster decrease in depressive symptoms and more improvement in functional recovery compared with esketamine treatment alone. The specific aims of this research study are as follows: Aim 1. To determine if there is a larger decrease in depressive symptoms in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone. Aim 2. To compare the speed of antidepressant response in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone. Aim 3. To assess if participants receiving BA concurrent with esketamine treatment perceive greater improvement in functioning (self-reported depressive symptoms, quality of life, anhedonia, hopelessness, and work and social functioning) compared to participants receiving esketamine alone. This study is a single-site, parallel-arm, randomized clinical trial investigating the effects of augmenting esketamine treatment with BA therapy, an empirically supported treatment for depression. Participants will be randomized to one of two groups: 1) concurrent esketamine and BA therapy started from treatment initiation, or 2) esketamine treatment alone. Esketamine treatment will be offered as treatment as usual. All study participants will be offered a 12 session course of BA therapy, half will be randomized to receive BA concurrently with their esketamine treatment from initiation. Participants randomized to the esketamine treatment alone arm will be offered a full course of BA sessions after week 12 during the maintenance phase of treatment or at the time esketamine treatment ceases, whichever is earlier. BA therapy will be delivered virtually or in person according to participant preference (mode of administration will be recorded and included in data analysis as appropriate). The aim of BA therapy is to help individuals learn to observe the relationship between what they did, felt, and thought and what was happening around them, and to identify conditions which maintained, increased, or weakened maladaptive behaviours. Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions. Other techniques include self-observation and self-report, elaboration of activity hierarchies, behaviour programming, rehearsal and behavioural modelling, and contingency management. Between-session homework will develop relevant and rewarding day-to-day routines liable to offer reinforcement in each participant's environment. An independent expert will assess the quality and adherence to BA for the trial. This will be the first clinical trial to test the concurrent use of esketamine and a behavioural intervention. The efficacy data for esketamine largely comes from randomized controlled trials and thus may not always reflect the clinical reality for individuals who present for treatment in hospital settings. Conducting research with esketamine in a naturalistic academic-hospital setting will inform clinical practice. The goal is to offer esketamine to individuals as part of a comprehensive treatment plan to help them achieve longer-term recovery as opposed to short-lived decrease in clinical symptoms. ### Conditions Module **Conditions:** - Depressive Disorder, Treatment-Resistant - Depressive Disorder, Major - Bipolar Disorder **Keywords:** - Major Depressive Disorder - Esketamine - Psychotherapy - Behavioural Activation - Bipolar Depression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This pilot study is a single-site, parallel-arm, randomized clinical trial. ##### Masking Info **Masking:** SINGLE **Masking Description:** Clinical outcome assessments will be performed by raters blind to treatment allocation and not the treating therapist or physician. Ratings will be acquired prior to treatment administration. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomized to this arm will be administered esketamine treatment as per standard clinical care in conjunction with behavioural activation (BA) therapy. Both treatments will be initiated in Week 1 of the induction phase (first 4 weeks of esketamine treatment). **Intervention Names:** - Behavioral: Behavioural Activation (BA) Therapy - Drug: Esketamine **Label:** Esketamine + Behavioural Activation Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants randomized to this arm will be administered esketamine treatment as per standard clinical care and will be offered a course of BA therapy (12 one hour sessions) after their completion of the trial. **Intervention Names:** - Drug: Esketamine **Label:** Esketamine Alone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Esketamine + Behavioural Activation Therapy **Description:** Participants will receive weekly one-hour BA sessions on a day they are not receiving esketamine, delivered virtually or in person as per participant preference. The aim is for participants to learn to observe the relationship between what they did, felt, and thought and what was happening around them, and to identify conditions which maintained, increased, or weakened maladaptive behaviours. Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions. Other techniques include self-observation and self-report, elaboration of activity hierarchies, behaviour programming, rehearsal and behavioural modelling, and contingency management. Between-session homework will develop relevant and rewarding routines to offer reinforcement in each participant's environment. Participants will be offered 12 BA sessions in total. **Name:** Behavioural Activation (BA) Therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Esketamine + Behavioural Activation Therapy - Esketamine Alone **Description:** Participants will receive intranasal esketamine twice weekly during the induction phase (first 4 weeks of treatment). Maintenance treatments are administered once per week or once every two weeks at the discretion of the treating physician for 8 additional weeks, totaling 12 weeks of esketamine treatment. Dosing for esketamine usually starts at 56mg on Day 1, followed by 56 or 84mg doses for subsequent treatments. **Name:** Esketamine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score **Measure:** Change in depressive symptoms **Time Frame:** Baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12 #### Secondary Outcomes **Description:** Time required to first meet response criteria (≥50% improvement in MADRS scores) **Measure:** Speed of therapeutic effects **Time Frame:** Induction phase (weeks 1-4) **Description:** Change in self-reported depressive symptoms, quality of life, anhedonia, hopelessness, and physical, emotional and social functioning **Measure:** Change in participant perceived functioning **Time Frame:** Baseline to end of induction phase (week 4), and the end of weeks 8 and 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * English speaking * Ages 18-65 * Participants meeting criteria for major depressive disorder (MDD) or bipolar disorder, depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). * Participants who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode. Exclusion Criteria: * Depression secondary to a stroke, cancer, or other severe medical illnesses. * Pregnant, lactating or of childbearing potential and unwilling to use an approved method of contraception during the study. * A history of intracerebral hemorrhage, vascular disease. * Active psychotic symptoms. * Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria. * A diagnosis of major neurocognitive disorder or a Montreal Cognitive Assessment (MOCA) score \<24. * Active suicidal intent with the absence of psychotic symptoms is not an exclusion criterion, as this is not atypical in individuals with treatment-resistant, and/or severe depression (safety monitoring will be carried out by research personnel/study psychiatrists). * Known history of intolerance or hypersensitivity to ketamine. * Any other condition that, in the opinion of the PI/study investigator(s), would adversely affect the participant's ability to complete the study or its measures. * The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Research Coordinator **Phone:** 613-722-6521 **Phone Ext:** 6934 **Role:** CONTACT #### Locations **Location 1:** **City:** Ottawa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Research Coordinator - **Phone:** 613-722-6521 - **Phone Ext:** 6934 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jeanne Talbot, MD PhD FRCP - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jennifer Phillips, PhD - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** The Royal Ottawa Mental Health Centre **State:** Ontario **Status:** RECRUITING **Zip:** K1Z 7K4 #### Overall Officials **Official 1:** **Affiliation:** The Royal's Institute of Mental Health Research **Name:** Jeanne Talbot, MD PhD FRCP **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Disorder - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Depressive Disorder, Major - ID: M29783 - Name: Depressive Disorder, Treatment-Resistant - Relevance: HIGH - As Found: Depressive Disorder, Treatment-Resistant - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000001714 - Term: Bipolar Disorder - ID: D000003865 - Term: Depressive Disorder, Major - ID: D000061218 - Term: Depressive Disorder, Treatment-Resistant ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Days per week - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431373 **Acronym:** CLARITY **Brief Title:** A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (CLARITY) **Official Title:** A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis #### Organization Study ID Info **ID:** PVT-2201-303 #### Organization **Class:** INDUSTRY **Full Name:** Priovant Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2027-08-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Priovant Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine the safety and efficacy (including corticosteroid-sparing effect) of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU). ### Conditions Module **Conditions:** - Uveitis, Posterior - Uveitis, Intermediate - Uveitis ### 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:** 220 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Brepocitinib 45 mg PO QD **Label:** Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo PO QD **Label:** Arm 2 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Description:** Brepocitinib 45 mg PO QD **Name:** Brepocitinib 45 mg PO QD **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 2 **Description:** Placebo PO QD **Name:** Placebo PO QD **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 **Time Frame:** 24 weeks #### Secondary Outcomes **Measure:** Time to treatment failure on or after Week 6 up to Week 24 **Time Frame:** 24 weeks **Measure:** Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at Week 6 up to Week 24 **Time Frame:** 24 weeks **Measure:** Change in central subfield thickness from best state achieved in each eye at or prior to Week 6 up to Week 24 **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult subjects (18-74 years old) * Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). * Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator: Active, inflammatory chorioretinal and/or retinal vascular lesion; OR ≥2+ vitreous haze grade (NEI/SUN criteria). * Weight \> 40 kg with a body mass index \< 40 kg/m2. Exclusion Criteria: * Has isolated anterior uveitis. * Has macular edema as the only sign of intermediate uveitis, posterior uveitis, or panuveitis. * Has confirmed or suspected current diagnosis of infectious uveitis * History of or have: 1. ymphoproliferative disorder 2. active malignancy; 3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. thrombosis and cardiovascular disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections **Maximum Age:** 74 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014603 - Term: Uveal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000015864 - Term: Panuveitis - ID: D000002833 - Term: Choroiditis - ID: D000015862 - Term: Choroid Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17353 - Name: Uveitis - Relevance: HIGH - As Found: Uveitis - ID: M18410 - Name: Uveitis, Posterior - Relevance: HIGH - As Found: Uveitis, Posterior - ID: M18411 - Name: Uveitis, Intermediate - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: M18408 - Name: Panuveitis - Relevance: LOW - As Found: Unknown - ID: M18412 - Name: Pars Planitis - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6073 - Name: Choroiditis - Relevance: LOW - As Found: Unknown - ID: M18406 - Name: Choroid Diseases - Relevance: LOW - As Found: Unknown - ID: T4396 - Name: Panuveitis - Relevance: LOW - As Found: Unknown - ID: T4439 - Name: Pars Planitis - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: T1187 - Name: Choroiditis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014605 - Term: Uveitis - ID: D000015866 - Term: Uveitis, Posterior - ID: D000015867 - Term: Uveitis, Intermediate - ID: D000015868 - Term: Pars Planitis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431360 **Brief Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid **Official Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid #### Organization Study ID Info **ID:** KY20240514-02 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### 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:** Feng Wang **Investigator Title:** Director of nuclear medicine department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone . **Detailed Description:** Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min ### Conditions Module **Conditions:** - Keloid ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sr-90 brachytherapy followed by hyperthermia. **Intervention Names:** - Other: hyperthermia **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Sr-90 brachytherapy alone. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** hyperthermia (using a heater, 44℃for 15 min) **Name:** hyperthermia **Other Names:** - heater **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. comparable anatomic location. **Measure:** Patient and Observer Scar Assessment Scale (POSAS) scores **Time Frame:** once every 3 months for 1 year after the last treatment **Description:** Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple). **Measure:** Vancouver Scar Scale (VSS) scores **Time Frame:** once every 3 months for 1 year after the last treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation； * Body surface keloid thickness: 2\~5mm, diameter ≥10mm. Exclusion Criteria: * Women who plan to become pregnant within 3 months or are pregnant or breastfeeding; * Patients with cicatricial constitution; * Abnormal coagulation function; * Patients who have received an adequate dose or course of radiation therapy; * People with previous immune system diseases, diabetes and other metabolic diseases. **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Feng Wang **Phone:** 86-025-52271455 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liang Shi **Phone:** 86-025-52271491 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Wang, Ph.D. - **Phone:** 86-025-52271455 - **Role:** CONTACT **Country:** China **Facility:** Nanjing First Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 **Location 2:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Wang - **Phone:** 86-025-52271455 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Liang Shi - **Phone:** 86-025-52271491 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Nanjing Medical Univerity **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 #### Overall Officials **Official 1:** **Affiliation:** Nanjing First Hospital, Nanjing Medical University **Name:** Feng Wang **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001832 - Term: Body Temperature Changes - ID: D000018882 - Term: Heat Stress Disorders - ID: D000014947 - Term: Wounds and Injuries - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M10654 - Name: Keloid - Relevance: HIGH - As Found: Keloid - ID: M2454 - Name: Hyperthermia - Relevance: HIGH - As Found: Hyperthermia - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M5111 - Name: Body Temperature Changes - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M20924 - Name: Heat Stress Disorders - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - 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: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007627 - Term: Keloid - ID: D000084462 - Term: Hyperthermia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431347 **Brief Title:** Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health **Official Title:** Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health #### Organization Study ID Info **ID:** 2024-0038 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04536 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2029-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To learn more about social and financial factors that may influence outcomes of TCT treatment at MD Anderson. **Detailed Description:** Primary Objective: To determine the relationship between participant social determinants of health (SDOH) and outcomes following transplantation and cellular therapy at MDACC. ### Conditions Module **Conditions:** - Transplant and Cell Therapy **Keywords:** - Social Determinants of Health ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants that agree to take part in this study, the study staff will first verify your demographic information (such as age, sex, race, and so on). Participants will then be asked about social barriers to care, including but not limited to: * primary language and confidence speaking English * education level * employment history * health literacy * legal history * caregiver status and literacy **Intervention Names:** - Behavioral: Social Determinants of Health Questionnaire **Label:** Transplant and Cell Therapy Candidates and Recipients ### Interventions #### Intervention 1 **Arm Group Labels:** - Transplant and Cell Therapy Candidates and Recipients **Description:** Participants will also complete a questionnaire about financial barriers to care within the past year, including income bracket and difficulty affording cost-of-living or medical expenses. **Name:** Social Determinants of Health Questionnaire **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Social Determinants of Health Questionnaire **Time Frame:** At 6, 12, 18, and 24 months post Transplant and Cell Therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. ≥ 18 years of age. 2. Received financial clearance for TCT. Exclusion Criteria 1) Did not receive financial clearance for TCT **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** MD Anderson Cancer Center ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Warren Fingrut, MD **Phone:** (832) 387-8363 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Warren Fingrut, MD - **Phone:** 832-387-8363 - **Role:** CONTACT ***Contact 2:*** - **Name:** Warren Fingrut, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Warren Fingrut, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431334 **Brief Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique **Official Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique #### Organization Study ID Info **ID:** A06-M25-23A #### Organization **Class:** OTHER **Full Name:** McGill University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** McGill University #### Responsible Party **Investigator Affiliation:** McGill University **Investigator Full Name:** Tyler Churchward-Venne **Investigator Title:** Assistant Professor of Exercise Physiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested. Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations. Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations. The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique. ### Conditions Module **Conditions:** - Healthy - Increased Metabolic Requirements - Dietary Reference Intakes ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 8 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants are to be randomly assigned varying levels of amino acid intakes ranging between 0.5 to 2.8 g/kg/d **Intervention Names:** - Dietary Supplement: Amino Acid Intake **Label:** Masters Level Cyclists **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Masters Level Cyclists **Description:** Amino acid intakes will vary between 0.5 to 2.8 g/kg/d **Name:** Amino Acid Intake **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Measured by continuous-flow isotope ratio mass spectrometry **Measure:** 13CO2 Excretion **Time Frame:** 7-weeks #### Secondary Outcomes **Description:** Measured by gas chromatography-mass spectrometry **Measure:** L[13C]phenylalanine Oxidation **Time Frame:** 7-weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18.5\< BMI \<35 kg/m\^2 * Overtly healthy masters level cyclists ≥65 years * Masters level cyclist training (\>4 days per week; \~100 km per week) * Body mass stable over previous 6-months * Availability for multiple metabolic trials (\~7 trials) * Ability to travel to and from laboratory facility Exclusion Criteria: * Recent history of weight loss or weight gain (\>5% body weight) * Uncontrolled hypertension * ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia) * Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza) * Currently using anti-inflammatory medications * Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions) * Regular tobacco user * Illicit drug use * Habitually ingesting ≥3 g/kg/bw **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** MALE **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tyler A. Churchward-Venne, Ph.D. **Phone:** (514) 398-4184 **Phone Ext:** 00839 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zachary Bell, Ph.D **Phone:** (514) 296-6960 **Role:** CONTACT #### Locations **Location 1:** **City:** Montréal **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zachary W Bell, PhD - **Phone:** 5142966960 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Tyler A Churchward-Venne, PhD - **Phone:** 5147938920 - **Role:** CONTACT ***Contact 3:*** - **Name:** Zachary W Bell, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Tyler A Churchward-Venne, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Micaela Forcione, BSc - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** McGill University **State:** Quebec **Zip:** H3A 0G4 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431321 **Brief Title:** Evaluation of a 2-session Parent Training Programme for Caregivers of Younger Children in Zimbabwe **Official Title:** A Pilot Cluster Randomised Controlled Trial of a Two-session Parent Training Programme for Delivery to Caregivers of Children Enrolled in Early Childhood Development in Harare, Zimbabwe #### Organization Study ID Info **ID:** WNDNOR001 #### Organization **Class:** OTHER **Full Name:** University of Cape Town ### Status Module #### Completion Date **Date:** 2024-09-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Parenting for Lifelong Health **Class:** UNKNOWN **Name:** Mikhulu Trust **Class:** UNKNOWN **Name:** Clowns Without Borders South Africa **Class:** UNKNOWN **Name:** Ministry of Primary and Secondary Education Zimbabwe #### Lead Sponsor **Class:** OTHER **Name:** University of Cape Town #### Responsible Party **Investigator Affiliation:** University of Cape Town **Investigator Full Name:** Noreen Wini Dari **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:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development. The RCT aims to assess the following objectives: Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised? **Detailed Description:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare, Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development. The RCT aims to assess the following objectives: Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised? The RCt will have 2 arms with 120 caregivers /arms. The intervention will be a 2-session parent training programme while the control is a 2-session nutrition knowledge dissemination workshop delivered over 2 sessions. ### Conditions Module **Conditions:** - Child Maltreatment **Keywords:** - Child Maltreatment - Parenting - Violence Against Children (VAC) - Prevention - Parenting Intervention - Early Childhood Development (ECD) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Each study arm will have 8 schools Schools will be randomly assigned to the study arm ##### Masking Info **Masking:** DOUBLE **Masking Description:** Research assistants and the statistician will be blinded until the analyses are completed. The randomisation process is concealed from research assistants in order to avoid experimenter bias. Complete statistical analysis plans will be prepared before the data is locked, and analysis tactics are predetermined. Until the data are finalised, the study statistician will not be aware of the treatment assignment **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Tabudirira Parenting Intervention for Early Childhood Development will be delivered to parents of children aged 4-5 years in Harare, Zimbabwe. Trained facilitators will deliver the programme face to face, and a group of 15 parents will have 3 facilitators. The facilitators comprise of teachers working as guidance and counselling coordinators and psychology graduates. The programme consists of 2 sessions that will be delivered once a week over 2 weeks, with each session lasting 2.5 to 3 hours. The session will have various activities which focus on learning from each other and practising positive parenting behaviours. At the end of each session, parents will receive a home activity which allows them to practise the content taught during the session. At the end of session 2 parents will receive a parent handbook with the summary of the 2 sessions. Schools will be used as venues and the facilitators will receive ongoing mentoring and coaching during programme delivery. **Intervention Names:** - Behavioral: Tabudira Parenting Intervention for Early Childhood Development **Label:** Parent training intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group (8 groups with 15 parents each) will receive a one-hour session on nutrition with facilitators trained by a nutritionist focusing on children aged 4-7 years. The parents will also receive a nutrition handbook. Zimbabwe is faced with the triple burden of malnutrition: underweight, micronutrient deficiencies and overweight. There is an ongoing need to protect and promote diets, services and practices through a multi-systems approach that supports optimal nutrition, growth, and development for all children, using a parent support group can help achieve the goal. The nutrition programme has no components of positive parenting or links to the reduction of violence against children but will serve as a placebo control for the attention received by parents. **Intervention Names:** - Other: Nutritional guide for younger children **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Parent training intervention **Description:** 2 session programme delivered weekly over 2 weeks using group-based delivery aimed at reducing child maltreatment, improving parenting behaviours and parent's mental health. **Name:** Tabudira Parenting Intervention for Early Childhood Development **Other Names:** - Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control **Description:** 2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child **Name:** Nutritional guide for younger children **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Barriers and enablers to delivery Barriers and enablers to parent engagement (attendance, homework completion) **Measure:** Implementation Outcomes **Time Frame:** 6 weeks #### Primary Outcomes **Description:** The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child **Measure:** Changes in frequency of child maltreatment: **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Changes in attitudes towards harsh parenting will be measured using two items from the ICAST-T measure used in measuring the primary outcome. The questions will seek to understand parental attitudes towards harsh discipline for example: In the past 6 weeks, how often did physical discipline seem like the only option for stopping bad behaviour? **Measure:** Changes in attitudes towards harsh parenting **Time Frame:** 6 weeks **Description:** will be measured using 1 item from the ICAST-T the question: In the past 6 weeks, how often did you not know what to do when your child misbehaved **Measure:** Changes in not knowing what to do when a child misbehaves **Time Frame:** 6 weeks **Description:** The Parenting Young Children Questionnaire (PARYC) has 9 items that contain statements of parenting behaviours that caregivers rate on a Likert scale from 1 (not at all) to 7 (most of the time). Two dimensions of the PARYC will be measured: Supporting Good Behaviour (e.g., "Notice/Praise good behaviour") and Setting Limits (e.g., "Stick to your rules"). The items included in the current questionnaire (Cronbach alpha 0.86). are informed by the metric invariance analysis of the measure done in a preceding study, pending publication. The preceding study measured the prevalence of violence against children and its correlates. The highest possible score is 63 indicating more parent-child engagement compared to the lowest possible score of 9 indicating fewer parent-child engagements. **Measure:** Spending time with child, praising, naming emotions **Time Frame:** 6 weeks **Description:** Two items, similar in structure to those in the PARYC, will be used to assess this e.g. How often do you spend time book sharing with your child? **Measure:** Changes in time spent engaging the child in book sharing **Time Frame:** 6 weeks **Description:** The Shona Symptoms Questionnaire (SSQ-14) will be used to assess parental mental health before and after the programme. The SSQ is a 14-item screening tool for common mental disorders and has a reliable internal consistency (0.85). It asks about symptoms such as thinking too much, failing to concentrate, work lagging, insomnia, suicidal ideation, unhappiness and so on, over 1 week. Highest total possible score of 14 indicates floundering parental mental health while a score of 0 indicates flourishing parental mental health **Measure:** Changes in caregiver mental health **Time Frame:** 6 weeks **Description:** The Multidimensional Measure of Work-Family Conflict (MMWFC) measures work-family conflict on three constructs: time, strain and behaviour. The scale has 12 items, with responses on a 7-point Likert scale ranging from strongly disagree to strongly agree. The following are examples of items in the questionnaire: my work keeps me from my family activities more than I would like, I am often stressed from my family responsibilities, and I have a hard time concentrating on my work. The internal reliability was 0.92 in phase 1. The highest possible score is 84 indicating increased work-family conflict compared to 12 which is the lowest possible score indicating better work-family balance. **Measure:** Changes in work-family conflict **Time Frame:** 6 weeks **Description:** : Four questions will be adapted from the Food and Agriculture Organisation of the United Nations guidelines for assessing nutrition-related knowledge, attitudes, and practices. The questions will assess the practices of the child's intake of healthy (2 items) and unhealthy snacks (2 items): How many times a day does your child eat candy? The items will be measured on a 6-point Likert scale ranging from Never to 6 times a day. The healthy eating scores will be reverse scored. The highest possible total is 24 indicating poor snacking practices compared to the lowest possible score of 4 for healthy snacking practices. **Measure:** Changes in Knowledge of Child nutrition **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18 years and above. * Be a caregiver to a child enrolled in Early Childhood Development Grade A at a school in Harare Northern Central School district. * Live with the child for a minimum of 5 days/ week. * Provide informed consent before any study proceedings. Exclusion Criteria * Aged below 18 * A child enrolled in a school outside Harare Northern Central School District * Child not enrolled in Early Childhood Development Grade A **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Noreen Wini Dari, MSc **Phone:** +263 718 886340 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Cathrine Ward, PhD **Phone:** +27 21 650 3422 **Role:** CONTACT #### Locations **Location 1:** **City:** Harare **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marian Mazingi District Official: Ministry of Primary and secondary Education - **Phone:** +263 772 864 277 - **Role:** CONTACT **Country:** Zimbabwe **Facility:** Harare Northen Central School District #### Overall Officials **Official 1:** **Affiliation:** University of Capetown **Name:** Noreen Wini Dari, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Open **Description:** Ziva Hub Anonymised Individual Participant Data **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** 2026 **URL:** https://zivahub.uct.ac.za/ ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431308 **Brief Title:** Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events **Official Title:** Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase #### Organization Study ID Info **ID:** ASMC-0003-24 #### Organization **Class:** OTHER **Full Name:** Ariel University ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-28 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ariel University #### Responsible Party **Investigator Affiliation:** Ariel University **Investigator Full Name:** Shiri Sherf Dagan **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy©. The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© titration phase \[20 weeks (T1)\] and weekly during the study period (for GI symptoms assessment). ### Conditions Module **Conditions:** - Obesity; Drug ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). **Intervention Names:** - Behavioral: nutritional intervention **Label:** Nutritional intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * Usual nutrition care treatment for patients treated with Wegovy© (RCT). * Prior to the initiation of AOM treatment, participant will receive general nutrition guidance based on national recommendations according to the Mediterranean diet. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Nutritional intervention group **Description:** A nutrition guidance before initiation of AOM treatment include recommendations for food choices and eating habits to minimize the occurrence and severity of GI symptoms during the up-titration phase, will be given by registered dietitian (RD) from the study team. Next, each week, participants will provide weekly reports of GI symptoms occurrence and severity, by responding to queries sent via WhatsApp/SMS and for occurring symptoms, an automatically structured nutrition and behavioral treatment recommendations will be sent. Three days after each report of GI symptom(s), participants will receive an additional message and will be asked to report the occurrence and severity of the GI symptom, and their compliance with the specific dietary instructions received. If participants expressed an interest in personalized dietary guidance on this matter, the study team RD will contact him/her by telephone, within a range of 48 hours, to provide individualized recommendations **Name:** nutritional intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Participants will be asked to provide at T0 biochemical tests obtained during the last 3 months, including complete blood count, lipid profile, fasting glucose, HbA1c, iron, transferrin, ferritin, vitamin B12, folate, and vitamin D **Measure:** Biochemical tests **Time Frame:** At baseline **Description:** years **Measure:** Demographics - age **Time Frame:** At baseline **Description:** married, single, divorced or widowed **Measure:** Demographics - marital status **Time Frame:** At baseline **Description:** less than high school, high school graduate, high school diploma, bachelors degree, masters degree, MD or doctoral degree **Measure:** Demographics - education **Time Frame:** At baseline **Description:** employee full time, employee part time, self-employed or other **Measure:** Demographics - occupation status **Time Frame:** At baseline **Description:** T2DM, prediabetes, dyslipidemia, HTN,sleep apnea, orthopedic problems, GERD, mental disorder or other **Measure:** Health status - Number of participants with coexisting medical conditions and their types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** usual medications **Measure:** Number of participants using regular medications and their types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** smoker, former smoker or never **Measure:** Smoking habits **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** multiviamin, Iron, vitamin D, folic acid, vitamin B12, calcium or other **Measure:** Number of participants ysing supplementation and their Types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** sleeping quality on a scale of 0-3 (0- very good, 1-quite good, 2- quite bad, 3- very bad) **Measure:** Lifestyle factors - Sleeping habits **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** number of exercises per week **Measure:** Lifestyle factors - frequency of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** exercise time in minutes **Measure:** Lifestyle factors - duration of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** aerobic or anaerobic **Measure:** Lifestyle factors - type of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) #### Primary Outcomes **Description:** GI symptoms rating scale (GSRS) - assess the degree of specific GI complaints Every question is rated by seven graded Likert-type scale (1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms) while a higher score of the whole questionnaire and by dimension represents more severe symptoms. **Measure:** Gastrointestinal symptoms assessment **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** Bristol stool scale - classifying the form of human feces into seven categories. Type 1-2 are considered abnormal hard stools and indicative of constipation type, and type 5-7 are considered abnormally loose/liquid stools and indicative of diarrhea or urgency **Measure:** Defecation texture **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** will be assessed according to five acceptable categories: \>3 BMs/day, 2-3 BMs/day, 1-2 BMs/day, 3-4 BMs/week, \<3 BMs/week **Measure:** Bowel Movement (BM) frequency **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** Participant subjective and objective reporting of GI symptoms **Measure:** Participants gastrointestinal symptoms report **Time Frame:** Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only) #### Secondary Outcomes **Measure:** Incretin-based AOM treatment discontinuation rate **Time Frame:** At the end of the study period (20 weeks) and weekly until 20 weeks **Description:** Weight (kg) by digital scale, height (cm) by altimeter. weight and height will be combined to report BMI in kg/(meter)\^2 **Measure:** Anthropometric measures - BMI **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** will be measured by tape measure (cm) **Measure:** Anthropometric measures - waist circumference (WC) **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Body composition analysis using Inbody370S® includes measuring of fat mass (kg) , percentage of body fat (BF%), fat-free mass (kg), and skeletal muscle mass (kg). **Measure:** Body composition **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** 3-days food diaries and Israeli Ministry of Health Food Frequency Questionnaire (FFQ) that will be modified for the current study population **Measure:** Dietary intake **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** General questions regarding eating patterns, hydration and foods intolerance **Measure:** Eating habits assessment **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Control of Eating Questionnaire (CoEQ) - The of CoEQ consists of 21 items (19 questions are rated by 100 mm VAS, and two question are open-ended). Greater score represents greater levels of Craving Control. **Measure:** Eating habits assessment - Control of Eating **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Handgrip (HG) muscle Strength - measure static muscle strength (kg) of the upper extremities by a digital hand dynamometer (Jamar plus digital©) **Measure:** Functional parameters - muscle strength **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** 30-seconds sit and stand test - counts the number of times the patient stands in 30 seconds. Higher scores means a better outcome. **Measure:** Functional parameters- leg strength and endurance **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** EQ-5D-3L questionnaire -include the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) .The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The EQ VAS records the patient's self-rated health. Participants will be asked to subjectively rate their overall state of health by using a 0 to 100 VAS, with a higher score reflects a better outcome. **Measure:** Quality of life assessment **Time Frame:** Change from baseline at the end of the study period (20 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * individuals aged ≥ 18 years * eligible to receive AOM \[i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)\] * who can read and speak Hebrew. Exclusion Criteria: * contraindications for treatment with Wegovy© \[i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, a history of acute pancreatitis from an unknown etiology, attempting conception, current pregnancy or breastfeeding\] * previous bariatric surgery or endo-bariatric procedure * history of chronic pancreatitis * treatment with AOM within 6 months before enrollment * patients with type 1 diabetes mellitus * patients who underwent other major GI surgery prior to medication treatment * patient with underlying GI disease \[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\] * a positive diagnosis of small-intestinal bacterial overgrowth (SIBO) * patients with active gastritis, gastroenteritis * chronic usage of promotility drugs or laxatives * patients with uncontrolled mental illness * significant cognitive deterioration * alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men (32). In addition, Participants who will decide not to initiate or stop Wegovy© treatment for a period of more than two consecutive weeks for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shiri Sherf-dagan, Ph.D **Phone:** +972747288004 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rotem Refaeli **Phone:** +972545797995 **Role:** CONTACT #### Locations **Location 1:** **City:** Ariel **Country:** Israel **Facility:** Ariel University **Zip:** 40700 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431295 **Brief Title:** Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements **Official Title:** Human Performance Evaluation of a Digital Visual Acuity Device: Visual Acuity-001 #### Organization Study ID Info **ID:** 23-007148 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Antonio J. Forte **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters. ### Conditions Module **Conditions:** - Visual Acuity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects for an ophthalmological examination that includes a visual acuity examination at Mayo Clinic in Florida have a digital visual acuity test conducted with the FaceScan device. **Intervention Names:** - Device: FaceScan **Label:** Digital Visual Acuity Test **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital Visual Acuity Test **Description:** Digital visual acuity device built for iOS ("iPhone") that conducts an assessment of visual acuity using a combination of integrated light detection and ranging (LiDAR) and voice processing. **Name:** FaceScan **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Number of subjects to have agreement between the visual acuity digital device and the clinical assessment **Measure:** Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements **Time Frame:** Baseline #### Secondary Outcomes **Description:** Total number of voice samples collected of spoken letters **Measure:** Voice samples **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥ 18 years) who come to Ophthalmology Clinic. * Willing and able to provide consent. Exclusion Criteria: * Individuals \< 18 years of age. * Unable to provide consent. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jacksonville **Country:** United States **Facility:** Mayo Clinic in Florida **State:** Florida **Zip:** 32224 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Antonio Forte, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431282 **Brief Title:** Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment **Official Title:** In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment #### Organization Study ID Info **ID:** 01-24 #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf **Investigator Full Name:** Lynhda Nguyen **Investigator Title:** Principle Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** * Weakly crossed-linked hyaluronic acid (HA) can be delivered through multiple injections into the dermal and subnormal layer to improve skin quality. However, this treatment comes with multiple bumps for several days. * Alternatively, HA can be delivered after CO2 laser or thulium laser pretreatment. As microscopic analysis after this treatment is limited, the object of the present study is to investigate the morphological cellular changes after CO2 laser and thulium laser delivered HA into human skin. ### Conditions Module **Conditions:** - Aging Skin ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Probands are treated with a CO2 laser. Afterwards a HA gel will be applied. **Intervention Names:** - Other: CO2 laser + HA **Label:** CO2 laser + HA **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Probands are treated with a thulium laser. Afterwards a HA gel will be applied. **Intervention Names:** - Other: Thulium laser + HA **Label:** Thulium laser + HA **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CO2 laser + HA **Description:** Probands will be treated with a CO2 laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used. **Name:** CO2 laser + HA **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Thulium laser + HA **Description:** Probands will be treated with a thulium laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used. **Name:** Thulium laser + HA **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Size of intercellular spaces after CO2 or thulium laser treatment compared to control. **Measure:** Size of intercellular spaces **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Size of keratinocytes after CO2 or thulium laser treatment compared to control. **Measure:** Size of keratinocytes **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Size of HA granules after CO2 or thulium laser treatment compared to control. **Measure:** Size of hyaluronic acid granules **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Distribution though the epidermal and dermal layers after CO2 or thulium laser treatment compared to control. **Measure:** Distribution of Hyaluronic Acid **Time Frame:** 30 minutes and 30 days after treatment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - healthy male and female patients Exclusion Criteria: * pregnancy, breast feeding * open wounds at the area to be treated **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hamburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lynhda Nguyen, Dr. med. - **Phone:** +49 (0)40 7410-0 - **Role:** CONTACT **Country:** Germany **Facility:** University Medical-Center Hamburg-Eppendorf **Status:** RECRUITING **Zip:** 20251 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25. **PMID:** 35837813 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431269 **Acronym:** NEURODEV-IPA **Brief Title:** Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease **Official Title:** Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease #### Organization Study ID Info **ID:** 21_0291 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier #### Secondary ID Infos **Domain:** 2024-A00552-45 **ID:** ID-RCB **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Montpellier #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease **Detailed Description:** Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life. In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment. Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation. This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population. ### Conditions Module **Conditions:** - Congenital Heart Disease in Children - Neurodevelopmental Disorders **Keywords:** - congenital heart disease - neurodevelopmental screening - advanced practice nurse - organization of care - neuropsychological assessment ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Screening for neurodevelopmental disorders by an advanced practice nurse **Label:** Screening for neurodevelopmental disorders by an advanced practice nurse **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Screening for neurodevelopmental disorders by an advanced practice nurse **Description:** Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale **Name:** Screening for neurodevelopmental disorders by an advanced practice nurse **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied **Time Frame:** 4 months (to obtain the neurophysiologist assessment) #### Secondary Outcomes **Description:** This rate will be calculated by dividing the complete IPA screenings (including HAS and the ASQ-3 parent's questionnaire) and children coming to the Complex Congenital Heart Defects consultation during the study period. **Measure:** Feasibility of the IPA screening for NDD **Time Frame:** 18 months **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (sensibility) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (specificity) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Measure:** Prevalence of NDD in the high risk population **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Congenital heart disease with stable status defined by last operation \>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion * Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life, * Patient aged 1 to 5 years. * No previous medical diagnosis of NDD * Parental or legal guardian's consent. * Social security affiliation (for France only) Exclusion Criteria: * Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network) * Neurodevelopmental status evaluation within the last 6 months. **Maximum Age:** 5 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marie VINCENTI, MD **Phone:** 04 67 33 66 39 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Clinical Research Associate **Phone:** 06 67 33 66 32 **Role:** CONTACT #### Locations **Location 1:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marie VINCENTI, MD - **Phone:** 04 67 33 66 39 - **Role:** CONTACT **Country:** France **Facility:** University Hospitial of Montpellier **Zip:** 34295 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: HIGH - As Found: Neurodevelopmental Disorders - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - 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: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000065886 - Term: Neurodevelopmental Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431256 **Brief Title:** Ph3 Multicenter, 3wk RDBPC Efficacy, Safety & PK Study of Evening Dosed MPH HCl ER Capsules (HLD200) in Children 4-5 Yr With ADHD **Official Title:** Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and Pharmacokinetic Study of Evening Dosed Methylphenidate Hydrochloride Extended-Release Capsules (HLD200) in Children Aged 4 to 5 Years With ADHD #### Organization Study ID Info **ID:** HLD200-112 #### Organization **Class:** OTHER **Full Name:** Ironshore Pharmaceuticals and Development, Inc ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ironshore Pharmaceuticals and Development, Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. **Detailed Description:** This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis. A total of 168 participants (56 per treatment arm) will be randomized at Visit 2. ### Conditions Module **Conditions:** - Attention Deficit Hyperactivity Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 168 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Matching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4) **Intervention Names:** - Drug: Placebo HLD200 capsules **Label:** Placebo Comparator **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4) **Intervention Names:** - Drug: HLD200 methylphenidate hydrochloride capsules **Label:** HLD200 20 mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for the first week (prescribed at Visit 2), with up-titration for the final 2 weeks to HLD200 20 mg active capsules (×2) (prescribed at Visits 3 and 4) **Intervention Names:** - Drug: HLD200 methylphenidate hydrochloride capsules **Label:** HLD200 40 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HLD200 20 mg - HLD200 40 mg **Description:** Doses: 20mg capsules **Name:** HLD200 methylphenidate hydrochloride capsules **Other Names:** - methylphenidate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo Comparator **Description:** Doses: 20mg capsules **Name:** Placebo HLD200 capsules **Other Names:** - placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version Total Score from Baseline (Visit 2) to Visit 5 for participants receiving HLD200 compared to participants receiving placebo in ITT population **Measure:** Primary Efficacy Endpoint **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** The change in Clinical Global Impression - Severity (CGI-S) score from Baseline (Visit 2) to Visit 5 for participants receiving HLD200 compared to participants receiving placebo in ITT population **Measure:** Secondary Efficacy Endpoint **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject and the subject's parent(s)/legal guardian(s) must be available for the duration of the study. The subject's parent(s)/legal guardian(s) must be able to read, write, and/or understand at a level sufficient to provide signed and dated informed consent. In accordance with ICH GCP Guideline E6 and other applicable regulations, the Investigator, or a person designated by the Investigator, will obtain written informed consent from each subject's parent(s)/legal guardian(s) (and the subject's assent, if applicable) before any study-specific activity is performed. The Investigator will retain the original copy of each signed consent/assent document. 2. Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable). 3. Subjects must have a diagnosis of ADHD as defined by the DSM-5 criteria with confirmation using the Mini - International Neuropsychiatric Interview for Children and Adolescents (MINI KID). 4. Subjects must meet the criteria for the therapeutic need for control of mild to moderate symptoms of ADHD at Screening (Visit 1) and/or Baseline (Visit 2) as determined by a medical evaluation and by an ADHD-RS-IV Preschool Version Parent score ≥ 93rd percentile cut-off normalized for sex in ≥ 1 of the following: Hyperactivity/Impulsivity subscale score (≥17 for boys; ≥14 for girls), Inattention subscale score (≥14 for boys; ≥12 for girls), or Total Score (≥32 for boys; ≥24 for girls); and a Clinical Global Impression - Severity (CGI-S) score ≥4. 5. Subjects must have a Peabody Picture Vocabulary Test 4 (PPVT-4) Standard Score ≥70 at Screening. 6. Subject has undergone an adequate course of nonpharmacologic treatment or has a severe enough condition in the opinion of the Investigator to consider enrollment without undergoing prior nonpharmacological treatment. 7. Subject's height and weight at Screening are between the 5th and 95th percentiles according to the Centers for Disease Control and Prevention growth charts by age and sex. 8. Subject must have a resting pulse less than 127 bpm, systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 American Academy of Pediatrics guidelines7 based on the average of 3 measurements 2 to 5 minutes apart at Visit 1 and Visit 2, (only a single measurement is required at Visit 2 unless an elevated excursion is noted which requires the averaged value of triplicate measurements). 9. Subject must be considered clinically appropriate for treatment with HLD200. 10. Subject must be in general good health based upon medical history, physical examination, clinical laboratory examinations, vital signs, and 12-lead electrocardiogram (ECG) assessment Exclusion Criteria: 1. History of, or current, medical condition, including gastrointestinal disorders (e.g., surgery, malabsorption syndrome, and other similar conditions), open-angle glaucoma, abnormally increased intraocular pressure (IOP), or laboratory result that, in the opinion of the Investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study related procedures. 2. Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, known family history of sudden death, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug. 3. History of seizure disorder (except febrile seizures prior to age 4 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 criteria). 4. Subject has any diagnosis of psychosis, bipolar I or II disorder, major depressive disorder, anxiety disorder, eating disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, tic disorders, disruptive mood dysregulation disorder, intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during screening. Additionally, subject has any other conditions that, in the Investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures. 5. Subject is currently considered at risk of suicide in the opinion of the Investigator, has previously made a suicide attempt, or has a history of, or is currently demonstrating active suicidal ideation or behavior. 6. History of severe allergic reaction or intolerance to MPH. 7. Alanine aminotransferase, aspartate aminotransferase, total bilirubin, or creatinine greater than 1.5 times the upper limit of normal. Elevated bilirubin due to Gilbert's syndrome is not exclusionary. 8. Use of prescription medications (except allowed medications) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (within 72 hours \[3 days\] of Baseline Visit 2), clonidine and guanfacine (5 days of Baseline Visit 2), atomoxetine (7 days of Baseline Visit 2), monoamine oxidase (MAO) inhibitors (14 days of Baseline Visit 2), and nonprescription/over-the-counter medications (except allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications must be cleared by the Medical Monitor prior to enrolling the subject. 9. Use of psychotropic medications including antidepressants, mood stabilizers, and antipsychotics within 14 days of Baseline. 10. Participation in a clinical trial with an investigational drug within the 30 days preceding study enrollment. 11. Initiation of non-pharmacological treatment within 30 days prior to Baseline (Visit 2). Subject may not initiate any new non-pharmacological treatment during the study. 12. Use of any other medications that might confound the results of the study or increase risk to the subject. 13. Subject is well-controlled on his/her current ADHD medication with acceptable tolerability. 14. In the opinion of the Investigator, the subject may have potential problems complying with the protocol or the procedures of the protocol, or for which the study could pose unnecessary safety risks. 15. Subject has a sibling or step-sibling that is concurrently participating in this study or who has previously participated in this study 16. Subject or caregiver is a participating Investigator, Sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned. 17. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol **Maximum Age:** 5 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019958 - Term: Attention Deficit and Disruptive Behavior Disorders - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9999 - Name: Hyperkinesis - Relevance: LOW - As Found: Unknown - ID: M4594 - Name: Attention Deficit Disorder with Hyperactivity - Relevance: HIGH - As Found: Attention Deficit Hyperactivity Disorder - ID: M21830 - Name: Attention Deficit and Disruptive Behavior Disorders - 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: D000001289 - Term: Attention Deficit Disorder with Hyperactivity ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018765 - Term: Dopamine Uptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M11748 - Name: Methylphenidate - Relevance: HIGH - As Found: Fed - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20832 - Name: Dopamine Uptake Inhibitors - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008774 - Term: Methylphenidate ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431243 **Brief Title:** A Clinical Study of Puesta Mesylate for Injection in Patients With Solid Tumors **Official Title:** An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Combination of Puesta Mesylate for Injection in the Treatment of Advanced Solid Tumors #### Organization Study ID Info **ID:** ZLPM-003-1.0 #### Organization **Class:** INDUSTRY **Full Name:** Chengdu Zenitar Biomedical Technology Co., Ltd ### Status Module #### Completion Date **Date:** 2026-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chengdu Zenitar Biomedical 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:** Primary Purpose Phase Ib Evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; and explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination of puesta mesylate in patients with advanced solid tumors; Determine the recommended phase II dose (RP2D) for the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa. To further evaluate the preliminary efficacy of the combination of puesta mesylate in patients with advanced solid tumors. Secondary objective Phase Ib Evaluate the safety and tolerability of poystat mesylate monotherapy in advanced solid tumors; To evaluate the preliminary efficacy of the combination of poystat mesylate in patients with advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa To further evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Exploratory Objective. To evaluate the pharmacodynamic significance of biomarkers in the combination of puesta mesylate for the treatment of advanced solid tumors. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Cohort A, subjects in the ascending-dose group received PM IV, administered at a frequency of BiW (2 times per week) for 2 weeks, i.e., on days 1, 4, 8, and 11 of each cycle, with a 1-week discontinuation to allow for a 21-day cycle (with a minimum interval of ≥48 h between each of the 2 doses within the same dosing cycle), and exemestane was administered orally once a day within 30 min after the end of breakfast as one tablet ( 25 mg). Based on the results obtained in the dose-escalation phase, the necessity of the phase IIa expansion cohort and the dose of PM to be administered will be decided after discussion by the SMC, and the phase IIa cohort expansion is expected to select 1-2 dose groups of 10-15 cases each, with a total of 19-54 cases in this cohort **Intervention Names:** - Drug: A group Purinostat Mesylate 6mg/m2 - Drug: A group Purinostat Mesylate 8.4mg/m2 - Drug: A group Purinostat Mesylate 11.2mg/m2 - Drug: A group Purinostat Mesylate 15.0mg/m2 **Label:** A group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In Cohort B, subjects in the ascending dose group all received PM IV drip administered at a frequency of BiW (2 times per week) for 2 consecutive weeks, i.e., on days 1, 4, 8, and 11 of each cycle, with a 1-week discontinuation for a 21-day cycle (with a minimum interval of ≥48 h between each of the 2 doses in the same dosing cycle). Tirelizumab was administered as 200 mg IV every 3 weeks, administered on the first day of each cycle. Based on the results obtained during the dose-escalation phase, the need for and the dose of the Phase IIa expansion cohort will be determined after discussion by the Safety Management Committee (SMC), and the Phase IIa cohort expansion is expected to select 1-2 dosage groups of 10-15 cases each. **Intervention Names:** - Drug: B group Purinostat Mesylate 6.0mg/m2 - Drug: B group Purinostat Mesylate 8.4 mg/m2 - Drug: B group Purinostat Mesylate 11.2 mg/m2 - Drug: B group Purinostat Mesylate 15.0 mg/m2 **Label:** B group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 6mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 6mg/m2 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 8.4mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 8.4mg/m2 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 11.2mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 11.2mg/m2 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 15.0mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 15.0mg/m2 **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 6.0mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 6.0mg/m2 **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 8.4mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 8.4 mg/m2 **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 11.2mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 11.2 mg/m2 **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 15.0mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 15.0 mg/m2 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as the proportion of subjects with an overall efficacy response of complete remission (CR) or partial remission (PR) after at least one baseline evaluation during the trial. **Measure:** Objective remission rate (ORR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) #### Secondary Outcomes **Description:** defined as the proportion of subjects with an overall efficacy response of CR after at least one baseline evaluation during the trial; **Measure:** Complete Remission Rate (CRR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the proportion of subjects with an overall efficacy response of CR, PR and stable disease (SD) after at least one baseline evaluation during the trial; **Measure:** Disease Control Rate (DCR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the duration from first remission (PR and above) to disease progression or death; **Measure:** Duration of remission (DOR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to the appearance of PR and beyond; **Measure:** Time to Tumor Remission (TTR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to disease progression or death **Measure:** Progression-free survival (PFS) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to death. **Measure:** Overall survival (OS) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age: ≥18 years and ≤75 years, regardless of gender; 2. at least one measurable lesion as defined by RECIST 1.1 in the Screening Phase (non-measurable lesions with simple bone metastases only are acceptable in the Dose Escalation Phase of the Breast Cancer Cohort); 3. single-agent dose-escalation phase in Phase Ib: Locally advanced or metastatic solid tumors, including but not limited to triple-negative breast cancer, colorectal cancer, and uroepithelial carcinoma, that have been diagnosed by histologic or cytologic confirmation of pathology and have failed standard therapy, or for which there is no standard treatment regimen available or for which standard therapy is not appropriate at this stage; Phase Ib Combination Dose Escalation Phase: 1. Combination exemestane for Cohort A (breast cancer): Perimenopausal, premenopausal, and postmenopausal women with breast cancer confirmed by histopathology or cytologic pathology to be estrogen receptor (ER)-positive, progesterone receptor (PgR)-negative or -positive, and non-HER2-positive (including HER2-negative and low-expressing populations); Progression or recurrence after at least 1 line of prior endocrine therapy (whether at advanced stage, in the setting of metastasis, or with neoadjuvant chemotherapy), and prior availability of no more than 1 line of chemotherapy (note: if prior endocrine therapy was adjuvant to exemestane, the disease-free interval after discontinuation of exemestane needs to be \>12 months); Not suitable for surgical resection therapy; Definition of menopause is subject to one of the following conditions: a) prior bilateral oophorectomy; b) 60 years of age and older; c) younger than 60 years of age, not on chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy within one year prior to enrollment, who has been naturally menopausal for more than 12 months, and whose serum follicle-stimulating hormone and oestradiol are at postmenopausal levels; d) younger than 60 years of age, who is undergoing tamoxifen moxifene or toremifene therapy, and serum follicle-stimulating hormone and estradiol levels are in the postmenopausal range for two consecutive periods; e). Failure to meet the above criteria is considered to be in the premenopausal or perimenopausal period, and female subjects will be required to meet the following criteria: initiation of a luteinizing hormone-releasing hormone (LHRH) agonist, such as goserelin, leuprolide, etc., at least 28 ± 2 prior to the first administration of study drug (hormone level eligibility will be required for those who have been on an LHRH agonist for ≥ 21 days and \< 26 days prior to the first administration of the study drug), and the subject requires continued use of this class of medication for the duration of study treatment; 2. Combination tirilizumab for treatment of Cohort B (solid tumors): Patients with locally advanced or metastatic solid tumors who have a cytologically or histologically confirmed diagnosis and have failed standard therapy, or for whom there is no standard therapeutic regimen, or for whom standard therapy is not appropriate at this stage, as defined by standard therapy failure for each tumor type below: Non-small cell lung cancer: (1) patients with metastatic no driver mutation: disease progression or recurrence after at least second-line treatment (including platinum-containing chemotherapy); (2) patients whose tumors have driver mutations such as EGFR, ROS1, ALK, etc., should have received a failed targeted therapy against these mutations, and then after at least second-line treatment (including platinum-containing chemotherapy) disease progression or recurrence; Small cell lung cancer: disease progression or recurrence after at least two lines of prior therapy; Colorectal cancer: disease progression or recurrence after at least two lines of prior therapy (standard chemotherapy regimens received include fluorouracil or its derivatives, oxaliplatin, and irinotecan, BRAF inhibitors for patients with BRAF V600E mutation, and PD-1/PD-L1 therapy for those who meet the MSI-H/dMMR criteria). (treatment); Squamous cell carcinoma of the head and neck: disease progression or recurrence after at least two lines of prior therapy, including platinum-containing chemotherapy; Uroepithelial carcinoma: disease progression or recurrence after at least two lines of prior therapy (guideline-recommended regimens include PD-1/PD-L1 therapy, platinum-containing chemotherapy regimens, paclitaxel-based chemotherapy regimens, vediclizumab, and vincristine, and erdatinib has been used in patients with FGFR2/3 mutations); Esophageal cancer: disease progression or recurrence after at least two lines of prior therapy, including platinum-containing chemotherapy; cervical cancer: disease progression or recurrence after at least two lines of prior therapy (including platinum-containing chemotherapy; patients meeting the criteria for PD-L1 positivity or TMB-H or MSI-H/dMMR need to have been treated with PD-1/PD-L1) Hepatocellular carcinoma: Disease progression or recurrence after at least two lines of prior therapy; Renal cell carcinoma: disease progression or recurrence after at least two lines of prior therapy; Phase IIa Dose Expansion Phase: The tumor type and tumor tissue biomarker requirements for each expansion cohort enrolled in Phase IIa will be based on Phase Ib data and SMC discussion for further decision making; 4. ECOG ≤ 1 point; 5. expected survival ≥ 12 weeks; 6. organ function levels must meet the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; 2. Hemoglobin (HGB) ≥ 90 g/L; 3. Platelet count (PLT) ≥100×109/L; 4. serum creatinine ≤1.5 × ULN or estimated creatinine clearance ≥60 mL/min (according to the Cockcroft and Gault formula); 5. serum total bilirubin (TBil) ≤ 1.5 x ULN, allowing TBil \> 1.5 x ULN but direct bilirubin (DBil) \< ULN for subjects with hepatic metastases or GILBERT syndrome; and AST and ALT ≤ 2.5 x ULN, allowing AST/ALT ≤ 5 x ULN for subjects with hepatic metastases or GILBERT syndrome; 7. those who agree to participate in this study and sign the informed consent form; 8. remission of all acute toxicities from prior anticancer therapy or surgery to baseline severity or NCI-CTCAE version 5.0 ≤ Grade 1 (with the exception of alopecia or other toxicities deemed by the investigator to pose no safety risk to the patient). Exclusion Criteria: 1. a known severe allergy to the study drug, combination drug, or any of its excipients (hydroxypropyl betacyclodextrin, arginine, glucosamine, mannitol); 2. current or prior other malignancy (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix) unless treated radically and with evidence of recurrence-free metastasis within the last 5 years; 3. symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases requiring steroid therapy within 2 weeks prior to the first dose of study drug. Subjects with carcinomatous meningitis or molluscum contagiosum spread; 4. last systemic antineoplastic therapy (chemotherapy, targeted therapy, immunotherapy, biologic agent therapy, etc.) within 4 weeks prior to the first PM administration, with the following stipulations: nitrosoureas (e.g., carmustine, lomustine, etc.) or mitomycin C within 6 weeks prior to the first administration of the study drug; oral fluorouracil, small molecule targeted drugs within 2 weeks prior to the first administration of the study drug, or within 2 weeks prior to the first administration of a known drug within 5 half-lives (whichever is longer); local palliative radiotherapy within 2 weeks prior to the first administration of study drug; final administration of endocrine therapy within 4 weeks prior to the first administration of study drug; and receipt of herbal or proprietary Chinese medicine with an antitumor indication within 2 weeks prior to the first administration of study drug; 5. patients who have received a prior HDAC inhibitor; 6. patients with prior exemestane therapy are not eligible for enrollment in the combination exemestane treatment cohort, but are permitted to be included if the patient has a disease-free interval DFI of \>12 months after exemestane adjuvant therapy; 7. patients previously treated with anti-PD-1/PD-L1 antibodies are not eligible for enrollment in the combination tirilizumab treatment cohort, unless the patient has had a prior benefit after treatment in the advanced/metastatic phase\* then inclusion is permitted; * Benefit following anti-PD-1/PD-L1 antibody therapy is defined as meeting any of the following: 1. Best efficacy of CR or PR as assessed by imaging after receiving anti-PD-1/PD-L1 antibody therapy alone or in combination with targeted/other immunologic agents; 2. Treatment with anti-PD-1/PD-L1 antibody in combination with chemotherapy with no imaging evidence of disease progression within ≤ 6 months of treatment. 8. those who have had a serious infection within 4 weeks prior to the first administration of PM, or who have had an active infection requiring oral or intravenous antibiotic therapy within the previous 2 weeks; 9. receiving blood transfusions, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, and granulocyte colony-stimulating factor within 2 weeks prior to the first dose of study drug; 10. breast cancer: symptomatic, advanced patients who have disseminated to viscera and are at short-term risk of life-threatening complications (patients with visceral crises), patients with inflammatory breast cancer; 11. prior immune-related adverse events of grade ≥3 on immunotherapy are not eligible for enrollment in the combination tirilizumab treatment cohort; 12. patients with active or pre-existing autoimmune disease with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) are not eligible for enrollment in the cohort of co-tirilizumab; the following patients are allowed: patients with type I diabetes mellitus, and patients with autoimmune thyroiditis who may be eligible for alternative therapy; 13. Patients who have received systemically administered corticosteroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of PM are not eligible for enrollment in the cohort of co-tirilizumab therapy; except for the following: treatment with topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids, and short-term prophylactic use of corticosteroids, eg. use of contrast media. 14. have uncontrolled or significant cardiovascular disease, including: (1) New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of PM, or the presence of an arrhythmia requiring treatment, left ventricular ejection fraction (LVEF) \<50% at screening; (2) Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undetermined cardiomyopathy); (3) Screening-phase symptomatic coronary heart disease requiring pharmacologic treatment; (4) A history of clinically significant QTcF interval prolongation or a mean corrected QT interval (QTc) \>450 msec (men) or \>470 msec (women) on 3 electrocardiograms (ECGs) of the QTcF interval during the screening period (retesting is required and 3 average corrected values are taken only if the first ECG suggests that the QTc is \>450 msec (men) or \>470 msec (women)). (only the first ECG suggesting a QTc \>450 msec (men) or \>470 msec (women) needs to be retested and averaged over 3 corrections); a history of long QT syndrome or a confirmed family history of long QT syndrome; a history of clinically significant ventricular arrhythmia or current use of antiarrhythmic medications or implantation of defibrillation devices for the treatment of ventricular arrhythmias; (5) Cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.) within 6 months prior to the first dose of PM; (6) Inadequate blood pressure control during the screening period (whether or not on antihypertensive medication): systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; (7) Other cardiovascular diseases judged by the investigator to be inappropriate for enrollment. 15. Uncontrolled electrolyte disturbances that may interfere with the action of QTc prolonging medications (e.g., hypocalcemia \<1.0 mmol/L, hypokalemia \<lower limit of normal, hypomagnesemia \<0.5 mmol/L), but retesting after interventional therapy is permitted; 16. current or past history of interstitial lung disease of any severity and/or severely impaired lung function; 17. the presence of third interstitial fluid (e.g., pleural fluid and ascites) that cannot be controlled by drainage or other means; 18. major surgical procedures requiring general anesthesia or not withdrawn from other clinical trials within 4 weeks prior to the first dose of PM; surgical procedures requiring local/epidural anesthesia from which the patient has not recovered (except for tissue biopsy) within 2 weeks prior to enrollment; 19. clinically significant active infection of the following, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B was defined as subjects who were HBsAg-positive or HBcAb-positive with HBV-DNA above the lower limit of detection (i.e., the upper limit of normal values in the testing department of each study center), who achieved HBV-DNA negativity after antiviral treatment, who received antiviral medications for at least 2 weeks prior to the first dose of medication, and who were willing to continue to be treated with anti-hepatitis B virus for the duration of the study were allowed to enroll in the study, and active Hepatitis C was defined as HCV antibody positivity and HCV-RNA above the lower limit of detection (upper limit of normal). Positive syphilis spirochete antibody (TP-Ab) and positive syphilis non-specific antibody titer (RPR); 20. a history of immunodeficiency, including a positive test for antibodies to human immunodeficiency virus (HIV), or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 21. participation in another interventional clinical trial within 4 weeks prior to enrollment; 22. female patients who are pregnant or breastfeeding or who are unable to ensure the use of contraception during the study period and for at least 6 months after the last treatment with poystat 23. other serious acute or chronic medical or psychiatric conditions or abnormal laboratory tests that may increase the risk of participation in the study or increase the risk associated with administration of the study drug or interfere with the results of the study, and other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in this study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Liangkun Sun, bachelor **Phone:** 15885742617 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zheng Jiang, bachelor **Phone:** 19048075294 **Role:** CONTACT #### Locations **Location 1:** **City:** Guanzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Liushan Qu - **Phone:** 020-81332587 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University **State:** Guangzhou **Zip:** 510000 **Location 2:** **City:** Chengdu **Country:** China **Facility:** Chengdu Xinhua Hospital **State:** Sichuan **Zip:** 610000 #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University **Name:** Herui Yao, Doctor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** West China Hospital **Name:** Yongsheng Wang, Doctor **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: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: LOW - As Found: Unknown - ID: M247237 - Name: Exemestane - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431230 **Acronym:** PEER-HEART **Brief Title:** School-based HIIT and Dose-Response Effects **Official Title:** Dose-response Relationship and High-intensity Interval Training Effects During Physical Education Lesson on Health Markers in Adolescents #### Organization Study ID Info **ID:** WUHSS #### Organization **Class:** OTHER **Full Name:** Wroclaw University of Health and Sport Sciences ### Status Module #### Completion Date **Date:** 2025-04-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wroclaw University of Health and Sport Sciences #### Responsible Party **Investigator Affiliation:** Wroclaw University of Health and Sport Sciences **Investigator Full Name:** Jaroslaw Domaradzki **Investigator Title:** PhD, Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There are experimental evidences of the importance of high intensity exercises in health outcomes improvement. However, there are limited knowledge about possibility to affect health outcomes in adolescents through exercises programs introduced into physical education (PE) lesson. Moreover, there is lack of the studies identifying people who do not respond to stimuli, as well as examining potential determinants of non-responsiveness. Thirdly, there are no studies examining the modification of exercise dose that should be reflected in the response in such individuals. Aim of this human experiment is to examine the effects of one cycle of 8-weeks high-intensity interval training (HIIT) implemented in physical education lesson on: (1) body composition (proportions of the body fat to the body muscles), (2) resting blood pressure, (3) physical efficiency. Study are conducted for two years (two cycles). Each year 300 students of two secondary schools, are involved in project: 15-16-year-olds in first year, 18-19-year-olds in second year. Students are divided in experimental groups -performing 8-weeks (twice a week) cycle of HIIT implemented into PE lesson, and the control groups - students following a typical PE programme. Each cycle consists of two parts. First part is related to the 8 weeks of HIIT training, while second part is related to the dose-expose study. All participants are examined during project before (Pre), after (Post) and Follow-Up intervention. Second part is planned after a break of several months. Persons who do not respond to the exercise stimulus in the first part will follow individually modified programmes. They will be measured before and after this additional training. To examine the assumed HIIT-induced changes in participants the investigators will apply: (1) anthropometric measurements: body height and weight, and BMI will be calculated, (2) body mass composition (fat and muscle mass), (3) resting blood pressure, (4) beep test which is field motor specific test to assess physical efficiency. The results of this project will help to answer the fundamental questions about HIIT induced morphological and physiological effects in adolescents, what is important from scientific and public health point of view. Particularly, in view of the growing pandemic of obesity, common elevated blood pressure and steadily declining physical fitness in children and adolescents. **Detailed Description:** I. Background Prevalence of overweight and obesity is well documented in the literature. This applies to both adults and the elderly, but increasingly also to children and school-age youth. Similar to adipose tissue, there is a constant increase in the percentage of young individuals with elevated blood pressure. Moreover, children and adolescents are steadily decreasing their physical efficiency. All these characteristics serve as indicators of overall health, defined as health-related fitness (HRF). Measurements represent the health potential that adolescents bring into adulthood, what is closely related to their efficient functioning in family and professional life. In the battle against lifestyle diseases during adolescence, there is a growing trend towards implementing intense short-term efforts. Evidence from numerous studies confirms the effectiveness of High-Intensity Interval Training (HIIT) in reducing body weight, improving body mass index (BMI), reducing body fat, and lowering resting blood pressure. Due to the reluctance of children and adolescents to engage in physical activity during leisure time, there is an increasing systemic implementation of HIIT in physical education classes to ensure widespread physical exercise among students. A separate issue is the lack of response to exercise in some individuals (so-called non-responders). There are few studies that attempt to find the optimal exercise dose to elicit a response in as many participants as possible, ideally in all participants (dose-response relationship). However, the effectiveness of training based on the duration of exercise and rest intervals, the type of exercises (endurance, resistance, etc.), and exercise intensity is still unknown. II. Research Project Objectives Therefore, the aims of this research are twofold: 1. to investigate the effectiveness of different forms of short-term, intense interval exercise in reducing body fat and resting blood pressure, as well as improving aerobic and anaerobic physical endurance; 2. after identifying non-responders and applying dose-response procedures, to develop modifications to the standard HIIT program and verify the effectiveness of these modifications in inducing the aforementioned positive changes. Hypothesis 1. The high-intensity intervention training, practising systematically during regular physical activity lessons, will affect body composition reducing body fat (through increased fat oxidation processes from very intensive exercises) and improve the fat to muscle mass proportions. In the experimental group participants with elevated blood pressure, blood pressure improvements will be observed what is connected with several physiological cardiovascular reactions. Thirdly, intensive physical short-time interval training will improve cardiorespiratory fitness. Hypothesis 2. There are frequency of participants who will not gain in different outcomes from intervention programme. Hypothesis 3. Programs of the HIIT intervention, individually tailored for non-responsive persons, including different determinants, induce the expected changes in the above-mentioned outcomes. III. Research design and work plan This project is longitudinal, planned for two years of study. Both years, called cycles, are Cluster Randomised Trials (in other words - Group-Randomized Trials, where research participants are not allocated to intervention independently, but as a group. Each cycle of the study has two parts. First part (called Common-HIIT) has two arms: experimental and control, while second part (called Dose-Response) has four arms: two experimental and two control. Simple random sampling without replacement is used to classify classes as experimental and control. The sampling frame is the list of classes with identifiers specific for each school (e.g. 1a, 1b, 2a etc.). Randomization process is carried out by the investigators of this study using specific library in R language. The project enrolls two types of students groups: experimental (EG) - circa 4 classes in each school, and control (CG) - circa 4 classes in each school. In Common-HIIT part, EG perform physical training intervention, while CG take part only in typical PE lessons. In Dose-Response part, non-responders (identified as persons who will not gain the effects during first part) will be randomly (the same procedure like in first part) divided into experimental group (NRs-E) and control group (NRs-C), while responders (identified as persons who will gain the effects during first part) will also be randomly (the same procedure like in the firs part) divided into experimental (Rs-E) and control (Rs-C) group. In Common-HIIT part, all participants are examined during preintervention, postintervention and follow-up measurements. While, in Dose-Response part they are examined twice: preintervention and postintervention dose-response intervention. IV. Research methodology IV.1 Subject characteristics. The sample size was calculated based on pilot studies using G\*Power v. 3.1, resulting in a minimum sample size of 310 individuals (with a 5% dropout margin). The study involves students from first and fourth grades, who are involved in project in first and second cycle, respectively. Two high schools in the city of Wrocław were selected for the study. Participants are separated in sex groups, what is related to rules of the schools. IV.2. Intervention procedures. The design used a parallel group study scheme (2 schools) with three replicates. In each school a different form of intervention based generally on the principles of the HIIT programme will be implemented. In one school a classical variant is planned, while in the other a variant using a plyometric mechanism is planned. The project use an intensive intermittent exercise intervention. In one school, a standard programme is planned, in the other a modification involving a plyometric form of exercise. The chosen high-intensity interval programme is very useful in the school setting due to its simplicity of implementation and short time. It can be easily implemented into a lesson without strongly interfering with the flow of the lesson and the fulfilment of the teacher's curricular tasks. In the intervention, 8 series of 20-second exercises and a 10-second rest are performed. The total duration is 4 minutes.The key is to perform the exercise on an intensity of 90%-100% of maximum effort. The short duration and the possibility to use different forms of exercise makes it attractive in the opinion of the participants and has a positive effect on motivation to exercise. In the first part of the study, regardless of the forms of exercise implemented in both schools, a standard HIIT intervention programme will be used. The intervention part will be preceded by a standard 10-minute pre-session warm-up. Participants will then embark on the main programme and perform intense work lasting 20 seconds and a 10-second rest interval. In the first four weeks, they will perform between four and six series, with the aim of doing a full cycle of eight series in the following four weeks. After all the series in a given cycle have been completed, there will be a 5-minute rest period. The teacher will then move on to the planned lesson tasks derived from the core curriculum. Achieving the correct exercise intensity is a critical factor in HIIT-type interventions. However, given that the intervention will take place in a school setting, it was assumed that participants would maintain an effort of at least 80% HRmax, throughout the 8-week period. Heart rate will be measured with Polar Verity Sense wristbands. Teacher are real-time control and motivate the student's effort as the intensity decreases. In the second part of the research, intervention modifications will be introduced that change the stimulus doses of the programmes. The details of the design of these modifications will be derived from the results obtained from the first part of the research.The following will be modified the proportions of work and rest breaks, the structure and/or form of the exercises. Non-responsive individuals (who did not responded to the exercise in the first part by lowering their body fat and/or blood pressure and/or improving their physical performance) and those who fail to maintain an effect over a period of 8 weeks will be allocated to subgroups in which they will be trained according to an appropriate modification. to subgroups where training will be modified accordingly. Heart rate values forming a time series will be stored in the application and exported to a database at the end of the project. These results will be collated with the measurements and survey data and used for detailed analyses. IV. 3. Measurements. Measurements are planned in three areas: morphological, cardiovascular and physical performance. Measurements of basic morphological characteristics will be carried out. Body height will be measured using an anthropometer with an accuracy of 0.1 cm (GPM Anthropological Instruments). Body weight will be measured on an electronic scale (body composition device) with an accuracy of 0.1 kg. Body composition will be also measured. Body composition device uses bioelectrical impedance method. Fat mass, muscle mass and water will be measured. On the basis of the measured morphological characteristics and body composition, the following are calculated indicators: relative body mass (BMI), relative fat mass (FMI), relative muscle mass (SMI) and muscle to fat ratio (MMI), muscle to fat ratio (MFR). Haemodynamic features of the blood circulation will be determined by resting measurements of systolic and diastolic blood pressure and heart rate. An electronic upper arm blood pressure monitor will be used. For the measurement of aerobic and anaerobic physical capacity, population tests are foreseen (respectively, a multi-level shuttle run, the so-called beep test. The measurements will be supplemented by the collection of survey data. This data will be the accompanying variables in the detailed, in-depth analyses. The following surveys are planned: the economic and social situation of the pupils' families (FAS scale), physical activity (IPAQ long form questionnaire) and frequency of food intake (KomPAN questionnaire). In addition, after each lesson unit, students will complete questionnaires with the subjective feeling of fatigue scale (RPE) and the lesson attractiveness scale (PACES). V. Statistical analysis Distributions of the collected data will be assessed. Depending on the type of distribution, parametric and non-parametric methods will be applied. In multivariate exploratory procedures, data not meeting the condition of normality of distribution will be transformed and scaled. Comparisons between multiple groups with repeated measures (MANOVA/ANOVA of mixed effects), examination of correlations (regression analysis in mixed models), examination of similarities (cluster analyses) and co-occurrence (correspondence analyses) are assumed. For dose-response relationship analyses, it is planned to use simple linear regression, polynomial regression (2nd and 3rd degree polynomial) and various multiple comparison procedures (Multiple Comparison Procedures family). The calculation will be carried out in the R environment \[43\] and other statistical software. ### Conditions Module **Conditions:** - Adolescents - Physical Activity - Adipose Tissue - Blood Pressure - Cardiorespiratory Fitness **Keywords:** - high-intensity interval training - adolescence - body composition - resting blood pressure - responders and non-responders - dose-response ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SH-EG - Standard HIIT Experimental Group, participants who will perform typical high-intensity interval training **Intervention Names:** - Behavioral: standard high-intensity interval training **Label:** Standard HIIT Experimental Group (SH-EG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SH-CG - Standard HIIT Control Group, participants that will not perform the HIIT cycles **Label:** Standard HIIT control group (SH-CG) **Type:** NO_INTERVENTION #### Arm Group 3 **Description:** PH-EG - Plyometric HIIT Experimental Group, participants who will perform plyometric high-intensity interval training **Intervention Names:** - Behavioral: plyometric high-intensity interval training **Label:** Plyometric HIIT Experimental Group (PH-EG) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** PH-CG - Plyometric HIIT Control Group, participants that will not perform the HIIT cycles **Label:** Plyometric HIIT Control Group (PH-CG) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard HIIT Experimental Group (SH-EG) **Description:** The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. It is based on the standard physical exercises: squats, push-ups, sit-ups, toe-touches, mountain climber, jumping jacks, standing abs twist and squat to side. **Name:** standard high-intensity interval training **Other Names:** - St-HIIT **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Plyometric HIIT Experimental Group (PH-EG) **Description:** The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. However, there is a difference, comparing to the St-HIIT, related to different exercises used in protocol. This kind of HIIT programme will be based on plyometric exercises: jumping jacks, skip A, skip C, jumps back into a push-up position and returns to the squat position, throwing the legs out of support and jumping out, jumping out of a squat. **Name:** plyometric high-intensity interval training **Other Names:** - Pl-HIIT **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** tthe body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in body fat reduction **Measure:** body fat weight (BF) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** the body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in muscle mass increase **Measure:** skeletal body muscle mass (SMM) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension) **Measure:** systolic blood pressure (SBP) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension) **Measure:** diastolic blood pressure (DBP) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** cardiorespiratory fitness (CRF), evaluate the potential effect of intervention on aerobic capacity; CRF is assessed with Multistage Fitness Test (MFT), and evaluates maximum rate of oxygen intake (VO2max). Participants perform continuous 20-metre shuttle runs, with the individual having to reach the opposite end of the 20-metre grid before the next sound signal. The time between signals decreases with each minute, forcing individuals to increase their running speed. Initial running velocity is of 8.5 km/hr and increases the speed by 0.5 km/hr each minute thereafter. The test is comprised of 23 levels. The result the participant achieved (the speed on the last level before the end) is transformed and the final outcome is maximum rate of oxygen intake. However, VO2max is calculated from formula: VO₂ max = -27.4 + 6.0 (speed); where speed is determined by the level achieved by the participant before he/she is withdrawn from the test. **Measure:** physical efficiency (CRF) **Time Frame:** Pre-HIIT, up to 24 weeks #### Secondary Outcomes **Description:** measurement from basis to vertex (top of head) **Measure:** body height (BH) **Time Frame:** Pre-HIIT,up to 24 weeks **Description:** measurement of the body mass with InBody electronic scale **Measure:** body weight (BW) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** the body composition measurement with bio-impedance electronic tool (InBody); this measurement is to evaluate the potential intervention risk of dehydration **Measure:** body water (BWat) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** measurement from seat surface to vertex (top of head) **Measure:** sitting height (SBH) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** Family Affluence Scale (FAS) questionnaire related to the family social-economic situation, information will be used as confounding/covariate variable Family Affluence Scale (FAS) is a tool for analysing social inequalities in health. It consists of six questions relating to: the student's own room by the student, number of cars in the family, number of computers in the family, trips abroad with the family for holidays or holidays, and the number of bathrooms in the house and the provision of a dishwasher with a dishwasher. The FAS scale takes a range from 0 to 13 points. According to international recommendations, families are divided into: poor (0-6 points); average (7-9 points) and affluent (10-13 points). **Measure:** social-economic situation **Time Frame:** Pre-HIIT **Description:** International Physical Activity Questionnaire (IPAQ) related to the physical activity, The IPAQ asks about domains: leisure time, domestic and gardening-yard, work-related and transport-related activity and sitting (inactivity). Intensity of the activity is defined as: walking, moderate-intensity and vigorous intensity. Result can be presented as continuous scores (metabolic equivalent in minutes per week) or categorical: 1. inactive - individuals who not meet criteria for Categories 2 or 3, 2. minimally active - any one of the following 3 criteria: * 3 or more days of vigorous activity, OR * 5 or more days of moderate-intensity activity OR * 5 or more days of any combination of walking, moderate-intensity or vigorous intensity (600 metabolic equivalent-min/week). 3. health - at least 1.5 hour of being active throughout the day **Measure:** physical activity **Time Frame:** Pre-HIIT **Description:** questionnaire (questionnaire of eating behaviors KomPAN) is a tool for measurement of frequency of eating specific groups of meal, it is useful for evaluation of the eating behaviors; information will be used as confounding/covariate variable It consists: 1. question on the number of meals per day, 2. follow-up questions, 3. questions on the frequency of food intake, which are components of: index of a healthy diet (positive HDI) and unhealthy diet index (negative HDI), 4. questions about the respondent's lifestyle and personal data (all). Answers are transform to the scores related to healthy and unhealthy dietary behaviors. Minimum points for both indexes is 0, maximum is 100. Scores can be transform to the categories: 1. small intensity of traits nutrition - 0-33 points 2. moderate intensity of traits nutrition - 34-66 points 3. high intensity of traits nutrition - 67-100 points **Measure:** dietary intake **Time Frame:** Pre-HIIT **Description:** Rating of Perceived Exertion scale (RPE) of subjectively perceived fatigue; information will be used as confounding/covariate variable It runs from 0 - 10, using numbers to rate how much effort an activity takes. It examines 4 factors: (a) how fast is breathing, (b) how fast heart is beating, (c) how tired muscles are, (d) how much is sweating. The RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). Scale: 6 - no exertion, 7-8 - extremely light, 9-10 - very light, 11-12 - light, 13-14 - somewhat hard, 15-16 - hard (heavy) 17-18 - very hard, 19 - extremely hard 20 - maximum exertion. **Measure:** fatigue perception **Time Frame:** within 10 minutes after each cycle of HIIT **Description:** Physical Activity Enjoyment Scale (PACES), the attractiveness perceived during exercise by participants; it will be used as confounding/covariate variable It contains 18 items used to assess enjoyment, particularly during the physical activity. Respondents are asked to rate feelings at the moment about the physical activity, using a 7-point bipolar rating scale. Eleven items are reverse scored. An overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment. **Measure:** perceived attractiveness of lessons **Time Frame:** within 10 minutes after each cycle of HIIT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * For all participants: 1. active student of school enrolled in project, 2. age 14-16 or 18-20, 3. active student of 1st class in the school (for participants 14-16 years of age) or 4th class in the school (for participants 18-20 years of age), 4. active participation in PE lessons (no medical or other exemption from lessons), 5. no medical contraindications 6. signed informed consent (parent/legal guardian) in case of under-age participant). Exclusion Criteria: * For all participants: 1. commitment to structured sports training 2. injury less than 3 months prior to the intervention **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wrocław **Country:** Poland **Facility:** Wroclaw University of Health and Sport Sciences **State:** Dolny Śląsk **Zip:** 51-612 #### Overall Officials **Official 1:** **Affiliation:** Wroclaw University of Health and Sport Sciences **Name:** Jarosław Domaradzki, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431217 **Acronym:** GBSCoP **Brief Title:** Group B Strep Correlates of Protection Study **Official Title:** Investigating for Immunological Correlates of Protection Against Invasive Group B Streptococcus Disease in Infants Less Than 90 Days of Age. #### Organization Study ID Info **ID:** GBS CoP #### Organization **Class:** OTHER **Full Name:** University of Witwatersrand, South Africa ### Status Module #### Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Start Date **Date:** 2019-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2019-03-05 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of KwaZulu **Class:** OTHER **Name:** University of Stellenbosch **Class:** OTHER **Name:** University of Pretoria **Class:** OTHER **Name:** University of Cape Town #### Lead Sponsor **Class:** OTHER **Name:** University of Witwatersrand, South Africa #### Responsible Party **Investigator Affiliation:** University of Witwatersrand, South Africa **Investigator Full Name:** Farzanah Laher **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:** Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries. The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants. These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease. **Detailed Description:** Observational Case-Control Study * A cohort of 15,000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital (n=10,000) and Rahima Moosa Mother and Child Hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019. * Enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery. * In parallel, enrolment of GBS cases will occur at the time of diagnosis of invasive GBS disease. These "retrospective cases" will be enrolled at multiple facilities across South Africa. * Infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations. Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. ### Conditions Module **Conditions:** - Maternal Health, Child Health, Infectious Diseases ### Design Module #### Bio Spec **Description:** Maternal blood, Vaginal Swab collection, cord blood collection, DBS collection **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 17842 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. Anti-CPS IgG concentrations were determined with the use of a quantitative direct immunoassay (Luminex) that measured levels of antibodies binding to CPS serotypes Ia, Ib, and II through V. **Measure:** Primary Objective **Time Frame:** 1 - 1.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH. 2. Subjects aged ≥18 years. 3. Able to understand and comply with planned study procedures. 4. Provides written informed consent. Exclusion Criteria: 1. Refusal to consent to study participation. 2. Receipt of any blood products in the past 4 weeks or anticipated during labour. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** 5.1.1. Cohort population Maternal-newborn dyads enrolled at CHBAH or RMMCH prior to or during delivery-admission, from whom maternal and cord blood are collected. 5.1.2. Control population Controls will be defined as newborns born to mothers enrolled into the cohort study, whose mother is colonized by a serotype homologous to that of a case to which they matched, but who do not develop invasive GBS disease within 90 days of life. Cases and controls will matched by serotype, gestational age (34-\<37 weeks and ≥37 weeks gestation) and maternal age (\<25 years, 25-\<35 years and ≥35 years). Maternal HIV infection status will be assessed as an effect modifier. ### Contacts Locations Module #### Locations **Location 1:** **City:** Johannesburg **Country:** South Africa **Facility:** Rmpru/Vpd **State:** Gauteng **Zip:** 1862 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: 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: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M16080 - Name: Streptococcal Infections - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431204 **Brief Title:** Obstetric Comorbidity Index in Postpartum Hemorrhage **Official Title:** Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With Postpartum Hemorrhage #### Organization Study ID Info **ID:** 351/2567(IRB2) #### Organization **Class:** OTHER **Full Name:** Mahidol University #### Secondary ID Infos **Domain:** Siriraj Institutional Review Board **ID:** Si 359/2024 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mahidol 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 objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery. **Detailed Description:** The prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. There has been development of the obstetric comorbidity index (OBCMI) by Bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. The score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. For instance, both the Charlson/Romano comorbidity index or the Elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality. The Obstetric Comorbidity Index has undergone thorough examination and validation across multiple nations. These findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance. However, within the context of Thailand, investigations concerning the Obstetric Comorbidity Index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. Therefore, this study aims to elucidate the correlation between the Obstetric Comorbidity Index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest University hospital, in THAILAND. Predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period. ### Conditions Module **Conditions:** - Cesarean Section Complications - Postpartum Hemorrhage - Morbidity;Perinatal **Keywords:** - cesarean section - postpartum hemorrhage - maternal morbidity - obstetrics comorbidity index ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 576 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications) **Intervention Names:** - Other: Obstetric comorbidity index **Label:** Patients with postpartum hemorrhage with severe maternal morbidity #### Arm Group 2 **Description:** Patients without the severe maternal morbidity conditions **Intervention Names:** - Other: Obstetric comorbidity index **Label:** Patients with postpartum hemorrhage without severe maternal morbidity ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with postpartum hemorrhage with severe maternal morbidity - Patients with postpartum hemorrhage without severe maternal morbidity **Description:** Obstetric comorbidity index score **Name:** Obstetric comorbidity index **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The prediction of severe maternal morbidity using obstetric comorbidity index presented in C-statistic (AUC of ROC) **Measure:** The prediction of severe maternal morbidity using obstetric comorbidity index **Time Frame:** in 72 hours after cesarean delivery #### Secondary Outcomes **Description:** Perioperative red blood cells transfusion in units **Measure:** Rate of blood transfusion **Time Frame:** in 72 hours after cesarean delivery **Description:** Quantity of postpartum hemorrhage in ml. **Measure:** Quantity of postpartum hemorrhage **Time Frame:** in 24 hours after cesarean delivery **Description:** Main cause of postpartum hemorrhage **Measure:** Cause of postpartum hemorrhage **Time Frame:** in 24 hours after cesarean delivery **Description:** Rate of intensive care unit admission **Measure:** Rate of ICU admission **Time Frame:** in 24 hours after cesarean delivery **Description:** Post operative complications eg. congestive heart failure, TRALI, acute kidney injury **Measure:** Rate of Postoperative complications **Time Frame:** in 72 hours after cesarean delivery **Description:** Neonatal Apgar score from 0 - 10 **Measure:** Neonatal Apgar score **Time Frame:** at 1-minute and 5-minute after delivery **Description:** Maternal death rate **Measure:** Rate of maternal mortality **Time Frame:** in 72 hours after cesarean delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1) Exclusion Criteria: * Cesarean delivery at less than 24 weeks of gestation * A patient chart that does not contain primary outcome data eg. absence of anesthetic record * Blood loss less than 1,000 ml in the first 24 hours postpartum **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The chart of patients who underwent cesarean delivery with the diagnosis of postpartum hemorrhage (bleeding \>, = 1,000 ml) and gestational age of more than 24 weeks. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Patchareya Nivatpumin, M.D. **Phone:** +66896662187 **Role:** CONTACT #### Locations **Location 1:** **City:** Bangkok Noi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Patchareya Nivatpumin, M.D. - **Phone:** +66896662187 - **Role:** CONTACT **Country:** Thailand **Facility:** Faculty of Medicine Siriraj Hospital **State:** Bangkok **Zip:** 10700 #### Overall Officials **Official 1:** **Affiliation:** Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND **Name:** Patchareya Nivatpumin, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from our hospital director. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - 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: D000011644 - Term: Puerperal Disorders - ID: D000014592 - Term: Uterine Hemorrhage ### 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 ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M9559 - Name: Postpartum Hemorrhage - Relevance: HIGH - As Found: Postpartum Hemorrhage - 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: M14499 - Name: Puerperal Disorders - Relevance: LOW - As Found: Unknown - ID: M17340 - Name: Uterine Hemorrhage - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006473 - Term: Postpartum Hemorrhage - ID: D000006470 - Term: Hemorrhage ### 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:** NCT06431191 **Brief Title:** Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture **Official Title:** Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear #### Organization Study ID Info **ID:** luyi #### Organization **Class:** OTHER **Full Name:** Beijing Jishuitan Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2023-03-18 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Jishuitan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Jishuitan Hospital **Investigator Full Name:** Yi Lu **Investigator Title:** Director of Sports Medicine Service of Beijing Jishuitan hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear. ### Conditions Module **Conditions:** - Full Rotator Cuff Tear - Microfracture Procedure - Double Raw Repair - Lateral Raw Repair ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** lateral raw repair for full tear rotator cuff combined microfracture procedure **Intervention Names:** - Procedure: lateral raw **Label:** Study group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** double raw repair for full tear rotator cuff combined microfracture procedure **Intervention Names:** - Procedure: double raw **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Study group **Description:** lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw **Name:** lateral raw **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** double raw repair for full tear rotator cuff combined microfracture procedure **Name:** double raw **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon **Measure:** rotator cuff re-tear rate **Time Frame:** 6, 12, 24 months postoperatively #### Secondary Outcomes **Description:** A score used to evaluate the pain, higher scores mean a worse outcome. **Measure:** VAS (Visual Analogue Scale) **Time Frame:** 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function, higher scores mean a better outcome. **Measure:** ASES(American Shoulder and Elbow Surgeons'Form) **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function,higher scores mean a better outcome. **Measure:** Constant score **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function **Measure:** UCLA (University LosAngeles scoring system) **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function,higher scores mean a better **Measure:** SST (simple shoulder test) **Time Frame:** 3,6,12,24 months postoperatively **Description:** Use a dynamometer to measure in N **Measure:** front extension, external rotation and internal rotation strength of shoulder **Time Frame:** 6,12,24 months postoperatively **Description:** surgical time, describe with minute **Measure:** surgical time **Time Frame:** immediately after the surgery **Description:** payment during the hospital stay, Treatment fee is calculated in RMB **Measure:** Hospitalization expenses **Time Frame:** immediately after the patient discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Arthroscopy confirmed small to medium full rotator cuff tear * Unilateral rotator cuff injury * Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * Young and middle-aged patients aged 20 to 60 Exclusion Criteria: * Previous shoulder surgery (incision or arthroscopy) * Combined with diseases of other parts of the same limb * Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * Bilateral onset * Unable or unwilling to receive clinical follow-up **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Beijing Jishuitan hospital **State:** Beijing **Zip:** 100000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012421 - Term: Rupture - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries - ID: D000013708 - Term: Tendon Injuries - ID: D000050723 - Term: Fractures, Bone ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tears - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M18332 - Name: Fractures, Stress - Relevance: HIGH - As Found: Microfracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000070636 - Term: Rotator Cuff Injuries - ID: D000015775 - Term: Fractures, Stress ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431178 **Brief Title:** General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients **Official Title:** A Comparative Study Between General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients #### Organization Study ID Info **ID:** 36264MD57/3/23 #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Aya Ebrahim Abdelhafez Mashal **Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes. **Detailed Description:** Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability. Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive. Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation. ### Conditions Module **Conditions:** - General Anesthesia - Dexmedetomidine - Ketamine - Local Infiltration - Atrial Septal Defect ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation. Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence. **Intervention Names:** - Other: General Anesthesia **Label:** General anesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable **Intervention Names:** - Other: Local anesthesia **Label:** Local anesthesia **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - General anesthesia **Description:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation . Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence. **Name:** General Anesthesia **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Local anesthesia **Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable **Name:** Local anesthesia **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Heart rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Heart rate **Time Frame:** Immediately after the intervention #### Secondary Outcomes **Description:** Mean arterial blood pressure will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Mean arterial blood pressure **Time Frame:** Immediately after the intervention **Description:** O2 saturation will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** O2 saturation **Time Frame:** Immediately after the intervention **Description:** Respiratory rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Respiratory rate **Time Frame:** Immediately after the intervention **Description:** Length of hospital stay will be measured from admission till discharge from hospital **Measure:** Lengh of hospital stay **Time Frame:** 28 days postoperative **Description:** Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU). **Measure:** Recovery time **Time Frame:** Immediately after discharge from post-anesthesia care unit **Description:** Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured. **Measure:** Complications **Time Frame:** 24 hours postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 3-8 years old. * Both genders. * American Society of Anesthesiologists (ASA) physical status II-III * Pediatric patients scheduled for elective transcatheter atrial septal defect closure. Exclusion Criteria: * Patients with multiple congenital anomalies. * Patients with congestive heart failure * Patients with Organ dysfunction liver or renal disease or pulmonary disease. * Recent chest infection. * Airway abnormalities. **Maximum Age:** 8 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aya E Mashal, Master **Phone:** 00201009167298 **Role:** CONTACT #### Locations **Location 1:** **City:** Tanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aya E Mashal, Master - **Phone:** 00201009167298 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mohammad E Okab, MD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Aymen A Abd Elmaksoud Yousef, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Jehan M Darwish, MD - **Role:** SUB_INVESTIGATOR **Country:** Egypt **Facility:** Aya Ebrahim Abdelhafez Mashal **State:** El-Gharbia Governorate, Egypt **Status:** RECRUITING **Zip:** 31527 ### IPD Sharing Statement Module **Access Criteria:** The data will be available upon a reasonable request from the corresponding author **Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After the end of study for one year. ## Derived Section ### Condition Browse Module - Ancestors - 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: M9431 - Name: Heart Septal Defects - Relevance: HIGH - As Found: Septal Defect - ID: M9432 - Name: Heart Septal Defects, Atrial - Relevance: HIGH - As Found: Atrial Septal Defect - 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: D000006343 - Term: Heart Septal Defects - ID: D000006344 - Term: Heart Septal Defects, Atrial ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### 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 - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M22662 - Name: Dexmedetomidine - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: LOW - As Found: Unknown - ID: M1673 - Name: Sevoflurane - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431165 **Brief Title:** Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study. **Official Title:** Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study. #### Organization Study ID Info **ID:** Pain management #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Omnia Yahia El Sayed Kamel **Investigator Title:** Lecturer of anesthesiology and surgical ICU and pain management **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed To investigate the effects of different doses of Intraoperative intravenous lidocaine infusion on intraoperative opioid consumption, perioperative pain control and incidence of postoperative chronic pain. **Detailed Description:** Enhanced recovery after surgery (ERAS) protocols or fast track surgery are a number of interventions which are carried out in the perioperative period. They are aimed to decrease the harmful effects of surgery on the body and help the patient recover better after surgery. ERAS has been shown to reduce the length of hospital stay, overall hospital costs, opioid consumption in the perioperative period and to reduce complication rates. One of the most important components of ERAS is adequate perioperative pain control using a multi-modal analgesic approach to help decrease dependence on opioids and provide better recovery and less postoperative hospital stay. Also, the severity and duration of acute postoperative pain is one of the predictors of chronic postsurgical pain (CPSP). Neuroplasticity (spinal sensitization) following the trauma of surgery can transform an acute pain to chronic pain if not treated effectively by aggressive management of acute pain. Lidocaine (or 2-(diethylamino)-N-(2.6-dimethylphenyl) acetamide) is the main prototype of amino-amide local anesthetics. It has analgesic, anti-hyperalgesic and anti-inflammatory properties, which enable its use as a general anesthetic adjuvant. It can reduce nociception, cardiovascular responses to surgical stress, postoperative pain, and analgesic requirements. Accordingly, Lidocaine infusion can have a role in enhancing postoperative quality of recovery, decreasing incidence of chronic postoperative pain and even increasing overall survival in patients undergoing major surgeries like in pancreatectomy. The Systemic effects of intravenous Lidocaine infusion depends on its plasma level which is affected by the rate and dose of administration, drug interactions and speed of metabolism and elimination. Around 90% of lidocaine undergoes hepatic metabolism (CYP3A4), with the production of active metabolites. During lidocaine continuous infusion, the accumulation of these metabolites may inhibit its biotransformation and might be involved in some cases of intoxication. The clearance rate of lidocaine is approximately 0.85 L/kg/h. Finally, lidocaine is eliminated by the kidney (10% of lidocaine is eliminated unchanged in the urine). The target plasma concentrations for Lidocaine for providing effective analgesia is 2.4 ± 0.6 μg/mL, while side effects as - have been reported when the plasma concentration was higher than 5-8 μg/mL. The suggested dosing regimens mentioned in literature to achieve this effective plasma level while avoiding toxicity is a bolus of 1-2 mg/kg at surgery start followed by infusion of 1-2 mg/kg/h over the duration of the surgery which is a relatively wide range, specially, considering the wide variability in type and duration of surgeries, demographics, physical and medical status of patients and type of anesthetic agents and drugs used which all can affect Lidocaine activity, elimination \& toxicity. To the best of our knowledge, no evidence exist in the literature that can point towards the ideal dosing regimen for intravenous Lidocaine infusion that can achieve the desired valuable clinical effects while decreasing the incidence of adverse side effects among the wide variety of surgeries and patients encountered within ERAS protocols. ### Conditions Module **Conditions:** - Perioperative Pain Management ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A prospective randomized controlled double blinded study ##### Masking Info **Masking:** TRIPLE **Masking Description:** Each patient will be assigned by a randomly computer generated number to one of the 3 groups and the group assignment will be put in a sealed envelope only accessible by the investigator responsible for preparing the drug syringes. The patient and data collectors will be blinded to the patient group allocation as well as the managing anesthiologists during the operation **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 69 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A: Bolus 10 ml Syringe with Lidocaine 0.5% (2.5 ml lidocaine 2% + 7.5 ml N.S), and infusion 50 ml Syringe with Lidocaine 0.5% (12.5 ml Lidocaine 2% + 37.5 ml N.S). **Intervention Names:** - Drug: Lidocaine IV **Label:** Group A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group B: Bolus 10 ml Syringe with Lidocaine 1% (5 ml lidocaine 2% + 5 ml N.S), and infusion 50 ml Syringe with Lidocaine 1% (25 ml Lidocaine 2% + 25 ml N.S). **Intervention Names:** - Drug: Lidocaine IV **Label:** Group B **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Group C: Bolus 10 ml Syringe with plain Lidocaine 2%, and infusion 50 ml Syringe with plain Lidocaine 2%. **Intervention Names:** - Drug: Lidocaine IV **Label:** Group C **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B - Group C **Description:** After confirming patient history, type of operation and patient group allocation, standard ASA monitoring will be attached to the patient then the I.V induction of anesthesia will be commenced using standard doses of Propofol \&Tracrium in addition to 1 μg/kg Fentanyl and 1 ml/10 kg from the bolus Lidocaine syringe followed after 3 minutes by endotracheal intubation, then the Lidocaine infusion Syringe will be attached to a separate I.V line at an infusion rate of 1 ml/10 kg/h. The patient will receive 1 gm of I.V paracetamol and the surgery will be allowed to proceed. **Name:** Lidocaine IV **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Fentanyl doses of 0.5 mic/kg will be given when there is increase in hemodynamics by 20% of baseline and this will be reported **Measure:** Total Intraoperative opioid consumption (Fentanyl) **Time Frame:** Every five minutes #### Secondary Outcomes **Measure:** Total opioid consumption (Morphine) in the first 24 hours postoperative. **Time Frame:** Every one hour postoperative for 24 hours **Description:** Time between end of surgery and the first dose of rescue analgesia administered to the patient **Measure:** Time of first rescue analgesia used in the first 24 hours postoperative **Time Frame:** Every one hour postoperative for 24 hours **Measure:** Incidence of side effects related to Lidocaine infusion during the first 24 hours postoperative. **Time Frame:** Every one hour postoperative for 24 hours **Measure:** Incidence of chronic postoperative pain 2 months after the surgery. **Time Frame:** Every week for 2 months postoperative. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients age between 18 and 65. * Patients with ASA I and II status. * Patients undergoing open laparotomy surgeries (including open cholecystectomies). Exclusion Criteria: * Patients unable to comprehend the informed consent. * Patients on long term pre-operative opioid regimens. * Patients with impairment in hepatic or renal functions. * Patients who are planned to receive any form of regional block for the surgery. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alaa Magdy Ahmed Hassan, Master **Phone:** 01090282616 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Amany Ezzat Ayad Ibrahim, Professor **Phone:** 01223429325 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omnia Y Kamel, MD - **Phone:** 01270130326 - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo University **Status:** RECRUITING **Zip:** 1111 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Mohammed Ahmed Mansour, Assistant professor **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Cairo University **Name:** Islam Ayman Mohammed Shawky, MD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Cairo University **Name:** Nora Amr Agiza, MD **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Cairo University **Name:** Omnia Y Kamel, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059350 - Term: Chronic Pain ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### 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 - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers ### Intervention Browse Module - Browse Leaves - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M4584 - Name: Atracurium - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431152 **Acronym:** EXO-OA01 **Brief Title:** Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis **Official Title:** Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study #### Organization Study ID Info **ID:** EXO-OA01 #### Organization **Class:** OTHER **Full Name:** Universidad de los Andes, Chile ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de los Andes, Chile #### 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 aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months. **Detailed Description:** The clinical investigation will represent a Phase 1 trial focusing on small extracellular vesicles derived from mesenchymal stem cell (MSC-sEV) in patients with symptomatic Kellgren II-III knee OA. The phase 1 component of the study will be an open-label dose escalation pilot study in which three cohorts of subjects with OA will receive increasing doses of UC-MSC-sEV administered as a single intra-articular (IA) injection. Each cohort will comprise four participants. Eligible study subjects will be enrolled at the "Clinica Universidad de los Andes". The small extracellular vesicles derived from umbilical cord mesenchymal stem cell (UC-MSC-sEV) will be prepared in the "Clinica Universidad de los Andes" GMP facility. The sEV-based therapeutic for clinical use will be manufactured in compliance with standardized procedures based on Good Manufacture Practice (GMP) regulations and all quality controls aforementioned. The sEV therapeutic will be transported to the patient administration site under controlled conditions, ensuring maintenance of a temperature range between 2-8°C. The sEV injection is expected to be administered within the first 6 h of product manufacture. The primary study endpoints of this trial will focus on the safety, feasibility, and toxicity of the sEV-based product. The phase I will examine (1) the incidence of immediate post-infiltration adverse reactions in patients; (2) the occurrence of synovitis post-infiltration in patients at 24 and 48 hours, as well as on days 7 and 15; (3) the frequency of post-infiltration pain reported by patients at 24 and 48 h, and on days 7 and 15; and (4) the prevalence of adverse events related to sEV therapy occurring beyond IA infiltration at 24 and 48 h, and on days 7 and 15, as well as at months 2, 4, 6, 8, 10, and 12. The secondary study endpoint will be determine the optimal dose for phase II trials. The criteria that will be considered are (1) Safety profile at infiltration at 24 and 48 h, and on days 7 and 15, as well as at months 2, 4, 6, 8, 10, and 12; (2) changes in WOMAC scores at months 2, 4, 6, 8, 10, and 12; and (3) alterations in the Visual Analog Scale (VAS) pain scores at months 2, 4, 6, 8, 10, and 12. ### Conditions Module **Conditions:** - Osteo Arthritis Knee ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intra-articular knee injection of exosomes (2 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** Low-Dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intra-articular knee injection of exosomes (6 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** Medial-Dose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Intra-articular knee injection of exosomes (2 x 10e10 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** High-Dose **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High-Dose - Low-Dose - Medial-Dose **Description:** Small extracellular vesicles derived from allogenic mesenchymal stromal cells, single dose **Name:** UC-MSC sEV **Other Names:** - Cellistem®sEV-OA **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Occurrence of any adverse reactions within 12 months of treatment **Measure:** Adverse Event **Time Frame:** 12 month #### Secondary Outcomes **Description:** Pain measured by Visual Analogue Scale (VAS) (0-100mm) after first week of treatment **Measure:** Incidence of injection-related pain according to Visual Analogue Scale (VAS) (0-100mm) **Time Frame:** 1-2 weeks **Description:** Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment **Measure:** Incidence of injection-related synovitis according to effusion grading scale of knee joint **Time Frame:** 1-2 weeks **Description:** Change in Visual Analogue Scale (VAS) (0-100mm) score every 2 months **Measure:** Pain change **Time Frame:** 12 months **Description:** Change in WOMAC subscale (Western Ontario and McMaster Universities Osteoarthritis IndexWomac) related to function (C) every 2 months Pain (0-20), Stiffness (0-8), functional capacity (0-68). **Measure:** Disability change **Time Frame:** 12 months **Description:** According to OMERACT-OARSI Criteria Index Response after 52 weeks **Measure:** Percentage of responders **Time Frame:** 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 30 to 70 years. * Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray) * VAS for pain ≥ 40 mm, without surgical indication in the affected knee. * In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm. * Stable knee with normal physical examination. * Signed Informed Consent Exclusion Criteria: * Symptomatic bilateral knee OA * BMI \> 30 kg/m2 * Joint instability at physical examination. * Mechanical meniscal tear on physical examination. * Associated conditions: active local or systemic infection, neoplasia, immunosuppression, pregnancy, anticoagulant therapy, coagulation disorders, inflammatory joint disease (autoimmune, by crystal or other), joint prosthesis, symptomatic spine or hip disease. * Recent use of intra-articular (last 6 months) or oral (last month) steroid therapy. * Recent use of intra-articular hyaluronic acid therapy (last 6 months) * Subchondral bone fracture. **Maximum Age:** 70 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jose Matas, MD **Phone:** +56 2 26183347 **Phone Ext:** 3347 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Francisco Espinoza, MD **Phone:** +56 2 26183347 **Phone Ext:** 3347 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bernardita Hurtado - **Phone:** 226182071 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Consuelo Covarrubias - **Phone:** 226182071 - **Role:** CONTACT **Country:** Chile **Facility:** Clinica Universidad de los Andes **State:** Las Condes **Status:** RECRUITING **Zip:** 2501 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteo Arthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteo Arthritis Knee - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431139 **Acronym:** INSPIRE **Brief Title:** Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury **Official Title:** Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial #### Organization Study ID Info **ID:** H-24001505 #### Organization **Class:** OTHER **Full Name:** Rigshospitalet, Denmark ### Status Module #### Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Christian Riberholt #### Responsible Party **Investigator Affiliation:** Rigshospitalet, Denmark **Investigator Full Name:** Christian Riberholt **Investigator Title:** Head of therapy and senior researcher, PT, MR, PhD **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 randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved. The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period. Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance. **Detailed Description:** This is a randomised multicentre clinical feasibility and pilot trial, where assessors and statisticians will be blinded. Forty-four participants with moderate to severe traumatic brain injury will be randomised to INSPIRE versus standard care as soon as they are able to understand and execute simple commands twice during one day. Participants in the INSPIRE group will undergo two weeks of intensive sit-to-stand exercise using an algorithm to increase the intensity daily. The trial uses predefined dose-limiting events to reduce training intensity in participants experiencing exercise-related adverse events that limit other daily activities and rehabilitation (e.g. muscle soreness and pain). Overall feasibility will be assessed by determining the inclusion rate, exercise completion rate, and completion of the Glasgow Outcome Scale - Extended. As exploratory clinical outcomes, the investigators will assess serious adverse events and adverse events not considered serious, physical function, cardiovascular and metabolic health, fatigue, and cognitive function. ### Conditions Module **Conditions:** - Traumatic Brain Injury **Keywords:** - Traumatic brain injury - Intensive exercise - Rehabilitation - Randomised trial - Feasibility - Pilot - Sit-to-stand exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** The trial will use assessors blinded to the allocation and in charge of testing the following outcomes: 30 seconds chair stand test, 10-meter walk test, 6-minute walking test, and the Montreal Cognitive Assessment Scoring (MoCA) Two statisticians that will perform the statistical analysis are blinded to the allocation **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention group. Daily intensive sit-to-stand exercises following a described algorithm and utilising motor-relearning principles of feedback to increase the participant's motivation. This exercise is an addition to standard care. **Intervention Names:** - Other: INSPIRE intervention protocol **Label:** INSPIRE group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treatment in this group will be standard care interventions performed at the rehabilitation department. **Label:** Standard care group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - INSPIRE group **Description:** 2-week training program with daily sit-to-stand exercises. Each working day the participant's goals will be adjusted, until exercising a minimum of 100 repetitions using an exercise progression table. When participants complete one level, they will progress to the next level the following day. Participants who do not reach the goals at level one will continue to strive to reach the 100 repetitions. The number of repetitions can be split and performed throughout the day. As the participants' capacity for doing the exercises increases, so will the number of repetitions within each bout of sit-to-stand. Participants are allowed to do the number of repetitions from a higher exercise level if they can and will continue by progressing from that level on the next day. The repetitions will be done from a height that makes it possible to accomplish the sit-to-stand movement. Therefore, the height of the sitting surface will be adjusted according to the participant's abilities. **Name:** INSPIRE intervention protocol **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Examples of this could be fatigue or muscle pain that limits the participant in other activities of daily living and thereby reduces their amount of other rehabilitation services during the day **Measure:** Dose-limiting events **Time Frame:** during the intervention, 72-hours after end of intervention **Description:** The scale is a global scale evaluating the independent function after traumatic brain injury. **Measure:** Glasgow Outcome Scale - Extended **Time Frame:** at discharge, 6 months, 1 year **Description:** The total number of sit-to-stands in each group will be measured using an activity monitor placed on the participant's sternum and hip (Sens motion®, Copenhagen, Denmark) **Measure:** Number of sit-to-stand exercises in each group during the intervention period (continuous outcome) **Time Frame:** during the intervention **Description:** The test is administered using a stopwatch and a chair. The participant is instructed to do sit-to-stand movements for 30 seconds. Time begins when the participant initiates the movement. **Measure:** Number of sit-to-stand exercises during the 30-second chair stand test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** Walkers are defined by the ability to walk at any pace, with any walking aid, over minimum 50 meters independently (i.e. independent from physical assistance). **Measure:** Walkers and non-walker (dichotomous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** The walkers in each group will undergo a 10-meter walk test to assess walking speed **Measure:** 10-meter walk test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** The walkers in each group will undergo a 6-minute walking test to assess and endurance **Measure:** 6-minute walking test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** Resting blood pressure will be measured on both arms for 5 minutes continuously before the first training session (8 am) using photoplethysmography to measure beat-to-beat blood pressure non-invasively. **Measure:** Resting blood pressure **Time Frame:** Baseline, 1 day after the intervention **Description:** An ordinary electrocardiogram available at the respective departments will be used to measure resting heart rate. **Measure:** Resting heart rate **Time Frame:** Baseline, 1 day after the intervention **Description:** The blood samples will be analysed for high-sensitivity C-reactive protein, neutrophil-to-lymphocyte ratio, HbA1c, blood glucose, c-peptide insulin, blood lipids, inflammatory biomarkers, neuronal cell injury biomarkers, astroglia cell injury biomarkers, and axonal injury biomarkers. Finally, biomarkers associated with subacute/chronic traumatic brain injury phase will be analysed. **Measure:** Blood samples **Time Frame:** Baseline, 1 day after the intervention **Description:** The MoCA is a short cognitive questionnaire designed to test for mild cognitive impairments. **Measure:** The Montreal Cognitive Assessment (MoCA) **Time Frame:** Baseline, 1 day after the intervention, 6 months, 1 year **Description:** The Fatigue Severity Scale examines the severity of fatigue with a 9-item scale, and how it can affect a person's daily lifestyle when they have a chronic disease/disorder. **Measure:** Fatigue severity scale (FSS) **Time Frame:** Baseline, 1 day after the intervention, 6 months, 1 year #### Primary Outcomes **Description:** The difference in the number of sit-to-stand performed in the INSPIRE group compared to the control group using linear regression during the two-week intervention period. **Measure:** Number of sit-to-stand **Time Frame:** during the intervention #### Secondary Outcomes **Description:** Of all eligible patients, at least 76% (95% CI 63% to 86%, 1-sample proportions test with continuity correction) must consent (by themselves or by proxy) to inclusion in the trial, corresponding to 44/58 eligible patients included **Measure:** The number of participants included in the trial **Time Frame:** 1,5 years **Description:** The number of participants completing the Glasgow Outcome Scale extended at six months and one year must be above 89% (95% CI 76% to 96%), corresponding to 40/44 participants. **Measure:** Participants completing GOSE **Time Frame:** 6 months, 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Moderate to severe traumatic brain injury with Glasgow Coma Score \<13 within the first 24 hours (ICD10, DS06) * Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Rigshospitalet, the Regional Hospital, Hammel Neurocentre or the Acquired Brain Injury Rehabilitation Centre, Alfred Hospital * 18 years old or older * Patients (or next of kin) should be able to understand written and spoken Danish or English to consent to participation in the trial validly * Specifically for Australian participants: eligibility for Medicare Exclusion Criteria: * Unstable fractures of the lower extremities * Amputation of lower extremity * Spinal cord injury * Total paralysis of both lower extremities * Agitated or combative behaviour * Diagnosed with a progressive neurological disorder (e.g. Alzheimer's, Parkinson's disease, multiple sclerosis) prior to traumatic brain injury, as it could potentially interfere with serum biomarker levels * Previous structural brain injury (e.g. stroke or brain surgery) * No valid consent from the participant or next of kin **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yasemin Ronahi Kücük, M.D **Phone:** +4527841237 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Christian G Riberholt, PT, MR, PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet **Name:** Christian G Riberholt, PT, MR, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet **Name:** Christina G Kruuse, Professor **Role:** STUDY_DIRECTOR ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - 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 ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431126 **Brief Title:** Animal-assisted and Nature Based Activities **Official Title:** Animal-assisted and Nature Based Activities for Young Adults With Autism and Social Withdrawel #### Organization Study ID Info **ID:** RK-997623 #### Organization **Class:** OTHER_GOV **Full Name:** Kronoberg County Council ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-07-07 **Type:** ACTUAL #### Start Date **Date:** 2020-09-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Kronoberg County Council #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments. The intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. Data consists of interviews with participants prior to and after the intervention, as well as one year later. The one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. In addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. Analysis will be carried out with qualitative content analysis, as well as health-economic calculations. ### Conditions Module **Conditions:** - Neuropsychiatric Syndrome - Autism Spectrum Disorder **Keywords:** - complementary therapies - feasability - young adults ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 13 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Animal-assisted and nature based activities **Label:** Animal-assisted and nature based group activity for young adults with autism **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Animal-assisted and nature based group activity for young adults with autism **Description:** Supervised activities on a farm, 2 half day/week for 12 weeks **Name:** Animal-assisted and nature based activities **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of sessions with participation **Measure:** Attendance **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Interviews **Measure:** Experiences of participation **Time Frame:** 12 weeks **Description:** Interview **Measure:** Occupational level **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-30 years * Autism Spectrum Disorder * Social withdrawn at least for one year * Social insurance benefits * Interest in being with animals Exclusion Criteria: * Ongoing drug abuse * Severe psychiatric comorbidity **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Växjö **Country:** Sweden **Facility:** Kronoberg County Council **Zip:** 35242 #### Overall Officials **Official 1:** **Affiliation:** Kronoberg County Council **Name:** Birgitta Gunnarsson, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431113 **Brief Title:** Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma **Official Title:** Effect of Fixed Combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline Quinone (Neuprozin Mito®) on Pattern Electroretinogram in Controlled Open Angle Glaucoma Patients:A Multicenter, Randomized, Single Blind, Cross-over Study #### Organization Study ID Info **ID:** NP-MITO #### Organization **Class:** OTHER **Full Name:** IRCCS Policlinico S. Matteo ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Federico II University **Class:** OTHER **Name:** University of Roma La Sapienza #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Policlinico S. Matteo #### Responsible Party **Investigator Affiliation:** IRCCS Policlinico S. Matteo **Investigator Full Name:** Rossi, Gemma Caterina Maria **Investigator Title:** Principal investigator, Ophthalmologist **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 examine the effect of the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) on pattern electroretinogram (PERG) in patients with primary open angle glaucoma on well controlled intraocular pressure It will also learn about the safety of this fixed combination. The main questions it aims to answer are: Does the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) improve PERG amplitude and/or latency? Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology? Does the fixed combination improve quality of life of glaucoma patients? Does the fixed combination have any effect on optical coherence tomography (OCT)? Researchers will compare the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma. Participants will: Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months. Visit the clinic at enrollment and once every 4 months (at month 4 and at month 8) for checkups and tests (visual field, OCT, PERG and quality of life questionnaire) **Detailed Description:** Our general purpose is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram. Primary objective To compare the effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) a tablet a day on PERG examination (p50 wave) at four months of therapy, compared to citicoline 800 mg alone (Cebrolux® - CIT), as add-on to standard topical therapy. Secondary objectives To compare the two treatments (Neuprozin Mito® - NPM vs citicoline - CIT - alone) in terms of: * visual acuity over time * visual field changes over time, if any * Quality of Life perception (National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire) over time * optical coherence tomography - OCT- changes over time, if any * Safety (Incidence of adverse events) Study design and planning Multicentric, randomized, 2-sequence, 2-period, 2-treatment, crossover study, with blind outcome assessor. Centers 1. Azienda Ospedaliera Universitaria Federico II ; UOC Oculistica, Napoli 2. Clinica Oculistica dell'Università degli Studi di Pavia, IRCCS Policlinico San Matteo Foundation, Pavia. 3. Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale, Università di Roma "Sapienza", Roma Study duration Study duration ; 14 months Enrolment period: 6 months Minimum Follow-up: 8 months Total sample size: 40 patients ### Conditions Module **Conditions:** - Glaucoma - Neuroprotection **Keywords:** - glaucoma - neuroprotection - citicoline - homotaurine - Pyrroloquinoline quinone - visual field - pattern electroretinogram - oct - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) fixed combination for 4 months followed by Cebrolux -CIT for 4 months, besides standard topical treatment **Intervention Names:** - Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Label:** Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Citicoline 800 (Cebrolux-CIT) for 4 months followed by Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) for 4 months, besides standard topical treatment **Intervention Names:** - Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Label:** Cebrolux -CIT for 4 months **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cebrolux -CIT for 4 months - Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM) **Description:** treatment for 4 months and then cross over to the other therapy **Name:** Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** amplitude of PERG waves (microVolt) **Measure:** To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on pattern-electroretinogram -PERG- amplitudes **Time Frame:** 4 months **Description:** latency of PERG waves (milliseconds) **Measure:** To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on PERG latencies **Time Frame:** 4 months #### Secondary Outcomes **Description:** visual acuity evaluation **Measure:** To compare the two treatments in terms of: • visual acuity over time **Time Frame:** 4 months **Description:** Pattern Standard Deviation and Mean Deviation (deciBell) **Measure:** To compare the two treatments in terms of: • visual field changes over time, if any **Time Frame:** 4 months **Description:** quality of life with questionnaire national eye institute-visual function questionnaire 25 items (NEI-VFQ25) (from 0=worst score/quality of life to 100 better score/quality of life) **Measure:** To compare the two treatments in terms of: • Quality of Life perception national eye institute-visual function questionnaire 25 items (NEI VFQ25) over time **Time Frame:** 4 months **Description:** retinal nerve fiber layer (RNFL) and ganglion cells complex (GCC) **Measure:** To compare the two treatments in terms of: • optical coherence tomography - OCT changes over time, if any **Time Frame:** 4 months **Description:** adverse events onset **Measure:** To compare the two treatments in terms of: • Safety (Incidence of adverse events) **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age \> 18 years; * diagnosis of primary OAG (POAG) from, at least, 3 years; * visual acuity \> 0.7 (7/10) decimals; * refractive error \< 5 Diopter (D) (spheric) and \< 2D (toric); * transparent diopter means (cornea and lens); * controlled intraocular pressure (IOP) (\<18 mmHg, morning value) with prostaglandin analogues as monotherapy; * stable intraocular pressure - IOP \< 18 mmHg in the last 2 years; * stable and unchanged topical therapy in the last 6 months; * at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm-SITA Standard) per year in the last 2 years; * early to moderate visual field defect (mean deviation, MD \<12 dB); * electrophysiological (pattern electroretinogram-PERG) parameters alterations similar to glaucomatous pathology; * written consent to participate to study procedures and data utilization in an anonymous form Exclusion Criteria: * ocular hypertension with normal optic nerve and visual field; angle closure glaucoma; congenital glaucoma; secondary glaucoma; normal tension glaucoma; * history of recurrent uveitis/scleritis/herpes infection; * pregnancy and breastfeeding; * contraindication to Citicoline and/or Homotaurine and/or pyrroloquinoline quinone -PQQ * contraindication to prostaglandine analogues * topical therapy with Brimonidine or beta-blockers as monotherapy or fixed combination * topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination * systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment * systemic betablockers * systemic therapies affecting patients' performance in visual field examination (sedatives); * glaucomatous scotomas within 10 degree from fixation * any condition limiting the patient's ability to participate in the study; * other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy; * other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, acute lateral sclerosis, multiple sclerosis) or pituitary disorders; * cerebral ischemia in the last 2 years * any change in topical therapy in the 6 months prior to enrollment or during the study period * concomitant participation to another clinical trial * any previous filtering and/or retinal surgery; * cataract surgery in the last 6 months; * any previous laser treatment for glaucoma in the last 5 years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gemma Caterina Maria Rossi, MD **Phone:** +393284838186 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gemma Caterina Maria Rossi, MD **Phone:** 3284838186 **Role:** CONTACT #### Locations **Location 1:** **City:** Pavia **Country:** Italy **Facility:** Gemma Caterina Maria Rossi **State:** PV **Status:** ACTIVE_NOT_RECRUITING **Zip:** 27100 **Location 2:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Name:** Ciro Costagliola, MD - **Role:** CONTACT **Country:** Italy **Facility:** Clinica Oculistica Università Federico II **Status:** RECRUITING **Zip:** 80100 #### Overall Officials **Official 1:** **Affiliation:** Federico II University eye Clinic, Naples **Name:** Ciro Costagliola, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma ### Intervention Browse Module - Ancestors - ID: D000018697 - Term: Nootropic Agents - ID: D000000927 - Term: Anticonvulsants - ID: D000018755 - Term: GABA Agonists - ID: D000018682 - Term: GABA Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M211514 - Name: Tramiprosate - Relevance: HIGH - As Found: Deep Anterior Lamellar Keratoplasty - ID: M6771 - Name: Cytidine Diphosphate Choline - Relevance: HIGH - As Found: Flutter - ID: M6034 - Name: Choline - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M20825 - Name: GABA Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T443 - Name: Choline - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000001355 - Term: Tramiprosate - ID: D000003566 - Term: Cytidine Diphosphate Choline ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431100 **Acronym:** GK-01 **Brief Title:** a Single-arm, Single-center, Open Clinical Study **Official Title:** Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** GK-01 #### Organization **Class:** INDUSTRY **Full Name:** Beijing Geekgene Technology Co., LTD ### Status Module #### Completion Date **Date:** 2026-11-19 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-07-19 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Beijing Geekgene Technology Co., LTD #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria. ### Conditions Module **Conditions:** - Gastric Cancer - Esophageal Cancer - Cervical Cancer - Non-Small Cell Lung Cancer NSCLC - Triple Negative Breast Cancer TNBC **Keywords:** - TRT - cell therapy - advanced tumor - safety - efficiency - adverse event ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 36 Months ### Arms Interventions Module #### Arm Group 1 **Description:** According to the cell transfusion protocol, GK01 cells were given at a certain dose level to observe the safety and tolerability of the patients after the transfusion, explore the pharmacokinetic/pharmacodynamic characteristics after the transfusion, and preliminarily evaluate the effectiveness of the experimental drug GK01 cells according to the RECIST 1.1 standard. **Intervention Names:** - Biological: TCR T-cells **Label:** cell therapy interventional single arm ### Interventions #### Intervention 1 **Arm Group Labels:** - cell therapy interventional single arm **Description:** The strengthened T cells are re-infused into the patient to achieve the killing effect **Name:** TCR T-cells **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the safety and tolerability of GK01 autologous tumor-reactive T cells (TRT) in patients with advanced solid tumors. **Measure:** safety and tolerability **Time Frame:** From enrollment to the end of follow-up visit at 22weaks or more #### Secondary Outcomes **Description:** To explore the specificity and persistence of GK01 autologous tumor-reactive T cells (TRT) expansion in patients with advanced solid tumors **Measure:** specificity and persistence **Time Frame:** From enrollment to the end of treatment at 28 days **Description:** To evaluate the initial efficacy of GK01 autologous tumor-reactive T cells (TRT) in the treatment of patients with advanced solid tumors based on RECIST 1.1 criteria **Measure:** initial efficacy **Time Frame:** From enrollment to the end of treatment at 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who meet all of the following criteria are eligible for admission to the study: 1. 18≤ age ≤75 years old, male or female; 2. Patients with incurable advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, and other malignancies who have failed standard treatment (standard treatment failure is defined as those treated according to the 2022 CSCO Guidelines and whose tumor efficacy is assessed as disease progression (PD) or tumor recurrence or inability to tolerate existing treatment options); 3. There are tumor tissues or cancerous exudative thoracoabdominal fluid that can be used to isolate TRTs: the total volume of the solid tissue taken must be \&amp;amp;gt; 0.5cm3 or the weight must be \&amp;amp;gt;0.5g, the cancerous exudative thoracoabdominal fluid taken should contain at least 5×10\^8 total cells, and the lesions taken have not been treated with oncolytic virus. 4. There is at least one measurable lesion (according to RECIST1.1 criteria) even after TRTs sampling/puncture biopsy; 5. ECOG score 0-1; 6. The expected survival period is greater than 3 months; 7. Sufficient hematology and end-organ function, as defined by the following laboratory test results, should be completed within 14 days prior to TRTs tumor tissue collection: 1. Blood routine: white blood cell count ≥2.5×10\^9/L; Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Absolute lymphocyte count (ALC) ≥1.0×10\^9/L; Platelet (PLT) ≥80×10\^9/L; Hemoglobin (HGB) ≥90g/L; 2. Coagulation function: International standardized ratio of prothrombin time (INR) ≤1.5×ULN; Partial prothrombin time (APTT) ≤1.5×ULN, unless anticoagulant therapy has been received within the previous 7 days; 3. Renal function: serum creatinine ≤1.5mg/dL (or 132.6μmol/L) or creatinine clearance ≥60mL/ min; 4. Liver function: aspartate aminotransferase (AST/SGOT) ≤3×ULN; Alanine transaminase (ALT/SGPT) ≤3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; Note: In patients with liver metastasis or primary liver tumor, aspartate and alanine aminotransferase should be ≤5×ULN; For patients with a history of Gilbert syndrome or suspected Gilbert syndrome, total bilirubin (TBIL) should be ≤3×ULN; 5. Urine routine: urinary protein \&amp;amp;lt;2+, or 24-hour urinary protein quantity \&amp;amp;lt;1g; 6. Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; 7. Pulmonary function tests with FEV1\&amp;amp;gt;60% or FEV1/FVC\&amp;amp;gt;0.7; 8. Blood oxygen saturation ≥ 93%. 8. Women of childbearing age who have a negative urine pregnancy test during screening and baseline and agree to use highly effective contraception for at least 1 year after the infusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and refrain from sperm donation for at least 1 year after the infusion; 9. No absolute or relative contraindications to surgery or puncture; 10. Any treatment for malignant tumors, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, tumor embolization, or Chinese medicine/herbal therapy with anti-tumor indications, must be discontinued 7 days before TRT sampling; 11. Sign a written informed consent (ICF) voluntarily, and have good compliance with the protocol requirements for visits or planned visits and other relevant research procedures. Exclusion Criteria: * Subjects who meet any of the following criteria will not be eligible to participate in this clinical trial: 1. Prior allergy to cyclophosphamide, fludarabine and interleukin-2 contraindications or to any component of the infusion product formulation or to other drugs to be used during the study (antibiotics, human serum albumin, dextran 40, etc.); 2. Any NCI CTCAE5.0 immune-related adverse reaction (irAE) grade \&amp;amp;gt;3 that has been permanently discontinued during any previous immunotherapy; 3. Patients with prior primary immunodeficiency and active autoimmune disease; 4. Previous history of organ allotransplantation, allogeneic stem cell transplantation and kidney replacement therapy; 5. Patients with current or past irreversible interstitial lung disease (except those caused by radiotherapy); 6. Combined with 2 or more malignant tumors; (Except for the following cases: malignant tumors that have been cured, such as non-melanoma skin cancer and in situ cervical cancer, bladder cancer, breast cancer, thyroid cancer, etc. that have survived more than 5 years without disease.) 7. Uncontrolled co-morbidity includes, but is not limited to, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) even after standard treatment, or any unstable cardiovascular and cerebrovascular disease, including transient ischemic attack, cerebrovascular accident, myocardial infarction, and unstable angina pectoral, that has occurred in the 6 months prior to treatment induction; Congestive heart failure rated III or IV by the New York Heart Association (NYHA); Ejection fraction \&amp;amp;lt; 50%; Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc. Electrocardiogram results show clinically significant abnormalities, or QTcF≥450ms (if the first examination is abnormal, the interval of at least 5 minutes, retest twice, using the comprehensive result/average value to judge eligibility); 8. Patients with esophageal or gastric varices that require immediate intervention (such as ligation or sclerotherapy) or are considered by the investigator or gastroenterologist or hepatologist to be at high risk of bleeding, have evidence of portal hypertension (including splenomegalysis on imaging), or have a history of varicose bleeding must undergo endoscopic evaluation within 3 months prior to enrollment; 9. Uncontrolled metabolic disorders, such as in patients with diabetes, or other non-malignant organ or systemic disease or cancer secondary reactions that can lead to higher medical risk and/or uncertainty in the evaluation of survival; 10. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade C or more severe cirrhosis, liver failure; 11. Clinically uncontrollable third space effusion, such as pleural fluid and ascites that could not be controlled by drainage or other methods before enrollment; 12. Combined with other serious organic disease or mental illness; 13. Patients with central nervous system metastasis; 14. Uncontrolled systemic active infection; 15. Receive vaccination within 2 months before signing the informed consent, or plan to receive vaccination during the study; 16. Currently or within 30 days before signing the informed consent to participate in clinical trials of other drugs or biotherapeutics, except cell therapy that has been fully metabolized; 17. have used within 4 weeks prior to the treatment, or have concomitant disease or active autoimmune disease that the investigator determined required the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local percutaneous absorption of glucocorticoids (i.e., no more than 5 mg/ day of prednisone or equivalent doses of other glucocorticoids); 18. Surgical treatment, interventional therapy, radiotherapy, chemotherapy and immunotherapy for the studied disease were performed within 2 weeks before the treatment; 19. HIV positive, serological test positive for syphilis, or clinically active hepatitis B or C, including carriers of the virus (for hepatitis B, HBsAg positive persons should be excluded; For hepatitis C, HCVAB-positive patients need to be excluded); 20. Women who are breastfeeding during pregnancy or lactation; 21. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 22. Other conditions deemed unsuitable for participation in this experiment by the researcher. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** GK01 cell transfusions were performed in 10 patients with advanced solid tumors, including but not limited to advanced non-small cell lung cancer, gastric cancer, and esophageal cancer. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yi Zhang, Doctor **Phone:** 86+15138928971 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ge Zhang **Phone:** 0086+13633861412 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yi Zhang, Doctor - **Phone:** 626-491-5096 - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital of Zhengzhou University **State:** Henan **Status:** RECRUITING **Zip:** 450052 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001943 - Term: Breast Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - 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: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000064726 - Term: Triple Negative Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431087 **Acronym:** GIS **Brief Title:** Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study **Official Title:** Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study #### Organization Study ID Info **ID:** S00822-NIM #### Organization **Class:** OTHER **Full Name:** University Hospital Tuebingen ### Status Module #### Completion Date **Date:** 2028-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Robert Bosch Hospital Stuttgart #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Tuebingen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS). **Detailed Description:** After baseline (t0), all participant will receive the following intervention: The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network. t1 (at the end of the program). t2 (3 months after t0). ### Conditions Module **Conditions:** - Subjective Stress **Keywords:** - Mindfulness - Healthy Lifestyle ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single-Center, an Arm, prospective intervention study. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will have two-hour sessions for 8 weeks. **Intervention Names:** - Other: Mindfulness course **Label:** Mindfulnes "Healthy Under Stress" Stress Management Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mindfulnes "Healthy Under Stress" Stress Management Program **Description:** Online or in presence Information on Mindfulness, healthy diet and exercise. **Name:** Mindfulness course **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often). **Measure:** Perceived Stress Scale **Time Frame:** After 8 Weeks (end of intervention) #### Secondary Outcomes **Description:** The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often). **Measure:** Perceived Stress Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment). **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** After 8 Weeks (end of intervention) **Description:** Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment). **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability). **Measure:** Quality of life Questionnaire **Time Frame:** After 8 Weeks (end of intervention) **Description:** Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability). **Measure:** Quality of life Questionnaire **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET). **Measure:** International Physical Activity Questionnaire **Time Frame:** After 8 Weeks (end of intervention) **Description:** The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET). **Measure:** International Physical Activity Questionnaire **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD. **Measure:** Mediterranean Diet Adhrence Screener **Time Frame:** After 8 Weeks (end of intervention) **Description:** The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD. **Measure:** Mediterranean Diet Adhrence Screener **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences. **Measure:** Mindful Attention and Awareness Scale **Time Frame:** After 8 Weeks (end of intervention) **Description:** The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences. **Measure:** Mindful Attention and Awareness Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** In order to evaluate the safety of the intervention, unforeseen events are documented. For this purpose participants are explicitly asked about the occurrence of these. **Measure:** Safety evaluation **Time Frame:** After 8 Weeks (end of intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties. * Informed consent. Exclusion Criteria: * Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study. * Participation in other clinical studies with behavioral, psychological or complementary medical interventions. * Insufficient knowledge of the German language. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marcela Winkler, Dr **Phone:** +49711 8181 **Phone Ext:** 2073 **Role:** CONTACT #### Locations **Location 1:** **City:** Stuttgart **Country:** Germany **Facility:** Robert-Bosch-Krankenhaus **State:** Baden Würtenberg **Zip:** 70341 #### Overall Officials **Official 1:** **Affiliation:** Robert Bosch Gesellschaft für Medizinische Forschung mbH **Name:** Marcela Winkler, Dr **Role:** STUDY_DIRECTOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431074 **Brief Title:** Radicle Calm 24: A Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes **Official Title:** Radicle Calm™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes #### Organization Study ID Info **ID:** RADX-P-2402 #### Organization **Class:** INDUSTRY **Full Name:** Radicle Science ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Radicle Science #### 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 randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes **Detailed Description:** This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for less feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study. ### Conditions Module **Conditions:** - Anxiety - Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be stratified based on gender at birth, then randomized to one of the study arms ##### Masking Info **Masking:** DOUBLE **Masking Description:** The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Calm Product Form 1 - control **Intervention Names:** - Dietary Supplement: Placebo Control Form 1 **Label:** Placebo Control 1 **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Calm Product Form 1 - active product 1 **Intervention Names:** - Dietary Supplement: Calm Active Study Product 1.1 Usage **Label:** Active Product 1.1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo Control 1 **Description:** Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. **Name:** Placebo Control Form 1 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Active Product 1.1 **Description:** Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks. **Name:** Calm Active Study Product 1.1 Usage **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include saliva-based biomarkers (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP). **Measure:** Change in concentration of at-home (direct-to-consumer) specimen assay (saliva) **Time Frame:** 6 weeks **Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include blood-based biomarkers (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). **Measure:** Change in concentration of at-home (direct-to-consumer) specimen assay (blood) **Time Frame:** 6 weeks **Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include stool sample (microbial diversity). Units of measure will vary depending upon biospecimen collected. **Measure:** Optional Change in concentration of at-home (direct-to-consumer) specimen assays (stool) **Time Frame:** 6 weeks #### Primary Outcomes **Description:** Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) **Measure:** Change in feelings of anxiety **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Mean difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) **Measure:** Change in stress **Time Frame:** 6 weeks **Description:** Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) **Measure:** Change in sleep **Time Frame:** 6 weeks **Description:** Mean difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) **Measure:** Change in mood (emotional distress) **Time Frame:** 6 weeks **Description:** Likelihood of achieving a MCID in sleep disturbance, as measured by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) **Measure:** Minimal clinically important difference (MCID) in feelings of anxiety **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) **Measure:** Minimal clinically important difference (MCID) in stress **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) **Measure:** Minimal clinically important difference (MCID) in sleep **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) **Measure:** Minimal clinically important difference (MCID) in mood (emotional distress) **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed * Resides in the United States * Endorses less anxiety as a primary desire * Has the opportunity for at least 20% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: * Reports being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * Reports current enrollment in another clinical trial * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensive, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) * Lack of reliable daily access to the internet **Healthy Volunteers:** True **Maximum Age:** 105 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Manager **Phone:** 760-281-3898 **Role:** CONTACT #### Locations **Location 1:** **City:** Del Mar **Country:** United States **Facility:** Radicle Science, Inc **State:** California **Zip:** 92014 #### Overall Officials **Official 1:** **Affiliation:** Radicle Science, Inc **Name:** Emily K. Pauli, PharmD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will not be shared with researchers outside of Radicle Collaborators on this study. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Radicle Science, Inc **URL:** http://radiclescience.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - 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: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431061 **Brief Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric **Official Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric #### Organization Study ID Info **ID:** EX-MKTG-158 #### Organization **Class:** INDUSTRY **Full Name:** Coopervision, Inc. ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Coopervision, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to compare the short-term clinical performance of two Toric contact lenses. **Detailed Description:** The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study. ### Conditions Module **Conditions:** - Astigmatism ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Masking Description:** Single **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will wear lens A for 15 minutes (Period 1). **Intervention Names:** - Device: Lens A (omafilcon B) **Label:** Lens A (omafilcon B) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All participants will wear lens B for 15 minutes (Period 2). **Intervention Names:** - Device: Lens B (comfilcon A) **Label:** Lens B (comfilcon A) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lens A (omafilcon B) **Description:** 15 minutes of daily wear. **Name:** Lens A (omafilcon B) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Lens B (comfilcon A) **Description:** 15 minutes of daily wear. **Name:** Lens B (comfilcon A) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect) **Measure:** Overall fit acceptance **Time Frame:** 15 Minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Are at least 17 years of age and has full legal capacity to volunteer. 2. Have understood and signed an information consent letter. 3. Are willing and able to follow instructions and maintain the appointment schedule. 4. Are an adapted soft toric contact lens wearer. 5. Do not habitually wear either of the two study lens types. 6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye. 7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye. 8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses. Exclusion Criteria: 1. Are participating in any concurrent clinical or research study. 2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use. 3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. 5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study. 6. Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day) 7. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log). **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Waterloo **Country:** Canada **Facility:** University of Waterloo #### Overall Officials **Official 1:** **Affiliation:** Centre for Ocular Research and Education **Name:** Lyndon Jones **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012030 - Term: Refractive Errors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4558 - Name: Astigmatism - Relevance: HIGH - As Found: Astigmatism - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001251 - Term: Astigmatism ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431048 **Brief Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition **Official Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition #### Organization Study ID Info **ID:** 2101744 #### Organization **Class:** OTHER **Full Name:** University of Missouri-Columbia ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jeffrey Coughenour #### Responsible Party **Investigator Affiliation:** University of Missouri-Columbia **Investigator Full Name:** Jeffrey Coughenour **Investigator Title:** Associate Professor of Clinical Surgery **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure. **Detailed Description:** The risk for malnutrition-associated complications is high for patients in the trauma- surgical-, and neurological intensive care units. Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy (PEG) tubes. In patients with a protected airway, enteral nutrition has been reported to continue during invasive surgical procedures. Nonetheless, University Hospital's current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours. However, the current American Society of Anesthesiologists (ASA) guidelines do not make provision for inpatients receiving supplemental enteral nutrition. Enteral nutrition contains protein, fat, and carbohydrates, mimicking what patients would consume with a solid food meal. Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure. ### Conditions Module **Conditions:** - Gastrostomy - Tracheostomy **Keywords:** - Percutaneous Endoscopic Gastrostomy - Tracheostomy - Enteral feeding ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The five groups per arm in this study are: 1. Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. 2. Nutrition will be stopped when the patient is called to the OR for scheduled procedure. 3. Nutrition will be stopped 4 hours before the scheduled procedure. 4. Nutrition will be stopped 6 hours before the scheduled procedure. 5. Nutrition will be stopped 8 hours before the scheduled procedure. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. - Other: Nutrition will be stopped when the patient is called to the OR for scheduled procedure. - Other: Nutrition will be stopped 4 hours before the scheduled procedure. - Other: Nutrition will be stopped 6 hours before the scheduled procedure. - Other: Nutrition will be stopped 8 hours before the scheduled procedure. **Label:** Patients receiving PEG nutrition, scheduled for tracheostomy placement. **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. - Other: Nutrition will be stopped when the patient is called to the OR for scheduled procedure. - Other: Nutrition will be stopped 4 hours before the scheduled procedure. - Other: Nutrition will be stopped 6 hours before the scheduled procedure. - Other: Nutrition will be stopped 8 hours before the scheduled procedure. **Label:** Patients receiving naso-enteral feeding, scheduled for PEG placement. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. **Name:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure. **Name:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure. **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 4 hours before the scheduled procedure. **Name:** Nutrition will be stopped 4 hours before the scheduled procedure. **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 6 hours before the scheduled procedure. **Name:** Nutrition will be stopped 6 hours before the scheduled procedure. **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 8 hours before the scheduled procedure. **Name:** Nutrition will be stopped 8 hours before the scheduled procedure. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure. **Measure:** Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement. **Time Frame:** 0-8 hours ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Patients aged \>18 years. * Patients who require a tracheostomy or PEG placement. Exclusion criteria: * Patients with gastric and/or bowel obstruction. * Patients unable to receive enteral nutrition. * Patients who are pregnant and/or breastfeeding. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antoinette Burger, PhD **Phone:** 5738843740 **Role:** CONTACT #### Locations **Location 1:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Antoinette Burger, PhD - **Phone:** 573-884-3740 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jeffrey Coughenour, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Patrick Ward, DO - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** University of Missouri Hospital **State:** Missouri **Zip:** 65212 #### Overall Officials **Official 1:** **Affiliation:** University of Missouri-Columbia **Name:** Jeffrey Coughenour, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431035 **Brief Title:** Caffeine & Bodybuilding Dehydration Ability **Official Title:** Effect of Caffeinated Chewing Gum on Dehydration Ability in Bodybuilding Athletes: a Crossover Trial #### Organization Study ID Info **ID:** 113-3 #### Organization **Class:** OTHER **Full Name:** National Taiwan Sport University ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chih-Hui Chiu #### Responsible Party **Investigator Affiliation:** National Taiwan Sport University **Investigator Full Name:** Chih-Hui Chiu **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:** 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. **Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. Methods: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. Record time from exercise to completion of dehydration, heart rate, HRV, energy expenditure, fat oxidation rate and carbohydrate oxidation rate. ### Conditions Module **Conditions:** - Caffeine - Placebo ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The participants were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. ##### Masking Info **Masking:** SINGLE **Masking Description:** Using placebo chewing gum **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chewing caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) for 10 minutes before test. **Intervention Names:** - Dietary Supplement: caffeine **Label:** caffeine gum **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Chewing placebo gum (without caffeine) for 10 minutes before test. **Intervention Names:** - Dietary Supplement: caffeine **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - caffeine gum - placebo **Description:** The participants chewed either caffeine gum (5 mg/kg for 10 minutes per chew) or a placebo (10 minutes per chew, using regular gum). **Name:** caffeine **Other Names:** - plocabo gum **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The participants start dehydration until dehydrated to 2% of their original body weight. **Measure:** dehydration speed **Time Frame:** 15 minutes after intervention #### Secondary Outcomes **Description:** The energy expenditure during dehydration **Measure:** energy expenditure **Time Frame:** 15 minutes after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * having won the top 8 places in a national competition, * having no cardiovascular or joint diseases * being an adult male Exclusion Criteria: * no top 8 finishes at national level * cardiovascular or joint disease, or any other condition that could be impaired by exercise * female and underage participants * previous caffeine allergy **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ChihHui Chiu, PhD **Phone:** +886-4-22213108 **Phone Ext:** 3486 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Che-Hsiu Chen, PhD **Phone:** +886-4-22213108 **Phone Ext:** 3108 **Role:** CONTACT #### Locations **Location 1:** **City:** Taichung **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ChihHui Chiu, PhD - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University of Sport **Status:** RECRUITING **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** National Taiwan University of Sport **Name:** ChihHui Chiu, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only participant number and experimental data are provided. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-23 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 488910 - Type Abbrev: Prot - Upload Date: 2024-05-24T06:10 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014883 - Term: Water-Electrolyte Imbalance - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6883 - Name: Dehydration - Relevance: HIGH - As Found: Dehydration - ID: M17624 - Name: Water-Electrolyte Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003681 - Term: Dehydration ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: 800 - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: 800 ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431022 **Acronym:** webSTAIR **Brief Title:** Web-administered STAIR for Patients on Behavioral Health Waitlists **Official Title:** The Feasibility, Acceptability, and Initial Effectiveness of Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) for Posttraumatic Stress Disorder (PTSD) Administered to Patients on Behavioral Health Waitlists #### Organization Study ID Info **ID:** H-44467 #### Organization **Class:** OTHER **Full Name:** Boston Medical Center ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Boston 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:** Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medinal Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic. ### Conditions Module **Conditions:** - Post Traumatic Stress Disorder **Keywords:** - Digital mental health intervention (DMHI) - Community health worker (CHW) - Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) - Stepped care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants on the Research, and Education Center (RESTORE) waitlist randomized to this arm will receive the self-managed web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR). **Intervention Names:** - Behavioral: webSTAIR **Label:** Self-directed webSTAIR **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants on the RESTORE waitlist randomized to this arm will receive the web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) with coaching support from a CHW. **Intervention Names:** - Behavioral: webSTAIR - Behavioral: CHW coaching **Label:** webSTAIR with coaching from a Community Health Worker (CHW) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Self-directed webSTAIR - webSTAIR with coaching from a Community Health Worker (CHW) **Description:** WebSTAIR is a self-paced, brief skills-focused treatment for PTSD that focused on improving one's ability to manage emotions and relationships. **Name:** webSTAIR **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - webSTAIR with coaching from a Community Health Worker (CHW) **Description:** CHWs will provide webSTAIR coaching, which includes motivational, problem solving, and cognitive-behavioral strategies to enhance skills practice and engagement. **Name:** CHW coaching **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants. **Measure:** Feasibility based on recruitment rate **Time Frame:** 3 months **Description:** The proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants. **Measure:** Feasibility based on assessment completion rate **Time Frame:** 3 months, 6 months **Description:** The attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant. **Measure:** Feasibility based on attendance rate **Time Frame:** 3 months **Description:** Client satisfaction/acceptability will be measured by the Client Satisfaction Questionnaire (CSQ-8) which is an 8 item instrument with each item having 4 potential responses form 1 to 4. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. **Measure:** Client satisfaction **Time Frame:** 3 months, 6 months #### Secondary Outcomes **Description:** The PCL-5 is a 20-item self-report checklist of PTSD symptoms based on the DSM-5 criteria1. It measures the degree to which respondents have been bothered by each symptom over the past month or week. To score the PCL-5, a cut-off raw score of 38 is used for a provisional diagnosis of PTSD. Additionally, the DSM-5 diagnostic rule requires at least one symptom from cluster B (questions 1-5), one from cluster C (questions 6-7), two from cluster D (questions 8-14), and two from cluster E (questions 15-20). **Measure:** PTSD Checklist for DSM-5 (PCL-5) **Time Frame:** baseline, 3 months, 6 months **Description:** The Trauma Symptoms of Discrimination Scale (TSDS) is a 21 item self-report measure designed to assess the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences. Participants report the frequency of their experience of discriminatory distress regarding trauma on a 4-point scale ranging from 0 (Never) to 3 (Often). Scores can range from 0 to 63 and higher scores are associated with more trauma symptoms of discrimination. **Measure:** Trauma Symptoms of Discrimination (TSDS) **Time Frame:** baseline, 3 months, 6 months **Description:** The WSAS is scored using a 9-point Likert-type scale ranging from 0 (no impairment) to 8 (severe impairment). Potential scores range from 0 to 40 with higher scores indicating higher levels of impairment in the assessed areas of a respondent's life. **Measure:** Work and Social Functioning (WSAS) **Time Frame:** baseline, 3 months, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Client on the RESTORE Center waitlist at Boston Medical Center * Over 18 years of age * Able to receive therapy in English or Spanish (per participant report) * Exposure to trauma (as indicated by the Life Events Checklist for the DSM-5 \[LEC-5\]) * Probable PTSD (as indicated by the PTSD Checklist for the DSM-5 \[PCL-5\] based on PCL score of 33+). * Reasonable to access to technology (e.g., phone, computer, internet access). Exclusion Criteria: * Patient declines to be in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sarah Valentine, PhD **Phone:** (617) 414-1989 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nuha Alshabani, PhD **Phone:** (617) 414-1989 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Center, Psychiatry Department **Name:** Sarah Valentine, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### 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: Post Traumatic 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 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431009 **Acronym:** RMS **Brief Title:** The Danish Region Midt Schizophrenia Cohort **Official Title:** The Danish Region Midt Schizophrenia (RMS) Cohort: Representative Cohort of Patients With a First-episode Schizophrenia Spectrum Disorder With Long-term Follow-up #### Organization Study ID Info **ID:** 2024-001 #### Organization **Class:** OTHER **Full Name:** University of Aarhus ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Aarhus #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this study is to recruit patients at the first diagnosis with a schizophrenia spectrum disorder (SSD) and ultra-high risk patients (UHR), defined as patients with drug abuse and psychotic symptoms indicating a risk for developing schizophrenia. Thereby, the investigators aim to establish a large representative cohort of patients with a first-episode SSD or patients at UHR, enabling investigations of the etiology and long-term prognosis of SSDs. The primary aim is to learn more about the importance of adverse childhood experiences (ACEs) and the immune system in the etiology and course of schizophrenia. Patients will be followed with planned visits after 1, 2, 3, 12 and 24 months including online questionnaires after 2, 6, 10 and 26 weeks. There will be the possibility to contact patients again for subsequent follow-up visits. **Detailed Description:** Study design: Cohort study with pre-defined longitudinal follow-up visits. Patients: Patients with a SSD (ICD-10: F20-29) or patients at UHR (ICD: 1\*.5) aged ≥15 years. Sample size: Within the Central Denmark Region (CDR), approximately 700 patients are each year diagnosed with a SSD and 100 with UHR. The investigators will establish recruitment at all psychiatric hospitals in the CDR between January 2024 until June 2025. Our aim is to establish continued recruitment of 100-150 patients/year. Hence, the investigators expect to recruit 300-350 patients during the period 2024-2026. Procedures: Patients will be included within three months of the first SSD or UHR diagnosis at one of the psychiatric hospitals in the CDR. Before inclusion, an interview with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will validate the diagnosis. At baseline and follow-up visits (details in the full protocol and Table 1), patients will be rated by use of the 6-item Positive and Negative Syndrome Scale (PANSS-6), the Clinical Global Impression Severity Scale (CGI-S), the Global Assessment of Functioning Scale (GAF), the Schizophrenia Quality of Life Scale (SQLS), Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Fagerström Test for Nicotine Dependence (FTND), Major Depression Inventory (MDI), the Aarhus Side effect Assessment Questionnaire (ASAQ), the "Udvalg for Kliniske Undersøgelser" side effect scale (UKU), and the Calgary Depression Scale for Schizophrenia (CDSS). Furthermore, patients will fill out the self-reported WHO Adverse Childhood Experience International Questionnaire (ACE-IQ) and the Insomnia Severity Index (ISI), the Epsworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI) to measure sleep. The Matrics Consensus Cognitive Battery (MCCB), which consists of 10 cognitive tests, will measure cognition. To measure consciousness, patients will fill out the Perceived Stress Scale (PSS), Toronto Alexithymia Scale (TAS-20), and Metacognition Superiority illusion. During the first three months, participants will wear an actigraph to have a proxy measure of activity and sleep. Blood sampling will be performed at baseline and after 3, 12 and 24 months to measure markers of inflammation and to enable genetic and epigenetic analyses. Heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. Patients will be treated according to clinical indication, i.e., they will receive routine clinical care at the local psychiatric hospital and participation in this study will not affect the treatment. Patients can be included in this study independent of whether they are treated with psychotropic drugs or not. Follow-up: Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation in the RMS cohort. Patients will have follow-up visits for the RMS study after 1, 2, 3, 12 and 24 months after the individual inclusion date and fill out online questionnaires after 2, 6, 10, and 26 weeks. Endpoints: The primary endpoint is the correlation between ACEs and inflammatory markers measured at baseline with the change on PANSS-6 from baseline to follow-up visits. Key secondary endpoints include changes in genetic, epigenetics, cognition, PSQI and ISI. Additional secondary endpoints include changes in ASAQ, UKU, SQLS, CDSS, GAF, CGI-S, body weight, hip and waist circumference, blood pressure, and heart rate. For patients enrolled in the study, all endpoints will initially be collected and several repeated during the study duration. Safety: Patients will follow treatment-as-usual at their local hospital, with the clinicians from the local hospital being responsible for safety monitoring according to local treatment guidelines. Blood sample results will be obtained from the patient's medical record (MidtEPJ) at the study visits to monitor biochemical safety parameters for medical treatment. Between follow-up visits for the RMS cohort, patients will follow guideline-based safety monitoring at the local psychiatric hospital. Study duration: Continuous. The investigators aim to establish continuous recruitment and that all patients with a first-episode SSD or UHR diagnosis fulfilling inclusion criteria will be offered participation in the RMS Cohort. ### Conditions Module **Conditions:** - Schizophrenia **Keywords:** - Schizophrenia - Antipsychotics - Adverse Childhood Experiences (ACE) - Immune system ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a SSD (ICD-10: F20-29) aged ≥15 years. **Intervention Names:** - Other: Treatment-as-usual **Label:** Schizophrenia #### Arm Group 2 **Description:** Patients at UHR (ICD: 1\*.5) aged ≥15 years. **Intervention Names:** - Other: Treatment-as-usual **Label:** Ultra High Risk ### Interventions #### Intervention 1 **Arm Group Labels:** - Schizophrenia - Ultra High Risk **Description:** Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation in the RMS cohort. **Name:** Treatment-as-usual **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the correlation between adverse childhood experiences (ACEs, from 0 to 13 ACEs measured via the World Health Organization (WHO) ACE-IQ), reported at baseline, with the change on the 6-item positive and negative symptom scale (PANSS-6, minimum score=0, maximum score=30), with higher PANSS-6 scores indicating greater symptom severity **Measure:** Adverse childhood experiences (ACEs) **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. #### Secondary Outcomes **Description:** Changes in cognition, measured via matrics consensus cognitive battery (MCCB, presenting T-scores (minimum=0, maximum=60) for 7 different cognitive domains) with higher scores indicating better cognitive functioning **Measure:** Cognition **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in sleep quality (measured via Pittsburgh Sleep Quality Index (PSQI, minimum score=0, maximum score=39) and Insomnia Severity Index (ISI, minimum score=0, maximum score=28), with both measures indicating worse sleep quality depending on higher scores on the scales) **Measure:** Sleep **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in quality-of-life (measuring psychosocial quality-of-life, energy+motivation, and symptoms+side effects via the Schizophrenia Quality of Life Scale (SQLS, minimum score=0, maximum score=30), with higher scores indicating worse quality-of-life) **Measure:** Quality-of-life **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in level of functioning, (measured via the Global Assessment of Functioning (GAF), with higher scores on a scale from 0 to 100 indicating better functioning) **Measure:** Level of functioning **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥15 years 2. Diagnosed within the previous 3 months with first-episode SSD (ICD-10: F20-29) or UHR (ICD-10: F1X.5) 3. Able to give informed oral and written consent. Exclusion Criteria: 1. Any coercive measure including patients in forensic psychiatry 2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study. **Minimum Age:** 15 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Any patient aged ≥15 years diagnosed with first-episode SSD or UHR diagnosis and without any coercive measure at the time of inclusion will be relevant for inclusion in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ole Köhler-Forsberg, MD, PhD **Phone:** 0045 78471610 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Aarhus University Hospital Psychiatry **Status:** RECRUITING **Location 2:** **City:** Herning **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Gødstrup **Status:** RECRUITING **Location 3:** **City:** Horsens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Horsens **Status:** RECRUITING **Location 4:** **City:** Randers **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Randers **Status:** RECRUITING **Location 5:** **City:** Silkeborg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Midt **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic 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: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012559 - Term: Schizophrenia ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M15642 - Name: Silver Sulfadiazine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430996 **Brief Title:** Caffeinated Chewing Gum on 400-meter Performance **Official Title:** Effects of Caffeinated Chewing Gum on 400-meter Performance and Fatigue Index of Sprinters: a Crossover Trial #### Organization Study ID Info **ID:** 113-2 #### Organization **Class:** OTHER **Full Name:** National Taiwan Sport University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** National Science and Technology Council #### Lead Sponsor **Class:** OTHER **Name:** Chih-Hui Chiu #### Responsible Party **Investigator Affiliation:** National Taiwan Sport University **Investigator Full Name:** Chih-Hui Chiu **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed. **Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva. ### Conditions Module **Conditions:** - Caffeine - Placebo **Keywords:** - exercise performance - fatigue index - α amylase ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants chewing caffeine gum 10 minutes before exercise **Intervention Names:** - Dietary Supplement: caffeine **Label:** caffeine gum **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants chewing placebo gum 10 minutes before exercise **Intervention Names:** - Dietary Supplement: caffeine **Label:** placebo gum **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - caffeine gum - placebo gum **Description:** The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent tests. **Name:** caffeine **Other Names:** - plocabo gum **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Measure the fatigue index (%) **Measure:** Running-Based Anaerobic Sprint Test (RAST) **Time Frame:** 15 minutes after intervention **Description:** Measure the 400-meter completion time (seconds) **Measure:** 400-meter sprinting **Time Frame:** 30 minutes after RAST ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 6 years of professional short sprinting training * 6 months of ongoing training, and * 3 months of recovery from sports injuries such as strains and sprains. Exclusion Criteria: * Non-specialized sprinters. * has not trained regularly for the past 6 months. * has recovered from an athletic injury. * less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taichung **Country:** Taiwan **Facility:** National Taiwan University of Sport **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** Sport Science Research Center **Name:** ChihHui Chiu, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only participant number and relevant experimental data are provided. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-23 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 467644 - Type Abbrev: Prot - Upload Date: 2024-05-24T06:04 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: 800 - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: 800 ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430983 **Brief Title:** Recurrent Liver Cancer: Reconceptualization and Reevaluation **Official Title:** Recurrent Liver Cancer: Reconceptualization and Reevaluation #### Organization Study ID Info **ID:** 2024KY16401 #### Organization **Class:** OTHER **Full Name:** Nanjing Medical University ### Status Module #### Completion Date **Date:** 2027-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing Medical University **Investigator Full Name:** Yewei Zhang **Investigator Title:** Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer. The main questions it aims to answer are: Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence? Researchers will compare the protein levels in the following groups: 50 recurrent liver cancer patients (training set) with abnormally high levels of the protein. 250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort. Participants will be required to: * Provide blood samples for protein analysis. * Undergo regular follow-up visits for monitoring and data collection. * Allow access to their medical records for relevant clinical information. **Detailed Description:** As part of the patient registry, investigators will implement the following registration procedures and other quality factors: Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study. Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness. Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results. Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines. Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights. ### Conditions Module **Conditions:** - Recurrent Liver Cancer - Primary Liver Cancer **Keywords:** - Recurrent Liver Cancer - Primary Liver Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** The training set for recurrent liver cancer patients is a subset of data collected from individuals who have been diagnosed with liver cancer that has returned after a period of remission or initial treatment. This data set is used to train machine learning models or other statistical methods to identify patterns or biomarkers that are indicative of cancer recurrence. The training set typically includes information such as patient demographics, medical history, previous treatments, and biological data, such as genetic mutations, protein levels, or imaging results. The goal is to use this data to develop a model that can accurately predict the recurrence of liver cancer in other patients, which can then be validated and tested using a separate data set, known as the validation set. **Label:** Training Set for Recurrent Liver Cancer Patient #### Arm Group 2 **Description:** The validation set for recurrent liver cancer patients is a distinct subset of data that is used to assess the performance and generalizability of a model or hypothesis developed from a training set. This set includes data from patients with recurrent liver cancer who were not part of the original training set. The purpose of the validation set is to test the model's ability to accurately predict or classify cases of recurrent liver cancer in a population that it has not been exposed to during its training phase. **Label:** Validation Set for Recurrent Liver Cancer Patient ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values. **Measure:** Sensitivity and Specificity of the Novel Protein Indicator **Time Frame:** Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed. **Description:** The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator. **Measure:** Positive and Negative Predictive Values **Time Frame:** Calculated after the threshold value has been determined and applied to the patient data (up to 3 years). #### Secondary Outcomes **Description:** Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator. **Measure:** Overall Survival (OS) **Time Frame:** Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years). **Description:** Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression. **Measure:** Progression-Free Survival (PFS) **Time Frame:** Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years). **Description:** Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study. **Measure:** Disease-Free Survival (DFS) **Time Frame:** Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years). **Description:** Time to progression (TTP) is the interval from the start of treatment until the tumor progresses or the patient's condition worsens to a defined level. This endpoint is particularly relevant for evaluating the effectiveness of the novel protein indicator in predicting and monitoring disease progression. **Measure:** Time to Progression (TTP) **Time Frame:** Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC * The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form * Agree to provide blood samples and have good clinical compliance * Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients) Exclusion Criteria: * Pregnant women * Those who have received organ transplantation * Non-HCC patients diagnosed with other tumors * Patients with primary hepatocellular carcinoma complicated by other tumors * Those judged by the researcher as not meeting the inclusion criteria **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 study population includes patients with primary hepatocellular carcinoma (HCC) and non-HCC liver cancers. Inclusion criteria are: diagnosis of primary HCC or non-HCC, ability to provide informed consent, agreement to supply blood samples, and clinical data completeness. Exclusion criteria include pregnancy, organ transplantation, other tumor diagnoses in non-HCC patients, HCC with other tumors, and researcher-determined ineligibility. The sample size is limited to ensure data precision and study validity. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** zhang yewei, doctor **Phone:** +86 13813885788 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Nanjing Medical University **Name:** zhang yewei, doctor **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Liver Cancer - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: T4700 - Name: Primary Liver Cancer - Relevance: HIGH - As Found: Primary liver cancer ### Condition Browse Module - Meshes - ID: D000008113 - Term: Liver Neoplasms - ID: D000012008 - Term: Recurrence ### 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:** NCT06430970 **Brief Title:** Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia **Official Title:** Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia: A Single Center Prospective Study #### Organization Study ID Info **ID:** MS.22.05.2001 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Asmaa Gameel **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Background In practice, however, not all anaemic patients undergo appropriate diagnostic tests for the detection of iron deficiency anemia (IDA), and a significant portion of patients with IDA do not receive endoscopic evaluations. Accordingly, this study aimed to detect the prevalence of significant endoscopic (upper and lower endoscopy) and pathological findings in patients presenting with unexplained iron deficiency anaemia. Methods One hundred twenty-four patients with confirmed IDA with no obvious cause who visited the Internal Medicine Clinic were randomly selected. Patients with active bleeding, pregnant or lactating females, or those with contraindications to sedation were excluded. Upper and lower endoscopy were held in the endoscopy unit of Specialized Medical Hospital and tissue biopsy from significant endoscopic findings was sent for histopathological examination. **Detailed Description:** Methods This is an open label prospective study conducted on one hundered twenty four patients with IDA who attended to the Endoscopy Unit, Specialized Medical hospital, Mansoura University. Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded. The study protocol was approved by our ethical committee, and written consents were taken from all subjects before the procedure. Measures All patients underwent Complete blood count (CBC) with detection of specific hematological parameters Serum ferritin, Iron and Total iron binding capacity, INR, serum albumin and bilirubin levels, ALT (Alanine Aminotransferase), AST (Aspartate aminotransferase), ESR, serum creatinine, occult blood in stool (FOBT kits ) small sample of stool collected in clean container, usually taken on consecutive days with precaution before testing include stopping non-steroidal anti-inflammatory drugs, vitamin C tablets ,raw vegetables and fruits and red meat often 48h to 72hour before test as they give false positive test (5) using immunochemical assay which detect globin chain of hemoglobin (6). All those proved with unexplained iron deficiency anemia were prepared to perform upper endoscopy and colonoscopy in later appointment. Procedures Esophgogastroduodenoscopy and colonscopy were performed in our endoscopy unit by the same endoscopist under conscious sedation, Endoscopic examination was done by (PENTAX medical EPK-I 5000, Tokyo, Japan). We usually started with colonscopic examintion. Complete ileocolonscopy was done to all patients then esohgeogastroduoenoscopy , any macroscopic lesion was detedcted ,documented and tissue biopsy was taken and sent for histopathological examination by the same pathologist. ### Conditions Module **Conditions:** - Gastrointestinal Diseases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 124 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: endoscopy **Label:** patients with iron deficiency anemia **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with iron deficiency anemia **Description:** upper and lower endoscopy **Name:** endoscopy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** diagnosis of the cause of anemia **Time Frame:** two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Sex: both * Age: from 18 to 70 years * Cases confirmed iron deciency anemia with no obvious cause. * Significant UGI pathology includes Barrett's esophagus, esophagitis (LA class ≥ C), esophagogastric varices, peptic ulcer disease, duodenal ulcer, angioectasia , and cancer (Wuerth BA and Rockey DC,2018). * Significant LGI pathology includes adenomatous polyps \>1cm, angioectasias, rectal ulcer, IBS , colon polyps and cancer. ( Ghassemi KA and Jensen DM,2013). Exclusion Criteria: * Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Asmaa Gameel, MD **Phone:** 01025835429 **Phone Ext:** 02 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Asmaa Gameel, MD - **Phone:** 01025835429 - **Role:** CONTACT **Country:** Egypt **Facility:** Mansoura University **State:** Dakhlia **Status:** RECRUITING **Zip:** 35516 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency Anemia - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M4077 - Name: Anemia, Hypochromic - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430957 **Brief Title:** OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia **Official Title:** Evaluation of OSA Risk Levels in the Preoperative Period of Adult Patients With Planned Dental Procedures Under Anesthesia and Correlation With Postoperative Complications; A Multicenter Study #### Organization Study ID Info **ID:** KU-ERKAN-002 #### Organization **Class:** OTHER **Full Name:** Kırıkkale University ### Status Module #### Completion Date **Date:** 2025-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** TC Erciyes University #### Lead Sponsor **Class:** OTHER **Name:** Kırıkkale University #### Responsible Party **Investigator Affiliation:** Kırıkkale University **Investigator Full Name:** Gözde Nur Erkan **Investigator Title:** Assistant Professor Doctor, Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea Risk Management - Postoperative Complications - Dental Caries Under General Anesthesia - Obstructive Sleep Apnea of Adult ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group lowSTOP-B #### Arm Group 2 **Description:** Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group intermediateSTOP-B #### Arm Group 3 **Description:** Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group highSTOP-B #### Arm Group 4 **Description:** The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group noneASA #### Arm Group 5 **Description:** Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group mildASA #### Arm Group 6 **Description:** Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group moderateASA #### Arm Group 7 **Description:** Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group severeASA ### Interventions #### Intervention 1 **Arm Group Labels:** - Group highSTOP-B - Group intermediateSTOP-B - Group lowSTOP-B **Description:** An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. **Name:** The STOP-BANG questionnaire for determining OSA risk level. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group mildASA - Group moderateASA - Group noneASA - Group severeASA **Description:** An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. **Name:** ASA recommended criteria for determining OSA risk level. **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Group highSTOP-B - Group intermediateSTOP-B - Group lowSTOP-B - Group mildASA - Group moderateASA - Group noneASA - Group severeASA **Description:** Respiratory complications as laryngospasm/bronchospasm, apnea, hypoxia, duration and amount of need for additional oxygen support and recovery time (duration of modified aldrete score of 9 and above) will be recorded. **Name:** Record of postoperative complications **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The STOP-BANG questionnaire and the criteria recommended by the ASA, which are recommended to be used routinely worldwide to determine OSA risk level, will be questioned in each patient. Patients with moderate and high risk scores from the STOP-BANG questionnaire and patients with significant OSA risk level according to ASA criteria will be referred to the pulmonology department and further evaluation will be requested. If deemed necessary by the Pulmonology department, a sleep test will be performed. With the sleep test result, the OSA risk level of the patients will be classified as none, mild, moderate and severe in terms of ASA criteria. **Measure:** Determination of OSA risk levels of patients **Time Frame:** Preoperative period **Description:** Respiratory complications including laryngospasm/bronchospasm, apnea, hypoxia that may develop in the postoperative period in patients, the duration of the need for additional oxygen support above the expected duration will be observed and recorded. **Measure:** Postoperative respiratory complications **Time Frame:** For 4 hours after the end of surgery **Description:** As indicators of airway obstruction; snoring/whistling respiration, hypertension and intercostal/sternal retractions will be observed and recorded in the study follow-up form. **Measure:** Follow-up of indicators of airway obstruction **Time Frame:** For 4 hours after the end of surgery **Description:** Duration of recovery (modified aldrete score of 9 and above) will be recorded **Measure:** Duration of recovery **Time Frame:** For 30 minutes after the end of surgery #### Secondary Outcomes **Description:** Patients who will receive an intermediate or high risk score from either of the two assessment questionnaires will be referred for further evaluation and diagnosis of suspected OSA. At the end of the diagnostic process, it is planned to investigate which of the two scoring systems more successfully identifies patients with OSA and assigns a higher risk. **Measure:** Comparison of the effectiveness of STOP-BANG questionnaire and ASA criteria in determining OSA risk level **Time Frame:** Perioperative period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia * Patients without a previous diagnosis of OSA Exclusion Criteria: * Individuals who do not want to participate in the study * Patients previously diagnosed with OSA * Necessity of emergency surgery **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18-80 years who applied to the anesthesia clinic for dental procedures planned to be performed under general anesthesia and who had no previous diagnosis of OSA. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gözde Nur Erkan, Asst. Prof. **Phone:** +905054334692 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic 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: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: 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 - ID: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive - ID: D000011183 - Term: Postoperative Complications ### 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:** NCT06430944 **Brief Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children **Official Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children #### Organization Study ID Info **ID:** MS-318-2023 #### Organization **Class:** OTHER **Full Name:** Kasr El Aini Hospital ### Status Module #### Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Start Date **Date:** 2022-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kasr El Aini Hospital #### Responsible Party **Investigator Affiliation:** Kasr El Aini Hospital **Investigator Full Name:** Ahmed Omar Sabry **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications. **Detailed Description:** Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification. ### Conditions Module **Conditions:** - Femur Fracture ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A folded towel was placed inside the tubular bandage over the centre of the abdomen, which helped create breathing space inside the cast. The towel's tail was brought towards the neck for easier removal. Then, a layer of the padded cast was applied using a large width for the body and a narrower one for the lower limb. A thick felt was added over this padding along the free edges of the chest and the leg. The first layer of the cast was applied to the leg and body in an eight-figure manner, taking care to connect the leg to the body securely. The reinforced cast slabs were applied between the body and the lower limb segments. The thigh segment was moulded to maintain a good reduction by keeping the anterolateral of the cast flat or slightly concave. Some clinicians moulded the segment enough to result in ten degrees of initial valgus. **Intervention Names:** - Procedure: Placing a hip spica cast for patients with femur fractures **Label:** Single limb spica casting: **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One and a half cast was applied in a single limb spica cast, extending to the opposite leg to the knee. Reinforced slabs were applied to hip joints in both limbs **Intervention Names:** - Procedure: Placing a hip spica cast for patients with femur fractures **Label:** Double limb spica cast: **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Double limb spica cast: - Single limb spica casting: **Description:** Placing a hip spica cast for patients with femur fractures. These hip spicas are made for each patient to stabilize the fracture in pediatric patients **Name:** Placing a hip spica cast for patients with femur fractures **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The Flynn evaluation system is based on the presence of leg length inequality, malalignment, pain, and minor and major complications. Each of these criteria is either defined as Excellent, successful or poor. **Measure:** Flynn's score **Time Frame:** 6 months #### Secondary Outcomes **Description:** we do xrays to confirm if there is any loss of reduction of the fracture **Measure:** loss of reduction **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children aged 2 to 6 years * Children with femur shaft fractures Exclusion Criteria: * Children younger than 2 years or older than 6 years * Articular fractures or fractures that cant be managed with a cast * Old fractures older than 3 weeks **Maximum Age:** 6 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Kasr Al Ainy-Cairo University- Faculty of Medicine **State:** Manial **Zip:** 11956 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000007869 - Term: Leg 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: Fracture - ID: M8402 - Name: Femoral Fractures - Relevance: HIGH - As Found: Femur Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000005264 - Term: Femoral Fractures ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430931 **Acronym:** ProTex **Brief Title:** Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery **Official Title:** Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial #### Organization Study ID Info **ID:** NL79184.100.22 #### Organization **Class:** OTHER **Full Name:** Meander Medical Center ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Health Holland #### Lead Sponsor **Class:** OTHER **Name:** Meander Medical Center #### Responsible Party **Investigator Affiliation:** Meander Medical Center **Investigator Full Name:** Esther Consten **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh. **Detailed Description:** Minimal-invasive ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) or cervicopexy are widely accepted treatments for patients suffering from pelvic prolapse. Choice of material used in VMR or SCRP - synthetic or biologic surgical mesh - remains subject of debate. Recent ban in the usage of non abdominal but transvaginal, mesh for pelvic organ prolapse (POP) in April 2019, by the Food and Drug Administration (FDA) has negatively influenced the perception on all sorts of surgical mesh. Currently, the most widely used mesh in VMR is synthetic and has shown good results regarding recurrence, mesh exposure and functional outcome. Although complication rates are low, the serious complications of fistulation, exposition, and dyspareunia are reasons to opt for a more expensive biological mesh. High-quality evidence of synthetic versus biological mesh is lacking, which does not stop resistance against synthetic mesh from growing. This has even led to concerns and questions about synthetic mesh use from the Dutch government addressed at the medical professionals and options for alternatives are being asked. Biological grafts are characterized by degradation of the implant and regeneration of host tissue. It is assumed that this process of degradation and remodeling decreases the risk of exposition and infection. However, this transformation may possibly lead to a higher chance of recurrence in the long term. Rate of recurrence, but also graft-related complications (GRC) to a lesser extent, largely depends on duration of follow-up. Since biological graft implementation in VMR and SCR is relatively new and its usage is restricted due to higher costs, evidence on biological mesh with long term follow-up is limited. In addition, there is a significant difference in various described biological meshes. This is important to keep in mind when comparing outcome of VMR or SCR with synthetic versus biologic mesh. In VMR there are no randomised controlled trials on synthetic versus biological mesh. The biological meshes studied thus far are Biodesign and Permacol. Mesh exposure rates after VMR with Biodesign and Permacol have both been studied in three studies in total (N = 349 and N = 425 in total respectively) and show low mesh exposure rates of 0 to 0.1%. In comparison, GRC after VMR with synthetic non-resorbable mesh (like polypropylene) are around 2%. Recurrence rates after synthetic mesh in VMR range between 2% and 14% after a median follow-up of 12-61 months. When comparing studies on biologic implants that report on recurrence rates there seems to be a slight difference in favor of Biodesign. Studies on Biodesign in VMR with a median follow-up ranging between 12 and 47 months show a recurrence rate around 5%. Literature on Permacol shows higher recurrence rates ranging between 5 to 14% after a median follow-up of 12 to 29 months. In sacrocolpopexy (SCP) allografts and xenografts have been investigated as an alternative for polypropylene. A randomised controlled trial compared SCP using polypropylene mesh with solvent cadaveric fascia lata. After one year of follow-up, polypropylene mesh had a higher anatomical cure rate than cadaveric fascia lata (91 percent versus 68 percent; p=0.007). Two GRC occurred in patients who received polypropylene mesh, while none occurred in the allograft group (p= 0.5). Another RCT with the same comparison and a follow-up of 5 years showed similar results, with considering cadaveric fascia not as strong of a support. Deprest et al. compared polypropylene mesh with porcine grafts in a prospective study and found xenografts to be associated with more apical failures and reoperations than with a polypropylene mesh (21 percent versus 3 percent; p = 0.01).However, there was no significant difference in functional outcomes between the two groups. An exposure rate of 11 percent was described in both groups. A more recent study concluded, by analyzing clinical outcomes and patients satisfaction, that a non-crosslinked ADM patch can be a good alternative to synthetic polypropylene mesh in patients undergoing SCP. Although Biodesign (Surgisis), Permacol and other are all grouped under the common denominator 'Biologic mesh', each of these products is unique. There are differences in tissue source, differences in the processes used to decellularize the tissue and differences in the final processing steps such as sterilization and preservation. As a result, there are significant variations in biological and clinical performance between these products. Permacol, which is purposely cross-linked pig dermis, behaves like a synthetic material in-vivo and induces a permanent foreign body response, leading to encapsulation. This prevents integration with and in the surrounding tissue. Consequently, high rates of mesh exposure occur with Permacol implants. Biodesign, one of the early biologics, is derived from small intestinal submucosa and is a non-cross-linked mesh. Likely due to its (proprietary) processing, Biodesign in practice often dissolves before healing and remodeling can take place. A novelty on the surgical mesh market is OviTex. It is produced by Aroa Biosurgery and consist of sterile sheep extracellular matrix (ECM) interwoven with a (absorbable or non-absorbable) synthetic fiber. OviTex comes with a grid of absorbable polyglycolic acid (PGA) or permanent polypropylene and with differing amounts of layers (Core, 1S and 2S). Unique to OviTex is its composition, which consists of essential components required for regeneration of host tissue. Additionally, the coupling of an ECM with a (absorbable) synthetic fiber provide strength without the need to cross-link the ECM. Moreover, OviTex is lower in costs than any other biological mesh on the market. Since the use of synthetic meshes in pelvic floor surgery has come under scrutiny, patients are tempted to undergo a resection rectopexy as an alternative to VMR with polypropylene. Apart from the fact that the resection is associated with a higher risk of complications due to the application of an anastomosis, the recovery time is much longer. The hospitalization period would be longer and therefore the costs compared to prolapse surgery with OviTex would be higher. Preliminary results of a recent pilot study at Meander MC showed that the use of an OviTex PGA (with absorbable grid) mesh in the pelvic floor is feasible and safe. Nevertheless, 2 out of 11 patients who completed follow-up of 6 months showed an early anatomical recurrence. This suggests that the use of permanent synthetic fiber may be necessary for a more durable repair and fewer recurrences than using OviTex PGA. Although resistance against synthetic grafts is growing, OviTex Permanent contains 96% sheep ECM and only 4% polymer, compared to the standard Prolene mesh which is 100% polymer (polymer areal density 16g/m2 OviTex 1S vs. 76g/m2 prolene). Furthermore, the polymer is embedded in the ECM which further attenuates any inflammatory response. Observations in primates show that the minimized amount of embedded synthetic reinforcement results in an implant that, histologically, behaves like a biologic mesh yet maintains its functional structure. This is the first prospective multicenter study using a OviTex 1S mesh. Although the material ovine was studies before, little is known about the feasibility of enrolling these patients into randomised studies in the Netherlands and about the feasibility, safety, and tolerance of the OviTex 1s is this setting. Therefore, the investigators decided to start with a phase II study. This allows for adequate monitoring of the feasibility, safety, and tolerance of the experimental treatment. There are no studies comparing OviTex to the current standard (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands) Therefore, a comparative study should be conducted before OviTex is used as a biologic alternative for polypropylene in VMR on a larger scale. Following the OviTex pilot study, we aim to conduct a follow-up study (ProTex trial) in which, both in the short and longer term, the efficacy of the OviTex mesh in pelvic floor surgery will be assessed in comparison with the current standard polypropylene, by means of a non-inferiority test. ### Conditions Module **Conditions:** - Colorectal Disorders - Prolapse - Prolapse Rectal - Prolapse Genital - Prolapse Pelvic - Rectocele - Prolapse Uterus - Cystocele - Enterocele - Prolaps Bladder - Prolapse; Cervix **Keywords:** - Prolapse - Abdominal prolapse Surgery - Biological mesh - OviTex - VMR - sacrocolporectopexy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multi-centre prospective non-inferior patient-preference study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 184 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Polypropylene mesh (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands; weight 78 g/m2) **Intervention Names:** - Procedure: Minimal invasive abdominal prolapse surgery using Polypropylene mesh **Label:** Polypropylene mesh **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** OviTex Reinforced BioScaffold, Permanent Polymer composed of ovine (sheep) forestomach extracellular matrix (ECM) and polypropylene. **Intervention Names:** - Procedure: Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh **Label:** OviTex 1S permanent mesh **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Polypropylene mesh **Description:** All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA). **Name:** Minimal invasive abdominal prolapse surgery using Polypropylene mesh **Other Names:** - Ventral mesh rectopexy - Sacrocolporectopexy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - OviTex 1S permanent mesh **Description:** All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA). **Name:** Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh **Other Names:** - Ventral mesh rectopexy - Sacrocolporectopexy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Post-operative complications. The Clavien Dindo Classification is used to rank the severity of a surgical complication **Measure:** Main study parameter/endpoint phase II: rate of complications **Time Frame:** 90days postoperative **Description:** Post-operative morbidity measured by reoperations, reinterventions, readmissions, **Measure:** Main study parameter/endpoint phase ll: number of participants with post-operative morbidity **Time Frame:** 90days postoperative **Description:** Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Pelvic Floor Distress lnventory-20 (PFDl-20). **Measure:** Main study parameter/endpoint phase Ill: Pelvic Floor Distress lnventory-20 score (PFDl-20) **Time Frame:** 12 months postoperative #### Secondary Outcomes **Description:** Questionnaire, validated scoring system: Altomare obstructive defecation score (ODS) with a maximum score of 31. A higher score on the Altomare scale indicates a greater severity of constipation. Scores will be compared before and after treatment. **Measure:** Constipation **Time Frame:** 12 months postoperative **Description:** Questionnaire, validated scoring system: Fecal Incontinence Severity Index (FISI) with a maximum score of 60. A higher FISI score indicates more severe fecal incontinence. Scores will be compared before and after treatment. **Measure:** Incontinence **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Patient Global Impression of Improvement (PGl-I). The PGI-I scale measures the patient's perception of improvement (or lack thereof) in their condition following treatment. 