[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Post Graduate Institute of Medical Education and Research, Chandigarh\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":673},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,52,81,111,137,163,197,223,247,276,306,330,358,380,401,427,455,483,502,523,550,575,603,633,650],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100617716","phase-4-dice-study--diastolic-improvement-with-carvedilol--empagliflozin-in-patients-with-cirrhosis-100617716",false,"NCT07322237","DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis","Empagliflozin + Carvedilol vs. Carvedilol Alone for Patients With Cirrhosis and Left Ventricular Diastolic Dysfunction and Impact on Hepatic Decompensation and Survival: A Double-Blind Placebo-Controlled Randomized Controlled Trial","DICE","Inclusion criteria\n\n* Age range of 18-65 years\n* Cirrhosis as diagnosed by histology or clinical laboratory and USG findings\n* LVDD (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion criteria\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* History of urinary tract \u002Fgenital infections in last 3 months\n* Patient on treatment with statin (one month before the study)\n* Advanced Cirrhosis (MELD\\>20)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker valvular heart disease\n* Cardiac rhythm disorder Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6months.","ALL","18 Years","65 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","1. This proposed double-blind placebo controlled randomized controlled trial incorporates recent advances in management of heart failure and portal hypertension using the SGLT-2 inhibitor i.e. EMPAGLIFLOZIN. The drug has been found to be useful in large trials on heart failure with preserved ejection fraction in the general population with improvement in MASLD progression, with improvement in body weight and hepatic steatosis but no change in liver fibrosis.\n2. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the development and progression of heart failure in patients with type 2 diabetes and in those with heart failure and a reduced and preserved ejection fraction. In patients with cirrhosis safety of empagliflozin in a dose of 10 mg has been demonstrated.\n3. Prevention of decompensation related events in cirrhosis is the key endpoint of any liver-directed therapy as the median survival in the compensated state exceeds 10 years but median survival in the decompensated state approximates 1.5 years. Previous data has demonstrated the risk of hepatic decompensation acute kidney injury and poor survival in patients with cirrhosis and heart failure with preserved ejection fraction (HFpEF) i.e. LVDD a large subset of whom meet criteria for CCM.",[28,29,30,31],"Cirrhotic Cardiomyopathy","Empagliflozin","Cardiometabolic Risk Factors","Cirrhosis",[33,34,35,36,37,38],"Empagliflozin in cirrhosis","Carvedilol in Cirrhosis","SGLT-2 inhibitor","Ascites","Diastolic heart failure","heart failure with preserved ejection fraction","RECRUITING","2026-05-13",{"date":42,"type":43},"2026-05-14","ACTUAL",{"date":45,"type":43},"2026-04-01",{"date":47,"type":22},"2029-06-30",{"name":49,"class":50},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100614499","microplastics-cirrhosis-and-portal-hypertension-100614499","NCT07280390","Microplastics, Cirrhosis and Portal Hypertension","The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India","Inclusion Criteria:\n\n* Age range of 18-70 years\n* Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.\n* Undergoing elective surgery or liver transplantation\n\nExclusion Criteria:\n\n* • Hepatocellular carcinoma\n\n  * Pregnancy or lactation\n  * Patients with HIV or retroviral therapy\n  * Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery","70 Years",{"count":61,"type":22},30,"OBSERVATIONAL","Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension.\n\nGlobally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health.\n\nPolystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity.\n\nThe study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.",[31,65,66,67,68,69],"Microplastics","Portal Hypertension Related to Cirrhosis","Nanoplastics","Pollution","Cirrhosis and Chronic Liver Disease",[65,67,71,31,72],"Plastic pollution","Portal hypertension",{"date":74,"type":43},"2026-05-15",{"date":76,"type":43},"2026-05-01",{"date":78,"type":22},"2027-02-25",{"name":49,"class":50},2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":51},"100492353","bile-acids-metabolism-and-genetic-mutation-profile-in-the-intrahepatic-cholestasis-of-pregnacy-in-indian-population-100492353","NCT05691036","Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population","Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in Indian Population- A Prospective Study","ICP","Inclusion Criteria -\n\n* Age \\> 21 years with consistent pruritus\n* Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \\> 40 U\u002FL or AST \\> 37 U\u002FL) or raised total serum bile acids (≥ 10 µmol\u002FL)\n* Able to understand and comply with the requirements of the study and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed\n* Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery\n* Agrees to provide information on perinatal and maternal outcomes at or after delivery\n\nExclusion Criteria:\n\n* Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) related liver disease, Epstein Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV) infection) hepatitis C virus (HBV), hepatitis E virus (HEV)\n* Primary dermatologic diseases associated with pruritus\n* Metabolic diseases (including alcohol abuse)\n* Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)\n* Autoimmune liver disease\n* Obstructive biliary diseases\n* Cholestatic drug-induced liver injury\n* Clinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseases\n* Twins and triplet pregnancy",true,"FEMALE","21 Years","45 Years",{"count":94,"type":22},150,"Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol\u002FL (and elevated serum transaminases), with increased risks of perinatal complications, including spontaneous preterm labor, fetal distress, infant respiratory distress syndrome, meconium-stained liquor (MSL), and sudden intrauterine death (IUD). The Incidence of ICP varies from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).",[97,98,99],"Intrahepatic Cholestasis of Pregnancy","Genetic Mutation","Health Related Quality of Life",[101,102,103],"Intrahepatic cholestasis of pregnancy","Genetic Mutations in pregnancy associated cholestasis","Pruritus",{"date":105,"type":43},"2026-05-18",{"date":107,"type":43},"2022-12-08",{"date":109,"type":22},"2026-07",{"name":49,"class":50},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":80},"100473442","oral-itraconazole-versus-combination-of-systemic-glucorticoids-and-oral-itraconazole-in-cpa-abpa-overlap-syndrome-100473442","NCT05444946","Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome","A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome","GLITZ","Inclusion Criteria:\n\nSubjects fulfil criteria for ABPA and CPA as below.\n\nThe criteria for CPA would include the presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG \\>27 mgA\u002FL or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions) and, (iv) exclusion of other pulmonary disorders with similar presentation.\n\nThe diagnosis of ABPA will be made based on the presence of all the following: (a) A.fumigatus specific IgE \\>0.35 kUA\u002FL; (b) total IgE ≥500 IU\u002FmL; (c) eosinophil count ≥500 cells\u002FµL); (d) A.fumigatus IgG\\>27 mgA\u002FL.