[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Asian Institute Of Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100633026","phase-4-apixaban-pk-trial-preventing-portal-hypertension-complications-in-cirrhosis-100633026",false,"NCT07521332","Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis","Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan","APIXABAN-PK","Inclusion Criteria:\n\n1. Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical\u002Fimaging findings.\n2. Evidence of portal hypertension, defined by:\n\n   Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia.\n3. Compensated or early decompensated cirrhosis (Child-Pugh B 7-10), with stable liver function defined as no change in Child-Pugh score \\>1 point in the preceding 3 months.\n4. Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale signs, or history of variceal bleeding) must undergo endoscopic variceal band ligation to obliteration before randomization.\n5. Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Active gastrointestinal bleeding within 6 weeks prior to enrollment.\n2. High bleeding risk:\n\n   * Platelet count \\\u003C50,000\u002FµL at baseline\n   * INR \\>1.8 (or \\>2.0 if secondary to cirrhosis without additional coagulopathy)\n   * Active peptic ulcer disease\n   * History of intracranial hemorrhage or hemorrhagic stroke\n   * Known bleeding diathesis\n3. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or on dialysis.\n4. Child-Pugh class C or Child-Pugh score ≥10.\n5. History of hypersensitivity to apixaban or carvedilol.\n6. Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.\n7. Concurrent anticoagulant or antiplatelet therapy (including aspirin, clopidogrel, warfarin, or other DOACs) that cannot be safely discontinued. A washout period of at least 5 half-lives is required before randomization.\n8. Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.\n9. Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.\n10. Current or planned liver transplantation.","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing portal hypertension-related complications in patients with cirrhosis. Conducted at the Gastroenterology and Hepatology Department and Clinical Trials Unit (CTU) of Asian Institute of Medical Sciences (AIMS) Hospital, Hyderabad, Pakistan, the trial will enroll eligible cirrhotic patients with portal hypertension. Participants will be followed for 12 months to monitor hepatic decompensation events, variceal bleeding, portal vein thrombosis, and mortality, while safety and tolerability of apixaban will be closely assessed. This study aims to provide local evidence for apixaban use in cirrhosis management in Pakistan.",[27,28,29,30,31,32],"Cirrhosis","Esophageal and Gastric Varices","Ascites","Hepatic Encephalopathy","Portal Vein Thrombosis","Portal Hypertension",[34,35,36,37,38,39,40,41,42,43,44,45,46,47],"apixaban","carvedilol","cirrhosis","portal hypertension","direct oral anticoagulant","variceal bleeding","hepatic decompensation","portal vein thrombosis","randomized controlled trial","Pakistan","Factor Xa Inhibitor","non-selective beta-blocker","prevention","liver disease","RECRUITING","2026-04-03",{"date":51,"type":52},"2026-04-09","ACTUAL",{"date":54,"type":52},"2026-04-01",{"date":56,"type":21},"2028-04-01",{"name":58,"class":59},"Asian Institute Of Medical Sciences","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":60},"100632398","phase-4-low-dose-semaglutide-for-weight-loss-in-obese-non-diabetic-pakistani-adults-100632398","NCT07513168","Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults","Efficacy and Safety of Low-Dose Semaglutide for Weight Loss and Cardiometabolic Improvement in Obese Pakistani Adults Without Type 2 Diabetes: A Single-Arm Open-Label Single-Center Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Body mass index (BMI ≥ 27.5 kg\u002Fm²) according to WHO Asian cut-offs.\n* No diagnosis of type 2 diabetes mellitus, confirmed by:\n\nFasting blood glucose \\\u003C 126 mg\u002FdL, and HbA1c \\\u003C 6.5% within three months prior to enrollment.\n\n* Willingness and ability to provide written informed consent.\n* Willingness to comply with study procedures, including weekly injections and lifestyle counseling.\n\nExclusion Criteria:\n\n* History of pancreatitis.\n* History or presence of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2).\n* Pregnant or lactating women.\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or hepatic impairment (ALT or AST \\> 3× upper limit of normal).\n* Current use of other anti-obesity medications.\n* Known hypersensitivity to semaglutide or any component of the formulation.\n* Any condition that, in the investigator's opinion, would interfere with participation, adherence, or safety in the study.",{"count":69,"type":21},60,[24],"This prospective, open-label, single-arm, single-center interventional pilot trial aims to evaluate the efficacy and safety of low-dose semaglutide for weight loss and cardiometabolic improvement in obese Pakistani adults without type 2 diabetes mellitus. The study will be conducted at the Asian Institute of Medical Sciences (AIMS), Hyderabad, Sindh, Pakistan. A total of 60 obese adults aged 18 years or older with a body mass index (BMI) of 27.5 kg\u002Fm² or greater according to World Health Organization Asian cutoffs and without type 2 diabetes mellitus (fasting blood glucose \\\u003C126 mg\u002FdL and HbA1c \\\u003C6.5%) will be enrolled. Eligible participants will receive once-weekly subcutaneous semaglutide following a standard dose titration schedule of 0.25 mg weekly for four weeks, 0.5 mg weekly for four weeks, and 1.0 mg weekly for the remaining 16 weeks, for a total treatment duration of 24 weeks. All participants will receive standardized lifestyle counseling, including a hypocaloric diet with a 500-750 kcal\u002Fday deficit and at least 150 minutes per week of moderate-intensity physical activity. The primary outcome is the percentage change in body weight from baseline to 24 weeks. Secondary outcomes include changes in body mass index, waist circumference, systolic and diastolic blood pressure, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), liver enzymes (alanine aminotransferase and aspartate aminotransferase), and quality of life. Safety will be assessed through continuous monitoring of adverse events and adverse drug reactions with causality assessment using the Naranjo Adverse Drug Reaction Probability Scale. Clinical and laboratory assessments will be conducted at baseline, 12 weeks, and 24 weeks. Data will be analyzed using descriptive and inferential statistics, including paired t-tests or non-parametric equivalents and repeated measures analysis, with a significance level of p \\\u003C 0.05. The study will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki, with approval from the AIMS Institutional Review Board and written informed consent obtained from all participants. The trial aims to generate locally relevant clinical evidence on the effectiveness and safety of low-dose semaglutide for obesity management in non-diabetic Pakistani adults.",[73,74,75],"Obesity","Weight Reduction","Cardiometabolic Risk Factors",[77,73,78,79,80,81,82,83,43,84],"Semaglutide","Weight loss","GLP-1 Receptor Agonist","Body Mass Index","Open label trial","Cardiometabolic risk","Single Arm Study","Obesity Pharmacotherapy",{"date":86,"type":52},"2026-04-06",{"date":88,"type":52},"2025-08-01",{"date":90,"type":21},"2026-12-01",{"name":58,"class":59},""]