1 - Very much improved: Significant improvement in condition. 2 - Much improved: Noticeable improvement in condition. 3 - Minimally improved: Slight improvement in condition. 4 - No change: Condition has not changed. 5 - Minimally worse: Slight worsening of condition. 6 - Much worse: Noticeable worsening of condition. 7 - Very much worse: Significant worsening of condition. **Measure:** Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Improvement (PGl-I). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Patient Global Impression of Severity (PGl-S). The PGI-S scale measures the patient's perception of the severity of their condition at a specific point in time. 1 - Normal: No symptoms. 2 - Borderline: Barely noticeable symptoms. 3 - Mild: Symptoms are present but do not significantly interfere with daily activities. 4 - Moderate: Symptoms are more noticeable and do interfere with daily activities. 5 - Severe: Symptoms are significant and very disruptive to daily activities. 6 - Very severe: Symptoms are extremely disruptive and may prevent daily activities. 7 - Extremely severe: Symptoms are debilitating. **Measure:** Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Severity (PGl-S). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the European Quality of Life Five Dimension (EQ-5D). The European Quality of Life Five Dimension (EQ-5D) measures health-related quality of life using a descriptive system with five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated at three severity levels, and an EQ visual analogue scale (EQ VAS) from 0 to 100 for overall health perception. **Measure:** Quality of life (Qol) pre- and postoperatively by the European Quality of Life Five Dimension (EQ-5D). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Pelvic Floor impact Questionnaire (PFIQ-7). Higher scores on the PFIQ-7 indicate a greater negative impact of pelvic floor disorders on the patient's quality of life. **Measure:** Quality of life (Qol) pre- and postoperatively by the Pelvic Floor impact Questionnaire (PFIQ-7) **Time Frame:** 12 months postoperative **Description:** Measured by reoperations, reinterventions, readmissions, and serious adverse advents. **Measure:** Number of patients with post-operative morbidity **Time Frame:** 12 months postoperative **Description:** Measured by defecogram or MR defecography in rest and during Valsalva maneuver. **Measure:** Number of patients with anatomic recurrence of the rectal prolapse **Time Frame:** 12 months postoperative **Description:** Complaints, physical examination, addition research, re-operation and readmission **Measure:** Rate of rectal prolapse recurrence and complications **Time Frame:** 12 months postoperative **Description:** Using the simplified Pelvic Organ Prolapse Quantification (sPOPQ) **Measure:** Number of patients with anatomic recurrence of pelvic organ prolapse (POP) **Time Frame:** 12 months postoperative **Description:** By the questionnaire Prolapse Incontinence Sexual Inventory Questionnaire (PSIQ-IR). Lower Scores: Indicate greater sexual dysfunction and more issues related to the conditions. **Measure:** Sexual functioning pre- and postoperatively scores on the PSIQ-IR **Time Frame:** 12 months postoperative **Measure:** Length of hospital stay in days **Time Frame:** 12 months postoperative **Measure:** Rate of extra outpatient visits because of complaints **Time Frame:** 12 months postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse; * Counselled for therapeutic options and given informed consent for VMR or SCR; * Counselled for different types of mesh (OviTex or Prolene) and randomisation; * Written informed consent for randomisation, OviTex implant or Prolene; * Written informed consent for observational data collection. Exclusion Criteria: * Mentally incompetent patients (unable to fulfil questionnaires). * Allergy to ovine rumen. * A medical history of pelvic radiation therapy. * Scheduled for a redo-rectopexy. * A medical history of previously implanted pelvic floor meshes or native tissue. * Language barrier **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marije Boom, drs. **Phone:** + 31 33 850 1716 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Esther Consten, Prof.dr **Role:** CONTACT #### Locations **Location 1:** **City:** Amersfoort **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marije Boom, drs. - **Phone:** +31 33 850 1716 - **Role:** CONTACT **Country:** Netherlands **Facility:** Meander Medisch Centrum **State:** Utrecht **Status:** RECRUITING **Zip:** 3813TZ ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000056887 - Term: Pelvic Organ Prolapse - ID: D000012002 - Term: Rectal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M21893 - Name: Rectocele - Relevance: HIGH - As Found: Rectocele - ID: M27101 - Name: Cystocele - Relevance: HIGH - As Found: Cystocele - ID: M17344 - Name: Uterine Prolapse - Relevance: LOW - As Found: Unknown - ID: M14847 - Name: Rectal Prolapse - Relevance: LOW - As Found: Unknown - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Enterocele - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - 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: D000020047 - Term: Rectocele - ID: D000052858 - Term: Cystocele - ID: D000011391 - Term: Prolapse - ID: D000006547 - Term: Hernia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430918 **Brief Title:** Neuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis **Official Title:** Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis #### Organization Study ID Info **ID:** 226092BK #### Organization **Class:** OTHER **Full Name:** Bozyaka Training and Research Hospital ### Status Module #### Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bozyaka Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Bozyaka Training and Research Hospital **Investigator Full Name:** Taciser Kaya **Investigator Title:** MD, Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality. **Detailed Description:** Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder. The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient. Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis. American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded. ### Conditions Module **Conditions:** - Neuropathic Pain - Knee Osteoarthritis - Sleep Disturbance **Keywords:** - neuropathic pain - Knee Osteoarthritis - Sleep Disturbance ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Knee OA patients diagnosed according to the ACR Classification Criteria **Intervention Names:** - Other: physical examination, questionnaires and inventories **Label:** Patients with knee osteoarthritis ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with knee osteoarthritis **Description:** Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. **Name:** physical examination, questionnaires and inventories **Other Names:** - Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value. **Measure:** Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** Jenkins Sleep Scale.The four-item questionnaire evaluates the frequency and intensity of certain sleep difficulties in respondents. Questions queries the number of days in which the patient was subjected to sleep problems. The maximum possible score is 20 and higher scores indicate much more sleep disturbance. A mean score of two or more is considered as sleep disturbance presence. **Measure:** Sleep quality **Time Frame:** through study completion, an average of 1 year **Description:** The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. It is used to detect whether the patient is in the depressive or anxious status. It is not a diagnostic tool but gives to physician an idea about the patient's emotional status. It consists of fourteen items. Seven items are related to anxiety and the other seven depression **Measure:** Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS) **Time Frame:** through study completion, an average of 1 year **Description:** KOOS evaluates the symptoms and functional problems related to knee OA and knee injury. It consists of five subscales. In this study authors intended to assess the life quality by using the quality of life level subscale of this scale. **Measure:** Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup **Time Frame:** through study completion, an average of 1 year **Description:** Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup **Measure:** Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup **Time Frame:** through study completion, an average of 1 year **Description:** Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain. **Measure:** Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain. **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent - Exclusion Criteria: Exclusion Criteria: 1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months. - **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. ### Contacts Locations Module #### Locations **Location 1:** **City:** Izmir **Country:** Turkey **Facility:** Izmir Bozyaka Training and Reseach Hospital **Zip:** 35300 #### Overall Officials **Official 1:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Taciser Kaya, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Berna Kirilmaz Colak, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Bugra Ince, Assoc. prof. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085. **PMID:** 32365479 **Citation:** Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24. **PMID:** 22120461 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M22655 - Name: Dyssomnias - Relevance: HIGH - As Found: Sleep Disturbance - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disturbance - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake 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: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee - ID: D000009437 - Term: Neuralgia - ID: D000020920 - Term: Dyssomnias - ID: D000020447 - Term: Parasomnias ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430905 **Brief Title:** Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART **Official Title:** A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Arenavirus-based Vector Therapy HB-502 and HB-501 in People With HIV on Suppressive Antiretroviral Treatment #### Organization Study ID Info **ID:** H-500-001 #### Organization **Class:** INDUSTRY **Full Name:** Hookipa Biotech GmbH ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hookipa Biotech GmbH #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART). The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection. The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV. This trial studies the safety, tolerability, and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV. Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment. **Detailed Description:** This is a first-in-human Phase 1b, randomized, double-blind, placebo-controlled, multicenter study of HB-502 and HB-501 alternating 2-vector therapy in participants with HIV who are in overall good health and on suppressive ART. The study will evaluate the safety, reactogenicity, and immunogenicity of HB-502 and HB-501 alternating 2-vector therapy. HB-502 and HB-501 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-502 and HB-501 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of \>80% of circulating HIV-1 viral variants. Two different dose levels (Dose Level 1 and Dose Level 2) of HB-502 and HB-501 alternating 2-vector therapy or placebo will be administered intramuscularly every 8 weeks for 24 weeks (i.e., 4 doses at Weeks 0, 8, 16, and 24), which is followed by a 24-week follow-up period. In total, approximately 30 participants aged 18 to 65 years will be enrolled in this study to receive HB-502 and HB-501 alternating 2-vector therapy or placebo. About 5 Investigators and study sites in the United States are expected to participate in this study. ### Conditions Module **Conditions:** - Human Immunodeficiency Virus (HIV) Infection **Keywords:** - human immunodeficiency virus - HIV - vaccine - immunotherapy - arenavirus - genetic vector - antiretroviral therapy - ART ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 1 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24). **Intervention Names:** - Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 - Other: Placebo **Label:** HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 2 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24). **Intervention Names:** - Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 - Other: Placebo **Label:** HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo **Description:** Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. **Name:** HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Description:** Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. **Name:** HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Description:** Administration of placebo to 5 participants. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assess the safety of HB-502 and HB-501 alternating 2-vector therapy compared with placebo by monitoring the type, frequency, and severity of unsolicited treatment-emergent and serious AEs, using the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with adverse events (AEs) **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess the frequency and type of solicited local injection site reactions in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with local injection site reactions **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess the frequency and type of solicited systemic reactogenicity events in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with systemic reactogenicity events **Time Frame:** From first dosing until 48 weeks after first dosing #### Secondary Outcomes **Description:** Assess changes from baseline in the magnitude of T cell response specific to the transgenes harbored in HB-502 and HB-501. **Measure:** Determine the magnitude of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess changes from baseline in the breadth of T cell responses to the different transgenes harbored in HB-502 and HB-501. **Measure:** Determine the breadth of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo **Time Frame:** From first dosing until 48 weeks after first dosing ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants 18 to 65 years of age. * Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening. * Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening. * Must have plasma HIV RNA levels of \<50 copies/mL (or lower limit of quantitation) for at least 48 weeks prior to enrollment. * Must have a cluster of differentiation (CD)4+ cell count \>450 cells/mm3 and CD4+ cell % of ≥15% obtained within 40 days prior to enrollment. * Is in good general health according to the clinical judgment of the site Investigator. Exclusion Criteria: * History of hypersensitivity or other contraindication to any of the components of the study interventions as determined by the Investigator. * HIV-associated malignancy according to the National Cancer Institute (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers. * History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy. * More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014). * Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 156 weeks (i.e., 3 years) prior to enrollment. * Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus RNA is detected \[qualitative\]). * Current untreated or incompletely treated active TB disease or untreated latent TB infection. * Has any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results. * Is a previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded). * Received non-HIV experimental vaccine(s) within the last 1 year. * Has congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site Investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the Investigator within 24 weeks prior to the start of study therapy. * Received blood products or immunoglobulin within 16 weeks prior to enrollment. * Received systemic steroids at a dose of ≥10 mg/day (prednisone equivalent) for \<30 within 14 days or for ≥30 days within 28 days of first dose of study treatment. * Received any vaccine within 4 weeks prior to enrollment. * Initiated antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary). * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or contraindicate participation in this study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator. * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 12 weeks after the last dose of trial treatment. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** General Hookipa Contact **Phone:** +1 240-367-5320 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Beth Israel Deaconness Medical Center **State:** Massachusetts **Zip:** 02215 #### Overall Officials **Official 1:** **Affiliation:** Hookipa Biotech GmbH **Name:** Head of Clinical Development **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012897 - Term: Slow Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: HIGH - As Found: Human Immunodeficiency Virus (HIV) Infection - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: Human Immunodeficiency Virus (HIV) Infection - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: HIGH - As Found: Immunodeficiency - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M15700 - Name: Slow Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000163 - Term: Acquired Immunodeficiency Syndrome - ID: D000015658 - Term: HIV Infections - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430892 **Brief Title:** RAPID-POP a Randomized Controlled Trial **Official Title:** Efficacy of the Pressure Optimization Protocol (POP )Versus Conventional Stent Deployment Strategy During Primary Percutaneous Coronary Intervention. #### Organization Study ID Info **ID:** IRB-23/2024 #### Organization **Class:** OTHER **Full Name:** National Institute of Cardiovascular Diseases, Pakistan ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Institute of Cardiovascular Diseases, Pakistan #### Responsible Party **Investigator Affiliation:** National Institute of Cardiovascular Diseases, Pakistan **Investigator Full Name:** Professor Abdul Hakeem **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:** Efficacy of the Pressure Optimization Protocol (POP) versus Conventional Stent Deployment Strategy during Primary PCI: An Open Label Randomized Clinical Trial The investigators will compare conventional rapid stent inflation/deflation during primary PCI with higher pressure and prolonged duration of stent deployment Study Hypothesis: The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow, significantly lesser occurrence of slow flow/no-reflow, and significantly higher rate of ST-Segment resolution during primary PCI. **Detailed Description:** Primary Objective The primary objective is to compare the rate of TIMI III flow achievement, slow flow/no-reflow, and ST-segment resolution between POP versus conventional stent deployment strategy during Primary PCI. Secondary Objective The secondary objective is in-hospital outcome (to compare the rate of major adverse cardiovascular events (MACE) during hospitalization between POP versus conventional stent deployment strategy during Primary PCI.) Material and Methods Study design: An open-label randomized controlled trial (RCT) with blinded outcome assessment Setting: Cath Lab NICVD Karachi ,Hyderabad and Sukkur Duration of study: 6 months Stent Deployment Protocol: Patients will be randomly assigned to either POP or conventional stent deployment approach groups in 1:1 ratio using the block randomization method. SAMPLE SIZE : 400 patients will be randomized into 2 groups with 1:1 Concealment: Allocation schema will remain accessible to the randomization and allocation team and will be communicated to the screening and recruitment team on a patient-on-patient basis. Blinding: This will be an open-label study, however, the outcome assessment will be blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed. Immediately post-procedure, a de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed. All the patients will be followed at 30 days and incidence of MACE will be recorded. In order to ensure the integrity and reliability of the data, all procedures and imaging assessments will be carried out by clinicians and technicians trained and standardized in the respective methodologies. Moreover, data will be stored in a secure, electronic database with restricted access to maintain patient confidentiality and data security. Regular data audits will be conducted to ensure accuracy and consistency throughout the trial. Data Analysis: Firstly, patient demographics and baseline clinical characteristics will be summarized using means and standard deviations for continuous variables and frequencies with percentages for categorical variables. Kaplan-Meier survival analysis will be used to determine the time-to-event data for outcomes such as target vessel failure, target vessel revascularization, cardiac death, and myocardial infarction. Log-rank tests will be employed to compare survival curves between the POP and Rapid I/D groups. Cox proportional hazards models will be used to compute hazard ratios (HRs) and their 95% confidence intervals (CIs) for each outcome of interest, adjusting for potential confounders. For categorical outcomes, chi-squared tests or Fisher's exact tests will be used, as appropriate. Continuous outcomes will be assessed using t-tests or Mann-Whitney U tests based on data distribution. Any unmatched or imbalanced variables between the two groups will be controlled using propensity score matching. To address potential confounding factors and biases, a sensitivity analysis will be performed. Lastly, all statistical analyses will be two-tailed, with a significance level set at p \< 0.05. Statistical software such as SPSS or R will be utilized for the analysis. ### Conditions Module **Conditions:** - Myocardial Infarction, Acute ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomized into two groups in 1:1 , one arm will be treated with POP protocol and the other arm will be treated with conventional method. ##### Masking Info **Masking:** SINGLE **Masking Description:** This will be an open-label study, however, the outcome assessment will be blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in this arm will be treated according to the POP protocol for stent deployment **Intervention Names:** - Procedure: Primary Percutaneous Coronary Intervention (PPCI) **Label:** POP Protocol **Type:** OTHER #### Arm Group 2 **Description:** Patients in this arm will be treated with conventional method (rapid inflation-deflation protocol) for stent deployment **Intervention Names:** - Procedure: Primary Percutaneous Coronary Intervention (PPCI) **Label:** Conventional method **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional method - POP Protocol **Description:** Patients presented with acute myocardial infarction undergoing primary percutaneous coronary intervention with stent deployment **Name:** Primary Percutaneous Coronary Intervention (PPCI) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** To assess flow in the vessel after deployment of stent **Measure:** TIMI III flow: TIMI III flow is defined as normal flow with complete filling of the distal vascular bed. **Time Frame:** periprocedurally (after stent deployment) **Description:** To assess is there any Slow-flow/no-reflow phenomenon , which is TIMI flow grade \< 3 and as myocardial blushing grade (MBG) \< 2. **Measure:** Slow-flow/no-reflow **Time Frame:** periprocedurally (after stent deployment) **Description:** Assessment of ST-segment resolution , The electrocardiographic resolution of the ST-segment elevation is defined as a reduction of \> 50% of the ST-segment elevation in the same lead within 60 min after the index procedure **Measure:** ST-segment resolution **Time Frame:** Time frame:60minutes after the procedure #### Secondary Outcomes **Description:** cardiovascular death **Measure:** Cardiovascular death ( CV death) **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Myocardial infarction of different territory **Measure:** Myocardial infarction **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** same territory Myocardial infarction **Measure:** Stent thrombosis **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Cerebrovascular events during hospital stay **Measure:** Cerebrovascular accident ( CVA /Stroke) **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Significant arrhythmias requiring treatment **Measure:** Arrhythmias **Time Frame:** Time frame: during hospitalization (in-hospital) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18 years and above. * Patients undergoing primary percutaneous coronary intervention (PCI) with stent implantation. * Presence of significant coronary artery stenosis (greater than 70% diameter reduction) confirmed by angiography. Exclusion Criteria: * Patients with Killip class IV * Patients with significant comorbidities such as end-stage renal disease or advanced liver disease which may interfere with the procedure or follow-up. * Prior history of coronary artery bypass grafting (CABG). * Refusal to give consent for study participation or procedure **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Abdul Hakeem, professor **Phone:** +923355554342 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Shakir Zada, fellow **Phone:** +923469467449 **Role:** CONTACT #### Locations **Location 1:** **City:** Karachi **Contacts:** ***Contact 1:*** - **Name:** Shakir Zada, FELLOW - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 2:*** - **Name:** HAROON ISHAQ, AP - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** AYAZ MIR, AP - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** FAIZA FAROOQ, AP - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** ABDUL HAMEED, FELLOW - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** FARAZ MEMON, AP - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** HASSAN BUT, AP - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** CHANDAR PARKASH, AP - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** QAMAR ZAMAN, FELLOW - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** National institute of cardiovascular diseases **State:** Sindh **Status:** RECRUITING **Zip:** 75510 #### Overall Officials **Official 1:** **Affiliation:** National Institute of Cardiovascular Diseases, Pakistan **Name:** ABDUL HAKEEM, PROF **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430879 **Acronym:** POWER-UP **Brief Title:** Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential **Official Title:** POWER-UP Trial (Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential) #### Organization Study ID Info **ID:** POWER-UP 001 #### Organization **Class:** INDUSTRY **Full Name:** SuperPatch Limited LLC ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Arizona **Class:** UNKNOWN **Name:** Clarity Science LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** SuperPatch Limited LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (VICTORY Patch; The Super Patch Company Inc.); using KangaTech, Catapult and Force Plates along with crossover control of trials within the same subject group not receiving an 'active' patch. **Detailed Description:** Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The VICTORY patch (SuperPatch Company, Toronto, Canada) that also incorporates this technology has shown anecdotal promise to improve athlete performance. With the tools currently in use at the University of Arizona, team coaches and physicians can measure the true impact of neuromuscular changes suggested by the VICTORY patch. This study will measure quadriceps and hamstring strength in isolation as well as peak output in jumping and speed testing within in season training programs with and without VICTORY patch use. When combined with new methods of assessing individual muscle strength (KangaTech) and Force plate as well as Catapult measurements of compound movements of the investigational muscles, the investigators can evaluate the true performance and changes in football athletes with the SuperPatch technology. ### Conditions Module **Conditions:** - Muscle Strength - Muscle Weakness **Keywords:** - muscle - quadriceps - hamstrings - college athletes - elite athletes - haptic technology - vibrotactile trigger technology - VTT - neuromuscular changes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized, double-blind, placebo controlled, crossover trial with functional measurements ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active patch (VICTORY PATCH). Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: VICTORY PATCH **Label:** Active/Treatment **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: Sham Patch without VTT **Label:** Non-Active/Control **Type:** SHAM_COMPARATOR #### Arm Group 3 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active or inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: VICTORY PATCH - Device: Sham Patch without VTT **Label:** Crossover **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Active/Treatment - Crossover **Description:** Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT) **Name:** VICTORY PATCH **Other Names:** - Haptic Vibrotactile Trigger Technology - VTT **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Crossover - Non-Active/Control **Description:** Sham Patch without haptic vibrotactile trigger technology (VTT) **Name:** Sham Patch without VTT **Other Names:** - Sham Comparator **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator. **Measure:** Any side effects reported by patients with be documented in athletic training electronic medical record and assessed by team physician and PI **Time Frame:** 10 days #### Primary Outcomes **Description:** Evaluation of change in quadriceps and hamstring function via KangaTech measurements (mm/Kg) **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of change in max power of the Ground Reaction Force (GRF) in quadriceps and hamstring function measured by the Vald force plate (F = m \* a ; 1 m/s2). **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of of Catapult Global Positioning System (GPS) and change in quadriceps and hamstring function to capture maximum acceleration and maximum speed (meters per second (m/s)) during their field workout. **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of change in subject response to The Borg Rating of Perceived Exertion (RPE) (scale= 1- 10) **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of performance (overall scores) based on concentration of patch placement among study subjects on either dominant medial forearm or dominant side, or mid-anterior thigh. **Measure:** Changes in performance based on patch location or playing position with the VICTORY Patch treatment. **Time Frame:** 10 days #### Secondary Outcomes **Description:** Evaluation of predictive baseline metrics of playing position and predictive modeling will be used to identify subject phenotype(s) with an optimal, and a least positive, response. The data used as inputs to construct the predictive models will be a collection of the survey results collected from patients at day 0. Optimal and least positive responses will be defined based on changes in performance and other functional measurement scores, and changes in concomitant medications used, in the treatment group between survey dates. **Measure:** Identification of subject phenotype(s) that will have the optimal response to treatment with the VICTORY Patch, as well as athletes having the least positive response. **Time Frame:** 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults 18 to 30, inclusive 2. Able to provide written informed consent 3. Have received a VICTORY Patch if in treatment group. 4. Is an athlete on a University of Arizona Varsity Athletic Team 5. Agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention. 6. Agree to place an adhesive patch on their skin, as instructed, based on selection group. Exclusion Criteria: 1. Use of drugs of abuse (illicit or prescription) 2. Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid. 3. Any current medical or musculoskeletal injury that would prohibit athletic participation 4. Any significant injuries in the last month prior to the intervention that may impact tested performance measures. 5. New injuries that occur during the course of study testing that may impact performance measures. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Peter Hurwitz **Phone:** 9177570521 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Arizona **Name:** Mark Sakr, DO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430866 **Acronym:** Eucalyptus **Brief Title:** Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) **Official Title:** A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy #### Organization Study ID Info **ID:** 20230127 #### Organization **Class:** INDUSTRY **Full Name:** Amgen ### Status Module #### Completion Date **Date:** 2026-10-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amgen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab. ### Conditions Module **Conditions:** - Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC) **Keywords:** - NSCLC - Keytruda - Pembrolizumab - ABP 234 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 154 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months. **Intervention Names:** - Drug: ABP 234 **Label:** ABP 234 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive pembrolizumab Q3W for up to 12 months. **Intervention Names:** - Drug: Pembrolizumab **Label:** Pembrolizumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ABP 234 **Description:** Administered by intravenous (IV) injection. **Name:** ABP 234 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Pembrolizumab **Description:** Administered by IV injection. **Name:** Pembrolizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose **Time Frame:** 21 days **Measure:** AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss) **Time Frame:** Weeks 16-19 #### Secondary Outcomes **Measure:** Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1) **Time Frame:** Up to 65 weeks **Measure:** Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1) **Time Frame:** Up to 65 weeks **Measure:** Cmax at Steady State (Cmax_ss) **Time Frame:** Weeks 16-19 **Measure:** Tmax at Steady State (Tmax_ss) **Time Frame:** Weeks 16-19 **Measure:** Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4) **Time Frame:** Week 4 pre-dose **Measure:** Ctrough at Stead State (Ctrough_ss) **Time Frame:** Weeks 16 and 19 pre-dose **Measure:** Number of Participants with Treatment-emergent Adverse Events **Time Frame:** Up to 16 months **Measure:** Number of Participants with Treatment-emergent Serious Adverse Events **Time Frame:** Up to 16 months **Measure:** Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs) **Time Frame:** Up to 16 months **Measure:** Number of Participants with Andit-drug Antibodies **Time Frame:** Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65 **Measure:** Disease-free Survival **Time Frame:** Up to 65 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females ≥ 18 years of age. * Pathological diagnosis of non-squamous NSCLC. * Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy. * For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers. * Treated with platinum-based chemotherapy: 1. Chemotherapy must have begun within 12 weeks after the resection surgery. 2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative. * Have adequate organ function as indicated by laboratory values. * Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration. * Participants must sign approved informed consent form (ICF). Exclusion Criteria: * Evidence of disease. * Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting. * History or presence of immune-mediated disorders. * Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll. * Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV). * Medical conditions requiring systemic immunosuppression. * History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc. * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis. * Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea. * Woman of childbearing potential who is pregnant or is breast feeding. * Woman of childbearing potential who is not consenting to use highly effective methods of birth control. * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control. * Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP). * Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease. * Live vaccine therapy within 4 weeks prior to IP administration. * Participation in another investigational drug study within 30 days prior to IP administration. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Amgen Call Center **Phone:** 866-572-6436 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Amgen **Name:** MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. **Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. **URL:** http://www.amgen.com/datasharing ### References Module #### See Also Links **Label:** AmgenTrials clinical trials website **URL:** http://www.amgentrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - 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:** NCT06430853 **Acronym:** PIP **Brief Title:** Psychobiological Interventions in Pregnancy **Official Title:** Psychobiological Effects of Lifestyle Interventions in Pregnancy #### Organization Study ID Info **ID:** IRB-74741 #### Organization **Class:** OTHER **Full Name:** Stanford University ### Status Module #### Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** Danielle Panelli **Investigator Title:** Instructor of Obstetrics and Gynecology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation. ### Conditions Module **Conditions:** - Pregnancy Complications - Mental Health Issue - Depression, Anxiety - Pregnancy, High Risk - Biological Clock Disturbance **Keywords:** - Pregnancy - Stress - Mental health - Depression - Anxiety - Telomeres - Cortisol - Physical activity - Exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 37 weeks of gestation. They will receive monthly text reminders to wear their watch as much as possible. **Intervention Names:** - Device: Actigraph watch **Label:** Usual step count **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Participants will be given a daily step count goal of 9,000 steps per day based on the Actigraph watch, between 20 and 37 weeks of gestation. They will receive monthly text reminders reminding them of the step count goal and offering ways to achieve this goal. **Intervention Names:** - Behavioral: Step count goal - Device: Actigraph watch **Label:** Step count goal **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Step count goal **Description:** The step count goal will be discussed at the beginning of the study, and participants will be able to see their step count on the Actigraph watch to facilitate achieving this goal. All participants will receive monthly reminders that are tailored for their intervention arm. **Name:** Step count goal **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Step count goal - Usual step count **Description:** Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch. **Name:** Actigraph watch **Other Names:** - Actigraph GT9X Link Accelerometer **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of \>=10 has been shown to be consistent with depressive symptoms. **Measure:** Change in Edinburgh Postpartum Depression Scale (EPDS) Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks gestation). #### Secondary Outcomes **Description:** The mean within person change in Edinburgh Postpartum Depression Anxiety Subscale score between randomization and the end of the study will be compared between the 2 arms. The three-question anxiety subscale on the EPDS (EPDS 3A) has a score range between 0-9, and a score \>=5 has been shown to be consistent with anxiety symptoms. **Measure:** Change in EPDS Anxiety Subscale Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks) **Description:** Mean within person change in STAI score between randomization and the end of the study will be compared between the 2 arms. The STAI is 40 questions, and the score ranges from 40 to 160. A STAI score \>=80 has been shown to be consistent with anxiety symptoms. **Measure:** Change in State-Trait Anxiety Inventory (STAI) Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks) **Description:** Maternal leukocyte telomere length will be measured from saliva samples and analyzed via quantitative PCR. Mean within-person change in leukocyte telomere length will be compared between the two arms. **Measure:** Change in leukocyte telomere length **Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks) **Description:** Maternal hair cortisol level will be measured from consecutive segments of hair strands. Mean within-person change in hair cortisol level will be compared between the two arms. **Measure:** Change in hair cortisol level **Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks) **Description:** Frequency of pregnancy complications including hypertensive disorders, diabetes, fetal growth restriction, placental abruption, preterm birth, or stillbirth will be abstracted from the medical record **Measure:** Frequency of pregnancy complications **Time Frame:** 6 weeks postpartum **Description:** Frequency of neonatal complications including NICU admission, 5-minute Apgar \<7, low birthweight, need for mechanical ventilation, or neonatal demise will be abstracted from the medical record **Measure:** Frequency of neonatal complications **Time Frame:** 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to read and write in English or Spanish * Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days * Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5 Exclusion Criteria: * Known allergy to steel or rubber * Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia * Plan to relocate and/or deliver at another institution * Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia) **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stanford **Country:** United States **Facility:** Stanford University **State:** California **Zip:** 94305 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Danielle M Panelli, MD, MS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: HIGH - As Found: Biological Clock Disturbance - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Pregnancy Complications - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000021081 - Term: Chronobiology Disorders - ID: D000011248 - Term: Pregnancy Complications - ID: D000003863 - Term: Depression ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9912 - Name: Hydrocortisone - Relevance: LOW - As Found: Unknown - ID: M155245 - Name: Hydrocortisone 17-butyrate 21-propionate - Relevance: LOW - As Found: Unknown - ID: M228609 - Name: Hydrocortisone acetate - Relevance: LOW - As Found: Unknown - ID: M263259 - Name: Hydrocortisone hemisuccinate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430840 **Acronym:** CAN-ASSIST **Brief Title:** Addressing Financial and Social Needs Among Patients With Cancer **Official Title:** Addressing Financial and Social Needs Among Patients With Cancer #### Organization Study ID Info **ID:** UCI-24-28 #### Organization **Class:** OTHER **Full Name:** University of California, Irvine #### Secondary ID Infos **Domain:** University of California Irvine IRB **ID:** 4937 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Chao Family Comprehensive Cancer Center #### Lead Sponsor **Class:** OTHER **Name:** University of California, Irvine #### Responsible Party **Investigator Affiliation:** University of California, Irvine **Investigator Full Name:** Gelareh Sadigh **Investigator Title:** Associate Professor In Residence **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Financial hardship and health-related social needs (e.g., insecurity about food, housing, transportation, utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Our study will test the efficacy of a multicomponent financial navigation and counseling program delivered by a financial navigator (CostCOM), vs. direct patient access to financial education materials and comprehensive list of local resources in the absence of a financial navigator (FinEd) vs. practice usual care among newly diagnosed cancer patients who screen positive for financial hardship and social needs. Investigators anticipate that both CostCOM and FinEd compared to enhanced usual care will improve cost-related cancer care nonadherence, financial worry, health insurance literacy, quality of life and sleep quality and decrease number of missed appointments. **Detailed Description:** Financial hardship and health-related social needs (HRSNs) (e.g., insecurity about food, housing, transportation, and utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Addressing financial hardship and HRSNs can mitigate their damaging health effects, yet screening for them is not the standard clinical practice. There is compelling evidence that out-of-pocket cost (OOPC) communication complemented by financial navigation and counseling delivered by a financial navigator (CostCOM intervention) will decrease financial hardship. However, implementation of this intervention is limited given shortage of financial navigators in many cancer centers. There is also evidence that patients with financial hardship have lower financial health literacy and financial self-efficacy. However, it is not clear whether direct access to local community or national resources and financial education (FinEd intervention) in the absence of financial navigators will meet patient's needs. Investigators propose a 3-arm pilot randomized controlled trial to assess potential efficacy differences in adherence, financial hardship, financial health literacy, quality of life, and sleep between CostCOM vs. FinEd vs. enhanced usual care (EUC) among 90 newly diagnosed cancer patients (1:1 non-metastatic vs. metastatic) who receive systemic or radiation therapy and are screened positive for financial and social needs. Our multidisciplinary team has experience with all facets of the proposed intervention. CostCOM patients will participate in two remote counseling sessions at baseline, and 3 months, and will receive (1) OOPC communication, individualized, patient-specific education of the anticipated medication OOPC; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients' financial concerns and enroll patients in financial assistance programs. FinEd patients will receive (1) a comprehensive list of local and national resources where patients can self-refer for financial and social needs; and (2) online and paper financial educational materials on topics such as health insurance and health insurance literacy, and navigating price estimator tools. EUC patients will receive usual care enhanced by screening for financial and social needs. Our goals are to compare the efficacy of CostCOM vs. FinEd vs. EUC at 6 months on (1) patient-reported cost-related cancer care nonadherence (defined as self-reported delay, forgo, stop or change in cancer care due to cost concerns), treatment completion and missed appointments (as obtained via medical record); (2) patient-reported financial worry, material hardship, health insurance literacy, and quality of life; and (3) patient-reported and objectively measured sleep quality using a sleep monitor. The study will support feasibility for a larger trial, and reveal efficacy estimates for potential CostCOM vs. FinEd differences in improving cancer patients' outcomes and approaches for incorporation into routine clinical practice. ### Conditions Module **Conditions:** - Cancer - Financial Hardship **Keywords:** - Sleep - Cancer - Financial Hardship - financial education - financial navigation - cost communication ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care + pre-screening for financial hardship and social risks **Intervention Names:** - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm A: Enhanced Usual Care (EUC) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling. **Intervention Names:** - Behavioral: CostCOM (Cost Communication, Financial navigation and counseling) - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm B: CostCOM **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy **Intervention Names:** - Behavioral: Provision of local and national resources to address financial and social needs - Behavioral: Financial Education - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm C: FinEd **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm B: CostCOM **Description:** Patients will receive two 1-hour, phone or video sessions with a remote financial counselor, each session will cover each of these 3 components of CostCOM. Out-of-pocket cost communication (OOPC): A review of insurance benefits and education of the patient-specific OOPC for anticipated treatment regimen if any (i.e., medication). The OOPC is provided as a total estimate and will be updated at 3-month session in case of changes in treatment or insurance. Financial navigation: Real-time professional guidance to identify financial assistance programs (e.g., co-pay, living expenses) that alleviate costs of care and discuss information to improve insurance coverage. Financial counseling: To address the range of patients' financial concerns and enroll patients in financial assistance programs. **Name:** CostCOM (Cost Communication, Financial navigation and counseling) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Arm C: FinEd **Description:** Patients will be provided with a comprehensive list of local resources (in patients' preferred language) in Orange County that can help with food insecurity, ir transportation, as well as contact information for national non-profit organization where patients can self-refer for financial navigation (e.g., Patient Advocate Foundation (PAF) **Name:** Provision of local and national resources to address financial and social needs **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Arm C: FinEd **Description:** Patient will receive online and paper educational materials on topics such as health insurance and health insurance literacy, navigating hospitals' price estimator tool. **Name:** Financial Education **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Arm A: Enhanced Usual Care (EUC) - Arm B: CostCOM - Arm C: FinEd **Description:** Patients in all arms will receive usual care, which includes routine oncology visits, use of available ancillary staff, and internal or external resources for co-pay assistance or free medication per normal clinic procedures. **Name:** Usual care **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Arm A: Enhanced Usual Care (EUC) - Arm B: CostCOM - Arm C: FinEd **Description:** Patients will be screened for financial hardship and health-related social risks. **Name:** Screening for financial and social needs **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Patients experience and satisfaction with intervention components will be assessed through an interview process from a subset of patients of Arm C: FinEd. Results will be qualitatively measured. **Measure:** Patients' experience with intervention **Time Frame:** 6-8 months after randomization #### Primary Outcomes **Description:** Number of patients who report any incidence during the 6 months (measured at 3, and 6 months) when they self-reports a positive response to any of: (1) delay, (2) forego, (3) stop, or (4) change in cancer prescribed medication due to cost, (5) refuse recommended cancer tests, or (6) skip cancer office visits due to cost. **Measure:** Patients' Cost-Related Cancer Care Non-Adherence **Time Frame:** Within 6-months after randomization #### Secondary Outcomes **Description:** Number of patients who receive all the prescribed cycle of chemotherapy and/or radiation therapy due within the 6-month study period. **Measure:** Patients' Treatment Completion **Time Frame:** Within 6-months after randomization **Description:** Proportion of treatment appointments or office visits that is marked as cancellation or no show in the absence of chart note advising patient not to show up the appointment. **Measure:** Patients' Missed Appointments **Time Frame:** Within 6-months after randomization **Description:** Number of patients who report any incidence during the 6-months (measured 3, and 6 months) with a self-reported positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy) because of their cancer care, or its treatment **Measure:** Patients' Material Financial Hardship **Time Frame:** Within 6-months after randomization **Description:** Patients level of of financial worry regarding their cancer care will be measured using the Comprehensive Score for Financial Toxicity (COST) 11-item (score 0-44). Higher score= Lower financial worry **Measure:** Patients' Financial Worry **Time Frame:** Within 6-months after randomization **Description:** Patients level of health insurance literacy measured by 21 items Health Insurance Literacy Measure (Score range 21-84). Higher score= higher health insurance literacy **Measure:** Patients' Insurance Literacy **Time Frame:** Within 6-months after randomization **Description:** Quality of life will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-10. T scores will be calculated ranging between 0-100. Higher score= higher quality of life. **Measure:** Patients' quality of life **Time Frame:** Within 6-months after randomization **Description:** Patients quality of sleep will be measured by an Insomnia Severity Index (ISI) that evaluates the severity of patients insomnia symptoms. (score 0-28). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). **Measure:** Patients' Sleep Quality (Subjective) **Time Frame:** Within 6-months after randomization **Description:** Patients total sleep time, sleep efficiency, nighttime awakening, and sleep latency, measured through a sleep ActiGraph **Measure:** Patients Sleep Quality (Objective) **Time Frame:** Within 6-months after randomization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Speak English or Spanish * 18 years or older * Were diagnosed with any stage of cancer within the last 120 days * Getting treatment in University of California Irvine-affiliated oncology clinics * Have already started treatment like radiation, or cancer medication * Screen positive for financial hardship or health-related social needs Exclusion Criteria: * Patients with indolent cancer undergoing observation alone * Eastern Cooperative Oncology Group (ECOG) Performance status above 2 * Patients not receiving any cancer-directed therapy * Patients participating in other therapeutic clinical trials covering the cost of treatment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gelareh Sadigh **Phone:** 949-510-7925 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Richard J Echeverria **Phone:** 949-745-5066 **Role:** CONTACT #### Locations **Location 1:** **City:** Costa Mesa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Health Cancer Center - Newport **State:** California **Zip:** 92627 **Location 2:** **City:** Orange **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Chao Family Comprehensive Cancer Center **State:** California **Zip:** 92868 **Location 3:** **City:** Yorba Linda **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Health - Yorba Linda **State:** California **Zip:** 92886 #### Overall Officials **Official 1:** **Affiliation:** University of California, Irvine **Name:** Gelareh Sadigh **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2567 - Name: Financial Stress - Relevance: HIGH - As Found: Financial Hardship - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086522 - Term: Financial Stress ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T244 - Name: Orange - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430827 **Brief Title:** Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma **Official Title:** Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma. #### Organization Study ID Info **ID:** CSPC-DNY-BTC-02 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** CSPC Ouyi Pharmaceutical Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Ba Yi #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Ba Yi **Investigator Title:** Director **Type:** SPONSOR_INVESTIGATOR ### 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 irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma. ### Conditions Module **Conditions:** - Biliary Tract Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle. **Intervention Names:** - Drug: irinotecan hydrochloride liposome injection - Drug: Capecitabine **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** rinotecan hydrochloride liposome injection (70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. **Name:** irinotecan hydrochloride liposome injection **Other Names:** - duoenyi **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Experimental **Description:** Capecitabine (1000 mg/m\^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle **Name:** Capecitabine **Other Names:** - Kapeitabin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the efficacy of anti-tumor **Measure:** Progression-free survival (PFS) **Time Frame:** baseline up to approximately 6 months #### Secondary Outcomes **Description:** To evaluate the efficacy of anti-tumor **Measure:** Objective response rate (ORR) **Time Frame:** baseline up to approximately 6 months **Description:** To evaluate the efficacy of anti-tumor **Measure:** Overall survival (OS) **Time Frame:** baseline up to approximately 12 months **Description:** To identify the quality of life by QLQ-C30（V3.0） **Measure:** Quality of life (QoL) **Time Frame:** baseline up to approximately 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient had good compliance, could understand the research process of this study, and signed a written informed consent. 2. Age ≥18 years. 3. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer). 4. Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs. 5. Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. 8. Has a life expectancy of greater than 3 months. 9. LVEF≥50%. 10. Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met): 1. ANC ≥1.5×10\^9/L 2. Hb≥90g/L 3. PLT ≥100×10\^9/L 4. total bilirubin ≤1.5 x ULN 5. ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN 6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥50mL/min (according to Cockcroft-Gault fórmula) 7. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN 11. Patients with biliary obstruction should receive adequate biliary drainage. 12. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk). 13. non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment. 14. There were no contraindications for the use of irinotecan liposomes and capecitabine. Exclusion Criteria: 1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma). 2. Uncontrolled pleural effusion or ascites. 3. Any known brain or meningeal metastases. 4. Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing. 5. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug. 6. Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). 7. Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency. 8. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc. 9. Grade 1 diarrhea with an increase in the number of stools \> 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention. 10. Had participated in other clinical investigators within 4 weeks before enrollment. 11. Unsuitable for participation in the trial by the investigator assessed. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yi Ba, PHD **Phone:** +86 010 69158705 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yi Ba, PHD - **Phone:** +86 010 69158705 - **Role:** CONTACT **Country:** China **Facility:** Peking Union Medicalcollege Hospital #### Overall Officials **Official 1:** **Affiliation:** PEKING UNION MEDICALCOLLEGE HOSPITAL **Name:** Yi Ba **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: 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 ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: International - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Function - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069287 - Term: Capecitabine - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430814 **Brief Title:** Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy **Official Title:** Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy #### Organization Study ID Info **ID:** AKF-403 #### Organization **Class:** OTHER **Full Name:** University of Southern Denmark ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Odense University Hospital **Class:** OTHER **Name:** Sygehus Lillebaelt **Class:** UNKNOWN **Name:** Esbjerg Hospital **Class:** OTHER_GOV **Name:** Sonderborg Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Southern Denmark #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy. **Detailed Description:** The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles. Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4. The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. ### Conditions Module **Conditions:** - Chemotherapy-induced Peripheral Neuropathy ### Design Module #### Bio Spec **Description:** The investigators are taking blood samples to analyze the NFL level, paclitaxel concentration, and looking at DNA sequencing associated with PIPN. The investigators will also take skin biopsies to look at the nerve fiber density and if gene and protein expression of relevant genes changes following paclitaxel treatment. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 188 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites. **Intervention Names:** - Other: No intervention **Label:** Breastcancer patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Breastcancer patients **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. **Measure:** NFL level correlation **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) #### Secondary Outcomes **Description:** To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood **Measure:** Paclitaxel exposure **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms. **Measure:** Genes and PIPN **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood. **Measure:** Genes and NFL **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood. **Measure:** Genes and Paclitaxel **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Investigate if and which specific drug-drug interactions are correlated to developing PIPN. **Measure:** Drug-drug interactions **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN. **Measure:** Skin biopsies **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment. **Measure:** IENFD **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain. **Measure:** PHS **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction. **Measure:** Nerve fiber dysfunction **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years * Willing to give informed consent * Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment * Able to speak and understand Danish * Diagnosed with breast cancer * Paclitaxel naïve patients Exclusion Criteria: * Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation * Type 1 or 2 diabetes * Pregnant * Breastfeeding * Relapse of cancer diagnosis * Diagnosed with human immunodeficiency virus (HIV) * Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves). * Previous treatment with neurotoxic chemotherapy * Chronic pain from another cause * Metastatic cancer **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ditte Bork Iversen, MSc Pharm, PhD **Phone:** +45 65 50 23 52 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tore B. Stage, Prof **Phone:** +45 65 50 36 78 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Southern Denmark **Name:** Ditte Bork Iversen **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Data on individual participants is not allowed due to GDPR **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: HIGH - As Found: Peripheral Neuropathy - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010523 - Term: Peripheral Nervous System Diseases ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430801 **Brief Title:** A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) **Official Title:** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease #### Organization Study ID Info **ID:** 7240-008 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** Merck **ID:** MK-7240-008 **Type:** OTHER **Domain:** EU CT **ID:** 2023-508636-61 **Type:** REGISTRY **Domain:** UTN **ID:** U1111-1298-6080 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2029-09-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-09-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. The primary hypotheses for Study 1 and Study 2 are that tulisokibart is superior to placebo in achieving the coprimary outcome measures of clinical remission by either Crohn's Disease Activity Index (CDAI, primary endpoint recommended by United States Food and Drug Administration \[US/FDA\]) or stool frequency and abdominal pain score (primary endpoint recommended by European Union European Medicines Agency \[EU/EMA\]) and endoscopic response. ### Conditions Module **Conditions:** - Crohn's Disease ### 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:** 1200 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive high dose induction of intravenous (IV) tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a high dose maintenance of subcutaneous (SC) tulisokibart every 2 weeks (Q2W). **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 1: High Dose Induction, High Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart every 4 weeks (Q4W). **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart - Other: SC Placebo **Label:** Study 1: High Dose Induction, Low Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart Q4W. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart - Other: SC Placebo **Label:** Study 1: Low Dose Induction, Low Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by SC placebo Q2W until week 52. In an extension, participants receive the low dose SC tulisokibart regimen. **Intervention Names:** - Other: IV Placebo - Other: SC Placebo **Label:** Study 1: Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 2: High Dose Induction **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 2: Low Dose Induction **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. In an extension, participants receive the low dose SC tulisokibart regimen. **Intervention Names:** - Other: IV Placebo **Label:** Study 2: Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Study 1: High Dose Induction, High Dose Maintenance - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 2: High Dose Induction - Study 2: Low Dose Induction **Description:** Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously **Name:** IV Tulisokibart **Other Names:** - PRA023 - MK-7240 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Study 1: High Dose Induction, High Dose Maintenance - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 2: High Dose Induction - Study 2: Low Dose Induction **Description:** Humanized monoclonal antibody that binds human TL1A, administered subcutaneously **Name:** SC Tulisokibart **Other Names:** - PRA023 - MK-7240 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Study 1: Placebo - Study 2: Placebo **Description:** Placebo matching IV tulisokibart **Name:** IV Placebo **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 1: Placebo **Description:** Placebo matching SC tulisokibart **Name:** SC Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Who Experienced an Adverse Event (AE) **Time Frame:** Up to approximately 222 weeks **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 1 will be presented. **Measure:** Study 1: Percentage of Participants who Discontinue Study Intervention due to an AE **Time Frame:** Up to approximately 208 weeks **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented. **Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented. **Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 2 will be presented. **Measure:** Study 2: Percentage of Participants Who Experienced an AE **Time Frame:** Up to approximately 182 weeks **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 2 will be presented. **Measure:** Study 2: Percentage of Participants who Discontinue Study Intervention due to an AE **Time Frame:** Up to approximately 168 weeks #### Secondary Outcomes **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥100 points from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12 **Time Frame:** Week 12 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12 **Time Frame:** Week 12 **Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for study 1 and study 2 will be presented. **Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12 **Time Frame:** Week 12 **Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a 50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for study 1 and study 2 will be presented. **Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52 **Time Frame:** Week 12 and Week 52 **Description:** The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission as defined by CDAI score \<150 and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52 **Time Frame:** Baseline and Week 52 **Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52 **Time Frame:** Baseline and Week 52 **Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented. **Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented. **Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12 **Time Frame:** Week 12 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 2 will be presented. **Measure:** Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12 **Time Frame:** Week 12 **Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 2 will be presented. **Measure:** Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6 **Time Frame:** Week 6 **Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented. **Measure:** Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12 **Time Frame:** Week 12 ### Eligibility Module **Eligibility Criteria:** The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has had a diagnosis of CD at least 3 months before study. * Has moderately to severely active CD. * Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies. Exclusion Criteria: * Has diagnosis of ulcerative colitis (UC) or indeterminate colitis. * Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement. * Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. * Has current stoma or need for colostomy or ileostomy. * Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. * Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease. * Has surgical bowel resection within 3 months of study. * Has prior or current gastrointestinal dysplasia. * Has chronic infection requiring ongoing antimicrobial treatment. * Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years. * Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Has active tuberculosis. * Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection. * Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-anti-TL1A antibody. **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** https://www.merckclinicaltrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease ### Intervention Browse Module - 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:** NCT06430788 **Brief Title:** A Study of Emapalumab for Pediatric Aplastic Anemia **Official Title:** Phase 2a/2b Study Emapalumab: A Window of Opportunity in Pediatric Aplastic Anemia #### Organization Study ID Info **ID:** 23-278 #### Organization **Class:** OTHER **Full Name:** Memorial Sloan Kettering Cancer Center ### Status Module #### Completion Date **Date:** 2029-05-21 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2029-05-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Memorial Sloan Kettering Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to find out whether upfront emapalumab treatment can help in sAA (Aplastic Anemia) treatment planning and increase the effectiveness of standard treatment options. ### Conditions Module **Conditions:** - Aplastic Anemia - Cytopenia - Hypocellular Marrow **Keywords:** - pediatric aplastic anemia - aplastic anemia - cytopenia - hypocellular marrow - Emapalumab - Memorial Sloan Kettering Cancer Center - 23-278 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 55 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will first receive Emapalumab for 6 weeks. After treatment with emapalumab, participants will receive standard IST with drugs called equine anti-thymocyte globulin (hATG) and cyclosporin (CsA) in addition to a lower dose of emapalumab **Intervention Names:** - Biological: Emapalumab **Label:** Emapalumab, then Standard IST **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will first receive Emapalumab for 6 weeks. After treatment with emapalumab, participants will have a standard hematopoietic stem cell transplant (HCT). **Intervention Names:** - Biological: Emapalumab **Label:** Emapalumab, then HCT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Emapalumab, then HCT - Emapalumab, then Standard IST **Description:** Emapalumab is an interferon gamma (IFNγ) blocking antibody **Name:** Emapalumab **Other Names:** - Gamifant **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of the study is to assess the efficacy of early upfront emapalumab on hematologic recovery within 6 weeks of starting therapy after a new diagnosis of Aplastic Anemia. Response will be determined by blood count. **Measure:** Best Response **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing workup for suspected newly diagnosed sAA: * Patients with severe cytopenias and a hypocellular marrow concerning for sAA * Patients that meet the definition for suspected sAA (Camitta Criteria) as follows: Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L * Patients that do not have evidence of leukemia or MDS * Patients \< 25 years of age at time of diagnosis * Able to tolerate emapalumab and IST (with standard institutional organ function criteria) Exclusion Criteria: * Uncontrolled infection at presentation. * Patients who have undergone previous treatment for sAA. * Patients with known inherited bone marrow failure * Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial * Patients with leukemia or MDS * Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joseph Oved, MD **Phone:** 1-833-MSK-KIDS **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jaap Jan Boelens, MD, PhD **Phone:** 1-833-MSK-KIDS **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Name:** Joseph Oved, MD - **Phone:** 1-833-MSK-KIDS - **Role:** CONTACT **Country:** United States **Facility:** Memorial Sloan Kettering Cancer Center (All Protocol Activities) **State:** New York **Status:** RECRUITING **Zip:** 10065 **Location 2:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anthony Sabulski, MD - **Phone:** 513-636-3200 - **Role:** CONTACT **Country:** United States **Facility:** Cincinnati Children's Hospital Medical Center (Data collection only) **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 45229 **Location 3:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Tim Olson, MD, PhD - **Phone:** 800-879-2467 - **Role:** CONTACT **Country:** United States **Facility:** Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 19104 **Location 4:** **City:** Richmond **Contacts:** ***Contact 1:*** - **Name:** Joe Laver, MD, MHA - **Phone:** 804-828-9213 - **Role:** CONTACT **Country:** United States **Facility:** Virginia Commonwealth Univeristy (Data Collection Only ) **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 23219 **Location 5:** **City:** Milwaukee **Contacts:** ***Contact 1:*** - **Name:** Larisa Broglie, MD - **Phone:** 414-266-2420 - **Role:** CONTACT **Country:** United States **Facility:** Medical College of Wisconsin (Data Collection AND Data Analysis) **State:** Wisconsin **Status:** NOT_YET_RECRUITING **Zip:** 53226 #### Overall Officials **Official 1:** **Affiliation:** Memorial Sloan Kettering Cancer Center **Name:** Joseph Oved, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: [email protected]. **IPD Sharing:** YES ### References Module #### See Also Links **Label:** Memorial Sloan Kettering Cancer Center **URL:** http://www.mskcc.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000001855 - Term: Bone Marrow Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M3170 - Name: Cytopenia - Relevance: HIGH - As Found: Cytopenia - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: LOW - As Found: Unknown - ID: M13118 - Name: Pancytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia ### Condition Browse Module - Meshes - ID: D000000740 - Term: Anemia - ID: D000000741 - Term: Anemia, Aplastic - ID: D000095542 - Term: Cytopenia ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M18961 - Name: Cyclosporine - Relevance: LOW - As Found: Unknown - ID: M6730 - Name: Cyclosporins - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown - ID: M4279 - Name: Antilymphocyte Serum - Relevance: LOW - As Found: Unknown - ID: M21134 - Name: Antibodies, Blocking - Relevance: LOW - As Found: Unknown - ID: M10406 - Name: Interferon-gamma - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430775 **Brief Title:** Exploring Prolonged AMR in ACL Reconstructed Patients **Official Title:** Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction #### Organization Study ID Info **ID:** G086223N #### Organization **Class:** OTHER **Full Name:** University Ghent #### Secondary ID Infos **Domain:** Ethical committee Ghent University **ID:** ONZ-2023-0365 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Research Foundation Flanders #### Lead Sponsor **Class:** OTHER **Name:** University Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (AMR) in anterior cruciate ligament (ACL) reconstructed patients. The main questions it aims to answer are: 1. Is there a link between the long-term occurence of AMR in ACL reconstructed patients and the level of kinesiophobia experienced before or after their ACL surgery? We hypothesize that ACL patients with higher levels of kinesiophobia are more likely to exhibit prolonged AMR as an unconscious reaction to protect their affected knee joint. 2. Is the long-term presence of AMR in ACL reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? Our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in ACL reconstructed patients. 3. Is the prolonged presence of AMR in ACL reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting AMR. 4. Is the long-term presence of AMR in ACL reconstructed patients linked to clinical parameters such as swelling, isometrich quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged AMR. Participants will: * Fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery: * Demopgraphical information * Knee Injury and Osteoarthritis Outcome Score (KOOS) * Lysholm Score (only question 1) * Tegner Activity Scale (current activity level, pre-injury activity level and desired activity level after recovery) * Numeric Rating Score (NRS) for pain levels during the day \& during the night * ACL-Return to Sport after Injury Scale (ACL-RSI) * Complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged AMR. ### Conditions Module **Conditions:** - Anterior Cruciate Ligament Injuries - Anterior Cruciate Ligament Rupture - Anterior Cruciate Ligament Tear - ACL - ACL Injury - ACL Tear - Anterior Cruciate Ligament Reconstruction - Arthrogenic Muscle Inhibition - Arthrogenic Muscle Responses ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 190 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Months ### Arms Interventions Module #### Arm Group 1 **Description:** The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled. **Label:** ACLR-patients ### Outcomes Module #### Primary Outcomes **Description:** A torque-based isometric biodex measurement using the interpolated twitch technique. **Measure:** Voluntary quadriceps activation **Time Frame:** 5 months post ACL reconstruction **Description:** Electromyographical measurement of quadriceps and hamstrings activation during jumping tasks: bilateral countermovement jump, unilateral countermovement jump and unilateral vertical drop jump with a 90° medial turn. **Measure:** Quadriceps and hamstrings activity / cocontraction during jumping tasks **Time Frame:** 5 months post ACL reconstruction #### Secondary Outcomes **Description:** Concentric and isokinetic Biodex measurements of the quadriceps and hamstrings strength. **Measure:** Quadriceps and hamstrings strength **Time Frame:** 5 months post ACL reconstruction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-40 years old. * Having suffered an ACL rupture. * Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg). Exclusion Criteria: * Revision ACL reconstruction. * Other severe injuries to the lower limbs within the past year. * Muscular or neurological disorders affecting lower limb functioning. * Fibromyalgia or chronic fatigue syndrome. **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Patients aged between 18 and 40 who have suffered an ACL rupture and for whom ACL reconstructive surgery is planned at AZ Delta Hospital in Roeselare. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Erik Witvrouw, prof. dr. **Phone:** +32 9 332 2609 **Role:** CONTACT #### Locations **Location 1:** **City:** Roeselare **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Thomas Tampere, Dr. - **Phone:** 051 23 63 70 - **Role:** CONTACT **Country:** Belgium **Facility:** AZ Delta Hospital (Campus Brugsesteenweg) **State:** West-Vlaanderen **Status:** RECRUITING **Zip:** 8800 ### IPD Sharing Statement Module **Description:** All collected IPD that underlie results in a publication will be shared. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** The data will become available after publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007718 - Term: Knee Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M601 - Name: Anterior Cruciate Ligament Injuries - Relevance: HIGH - As Found: Anterior Cruciate Ligament Injuries - ID: M15241 - Name: Rupture - Relevance: HIGH - As Found: Rupture - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M10738 - Name: Knee Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries - ID: D000012421 - Term: Rupture - ID: D000070598 - Term: Anterior Cruciate Ligament Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430762 **Brief Title:** Therapeutic Exposures and Risk Factors in MRONJ **Official Title:** Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw #### Organization Study ID Info **ID:** CIBON-MAR-A.1 #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2027-04-26 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Investigator Affiliation:** Marmara University **Investigator Full Name:** Ferit Bayram **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. By doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life. ### Conditions Module **Conditions:** - Medication-Related Osteonecrosis of Jaw ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** This outcome measures the overall health status and activity levels of patients with MRONJ using the Karnofsky Performance Scale (KPS). KPS rates patients on a scale from 0 to 100, where higher scores indicate greater independence and lower morbidity risk, while lower scores reflect dependency and the need for substantial medical intervention. The scale's aim is to quantify the extent to which patients can perform everyday life activities without assistance. At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken. **Measure:** Change in Karnofsky Performance Status **Time Frame:** 24 months **Description:** A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken. **Measure:** Change in Oral Health-related Quality of Life **Time Frame:** 24 months **Description:** Staging of the lesion in the mouth will be according to the definition of the American Association of Oral and Maxillofacial Surgeons (Ruggiero et al. 2022). Clinical examination will be performed at baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if necessary). **Measure:** Change in staging of MRONJ **Time Frame:** 24 months **Description:** Various biochemical markers indicative of bone metabolism and inflammatory response in patients with medication-related osteonecrosis of the jaw (MRONJ) will be evaluated. The markers include serum calcium, ionized calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, C-telopeptide (CTX), Vitamin D3, C-reactive protein (CRP), and leukocyte count. Blood samples collected at baseline will be analyzed. **Measure:** Biochemical Markers Related to Bone Metabolism and Inflammatory Response **Time Frame:** Baseline **Description:** This outcome involves utilizing the Composite Radiographic Index to track and characterize the progression of lesions in patients with medication-related osteonecrosis of the jaw. This index evaluates: * Location of the lesion: Maxilla anterior, Maxilla posterior, Mandible anterior, Mandibular posterior. * Lyric changes: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sclerosis: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Periosteal bone formation: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sequestration: Scored as 0 (None), 1 (Localized), 2 (Widespread). Radiographs will be taken at the initial visit to establish a baseline for each patient. Subsequent radiographs will be taken only if clinically indicated to monitor the presence and progression of osteonecrotic lesions. **Measure:** Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged 18 and over * Male or female individuals * Individuals who apply to the Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery due to medication-related osteonecrosis of jaw during the study period * Individuals or their legal representatives who have given written consent to participate in the study Exclusion Criteria: * Non-drug-related osteonecrosis/osteomyelitis * Osteoradionecrosis * Metastasis to the oral region * Individuals who have not given written consent to participate in the study * Individuals under the age of 18 **Healthy Volunteers:** True **Maximum Age:** 110 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population for this research comprises individuals aged 18 and over, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. The study excludes individuals with non-drug-related osteonecrosis or osteomyelitis, osteoradionecrosis, those with metastasis to the oral region, individuals who have not provided consent, and those under the age of 18. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ferit Bayram, PhD **Phone:** 00902167775000 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ferit Bayram, Ph. D. - **Phone:** 2167775074 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ahmet Akıcı, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Tunç Akkoç, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Korkut Ulucan, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Volkan Aydın, Assoc. Prof. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Gökhan Göçmen, Assoc. Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Marmara University School of Dentistry **Status:** RECRUITING **Zip:** 34854 #### Overall Officials **Official 1:** **Affiliation:** Marmara University Faculty of Dentistry **Name:** Ferit Bayram, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21. **PMID:** 35300956 **Citation:** Friendlander AH, Ettinger RL. Karnofsky performance status scale. Spec Care Dentist. 