\n\nExclusion Criteria:\n\n(i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) \\>10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake of antifungal triazoles for \\>3 weeks in the preceding three months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); and, (vi) pregnancy.","15 Years","90 Years",{"count":122,"type":22},104,[124],"NA","While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the \"overlap group\" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.",[127,128],"Chronic Pulmonary Aspergillosis","Allergic Bronchopulmonary Aspergillosis","2026-04-04",{"date":131,"type":43},"2026-04-07",{"date":133,"type":43},"2022-06-15",{"date":135,"type":22},"2027-02-01",{"name":49,"class":50},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":145,"maxAge":120,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":51},"100607149","phase-3-safety-and-efficacy-of-dexmedetomidate-vs-midazolam-for-procedural-sedation-during-medical-thoracoscopy-100607149","NCT07184801","Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy","A Randomized Controlled Trial for Studying the Efficacy and Safety of Dexmedetomidine Vs Midazolam for Procedural Sedation During Medical Thoracoscopy","DEMISE-MT","Inclusion Criteria:\n\n1. Age≥18 and ≤80 years\n2. Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion\n\nExclusion Criteria:\n\n1. Patients with ICD in situ for more than 5 days\n2. SP02\\\u003C92%\n3. Haemodynamic instability (systolic blood pressure ≤90 mmHg or \\>180mmHg, or diastolic BP \\>110mmHg) before the procedure\n4. MI\u002Funstable angina in the last 3 months\n5. Hb\\\u003C8g\u002FdL, platelet\\\u003C50000 cells\u002FdL\n6. Lack of pleural space due to adhesion\n7. Uncorrected coagulopathy (PT\\>3 secs above control; APTT\\>10 secs above control\n8. Failure to provide informed consent\n9. Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study\n10. Patients who required any anaesthetic\u002Fanalgesic agent in past 7 days\n11. Patients on psychotropic drugs that may alter sensorium","12 Years",{"count":147,"type":22},56,[149],"PHASE3","Medical thoracoscopy can be performed under procedural sedation (conscious sedation) in most of the cases. Procedural sedation is a state where the patient lies comfortably without much movement, does not feel pain and has a dissociative state (separation of mind and body. In view of the existing literature, we hypothesize that use of dexmedetomidine for procedural sedation during medical thoracoscopy will improve the ease of performing the procedure, lower the consumption of rescue analgesics and risk of intra- and post-procedure complications, improve the yield, shorten the recovery period and reduce the post-procedure pain in comparison to midazolam. In this study we propose to show that procedural sedation with dexmedetomidine during medical thoracoscopy is more beneficial for both patient and the clinician in terms of yield and shorter procedure time in comparison with conventional midazolam-fentanyl combination.",[152],"Medical Thoracoscopy",[154],"Thoracoscopy, Midazolam, sedation","2026-03-17",{"date":157,"type":43},"2026-03-18",{"date":159,"type":43},"2025-10-01",{"date":161,"type":22},"2026-12-31",{"name":49,"class":50},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100626542","phase-1-affordable-made-in-india-microspheres-for-liver-cancer-therapy-100626542","NCT07436988","Affordable Made-in-India Microspheres for Liver Cancer Therapy","Multicentric Study on Indigenous and Affordable Microspheres for Selective Internal Radiation Therapy (SIRT) of Unresectable Liver Cancer","ReLIVE","Inclusion Criteria:\n\n1. Age greater than or equal to 18 years (male or female)\n2. Histologically or radiologically confirmed diagnosis of HCC deemed inoperable\n3. Barcelona Clinic Liver Cancer stage B with ECOG performance status between 0 and 2\n4. At least one measurable lesion with longest diameter greater than or equal to 5 cm on cross sectional imaging\n5. Portal vein thrombosis may be present or absent\n6. Laboratory criteria:\n\n   1. Serum creatinine less than or equal to 1.5 mg per dL\n   2. Total bilirubin less than or equal to 2.0 mg per dL\n   3. AST or ALT less than or equal to 5 times upper limit of normal\n   4. Leukocyte count greater than or equal to 1500 per microliter\n   5. Platelet count greater than or equal to 50000 per microliter\n   6. Prothrombin time less than or equal to 1.3 times control or INR less than or equal to 1.5\n7. Karnofsky performance status greater than 70\n8. Ability and willingness to provide written informed consent for participation in the IEC approved protocol\n\nExclusion Criteria:\n\n1. Women of childbearing potential who are unwilling or unable to use effective contraception or who are pregnant or lactating\n2. Child Pugh class C liver function\n3. Presence of extrahepatic metastases\n4. Severe chronic pulmonary disease with hypoxemia or NYHA class three or four heart failure\n5. Myocardial infarction within the past six months\n6. Unstable arrhythmia or symptomatic cardiac disease\n7. Any other serious uncontrolled illness that in the investigator's opinion would compromise study participation\n8. History of other malignancy except adequately treated basal cell carcinoma or cervical carcinoma in situ within the last five years\n9. Major surgery within four weeks prior to enrolment\n10. Active uncontrolled bacterial infection requiring systemic therapy\n11. Liver rupture, tumor penetration of the liver capsule, tumor invasion of the biliary system, or biliary obstruction\n12. Known allergy or hypersensitivity to any component of the investigational or comparator microspheres\n13. Prior treatment with Selective Internal Radiation Therapy (SIRT)\n14. Estimated overall survival less than one month",{"count":172,"type":22},18,[174],"PHASE1","Primary liver tumors, with hepatocellular carcinoma (HCC) accounting for 80%, represent 6% of global cancer incidence and 9% of global cancer-associated mortality.HCC remains the leading causes of cancer-related deaths worldwide, due to late diagnosis. Although local-stage liver tumors are curable with tumor resection or livertransplantation, 65-70% of diagnosed cases are not suitable for resection due to large or multifocal lesions. For these patients, local therapies such as transcatheterarterial chemoembolization (TACE) or selective internal radiation therapy (SIRT) are appropriate at intermediate stages. In cases of advanced and metastatic livertumors, systemic therapies like sorafenib are the standard approach. Selective Intra-arterial Radionuclide Therapy (SIRT) offers a promising treatment for inoperableliver tumors by delivering beta-emitting radiolabeled microspheres directly to tumor sites through the liver's dual blood supply. However, the high cost of standard90Y-microspheres has limited accessibility for patients. This current project aims to develop, optimize, and validate the indigenously prepared microspheres forradiolabeling with 188Re from commercially available generator and indigenously produced radionuclide 177Lu (BARC Mumbai) for SIRT in liver cancer. With hightransformational impact, the current multicentric research will lead to a potentially safe, effective, and promising low-cost SIRT solution for low-income settings.Through collaboration across multiple centers, the study will evaluate the efficacy of microspheres labelled with both radionuclides. By establishing these accessibleSIRT options, this project strives to reduce financial barriers to treatment, advancing the goals of \"Jai Anusandhan\" towards building innovative therapeutics throughcollaborative research project and improving outcomes for patients with limited options.",[177],"Hepatecellular Carcinoma",[179,180,181,182,183,184,185,186],"SIRT","Hepatocellular Carcinoma","188Re-Microspheres","90Y-Theraspheres","RADIANT","Targeted therapy","Liver Cancer","TARE","NOT_YET_RECRUITING","2026-03-11",{"date":190,"type":43},"2026-03-12",{"date":192,"type":22},"2026-02-15",{"date":194,"type":22},"2028-10-15",{"name":49,"class":50},5,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":51},"100623372","nasojejunal-feeding-versus-oral-feeding-following-endoscopic-drainage-of-walled-off-pancreatic-necrosis-100623372","NCT07395778","Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis","Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Patients of acute pancreatitis (AP) with 18-75 years of age\n2. Patients with symptomatic WON requiring EUS guided transluminal drainage\n3. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Patients with collection not amenable for EUS guided drainage (distance of WON \\>1 cm from the gastrointestinal lumen)\n2. Known malignancy or immunocompromised state\n3. Previous upper gastrointestinal(GI) surgery interfering with absorption\n4. Active GI bleeding\n5. GI obstruction, ileus or persistent vomiting\n6. Patients moribund to undergo endoscopic procedure (Glasgow coma scale \\\u003C8 or patients on ventilatory support)\n7. Patients with irreversible coagulopathy like platelets \\\u003C50,000\u002Fmm3 and\u002For INR\\>1.5\n8. Pregnant or lactating female","75 Years",{"count":206,"type":22},50,[124],"The goal of this randomized control trial is to assess whether nasojejunal feed is better than oral nutrition in patients who are undergoing endoscopic cystogastrostomy of walled off necrosis following acute pancreatitis. It will also try to answer, the incidence of infections and feed tolerance.\n\nThe main question it tries to answer is\n\n1. whether nasojejunl feed is better than oral feed in patients undergoing endoscopic cystogastrostomy in walled off necrosis following acute pancreatitis\n2. How much infections they develop, whether they are able to tolerate the feed, weight gain and reintervention rates in each group",[210,211,212],"Walled Off Pancreatic Necrosis","Acute Pancreatitis (AP)","Endoscopic Ultrasound-Guided Drainage",[214],"Cystogastrostomy, Walled off pancreatic necrosis, nutrition","2026-01-31",{"date":217,"type":43},"2026-02-09",{"date":219,"type":43},"2025-10-18",{"date":221,"type":22},"2027-01",{"name":49,"class":50},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":80},"100576841","phase-4-efficacy-of-pregabalin-for-diabetic-pruritus---a-randomized-controlled-study-100576841","NCT06790537","Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.","PREDICT","Inclusion Criteria:\n\n1. Adults (\\>18 years) with Type 2 Diabetes Mellitus\n2. HbA1c \\\u003C10% and on stable medication for at least 1 month before enrolment.\n3. Presence of chronic pruritus (lasting for six weeks or longer) \\[2\\].\n4. Generalized or localised pruritus affecting more than one major body area\\*\n5. Baseline VAS score of ≥5 $ \\*Pruritus including Generalized or localized pruritus as long as it involves two or more areas as per the 5D Itch Scale distribution \\[Head\u002Fscalp, face, chest, abdomen, back, buttocks, thighs, lower legs, feet\u002Ftoes, arms, palms, hands\u002Ffingers, groin, and clothing contact points (waistbands\u002Fundergarments).\n\n$ Baseline VAS score of ≥5 is included to ensure sufficient severity of pruritus for measurable improvement.\n\nExclusion Criteria:\n\n1. Types of Diabetes:\n\n   o Gestational Diabetes, pregnant and breastfeeding women with T2DM, Type 1 DM.\n2. Pruritus Duration and Causes:\n\n   * Pruritus of less than six weeks' duration.\n   * Pruritus associated with systemic conditions such as uraemia (CKD stage IV\u002FV), cholestatic liver diseases, viral hepatitis, HIV infection, uncontrolled hypothyroidism\\* or hyperthyroidism\\^, myeloproliferative disorders, Chronic venous insufficiency in legs or Postherpetic pruritus.\n\n     \\*Uncontrolled hypothyroidism - T3 \u002F T4 below the upper limit of normal.\n\n     \\^Uncontrolled hyperthyroidism- T3\u002FT4 above the upper limit of normal.\n   * Pruritus due to primary dermatological disorders presenting with skin lesions (e.g., atopic dermatitis, eczema, psoriasis, allergic contact dermatitis, urticarial disorders, lichen planus, prurigo nodularis, asteatotic dermatitis).\n3. Use of Medications Affecting Pruritus:\n\n   o Current or recent use (within 2 weeks before study initiation) of systemic treatments that may impact pruritus, including gabapentins (e.g., pregabalin, gabapentin), tricyclic antidepressants (TCA), antihistamines, corticosteroids, and calcineurin inhibitors.\n\n   Rationale: Since these medications are commonly used for neuropathic pain or Pruritus which coexists with diabetic pruritus, their recent use may affect pruritus severity and treatment response. Patients using these drugs for neuropathic pain or other conditions should undergo a washout period of 2 weeks before study initiation.\n4. Drug Hypersensitivity and Reactions:\n\n   o Known allergies or hypersensitivity to pregabalin or emollient.\n5. Psychiatric and Immunocompromised Status:\n\n   * Severe psychiatric disorders that may interfere with the evaluation of pruritus or adherence to the study protocol.\n   * Immunocompromised patients (e.g., post-transplant, immunosuppressive therapy). Pruritus due to Notalgia paresthetica or brachioradial pruritus, post burn pruritus, opioid-induced pruritus.\n6. People with Substance abuse disorders.",{"count":231,"type":22},46,[25],"Brief Summary:\n\nThe goal of this randomized controlled study is to learn if pregabalin combined with emollients can reduce pruritus (itching) in people with Type 2 Diabetes Mellitus. The main questions it aims to answer are:\n\nDoes pregabalin combined with emollients reduce pruritus severity compared to a placebo combined with emollients? What is the impact of pregabalin on the quality of life of participants suffering from diabetic pruritus? we will compare pregabalin plus emollient to a placebo plus emollient to see if pregabalin works better for reducing pruritus.\n\nParticipants will:\n\nReceive either pregabalin 75 mg daily along with emollient therapy or a placebo along with emollient therapy.\n\nVisit the clinic at weeks 4, 8, and 12 for follow-up assessments, including:\n\nPruritus severity using the Visual Analog Scale (VAS) and 5-D Itch Scale. Patient Global Impression of Change (PGIC) to measure overall improvement. This study will help determine if pregabalin, a drug used for neuropathic pain, can be an effective treatment for pruritus in people with diabetes.",[235,236],"Diabetic Pruritus","Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity",[238],"Efficacy of pregabalin for control of generalised pruritus in Diabetic patients","2025-12-30",{"date":241,"type":43},"2026-01-05",{"date":243,"type":43},"2025-04-17",{"date":245,"type":22},"2026-06-30",{"name":49,"class":50},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":51},"100614980","echocardiography-guided-cirrhosis-and-liver-failure-intensive-care-protocol-sepsis-100614980","NCT07286643","Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis","Point-of-care Echocardiogram (POCUS) Guided Resuscitation Versus Conventional Goal- Directed Therapy in the Management of Cirrhosis With Severe Sepsis or Septic Shock: A Randomised Controlled Trial","ECLIPSE-I","Inclusion Criteria:\n\n1. Critically ill patient with cirrhosis of any etiology\n2. Sepsis-related Hypotension (MAP \\\u003C65mmHg or SBP \\\u003C90mmHg)\n3. 18-65 yrs of age -\n\nExclusion Criteria:\n\n1. Already on vasopressors\u002Finotropes\n2. Severe pre-existing cardiopulmonary disease like porto-pulmonary hypertension (PPH), known coronary artery disease, congenital or valvular heart disease, prosthetic cardiac valves, dilated or restrictive cardiomyopathy.\n3. Poor chest wall window due to left pleural effusion, left pneumothorax, small intercostal spaces that restrict performance of a POCUS.\n4. Active bleeding like variceal bleed\n5. Cerebrovascular events\n6. Chronic renal disease - End Stage Renal Disease (ESRD)\u002F patient on renal replacement therapy\n7. Admission to ICU following liver transplantation, burns, cardiac surgery\n8. Previous transjugular intra hepatic portosystemic shunt (TIPS),\n9. Hepatocellular carcinoma\n10. Pregnant or lactating women\n11. Informed consent refused by patient or attendants\n12. Active COVID-19 infection",{"count":256,"type":22},140,[124],"* Point-of-care echocardiography is used to guide septic shock resuscitation in patients with severe sepsis in the intensive care unit (ICU), but without systematic evidence for efficacy in critically patients with Cirrhosis and Severe Sepsis.\n* Due to portal hypertension, these patients have a hyperdynamic circulation, increased capillary permeability, splanchnic arteriolar vasodilation, reduced effective circulating blood volume and may have latent cirrhotic cardiomyopathy (CCM).\n* Hence assessment of volume status and cardiac reserve using conventional central venous pressure (CVP) or mean arterial pressure (MAP) remains difficult.\n\nNovelty:\n\n* In two recent trials, the role of 5% albumin vs PlasmalyteTM (FRISC study)(1) and 20% albumin vs. PlasmalyteTM (ALPS study) (2) were reported as the primary resuscitation fluid. Neither trial showed a clear long term survival benefit of albumin over balanced salt solution (BSS). In fact, the ALPS trial reported that there was increased risk of pulmonary edema with use of 20% albumin as fluid resuscitation.\n* A major limitation of such trial data is that the focus is on choice of fluid rather than looking at hemodynamic goals of resuscitation, resulting in protocolized overzealous fluid administration.\n* This may result in albumin-related pulmonary edema, and precipitation of overt heart failure in patients with silent CCM.\n* POC-Echo-based fluid resuscitation can prevent pulmonary edema and consequently respiratory failure, while ensuring renal and tissue perfusion.\n* It is unclear if choice of fluid or appropriate targets of resuscitation drive the survival benefit in the intensive care management of cirrhosis with severe sepsis.\n\nObjectives:\n\n* The investigators will conduct an ICU based randomised controlled feasibility trial comparing two measures of resuscitation: Echocardiography (ECHO) Guided septic shock resuscitation vs. a modified Goal-Directed Fluid Therapy (GDT) as recommended by sepsis guidelines which use protocol fluids.\n* The study will validate the role of POC-Echo parameters as volume assessment tools (cardiac index, systemic vascular resistance index) to determine endpoints of fluid resuscitation and need for vasopressors.\n* Lastly, the study aims to determine the presence of CCM in this population, and its impact on clinical outcomes.\n\nMethods POC-ECHO will be done within 1 hours of admission to the liver ICU and at 24h, 48 h and 72 hours in patients with cirrhosis with systolic blood pressure of \\\u003C90 mmHg or a mean arterial pressure \\\u003C65 mmHg. Resuscitation target is maintenance of MAP ≥65 mmHg with use of fluids and\u002For vasopressors. Clinical, cardiac biomarkers, and survival data based on resuscitation fluids will be prospectively collected. CCM will be defined as per CCM Consortium (2020) criteria.\n\nExpected outcome.\n\nThe key questions to be answered in the resuscitation of critically ill patients with cirrhosis and sepsis induced hypotension are:\n\n1. What should be best method of ensuring adequate fluid resuscitation i.e. fluid resuscitation protocol?\n2. Which measurable clinical parameter can be used to determine adequacy of fluid resuscitation, and as a predictor of mortality outcomes at 7 and 28 days?\n3. Whether early fluid resuscitation translates into better clinical outcome in decreasing duration of hospital and intensive care unit (ICU) stay, prevention of AKI and prevention of secondary sepsis?",[260,28,261],"Cirrhosis, Liver","Septic Shock",[263,264,265,266,267],"echocardiography","cardiac output monitoring","hemodynamics","fluid resuscitation.","POCUS","2025-12-13",{"date":270,"type":43},"2025-12-16",{"date":272,"type":22},"2026-01-01",{"date":274,"type":22},"2028-12-30",{"name":49,"class":50},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":51},"100557435","phase-4-bcaa-vs-rifaximin-in-patients-with-cirrhosis-for-secondary-prophylaxis-of-he-100557435","NCT06538077","BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE","Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial","HERB","Inclusion Criteria:\n\n1. Cirrhosis defined by standard clinical, ultrasonographic findings and\u002For histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.\n2. Any gender\n3. Discharged from the hospital following an episode of overt hepatic encephalopathy.\n4. Participants able to give informed consent\n\nExclusion Criteria:\n\n1. Subjects with active bacterial or fungal infection\n2. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.\n3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.\n4. Conditions that can impact interpretation of cognitive function:\n\n   i) Untreated viremic hepatitis C virus infection ii) Established neurological\u002Fdegenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects\n5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.\n6. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III\u002FIV or ejection fraction\\\u003C30% ii) COPD: GOLD \\>2, ii) Chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n7. Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.\n8. Patients with MELD\\>20\n9. Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities.\n10. Patients with TIPS shunt in situ\n11. Pregnancy (urine pregnancy test at inclusion)\n12. Refusal or inability to give informed consent",{"count":285,"type":22},336,[25],"Rationale\n\n* Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.\n* A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.\n\nNovelty:\n\n* This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.\n* The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,\n\nObjectives:\n\n* To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology\n* Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome\n* Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.\n* Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).\n* Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.",[289,290,291],"Hepatic Encephalopathy","Decompensated Cirrhosis","Minimal Hepatic Encephalopathy",[293,294,295,296,297],"Hepatic encephalopathy","Branched-chain amino acids","Computerized neurocognitive test battery","Double blind placebo controlled multicentric randomized controlled trial","rifaximin","2025-06-05",{"date":300,"type":43},"2025-06-10",{"date":302,"type":43},"2025-02-01",{"date":304,"type":22},"2027-08",{"name":49,"class":50},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":329,"locationsCount":51},"100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277","NCT06431919","Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival","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","CIRROSTAT","Inclusion Criteria:\n\n* Age range of 18-65 years\n* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,\n* CCM (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* Patient previously treated with statin (one month before the study)\n* Contraindications to statins\n* Advanced Cirrhosis (CTP score\\>9)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker, valvular heart disease\n* Cardiac rhythm disorder, Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic portosystemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6 months.\n* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)",{"count":315,"type":22},260,[124],"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.\n\nRationale:\n\nCirrhosis 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.\n\nNovelty: 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.\n\nObjectives:\n\nThe 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.\n\nMethods:\n\nThis is a 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.\n\nExpected Outcome:\n\nThe investigators 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).",[290,28,260,319,320],"Left Ventricular Diastolic Dysfunction","Acute Kidney Injury",[290,28,322,323],"Left ventricular diastolic dysfunction","Acute kidney injury",{"date":325,"type":43},"2025-06-08",{"date":300,"type":22},{"date":328,"type":22},"2028-02",{"name":49,"class":50},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":89,"sex":17,"minAge":338,"maxAge":204,"enrollmentInfo":339,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":51},"100590037","modified-desmopressin-mdesmo-using-cold-kit-for-petct-100590037","NCT06962202","Modified Desmopressin (mDesmo) Using Cold-Kit for PET\u002FCT","Modified Desmopressin (Mdesmo Cold-Kit) for PET Imaging to Localize Adrenocorticotropic Hormone (ACTH) Dependent Cushing Syndrome (CS)","Ga-68 mDesmo","Inclusion Criteria:\n\n1. Patients diagnosed with endogenous Cushing's syndrome\n2. Patients in the age group of 5 to 75 years.\n3. Patients willing to give informed consent.