2009 Jul-Aug;29(4):147-8. doi: 10.1111/j.1754-4505.2009.00088.x. No abstract available. **PMID:** 19573040 **Citation:** Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. **PMID:** 9332805 #### See Also Links **Label:** AAOMS MRONJ staging **URL:** https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009336 - Term: Necrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12943 - Name: Osteonecrosis - Relevance: HIGH - As Found: Osteonecrosis - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010020 - Term: Osteonecrosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430749 **Acronym:** MicroPro2 **Brief Title:** Targeted Microwave Tissue Coagulation for Prostate Cancer **Official Title:** Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation #### Organization Study ID Info **ID:** CTREC-S220202 #### Organization **Class:** OTHER **Full Name:** Kyoto Prefectural University of Medicine #### Secondary ID Infos **Domain:** Japan Registry of Clincal Trials **ID:** jRCTs052240015 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Osamu Ukimura #### Responsible Party **Investigator Affiliation:** Kyoto Prefectural University of Medicine **Investigator Full Name:** Osamu Ukimura **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by microwave only in the specific area of cancer "that should be treated for saving of life"; while, leaving a portion of the normal prostate tissue that is not cancerous. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications. **Detailed Description:** This trial will to provide an ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and this trial will assess efficacy and safety endpoints for up to post-operative 6 months. This trial will assess patient quality of life (QOL) as well. ### Conditions Module **Conditions:** - Prostate Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single Group Assignment ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients. **Intervention Names:** - Device: Microtaze **Label:** Microwave Tissue Coagulation Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Microwave Tissue Coagulation Arm **Description:** Targeted Microwave Tissue Coagultion **Name:** Microtaze **Other Names:** - AFM-712 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Achievement of 1) serum marker, 2) imaging, and 3) histopathological examination, below 1. A 50% or greater reduction from the preoperative serum PSA level at postoperative 3 or 6 months 2. A reduction of PI-RADS category of the targeted prostate cancer lesion down to 3 or lower (Including 'difficult to judge' and 'change after treatment') at MRI images at postoperative 6 months 3. No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy of the prostate performed at postoperative 6 months **Measure:** Disappearance of cancer at 6 month after microwave coagulation evaluated by combination of the responses in PSA, MRI, and Prostate biopsy **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients who have a single lesion of PI-RADS category 3 or 4 lesion on MRI image at enrollment and which is proved as a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a single lesion of PI-RADS category 4 or 5 lesion on MRI image at enrollment and which is proved as a Gleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment 2. Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment 3. Patients between the ages of 20 and 85 when providing consent to participate in this trial 4. Patients from whom consent is obtained prior to enrollment in this trial Exclusion Criteria: 1. Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images at enrollment and which is a diameter of less than 10 mm and Gleason score of 6 on the histopathology of the prostate needle biopsy at enrollment (the lesion is referred to as 'non-target lesions') (the diameter of the lesion is defined as the longer one of the lesion diameter identified on MRI images at enrollment or the tumor length as measured on histopathology of prostate needle biopsy) 2. Patients to have 4 or more non-target lesions (non-target lesions are defined as the lesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRI image at enrollment and Gleason score 6 on biopsy at enrollment) 3. Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment and Gleason score 8 on histopathology of prostate needle biopsy at enrollment (the lesion is referred 'excluded lesions') 4. Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment 5. Patients in whom the distance from the target prostate cancer lesion to the rectum is 10 mm or less on MRI images (coronal or sagittal) obtained during enrollment 6. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment 7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment 8. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment 9. Patients with active multiple cancers 10. Patient who wear a pacemaker 11. Patients for whom MRI scans are contraindicated 12. Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum 13. Patients with a prothrombin time\<50% or platelet count\<60,000/mm3 during enrollment 14. Patients deemed to be ineligible by an investigator **Maximum Age:** 85 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Osamu Ukimura, Professor **Phone:** +81 75 251 5595 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Toshiko Ito-Ihara, M.D. **Phone:** +81 75 251 5308 **Role:** CONTACT #### Locations **Location 1:** **City:** Kyoto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Osamu Ukimura, M.D., Ph.D. - **Phone:** +81 75 251 5595 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Toshiko Ito-Ihara, M.D., Ph.D. - **Phone:** +81 75 251 5308 - **Role:** CONTACT **Country:** Japan **Facility:** Kyoto Prefectural University of Medicine **Status:** RECRUITING **Zip:** 602-8566 #### Overall Officials **Official 1:** **Affiliation:** Kyoto Prefectural University of Medicine **Name:** Osamu Ukimura, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### 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:** NCT06430736 **Acronym:** PRONTO **Brief Title:** PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab) **Official Title:** Prospective Comparison Between Prophylactic and On-demand Use of Tocilizumab in CAR-T Recipients - a Randomized, Two Arm, Open-label, Single-center Trial #### Organization Study ID Info **ID:** PRONTO #### Organization **Class:** OTHER **Full Name:** Insel Gruppe AG, University Hospital Bern ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Insel Gruppe AG, University Hospital Bern #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients. This study aims to identify safety and efficacy of prophylactic Tocilizumab treatment. In particular, to explore whether prophylactic Tocilizumab treatment can decrease the incidence and severity of CRS (and subsequent eventual neurotoxicity) following CAR-T-treatment. **Detailed Description:** Adoptive immunotherapy with CD19 (cluster of differentiation antigen 19) targeting chimeric antigen-receptor (CAR-)T cells is an effective therapeutic strategy against relapsed or refractory B-cell malignancies, including B-cell lymphomas, B-ALL (acute lymphoblastic leukemia) and myeloma. Currently, up to 50 commercial CAR-T-cell treatments are performed annually at the Inselspital in Bern, making it by far the largest center for CAR-T cell treatment in Switzerland. CAR-T treatment is associated with well-described acute adverse events, including cytokine release syndrome (CRS) and neurotoxicity, termed immune effector cell associated neurologic syndrome (ICANS). CRS (at all grades) occurs in between 42 to 93% of all patients with variations among available products, and ICANS can occur (at all grades) in 21% up to 64%. Acute complications of CAR-T cell therapy are the result of rapid CAR-T cell expansion and of a hyper-inflammatory state related to cell activation. Interleukin (IL-6) is a central mediator of cytokine-responses in CRS and ICANS together with other cytokines and chemokines involved. IL-6 interacts with its receptor (IL-6R) in either membrane-bound form, leading to "classic" IL-6 signaling after interacting with GP130, or soluble in plasma, where the IL-6 / IL-6R complex interacts with GP130 expressing cells in "trans" IL-6 signaling. Tocilizumab is a humanized monoclonal antibody that binds the IL-6R in both its soluble and membrane-bound forms. Tocilizumab treatment has become the standard of care for patients presenting with CRS (at all grades), together with antipyretic treatment (grades 1 or 2 at the regular ward) or with vasoactive and/or ventilation support at the intensive care unit (grades 3 and 4). The study aims to assess the incidence of CRS of all grades, as well as the incidence of ICANS of all grades, the duration of hospitalisation and the need of platelet and erythrocyte transfusion within the first three months after CAR-T treatment in patients receiving prophylactic Tocilizumab compared to patients receiving on-demand Tocilizumab. ### Conditions Module **Conditions:** - Myeloma - Lymphoma - Leukemia **Keywords:** - Tocilizumab - Myeloma - Leukemia - Lymphoma - CRS - ICANS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, two arm, open-label, single-center trial. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the experimental arm, patients will receive a single standard dose of Tocilizumab (Actemra®) 8 mg/kg b.w. intravenously infused over 1 hour in 250 ml NaCl 0.9%, with completion of the infusion 1 hour prior to the infusion of the CAR-T cells. Prior to Tocilizumab administration, no specific premedication is given. The treatment of eventual subsequent CRS will be identical as in patients in the standard arm. **Intervention Names:** - Drug: Tocilizumab before CAR-T cell infusion **Label:** Tocilizumab prophylactic **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the standard arm, patients will receive conventional antipyretics and Tocilizumab at first clinical signs (being grade 1 or higher) of emerging CRS. Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously over one hour in 250 ml NaCl 0.9%, and it will be repeated after 8 hours for a maximum of four administrations in patients with ongoing signs of CRS. Prior to Tocilizumab administration, no specific premedication is given. **Intervention Names:** - Drug: Tocilizumab at emerging CRS **Label:** Tocilizumab on demand **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tocilizumab prophylactic **Description:** Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, with completion of the infusion 1 hour prior to infusion of CAR-T cells. Treatment of eventual subsequent CRS/ICANS will be identical as in patients in the standard arm. **Name:** Tocilizumab before CAR-T cell infusion **Other Names:** - Prophylactic **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tocilizumab on demand **Description:** Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, and it will be repeated after 8 hours for a maximum of four administrations in patients with ongoing signs of CRS. **Name:** Tocilizumab at emerging CRS **Other Names:** - On demand **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of patients with CRS of any grade according to the ASTCT (American Society for Transplantation and Cellular Therapy ) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics **Measure:** Incidence of CRS of all grades **Time Frame:** 30 days #### Secondary Outcomes **Description:** Number of patients with ICANS of any grade according to the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics **Measure:** Incidence of ICANS of all grades **Time Frame:** 30 days **Description:** Number of days from admission to discharge from hospital **Measure:** Hospitalization duration **Time Frame:** 30 days **Description:** Number of transfusion (erythrocyte) given **Measure:** Erythrocyte transfusion needs **Time Frame:** 90 days **Description:** Number of transfusion (platelet) given **Measure:** Platelet transfusion needs **Time Frame:** 90 days **Description:** Number of admissions to the intensive care unit **Measure:** Incidence of admissions to the intensive care unit **Time Frame:** 30 days **Description:** Number of infections per patient **Measure:** Incidence of infections **Time Frame:** 90 days **Description:** Overall survival assessment are based on physician's reporting of the assessments of the various disease types involved at day 90 and day 180 **Measure:** Overall survival rates **Time Frame:** 180 days **Description:** Relapse assessment are based on physician's reporting of the assessments of the various disease types involved at day 90 and day 180 **Measure:** Progression-free survival rates **Time Frame:** 180 days **Description:** daily assessment of IL-6 during the hospitalisation and at day 90 and day 180 **Measure:** IL-6 to monitor CRS **Time Frame:** 180 days **Description:** Peripheral molecular DNA CAR-T level measurement performed at day 0, day 8 and once a month during months 2 to 6 **Measure:** Peripheral molecular CAR-T levels **Time Frame:** 180 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients planned to receive commercial CAR-T treatment for all registered indications comprising lymphomas, leukemias or myeloma at a single academic center (Bern Inselspital) * With written informed consent * Considered by the investigator to be clinically fit for this treatment * Patients aged ≥18 years Exclusion Criteria: * Previous Tocilizumab treatment within 3 months prior to CAR-T infusion * Patients with treatment with an investigational compound within 8 weeks prior to CAR-T infusion * Women who are pregnant or breast feeding, or women intending to become pregnant during the study period; or participants lacking safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases during study treatment and for a total of 12 months; Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Thomas Pabst, Prof. **Phone:** +41 31 632 84 30 **Role:** CONTACT #### Locations **Location 1:** **City:** Bern **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Thomas Pabst, Prof. - **Phone:** 0041316328430 - **Role:** CONTACT **Country:** Switzerland **Facility:** Insel Gruppe AG **State:** BE **Zip:** 3010 #### Overall Officials **Official 1:** **Affiliation:** Insel Gruppe AG Bern Switzerland **Name:** Thomas Pabst, Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** email contact: [email protected] **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** 24 months ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M12058 - Name: Multiple Myeloma - Relevance: LOW - As Found: Unknown - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000007938 - Term: Leukemia ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430723 **Brief Title:** The Impact of Obesity on Short Stem Total Hip Arthroplasty **Official Title:** Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip #### Organization Study ID Info **ID:** EK 1258/2023 #### Organization **Class:** OTHER **Full Name:** Krankenhaus Barmherzige Schwestern Linz ### Status Module #### Completion Date **Date:** 2024-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Krankenhaus Barmherzige Schwestern Linz #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty. **Detailed Description:** Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain. While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends. In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA. ### Conditions Module **Conditions:** - THA - Obesity **Keywords:** - subsidence - obesity - short stem total hip arthroplasty - tha ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 216 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Body mass index \< 30 kg/m2 **Intervention Names:** - Procedure: Total hip arthroplasty **Label:** Non-obese #### Arm Group 2 **Description:** Body mass index \>= 30 kg/m2 **Intervention Names:** - Procedure: Total hip arthroplasty **Label:** Obese ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-obese - Obese **Description:** Total hip arthroplasty using short stem via an minimally invasive anterolateral approach **Name:** Total hip arthroplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), \[mm\] **Measure:** Subsidence **Time Frame:** 2 years **Description:** Clinical outcome, \[0-100points\] **Measure:** Harris Hip Score **Time Frame:** 2 years #### Secondary Outcomes **Description:** Surgery time from cut to skin closure, \[minutes\] **Measure:** surgery time **Time Frame:** 2 years **Description:** Length of postoperative stay in hospital \[days\] **Measure:** Length of stay **Time Frame:** 2 years **Description:** Blood loss calculated according to laboratory test results of hematocrit \[ml\] **Measure:** Blood loss **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020 2. availability of preoperative and postoperative radiographs for assessment of subsidence 3. a minimum BMI of 30kg/m2 for the obese group 4. a minimum follow-up of 24 months. Exclusion Criteria: 1. former surgeries of the hip in question 2. incomplete clinical data 3. incomplete radiological data **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m\^2) and non-obese (BMI \< 30 kg/m\^2), with an age of minimum 18 years, but no maximum age. ### Contacts Locations Module #### Locations **Location 1:** **City:** Linz **Country:** Austria **Facility:** Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie **Zip:** 4010 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430710 **Brief Title:** Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite **Official Title:** Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect #### Organization Study ID Info **ID:** ORTHO-109-2H #### Organization **Class:** OTHER_GOV **Full Name:** Faculty of Dental Medicine for Girls ### Status Module #### Completion Date **Date:** 2024-03-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-02 **Type:** ACTUAL #### Start Date **Date:** 2022-09-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Faculty of Dental Medicine for Girls #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite **Detailed Description:** this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) \[miniscrew\] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period. ### Conditions Module **Conditions:** - Deep Overbite **Keywords:** - Anterior deep bite - Intrusive arch - Miniscrews ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Miniscrews for incisor intrusion **Intervention Names:** - Device: Intrusion **Label:** Mninscrew **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Continuous arch technique for incisor intrusion **Intervention Names:** - Device: Intrusion **Label:** Intrusive arch **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intrusive arch - Mninscrew **Description:** 2 different methods for incisor intrusion **Name:** Intrusion **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** measure in mm the distance of apical movement **Measure:** Measure distance of insicors intrusion **Time Frame:** 2 years #### Secondary Outcomes **Description:** By unit on Visual Analogue Scale **Measure:** Pain intensity **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Class I or Class II malocclusion with minimal crowding. 2. 70% to 100% overbite. 3. High lip line with gingival display on smiling and super-eruption of maxillary incisors. 4. All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less. Exclusion Criteria: 1. Having missing teeth on the anterior maxillary area. 2. Any history of trauma or root canal treatment. 3. Previous orthodontic treatment. 4. Low lip line duing social smile. 5. Having any hormonal disorder or syndromes. **Healthy Volunteers:** True **Maximum Age:** 22 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Al-Azhar University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008310 - Term: Malocclusion - 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M28896 - Name: Overbite - Relevance: HIGH - As Found: Overbite - ID: M11303 - Name: Malocclusion, Angle Class II - Relevance: HIGH - As Found: Overbite - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M11301 - Name: Malocclusion - 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: D000057887 - Term: Overbite - ID: D000008312 - Term: Malocclusion, Angle Class II ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430697 **Acronym:** PAREA **Brief Title:** Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA] **Official Title:** Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit #### Organization Study ID Info **ID:** 22-AOI-13 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nice #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...) ### Conditions Module **Conditions:** - Intensive Care Unit Syndrome **Keywords:** - Intensive Care Unit - PARACETAMOL - blood pressure ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: paracetamol administration **Label:** Treatment with paracetamol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment with paracetamol **Description:** Patient hospitalized in Intensive Care Unit with a continuous measurement of blood pressure with a catheter and who have an administration of paracetamol by intravenous or per os **Name:** paracetamol administration **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients with clinically significant low blood pressure occurring within one hour of administration of paracetamol IV or per os. Clinically significant low blood pressure is defined as an average blood pressure of less than 60 mmHg and/or a decrease in average blood pressure of more than 15%, and/or need for vascular filling and/or initiation or increase of the dose of noradrenaline **Measure:** Measure frequency of low blood pressure following paracetamol administration **Time Frame:** One hour after administration of paracetamol #### Secondary Outcomes **Description:** Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to The IGS II score (Simplified Severity Index II) is a score used to assess the severity of a patient and is one of the scores used in intensive care and SOFA score. Components: The IGS II includes several variables, such as age, chronic health conditions, vital signs, and laboratory values. These factors are combined to calculate a numerical score. Scoring: The higher the IGS II score, the greater the predicted risk of mortality. The score ranges from 0 to 100, with higher values indicating more severe illness. **Measure:** Measure of blood pressure following paracetamol administration according to IGS II score **Time Frame:** One hour after administration of paracetamol **Description:** Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to administration's route **Measure:** identify predictors linked to paracetamol administration route **Time Frame:** One hour after administration of paracetamol **Description:** Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to dosage **Measure:** identify predictors linked to paracetamol dosage **Time Frame:** One hour after administration of paracetamol **Description:** Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to the SOFA score. The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score,is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. Each system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables are collected serially every 24 hours of a patient's ICU admission12. The total SOFA score ranges from 0 (best) to 24 (worst) points. It's a valuable tool for predicting clinical outcomes in critically ill patients **Measure:** Measure of blood pressure following paracetamol administration according to SOFA score **Time Frame:** One hour after administration of paracetamol ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion: * 18 years of age or older * Patient with arterial catheter * Indication of paracetamol's administration by the patient's attending practitioner. * No opposition to patient or support person participation in the study if the patient is unable to participate ExclusionCriteria: * No Social Security Patient * Pregnant or nursing patient. * Patient with a legal protection measure * Hypersensitivity and/or allergy to paracetamol. * Contraindication to the use of paracetamol. * Patient opposition to health data collection. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kamila BURDZENIDZE, Study nurse **Phone:** 04 92 03 92 20 **Role:** CONTACT #### Locations **Location 1:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kamila BURDZENIDZE, Study nurse - **Phone:** 04 92 03 92 20 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kamila BURDZENIDZE - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE ARCHET **Zip:** 06000 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - 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: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2340 - Name: Acetaminophen - Relevance: HIGH - As Found: Vaginal - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000082 - Term: Acetaminophen ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430684 **Acronym:** SGLT2I-IN-KIDS **Brief Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease **Official Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease #### Organization Study ID Info **ID:** SGLT2I-IN-KIDS #### Organization **Class:** OTHER **Full Name:** Ann & Robert H Lurie Children's Hospital of Chicago #### Secondary ID Infos **ID:** K23DK138313 **Link:** https://reporter.nih.gov/quickSearch/K23DK138313 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Ann & Robert H Lurie Children's Hospital of Chicago #### Responsible Party **Investigator Affiliation:** Ann & Robert H Lurie Children's Hospital of Chicago **Investigator Full Name:** Alexander Kula **Investigator Title:** Assistant Professor of Pediatrics (Nephrology) **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are: 1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)? 2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests? Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care. Study Procedures Include * For participants randomly selected for treatment, take empagliflozin once daily for 3 months * Phone calls with researchers every 2 weeks for check-ins * For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests * All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests ### Conditions Module **Conditions:** - Chronic Kidney Diseases - Pediatric Kidney Disease **Keywords:** - Sodium Glucose Co-Transporter 2 Inhibitor - SGLT2i - Pediatric CKD - Feasibility Study - Clinical Trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Empagliflozin 10mg daily for 3 months (n=20) **Intervention Names:** - Drug: Empagliflozin 10 MG **Label:** Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will not take empagliflozin (n=20) **Label:** Standard of Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment **Description:** Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older **Name:** Empagliflozin 10 MG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Compared to the number recruited, how many participants complete the study **Measure:** Percentage of participants who complete all study procedures **Time Frame:** 4 years #### Secondary Outcomes **Description:** In-clinic systolic blood pressure **Measure:** Systolic Blood Pressure **Time Frame:** 3 months **Measure:** Serum N-terminal pro-brain natruetic peptide (NT-proBNP) **Time Frame:** 3 months **Measure:** Urine Albumin to Creatinine Ratio (UACr) **Time Frame:** 3 months **Description:** Measuring using echocardiography **Measure:** Left Atrial Reservoir Strain **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2 Exclusion Criteria: * Heart Disease * Diabetes * Pregnancy * Recipient of solid organ transplant * history of chemotherapy or stem cell transplant * moderate to severe persistent asthma * liver disease * class 2 or greater obesity * inability to follow study procedures due to cognitive impairment * obstructive uropathy or requirement for intermittent urinary catheterization * systolic blood pressure \<100mgHg * orthostatic hypotension * current use of an SGLT2i * anticipated need for titration of anti-hypertensives within 3 months * active use of any immunosuppressive medications * lack of clearance by primary nephrologist for participation **Maximum Age:** 25 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexander J Kula, MD, MHS **Phone:** 312-227-6160 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexander J Kula, MD, MHS - **Phone:** 312-227-6160 - **Role:** CONTACT **Country:** United States **Facility:** Ann & Robert H. Lurie Children's Hospital of Chicago **State:** Illinois **Zip:** 60611 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M258082 - Name: Empagliflozin - Relevance: HIGH - As Found: Part 1 - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000570240 - Term: Empagliflozin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430671 **Acronym:** RED4MS **Brief Title:** Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis **Official Title:** Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial #### Organization Study ID Info **ID:** MSB-IG-H-2101 #### Organization **Class:** INDUSTRY **Full Name:** Cellerys AG ### Status Module #### Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Novartis **Class:** INDUSTRY **Name:** Scope International AG **Class:** INDUSTRY **Name:** Tetec AG **Class:** INDUSTRY **Name:** Jung Diagnostics GmbH #### Lead Sponsor **Class:** INDUSTRY **Name:** Cellerys AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance. **Detailed Description:** The RED4MS trial is designed as a combination of a phase Ib (part A) and a phase IIa (part B) study. Part A is an open-label, dose-escalation study, enrolling 9 RRMS patients in three ascending dose groups. The first patient (sentinel) in each dose group will receive one cycle of the therapy, while the remaining patients will receive two treatment cycles. Part B is a baseline-to-treatment, dose-blinded, randomized study and is designed to test the safety and efficacy of three different doses of CLS12311. During baseline phase, a total of 45 patients with active disease on magnetic resonance imaging (MRI) will be selected for the treatment phase and randomized in a 1:1:1 ratio into one of three dosing groups. Each patient will receive two cycles of therapy. ### Conditions Module **Conditions:** - Relapsing-remitting Multiple Sclerosis (RRMS) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Individual patients will be assigned to three parallel dose groups. In Part A patients will be allocated in the low, medium, high dose group according to the order of recruitment. In Part B patients will be randomized in a ratio 1:1:1 into one of the three dosing groups. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Part A is an open label Phase I trial Part B is randomized, dose-blinded Phase II trial **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 135 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Low dose CLS12311 **Intervention Names:** - Drug: CLS12311 low - Drug: uncoupled RBCs **Label:** CLS12311 low **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Medium dose CLS12311 **Intervention Names:** - Drug: CLS12311 medium - Drug: uncoupled RBCs **Label:** CLS12311 medium **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** High dose CLS12311 **Intervention Names:** - Drug: CLS12311 high **Label:** CLS12311 high **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CLS12311 low **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 low **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - CLS12311 medium **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 medium **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - CLS12311 high **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 high **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - CLS12311 low - CLS12311 medium **Description:** autologous Red Blood Cells (RBCs) **Name:** uncoupled RBCs **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number and severity of adverse events (AEs) and serious adverse events (SAEs) and worsening of disease measured by clinical (relapses) and imaging (number \& size of brain MRI lesions) **Measure:** Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** The cumulative number of new brain lesions on the MRI scans developed in the post-treatment phase during weeks 16-24 compared to pre-treatment number of new brain lesions developed during weeks -8 and 0 for any dose **Measure:** Overall reduction in the number of new brain lesions in treatment phase vs. pre-treatment phase [Efficacy of CLS12311] **Time Frame:** completion of treatment phase, on average 24 weeks #### Secondary Outcomes **Description:** Number and severity of treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) in each dose group **Measure:** Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Number of confirmed relapses in the treatment phase in each dose group **Measure:** Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Expanded Disability Status Scale (EDSS) in each dose group **Measure:** Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Timed 25-Foot Walk (T25-FW) in each dose group **Measure:** Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in 9-Hole Peg Test (9-HPT) in each dose group **Measure:** Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Symbol Digit Modalities Test (SDMT) in each dose group **Measure:** Incidence of patients experiencing worsening of SDMT in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Number of new lesions on brain MRI in weeks 16-24 in each dose group **Measure:** Efficacy of CLS12311 in reducing number of new brain lesions as a surogate for inflammatory disease activity **Time Frame:** completion of treatment phase, on average 24 weeks **Description:** Number of new brain lesions in defined subgroups, stratified for HLA or immunological parameters through the treatment phase **Measure:** Efficacy of CLS12311 in reducing the number of new brain lesions in defined subgroups **Time Frame:** completion of treatment phase, on average 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria (Part A and B): 1. RRMS according to the 2017 McDonald criteria 2. Male or female patients (assigned at birth) aged 18-55 years inclusive 3. Disease duration (since diagnosis) \<10 years 4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5 5. ≥1 relapse or new CEL/T2 in previous 12 months (only Part B) 6. Untreated patients or patients being off therapy for the time-periods listed under exclusion criterion No. 2. Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators 7. Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a highly effective method of contraception throughout the treatment phase or at least for 4 weeks after the last dose of the study drug 8. Male patients willing to use contraception (such as a condoms) throughout the treatment phase or at least for 4 weeks after the last dose of the study drug, unless surgically steril Exclusion Criteria (Part A and B): 1. Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency) 2. Prior treatment with any of the medications specified in the protocol 3. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis 4. Long-Covid19 syndrome 5. History of splenectomy or chronic liver disease 6. History of coronary artery disease, chronic heart failure, aortic stenosis 7. Current anticoagulation therapy 8. Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure according to the International Society of Hypertension (ISH) guidelines) despite treatment or without treatment 9. History of stroke 10. Pregnant female confirmed by a positive pregnancy test or breast-feeding 11. History of alcohol or drug abuse within the 1 year prior to screening visit 1 12. History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ 13. History of or existing relevant central nervous system disorder (other than MS) 14. Allergy to gadolinium-based contrast agents 15. Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures. 16. Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5-12.5 g/dl in females and 12.5-13.5 g/dl in males) 17. Erythrocyte count \<4.0 E12/L in female and \<4.5 E12/L in male patients (may be repeated if \>3.8 E12/L in female and \>4.3 E12/L in male) 18. Lymphopenia with total lymphocyte counts ≤1000/µl (may be repeated if \>800/µl) 19. Positive HIV testing 20. Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection 21. Patient is not eligible for blood donation according to local regulations 22. Having one or more of the following laboratory results: 1. Estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2) 2. ALT or AST \>3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN) 3. Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease 4. Platelet count ≤100x109/L (may be repeated if 80-100x 109/L) 5. Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andreas Lutterotti, MD **Phone:** +41 41 544 98 80 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nathalie Fournichot **Phone:** +41 41 544 98 80 **Role:** CONTACT ### IPD Sharing Statement Module **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 ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M22314 - Name: Multiple Sclerosis, Relapsing-Remitting - Relevance: HIGH - As Found: Relapsing Remitting Multiple Sclerosis - 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 ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000020529 - Term: Multiple Sclerosis, Relapsing-Remitting - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430658 **Acronym:** NEXUS-2 **Brief Title:** Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer **Official Title:** NEoadjuvant Total rX for Borderline Unresectable Esophageal Squamous Cell Carcinoma: a Prospective Randomized, Three-Arm, Open-Label Phase II Trial (NEXUS-2) #### Organization Study ID Info **ID:** NEXUS-2 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** YIN LI **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:** Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy. This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC. ### Conditions Module **Conditions:** - Esophagus Cancer **Keywords:** - Esophagus Cancer - Chemoradiotherapy - conversion surgery - immunotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Surgery was evaluated after chemoradiotherapy (40-41.4Gy/1.8-2Gy/20-23 fractions) followed by two cycles of chemotherapy and immunotherapy **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** ChemoRT+Immuno **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Surgery was evaluated after two cycles of chemotherapy and immunotherapy followed by chemoradiotherapy(40-41.4Gy/1.8-2Gy/20-23 fractions) **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** Immuno+ChemoRT **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Surgery was evaluated after concurrent definitive chemoradiotherapy (50-50.4Gy/1.8-2Gy/25-28fractions) and immunotherapy. **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** ChemoRT **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ChemoRT - ChemoRT+Immuno - Immuno+ChemoRT **Description:** Different sequences and methods of treatment to convert surgery **Name:** Tislelizumab (BGB-A317) with chemoradiotherapy **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm. **Measure:** R0 resection rate **Time Frame:** 4 months #### Secondary Outcomes **Description:** Defined as the proportion of patients still alive within one year from treatment initiation. **Measure:** 1-year OS rate **Time Frame:** 1 year after all treatment **Description:** Defined as the proportion of patients without disease progression or death within one year from treatment initiation. **Measure:** 1-year PFS **Time Frame:** 1 year after all treatment **Description:** To investigate whether ctDNA variation can be used for MRD monitoring in patients with unresectable locally advanced ESCC. **Measure:** Efficacy of circulating tumor DNA (ctDNA) in minimal residual disease (MRD) monitoring **Time Frame:** 6 month **Description:** Adverse event during chemoRT or immunotherapy **Measure:** Safety profile **Time Frame:** 4 month **Measure:** Pathological response **Time Frame:** 4 month **Measure:** Postoperative complications **Time Frame:** 4 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed sorely ESCC without other histology subtypes. 2. Thoracic esophageal cancer. 3. No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy. 4. Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI). 5. The Karnofsky Performance Scale (KPS) ≥70. 6. Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\*9/L; neutrophil count (NEUT) ≥ 1.5×10\*9/L; platelets (PLT) ≥ 100×10\*9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL. Exclusion Criteria: 1. Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. Patients have undergone any type of anti-cancer treatment. 3. Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases. 4. Investigators assessed major vessel involvement with high-risk hemorrhage. 5. A higher probability of esophageal perforation during conversion therapy. 6. Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus. 7. Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents. 8. Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery. 9. Pregnant or lactating women and women of childbearing potential who lacked effective contraception. 10. Non-compliance with the inclusion criteria judged by investigators. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xin Wang, Doctor **Phone:** 13311583220 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ziyu Zheng, B.M **Phone:** 13552252161 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xin Wang, MD - **Phone:** +861013311583220 - **Role:** CONTACT **Country:** China **Facility:** Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) **Status:** RECRUITING **Zip:** 100021 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophagus Cancer - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - 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: Esophagus Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Meet - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06430645 **Brief Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia **Official Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia #### Organization Study ID Info **ID:** esketamine_2024 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ruquan Han **Investigator Title:** Director of Anesthesiology Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Esketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor different from other gamma-aminobutyric acid (GABA) receptor agonists. Recent studies showed that subanesthetic doses of ketamine not only deepen anesthesia but also accelerate recovery from isoflurane anesthesia in mice. It is necessary to verify if it applies to human. Besides inducing behavioral unresponsiveness, an optimal and important goal of general anesthesia is to prevent connected consciousness. The results of many studies support the conclusion that anesthesia-related unconsciousness is a consistent functional disconnection of lateral frontoparietal networks.The goal of this clinical trial is to learn if subanaesthetic doses of esketamine works to accelerate the recovery of consciousness from propofol anesthesia. It will also learn about the change of brain network when administrated the esketamine during propofol anesthesia. The main questions it aims to answer are: 1. Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia? 2. What will happen to brain network connection after different doses of esketamine during propofol anesthesia? ### Conditions Module **Conditions:** - Post-anesthesia Recovery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug：esketamine (0.3mg/kg) **Intervention Names:** - Drug: Esketamine **Label:** low dose of esketamine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Drug：esketamine(0.6mg/kg) **Intervention Names:** - Drug: Esketamine **Label:** high dose of esketamine **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Drug：0.9% saline **Intervention Names:** - Drug: Saline **Label:** control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - low dose of esketamine **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.3mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. **Name:** Esketamine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - high dose of esketamine **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.6mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. **Name:** Esketamine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - control group **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). The same volume of 0.9% saline instead of esketamine will be given to the control group after stable plasma concentration of propofol deep sedation. **Name:** Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Recovery time will be defined as the time from terminating propofol administration to opening eyes to verbal stimuli (participants addressed by name) or, if necessary, mild tactile stimuli (a tap in the shoulder) every 30 seconds. **Measure:** Recovery time **Time Frame:** 2 hours #### Secondary Outcomes **Description:** The task includes process-dissociation procedure with the word-stem completion. The value ranges from -1 to 1. If the value is less than or equal to 0, it means no memory. If the value is more than 0, it means memory is detected. **Measure:** Explicit memory scores and implicit memory scores **Time Frame:** 2 hours **Description:** The judges of structured interviews includes three main categories: reports of no recall of any experiences, white reports and reports with specific content. **Measure:** Subjective experience report **Time Frame:** 2 hours **Description:** Time to complete the Grooved Pegboard Test with dominant and non-dominant hand. **Measure:** Grooved Pegboard Test points **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Patients state index **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Spectral edge frequency **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Burst suppression duration **Time Frame:** 2 hours **Description:** Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain. **Measure:** Original EEG **Time Frame:** 2 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged from 18 years to 50 years * Patients scheduled for elective operative hysteroscopy * Willing to sign informed consent Exclusion Criteria: * Contraindications of propofol and esketamine * Contraindications for EEG; * ASA≥III; * BMI≥30 kg/m2 or BMI\<18 kg/m2; * The MMSE scale score is lower than the normal value; * Alcohol or drug abuse; * Untreated or under-treated hypertension, hyperthyroidism, risk of increased intracranial pressure, audio-visual impairment, history of psychiatric disorders or neurological diseases, malignant tumors or other major diseases; * Use of other neurological drugs or drugs known to interact with propofol and esketamine in the past 2 weeks; * Pregnant and lactating women; * The operation duration is shorter than 15 minutes or longer than 60 minutes. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yang Li, Master **Phone:** +86 18810637134 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ruquan Han, Ph.D - **Phone:** 86-13701285393 - **Role:** CONTACT **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **State:** Beijing **Status:** RECRUITING **Zip:** 100070 #### Overall Officials **Official 1:** **Affiliation:** Beijing Tiantan Hospital **Name:** Ruquan Han, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Days per week - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M8608 - Name: Flurbiprofen - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown - ID: M256863 - Name: Flurbiprofen axetil - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-05-31