\n\nExclusion Criteria:\n\n1. Patient with exogenous exposure to steroids\n2. Ongoing pregnancy\n3. Severe comorbid conditions that may interfere with the study.","5 Years",{"count":340,"type":22},100,"The incidence of Cushing syndrome (CS) is 1.2-3.2 cases per million per year, of which adrenocorticotropic Hormone (ACTH)-dependent disease comprises approximately 70-80% of cases. Among these, nearly 90% of ACTH-dependent CS are due to pituitary-dependent CS, known as Cushing disease (CD). The management of ACTH-dependent CS relies on distinguishing Cushing disease (or Corticotropinoma) from ectopic Cushing syndrome (ECS) followed by localization of the tumor in the sella. The diagnosis of CD is very challenging, especially when they are microadenomas (\\\u003C6 mm). Current imaging techniques, such as magnetic resonance imaging (MRI), have limitations in accurately delineating (sensitivity 60%) these tumors. Even if the lesion is detected inside the pituitary, the functionality of the tumor is questionable, as there can be innocent pituitary tumors which actually are not the cause of Cushing syndrome in a particular case. The diagnosis gets more complex with the fact that 10% of the ECS cases are reported to have an incidental non-functioning pituitary tumor, this can complicate the diagnosis of ECS. Though the localizing accuracy of bilateral inferior petrosal sinus sampling (BIPSS) is 90%, the lateralization (40-70%) of corticotropinoma (whether the lesion is located on the right or left side) based on BIPSS is still questionable. These challenges contribute to the fact that in approximately 30% of cases of CD, the source of ACTH excess remains occult. The lack of information on accurate localization and lateralization of corticotropinoma leads to reduced remission rates after surgery. Therefore, novel approaches to diagnosing Cushing disease are needed.\n\nWe have developed a novel radiopharmaceutical Gallium-68- 1,4,7,10-tetraazacyclododecane-N,N',N',N'-tetraacetic acid-modified desmopressin (68Ga-DOTA-mDesmo) for Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT). This radiopharmaceutical has the potential to selectively target the overexpressed V1b receptors in patients diagnosed with Cushing disease. The clinical studies demonstrated 100% diagnostic accuracy of 68Ga-DOTA-mDesmo PET\u002FCT in delineating corticotropinomas, surpassing the accuracy of CE-MRI and BIPSS, regardless of adenoma size. However, the small sample size and regional patient recruitment may affect the generalizability of the results.\n\nThe project aims to assess the diagnostic sensitivity and specificity of 68Ga-DOTA-mDesmo in a diverse Cushing syndrome population. This will lead to development and validation of a superior, non-invasive diagnostic modality for accurate corticotropinoma delineation, aiding neuro-navigation during surgery and potentially improving treatment outcomes for ACTH-dependent Cushing syndrome.",[343],"Cushing Syndrome",[345,346,347,348,349],"ACTH","bilateral inferior petrosal sinus sampling","Corticotropinoma","transsphenoidal surgery","PET\u002FCT","2025-05-15",{"date":352,"type":43},"2025-05-20",{"date":354,"type":43},"2022-08-15",{"date":356,"type":22},"2025-10",{"name":49,"class":50},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":51},"100581193","phase-3-empirical-intravenous-beta-lactam-plus-metronidazole-vs-oral-cefixime-plus-metronidazole-for-the-treatment-of-liver-abscess-100581193","NCT06847126","Empirical Intravenous Beta-Lactam Plus Metronidazole Vs Oral Cefixime Plus Metronidazole for the Treatment of Liver Abscess","Comparison of Empirical Intravenous Beta-Lactam Antimicrobials Plus Metronidazole and Oral Cefixime Plus Metronidazole Therapy for the Treatment of Liver Abscess: an Open Label Randomized Controlled Clinical Trial","Inclusion Criteria: All symptomatic patients with liver abscess verified by radiological imaging, either by computed tomography (CT) scan or ultrasound (USG), regardless of gender (male or female) and age ≥ 18 years, will be screened for registration in the study.\n\n\\-\n\nExclusion Criteria: Patients with past history of liver abscess, chronic kidney disease (CKD), hypersensitivity to either Metronidazole or Cefixime or Beta-lactam antimicrobials will not be allowed to participate in the study. Patients with organ dysfunction with shock (blood pressure \\\u003C 90\u002F60 mmHg), acute respiratory distress syndrome requiring oxygen therapy (PaO2\u002FFiO2 ≤ 300 or SpO2 ≤92%), encephalopathy (altered sensorium with GCS \\\u003C 15), acute kidney injury (increase in serum creatinine to ≥ 1.5 times from the baseline or serum creatinine ≥ 1.5) and not able to take orally will not be considered for participation in the study. Patients who are pregnant, have already received antimicrobials for more than 48 hours before to admission, or are receiving blood thinners such as antiplatelets or anticoagulants within 4 weeks of presentation and are unwilling to provide informed consent will also be excluded from the trial.\n\n\\-",{"count":366,"type":22},220,[149],"Liver abscess (LA) is potentially life threatening medical emergency requiring prompt medical intervention. The backbone of therapy is prompt empirical antimicrobial with or without percutaneous drainage\u002F aspiration of the abscess. The standard care for liver abscess includes empirical antimicrobials consisting both antibacterial and amoebicidal agents along with percutaneous drainage or aspiration of the collection. The antimicrobial regimen should cover against E. histolytica until microbial etiology is established or liver abscess of amoebic etiology is ruled out. But still there is no straightforward general agreement or evidence based on clinical studies regarding the standard protocol for empirical antimicrobials concerning choice, route of administration or duration of antimicrobials therapy. Most of the experts preferred intravenous antimicrobials over oral antimicrobials for the treatment of liver abscess with or without complication. But, there is no clinical trial evidence to support the rational of using intravenous antibiotics up front instead of oral antimicrobials. Recently published institutional study also suggested that empirical oral antimicrobials (Cefexime\u002FCiprofloxacin) were efficacious for the treatment of uncomplicated liver abscess, successfully managing around 90 % cases of liver abscess. When treating a liver abscess, the choice of antimicrobials and the administration technique must be specially tailored depending upon the existence of complications and the patient's clinical reaction. In the absence of clinical trials, the rational for using of intravenous broad spectrum antibiotics upfront instead of oral antimicrobials for the treatment of liver abscess with or without complications is doubtful and may appear injudicious contributing future rise of antimicrobial resistance. The use of intravenous antibiotics upfront may also unnecessarily lengthen hospital stays, enhance therapeutic expenditure, and raise the risk of hospital-acquired infections in patients who are capable for taking antimicrobials orally. Oral antimicrobials strategy will promote earlier discharge from the hospital and the patient can return to usual activities earlier. This study aims to provide valuable insights into the comparison and efficacy of empirical intravenous Beta-lactam antimicrobials plus Metronidazole and oral Cefixime plus Metronidazole therapy for the treatment of uncomplicated liver abscess. In this randomised controlled open label clinical trial all the patients with newly diagnosed liver abscess confirmed with radiology imaging, either by USG or CT scan, presenting at emergency or medical OPD will be screened for enrolment in the study. Following written informed consent from the participants and\u002For their legal guardian, those who meet the inclusion and exclusion criteria will be recruited in the study. Subsequently the participants will be randomized into either intravenous or oral antimicrobial group. The intravenous-group will receive Beta-lactam antimicrobials (i.e Piperacillin-Tazobactum 4.5g q 8 hourly or Ceftriaxone 1g q 12 hourly or Meropenem 1g q 8 hourly or Imipenem-Cilastatin 500mg q 6 hourly) Plus intravenous Metronidazole 750mg q 8 hourly for 2weeks. The oral-group will receive tablet Cefixime 200 mg q 12 hourly plus tablet Metronidazole 800 mg q 8 hourly for 2 weeks. Both the group will be provided standard care of therapy including percutaneous drainage or aspiration as per indication and will be followed up for 8 weeks. The primary outcome of clinical cure and secondary outcome of incidence of treatment failure, mortality, duration of antimicrobial therapy, recurrence, adverse drug reaction (ADR), complications will be compared between the groups.",[370],"Liver Abscess",[372],"Liver Abscess, Empirical antimicrobials, Beta-lactam antimicrobials, Intravenous, Oral, Cefixime, Metronidazole","2025-04-10",{"date":375,"type":43},"2025-04-13",{"date":377,"type":43},"2025-02-25",{"date":245,"type":22},{"name":49,"class":50},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":51},"100529526","phase-3-a-randomized-trial-of-prednisolone-itraconazole-or-their-combination-in-allergic-bronchopulmonary-aspergillosis-100529526","NCT06174922","A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis","A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary Aspergillosis","PICA","Inclusion Criteria:\n\nConsecutive subjects of acute stage allergic bronchopulmonary aspergillosis (ABPA) complicating asthma per the revised ISHAM-ABPA working group criteria\n\n* newly diagnosed subjects with uncontrolled asthma or symptoms or radiology suggesting active lesions attributable to ABPA and meeting the diagnostic criteria of ABPA\n* those previously meeting the diagnostic criteria for ABPA and presenting with sustained (≥2 weeks) clinical or radiological worsening; and increase in serum total IgE by ≥50% of the last recorded IgE value during clinical stability.\n\nExclusion Criteria:\n\n* occurrence of ≥3 ABPA exacerbations in the last 18 months before enrollment\n* contraindications to the use of either prednisolone or itraconazole\n* subjects who have received oral prednisolone (or equivalent) ≥30 mg for ≥2 weeks or itraconazole (or voriconazole or posaconazole or isavuconazole) for more than 2 weeks, in the last 3 months\n* chronic medical illnesses, including uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure, chronic heart failure, and others\n* patient on immunosuppressive drugs\n* pregnancy\n* enrollment in another trial of ABPA\n* failure to provide informed consent\n* asthma exacerbation: worsening respiratory symptoms for at least 24 hours without immunological or radiological deterioration of ABPA\n* infective\u002Fbronchiectasis exacerbation: clinical deterioration for at least 24 hours with increase in cough; breathlessness; sputum volume or consistency; sputum purulence; fatigue, malaise, or fever; and hemoptysis without immunological or radiological deterioration of ABPA\n* serologic ABPA",{"count":389,"type":22},300,[149],"The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy.\n\nIn this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.",[128],"2025-02-26",{"date":395,"type":43},"2025-02-28",{"date":397,"type":43},"2023-12-01",{"date":399,"type":22},"2026-06",{"name":49,"class":50},{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":408,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":409,"conditions":410,"keywords":415,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":51},"100545760","cardiac-dysfunction-in-patients-with-fatty-liver-disease-100545760","NCT06386094","Cardiac Dysfunction in Patients with Fatty Liver Disease","Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease","Inclusion Criteria:\n\n* Age range of 18-65 years\n* metabolic dysfunction associated steatotic liver disease as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Hypertension\n* Valvular heart disease\n* Sick sinus syndrome\u002F Pacemaker\n* Cardiac rhythm disorder\n* Hypothyroidism\n* Hyperthyroidism\n* Portal vein thrombosis\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males at the time of assessment",{"count":94,"type":22},"Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and\u002For altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E\u002Fe' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.",[411,412,413,414],"NAFLD","Cardiac Disease","Fatty Liver","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease",[416,28,417,418],"MASLD","Heart failure in Cirrhosis","Coronary Artery Disease","2025-01-27",{"date":421,"type":43},"2025-01-29",{"date":423,"type":43},"2023-07-15",{"date":425,"type":22},"2027-11-15",{"name":49,"class":50},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":51},"100560162","contact-cast-versus-posterior-slab-as-offloading-modality-for-charcot-neuroarthropathy-100560162","NCT06573554","Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy","Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy of Foot in Diabetes (OFFLOAD Study): A Multicentric, Non-inferiority Study","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Unilateral pedal swelling\n* Active Charcot Neuroarthropathy\n* Age: 18 years and above.\n* Ability to Provide Consent\n\nExclusion Criteria:\n\n* presence of pedal ulcer,\n* osteoporosis (T score \\\u003C-2.5 at lumbar spine or hip),\n* gout,\n* active peptic ulcer disease,\n* steroid intake in the last three months,\n* estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\u002Fm2,\n* active dental caries or invasive dental procedure,\n* peripheral vascular disease (ABI \\\u003C 0.7),\n* bilateral foot involvement,\n* pregnant\u002F lactating women and\n* those who had recently received antiresorptive agents (in the previous 12 months).\n* Negative consent",{"count":435,"type":22},80,[124],"Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot. The study compares two treatments: a standard knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker. Both aim to immobilize and offload the foot to promote healing. The study will involve diabetic patients with specific criteria and exclude those with conditions like foot ulcers or severe kidney issues. Patients will be randomly assigned to one of the two treatments and followed for up to a year. The primary goal is to see how many patients achieve remission within six months, with secondary goals including remission within twelve months, time to remission, quality of life, and foot health. Statistical tests will be used to analyze the data and determine the effectiveness of each treatment. The study aims to improve CN treatment and provide better options for patients.",[439],"Charcot Neuroarthropathy",[439,441,442,443,444,445,446],"Total Contact Cast","Diabetic Foot","Posterior Slab","Vibration Perception Threshold","Peripheral Neuropathy","Diabetes Mellitus","2025-01-18",{"date":449,"type":43},"2025-01-22",{"date":451,"type":43},"2024-12-11",{"date":453,"type":22},"2027-03-31",{"name":49,"class":50},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":51},"100566419","phase-4-prednisolone-for-12-versus-6-months-to-treat-pulmonary-sarcoidosis-100566419","NCT06654934","Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis","Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial","DURASARC","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung\u002Fmediastinal lymph nodes\n* Diagnosis of sarcoidosis made on cytological or histological samples\n* Having significant symptoms requiring immunosuppressive treatment and\u002For having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrapulmonary manifestation of the disease requiring treatment with low-medium dose glucocorticoids\n* Onset of symptoms within two years of study entry\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)\n* Having absolute contraindication for prednisone (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)\n* Unwilling to participate in the study\n* Having received glucocorticoids (prednisolone equivalent \\>15 mg\u002Fday) for more than three weeks in the preceding year",{"count":340,"type":22},[25],"In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.",[467],"Sarcoidosis",[469,470,471,472,473,474],"granulomatous disease","interstitial lung disease","diffuse lung disease","tuberculosis","steroid","ILD","2024-10-21",{"date":477,"type":43},"2024-10-23",{"date":479,"type":22},"2024-11",{"date":481,"type":22},"2026-12",{"name":49,"class":50},{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":51},"100552939","phase-4-rct-of-nintedanib-in-fibrotic-sarcoidosis-100552939","NCT06479603","RCT of Nintedanib in Fibrotic Sarcoidosis","A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis","NINSARC","Inclusion Criteria:\n\n* Age more than 18 years\n* Diagnosed with pulmonary sarcoidosis (clinico-radiologic presentation consistent with pulmonary sarcoidosis (with or without extrapulmonary involvement) along with presence of non-necrotising granulomatous inflammation in any of the involved organ\u002Ftissue and exclusion of a known cause for the granulomatous inflammation OR in the absence of demonstration of granulomatous inflammation in tissues, a diagnosis of fibrotic pulmonary sarcoidosis on a multidisciplinary discussion (enrolment of subjects meeting the latter criteria will be capped at 20% of the planned sample size)\n* Presence of signs of fibrosis on a computed tomography scan such as coarse reticulation, irregular lines, traction bronchiectasis, fibrotic masses, or honeycombing involving ≥20% of the lung fields on visual examination\n* Having symptoms of breathlessness grade 1 or more on the modified Medical Research Council (mMRC) scale or persistent cough for more than 3 months\n* Forced vital capacity (FVC) \\<80% predicted value for the age and sex of the subject using the reference equations for our subjects OR an exertional desaturation of 4% or more on a six-minute walk test (6MWT)\n* Receiving stable immunomodulatory treatment which includes standard of care drugs such as glucocorticoids alone or in combination with methotrexate, azathioprine, or mycophenolate mofetil for more than 3 months in a stable dose\n\nExclusion Criteria:\n\n* Known cardiopulmonary or other comorbid illness that can explain the subject's illness except group 3 pulmonary hypertension due to fibrotic pulmonary sarcoidosis\n* Hypersensitivity or contraindication to nintedanib (including high dose antiplatelets or anticoagulants, and bleeding diatheses)\n* Received an antifibrotic drug such as pirfenidone or nintedanib for ≥8 weeks in the past one year\n* Baseline deranged liver function (alanine aminotransferase and aspartate aminotransferase or bilirubin more than 1·5 times the upper normal limit \\[except in the case of Gilbert's syndrome\\])\n* Serum creatinine higher than 2.0 mg\u002FdL\n* Uncontrolled congestive heart failure\n* Other serious concomitant medical illness (eg, cancer), chronic debilitating illness (other than chronic HP), or drug abuse\n* Pregnancy (documented by urine pregnancy test) or breastfeeding\n* Unwilling to participate in the study",{"count":492,"type":22},120,[25],"Sarcoidosis is generally managed with outdoor immune modulatory drugs, most commonly oral steroids and at times drugs like methotrexate or azathioprine as a steroid sparing agent.\n\nAround 15-20% of sarcoidosis patient develop fibrosis of the lung parenchyma. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis it may be possible to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients.\n\nThe hypothesis of this study is that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis",[496],"Sarcoidosis, Pulmonary",{"date":477,"type":43},{"date":499,"type":43},"2024-06-30",{"date":215,"type":22},{"name":49,"class":50},{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100564152","phase-4-tofacitinib-vs-tofacitinib-with-mesalamine-in-ulcerative-colitis-100564152","NCT06625450","TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS","TOFACITINIB COMPARED TO TOFACITINIB WITH MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Diagnosed cases of UC by endoscopy and biopsy\n* Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine\n\nExclusion Criteria:\n\n* Incomplete evaluation\n* Uncertain diagnosis\n* Active disease\n* Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U\n* Unwilling to participate in study\n* Pregnant and lactating women or those who are planning pregnancy in the forthcoming 2 years\n* Patients with any suspected or proven malignancy\n* Subjects with severe comorbidities\n* Prior history of venous thromboembolism.\n* Subjects undergoing major surgery\n* Myocardial infarction within previous 3 months\n* Heart failure",{"count":510,"type":22},75,[25],"All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.",[514],"Ulcerative Colitis","2024-10-02",{"date":517,"type":43},"2024-10-03",{"date":519,"type":22},"2024-10",{"date":521,"type":22},"2026-01",{"name":49,"class":50},{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":51},"100544794","early-phase-1-masld-in-primary-hypothyroidism-and-efficacy-of-dapaglifozin-100544794","NCT06373523","MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin","SHIELD","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Patients with Primary Overt hypothyroidism (Low FT3\u002FLow FT4 and TSH\\>ULN)\n\nExclusion Criteria:\n\n1. Patients with Diabetes Mellitus(T1DM AND T2DM)\n2. Patient with Secondary Hypothyroidism\n3. Patients with other Endocrinopathies who are at risk of MASLD (T1DM and T2DM, Growth Hormone Insufficiency,Cushing Syndrome)\n4. Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases (chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction)\n5. Patient with Drug Induced Liver Injury(DILI)\n6. Patients with Decompensated Cirrhosis or Portal hypertensionPatients with Cirrhosis or Portal hypertension\n7. Patients with HCC or any other malignancy\n8. Drugs like OCPS\n9. Patients \\\u003C18 years of age\n10. Patients already on Vitamin E or pioglitazone\n11. Pregnancy\u002FLactation\n12. Patients who are too sick to carry out the protocol\n13. Those who do not consent to participate in the study",{"count":531,"type":22},60,[533],"EARLY_PHASE1","Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD\u002FNASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy\u002Fhistology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis\u002Fcirrhosis with high accuracy.The novelty of utilizing the concept of \"drug repositioning\" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis\u002Fhepatic fibrosis in NAFLD patients with Primary Hypothyroidism.",[536,537],"Hepatic Steato-Fibrosis","Non-Alcoholic Fatty Liver Disease",[539,540,541],"Dapaglifozin","MRI-PDFF","Primary hypothyroidism","2024-08-08",{"date":544,"type":43},"2024-08-09",{"date":546,"type":22},"2024-09-01",{"date":548,"type":22},"2025-07-30",{"name":49,"class":50},{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":51},"100557428","a-neuro-cognitive-and-psychosocial-intervention-module-in-people-with-epilepsy-100557428","NCT06537986","A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy","Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy","Inclusion Criteria:\n\n1. Participants of 18 - 45 years of age.\n2. either gender\n3. Willing to participate and sign the informed consent\n\nExclusion Criteria:\n\n1. Patients with other neurological disorders\n2. any other trial at inclusion\n3. should not have any major psychiatric disorder\n4. pregnant and lactating mothers\n5. also, patients who would not be giving informed consent\n6. Patients with intellectual disabilities.",{"count":531,"type":22},[124],"Patients with epilepsy, especially drug-resistant epilepsy, have a lot of cognitive \\& psycho-social issues. There is little evidence pertaining to the efficacy of the various cognitive-behavioral interventions and cognitive retraining modules used in epilepsy patients in the Indian context. The real value of these interventions needs further consolidation in terms of its assessment and efficacy. The available literature is scanned and having limitations in terms of assessment tool used, sample size, and also lacks a broader spectrum of psychosocial interventions used. In view of the above limitations, we plan to specially develop \\& test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions. This module will help in planning the future needs of epileptic patients in terms of not only medication but also guide us in choosing the kind of interventions to be used with a particular patient or group of patients.",[561],"Drug Resistant Epilepsy",[563,564,565,566],"Epilepsy,","Neurocognitive","Psychosocial","module","2024-07-31",{"date":569,"type":43},"2024-08-05",{"date":571,"type":43},"2022-02-15",{"date":573,"type":22},"2025-04-30",{"name":49,"class":50},{"id":576,"slug":577,"hasResults":11,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":51},"100550463","phase-3-a-trial-to-compare-nebulized-amphotericin-b-and-nebulized-normal-saline-as-maintenance-in-patients-with-chronic-pulmonary-aspergillosis-100550463","NCT06447402","A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis","A Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral Itraconazole","NAB-CPA","Inclusion Criteria:\n\n* consecutive subjects with CPA who have received 12 months therapy with oral itraconazole\n\nExclusion Criteria:\n\n(i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of \\>10 mg prednisolone (or equivalent) for at least 3 weeks in last 3 months, or a diagnosis of human immunodeficiency virus syndrome, ; (iii) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (iv) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); (v) pregnancy.",{"count":584,"type":22},196,[149],"The treatment of CPA is with oral itraconazole for 6-12 months. Oral itraconazole results in better clinical outcomes in CPA compared to supportive care. A recent study comparing 6 months with 12 months of oral itraconazole for longer duration treatment found longer duration reduced CPA relapse and improved clinical outcomes. However, longer duration of itraconazole could cause emergence of drug resistant Aspergillus fumigatus and therapy related adverse event. A recent study found nebulized amphotericin B non-inferior to oral itraconazole for treating CPA as primary therapy. However, the study was small and included patients with simple aspergilloma and used nebulized amphotericin B for 7 days.To be effective, an inhaled drug should be delivered in sufficient quantity to achieve therapeutic levels.The minimum inhibitory concentration of amphotericin B for A.fumigatus is 0.5 mg\u002FL. In one study, nebulization of 30 mg of amphotericin B deoxycholate achieved a mean concentration of 0.68 mg\u002FL in the bronchoalveolar lavage fluid. Notably, the serum levels of amphotericin B after nebulization are 20 times less than after systemic administration and is safer. Further, there is a dose-response relation with nebulized amphotericin B, the higher the dose used for nebulization, the higher are the levels achieved in the lung tissue. Nebulized amphotericin B has been used in lung transplant recipients to prevent invasive aspergillosis. Also, two recent studies have demonstrated that use of nebulized amphotericin B as maintenance therapy led to a reduction in ABPA relapse rates and prolonged time to exacerbation. We believe that inhaled amphotericin B as a maintenance therapy could reduce CPA relapse and prolong time to relapse. In this study, we plan to evaluate nebulized amphotericin B as a maintenance therapy in clinically stable CPA patients treated with 12 months of oral antifungal therapy",[127,588,589],"CPA","Aspergilloma",[591,592,588,593,594],"CCPA","CFPA","Post TB lung abnormality","PTLD","2024-06-06",{"date":597,"type":43},"2024-06-10",{"date":599,"type":43},"2024-06-03",{"date":601,"type":22},"2026-08-31",{"name":49,"class":50},{"id":604,"slug":605,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":11,"sex":17,"minAge":610,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":616,"conditions":617,"keywords":620,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":51},"100539604","phase-2-intravenous-methylene-blue-for-treating-refractory-neonatal-septic-shock-100539604","NCT06306001","Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock","Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial","Screening Criteria: preterm infants (\\\u003C37 weeks, \\\u003C28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following\n\n1. Definite\u002Fprobable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein \\>10 mg\u002FdL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists.\n2. Shock: adapted from the definition given by Davis et al 2017\n\n   1. Either SBP \\\u003C age and gestation appropriate cut-off OR\n   2. Presence of any 2 of the following 6 parameters i. HR \\>205\u002Fmin ii. Central pulses either week OR bounding iii. CRT \\>3 sec OR flash refill (\\\u003C1 sec) iv. skin mottled\u002Fcool OR flushed v. urine output \\\u003C0.5 ml\u002Fkg\u002Fh in the preceding 6 hours vi. DBP \\\u003C age and gestation appropriate cut-off\n3. Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml\u002Fkg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg\u002Fkg\u002Fmin) or epinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin) or norepinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin).\n\nExclusion Criteria:\n\nexcluded if ≥1 criterion positive:\n\n1. G6PD deficient or family history of G6PD deficiency\n2. Potentially lethal malformation\n3. Congenital heart disease\n4. Severe acute kidney injury\n5. Family history of allergy to methylene blue or food dyes","0 Days","28 Days",{"count":613,"type":22},130,[615,149],"PHASE2","Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:\n\n1. Whether MB treatment reduces death to any cause as compared to no MB treatment.\n2. Whether treatment with MB reduces the time to achieve normal blood pressure\n3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.\n4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.",[618,619],"Neonatal Sepsis","Shock, Septic",[621,622,623,624],"Methylene blue","Neonate","Septic shock","Clinical trial","2024-03-05",{"date":627,"type":43},"2024-03-12",{"date":629,"type":22},"2024-03-15",{"date":631,"type":22},"2027-02",{"name":49,"class":50},{"id":634,"slug":635,"hasResults":11,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":640,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":647,"leadSponsor":649,"locationsCount":51},"100523421","cirrhotic-cardiomyopathy-based-on-point-of-care-echocardiography-biomarkers-and-histology-100523421","NCT06095466","Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Inclusion Criteria:\n\n* Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following:\n\n  * Age range of 18-65 years\n  * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Valvular heart disease\n* Sick sinus syndrome\u002F Pacemaker\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males at the time of assessment",{"count":94,"type":22},"Cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E\u002Fe' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre.",[28,260,412],"2023-10-18",{"date":645,"type":43},"2023-10-23",{"date":423,"type":43},{"date":648,"type":22},"2026-10-15",{"name":49,"class":50},{"id":651,"slug":652,"hasResults":11,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":51},"100398799","hypofractionated-adjuvant-radiotherapy-in-1-versus-2-weeks-in-high-risk-patients-with-breast-cancer-hypart-100398799","NCT04472845","HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).","HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.","HYPART","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Female or male\n3. Invasive carcinoma of the breast\n4. Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)\n5. Concurrent trastuzumab and hormone therapy is allowed\n6. Axillary staging and\u002For dissection\n7. Complete microscopic excision of primary tumour\n8. pT3-4pN2-3 M0 disease\n9. Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy.\n10. Written informed consent\n11. Able to comply with follow-up\n\nExclusion Criteria:\n\n1. Supraclavicular node or internal mammary node or distant metastasis\n2. Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or(ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free\n3. Contralateral breast cancer, including DCIS, irrespective of date of diagnosis\n4. Breast reconstruction using implants\n5. Pregnancy\n6. Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed)",{"count":659,"type":22},1018,[124],"We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy\u002F15#\u002F3wks to the chest wall after mastectomy and 40Gy\u002F16#\u002F3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.",[663,664,665],"Breast Cancer","Hypofractionation","Radiotherapy Side Effect","2022-12-07",{"date":107,"type":43},{"date":669,"type":43},"2021-03-30",{"date":671,"type":22},"2028-08-20",{"name":49,"class":50},""]