[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-encephalopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,53,79,105,138,160,189,227,253,276,309,333,351,375,397,425,444,469,499,546,568],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100596512","affect-of-melatonin-on-sleep-and-cognition-in-cirrhosis-100596512",false,"NCT07046429","Affect of Melatonin on Sleep and Cognition in Cirrhosis","Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial","SNORE-HE","Inclusion Criteria:\n\n* Cirrhosis with clinically significant portal hypertension or decompensation defined by Baveno VII criteria \\[de Franchis R et al 2022\\]\n* Adults over age 18\n* CHE (defined by PHES≤ -4) or previously diagnosed HE\n* Disturbed sleep, with Pittsburgh Sleep Quality Index (PSQI) ≥5\n* Possession of a \"smart phone\" with Bluetooth capability and ability to download the Oura application (Apple iOS version 14.0 or greater or Android version 8.0 or higher)\n\nExclusion Criteria:\n\n* Use of melatonin regularly (3x per week) if unable\u002Funwilling to discontinue for the study\n* Inability provide informed consent\n* Heavy current alcohol use (\\>7 drinks weekly for women and 14 drinks weekly for men)'\n\n  \\-- Body mass index \\>40\n* Known prior sleep disorder including obstructive sleep apnea\n* Use of other prescription neuromodulating sleep aides\n* Self-reported pregnancy during study screening, as sleep physiology is different in this population","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn the affect of melatonin on sleep, cognitive function, and quality of life (QoL) in patients with cirrhosis and a complication called hepatic encephalopathy (HE). The main questions this study aims to answer are:\n\n* Does taking melatonin increase REM sleep, an important part of healthy sleep that is reduced in cirrhosis?\n* Does taking melatonin improve cognitive function and reported QoL?\n\nThis is a pilot study, where participants will:\n\n* take one month of melatonin, followed by one month of thiamine, which is another supplement but is not suspected to impact sleep significantly.\n* Undergo cognitive testing and take surveys\n* Wear a commercial wearable sleep tracker\n* Have a formal sleep study and salivary melatonin collection at the end of taking each supplement at our sleep center Participants will be blinded, and neither they nor the researchers will know which supplement they are taking first and which they are taking second. They will also be randomized, with half starting with melatonin and the other half starting with thiamine.",[27,28,29,30],"Hepatic Encephalopathy","Covert Hepatic Encephalopathy","Cirrhosis","Sleep Disturbances and Insomnia",[32,33,34,35,36,37,38,39],"cirrhosis","hepatic encephalopathy","covert hepatic encephalopathy","portal hypertension","sleep disturbances","insomnia","sleep problems","wearable technology","RECRUITING","2026-07-27",{"date":43,"type":44},"2026-07-29","ACTUAL",{"date":46,"type":44},"2025-08-05",{"date":48,"type":21},"2026-12-31",{"name":50,"class":51},"Weill Medical College of Cornell University","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100639822","a-prospective-cohort-study-on-the-epidemiological-investigation-diagnosis-and-treatment-of-hepatic-encephalopathy-100639822","NCT07612670","A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy","Inclusion Criteria:\n\n* For patients with liver cirrhosis and the general healthy population, the diagnosis of liver cirrhosis is made by doctors based on imaging, elastography, biopsy or clinical symptoms.\n* The patients themselves and their accompanying family members have smart phones, are proficient in using WeChat and mini-programs, and have a stable network environment.\n* They voluntarily sign the informed consent form, have good compliance, and fully understand this study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old;\n* Women planning to get pregnant, already pregnant or during lactation;\n* Incomplete relevant data information required;\n* Unable to proficiently use WeChat mini-program or unstable network environment;\n* Red-green color blindness or other irreparable visual impairments;\n* Heart, lung, or kidney failure or unstable vital signs;\n* Unwilling to participate in the study or unable to sign the informed consent form;\n* Any other situation that may interfere with the study assessment, increase the risk for the subjects, or affect their completion of the study, as judged by the researcher and deemed unsuitable for participating in this study;\n* Have participated in or are currently participating in other clinical trials within the past 3 months;",true,"75 Years",{"count":62,"type":21},700,"2 Years","OBSERVATIONAL","Purpose Hepatic encephalopathy (HE) is a serious complication of liver cirrhosis that can cause memory loss, slow reaction, and even coma. In China, large-scale epidemiological data on HE are lacking, early diagnosis remains difficult, and treatment needs improvement. This study aims to investigate the prevalence of HE in Chinese liver disease patients and to explore better diagnostic methods and treatment strategies.\n\nDesign This is a prospective, multicenter cohort study led by Jiangsu Province Hospital, in collaboration with 7 other hospitals in Jiangsu Province. Between April 2026 and December 2029, the study plans to enroll over 700 patients with liver cirrhosis and 120 healthy volunteers.\n\nWhat participants will do Participants will use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly. They will be followed up at month 1, 3, 6 after enrollment, and then every six months. The research team will collect routine laboratory results, medication records, and quality-of-life data.\n\nBenefits and risks Participants will receive closer health monitoring, which may help detect changes early. The study involves no additional drugs or invasive procedures, so risks are very low. All personal information will be kept strictly confidential and used only for medical research.\n\nVoluntary participation Participation is completely voluntary, and participants can withdraw at any time without affecting their routine medical care.",[27,67,68],"Minimal Hepatic Encephalopathy","Liver Cirrhosis","NOT_YET_RECRUITING","2026-07-14",{"date":72,"type":44},"2026-07-15",{"date":74,"type":21},"2026-08-01",{"date":76,"type":21},"2028-03-31",{"name":78,"class":51},"The First Affiliated Hospital with Nanjing Medical University",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":52},"100647049","early-phase-1-fecal-microbiota-transplantation-for-the-treatment-of-refractory-hepatic-encephalopathy-after-tips-surgery-100647049","NCT07683936","Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery","A Prospective Exploratory Study on Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery","Inclusion Criteria:\n\n* Age: 18 - 75 years old, both genders are eligible\n* Successful implementation of covered stent TIPS\n* Those who experienced recurrence of hepatic encephalopathy after TIPS surgery and still used lactulose and rifaximin (within 6 months after intervention with rifaximin and lactulose, West Haven grade ≥ 2 hepatic encephalopathy occurred at least 2 times)\n* Meet the conditions for receiving fecal microbiota transplantation through nasogastric tube (no severe anatomical abnormalities in the upper digestive tract; basic intestinal motility is normal; can tolerate the insertion of nasogastric tube and the subsequent infusion process)\n* Obtain the patient's written informed consent\n\nExclusion Criteria:\n\n* Patients with active gastrointestinal bleeding or perforation accompanied by severe damage to the intestinal barrier due to various reasons\n* Patients with congenital or acquired immunodeficiency diseases, those who have received high-risk immunosuppressive or cytotoxic drug treatment within the recent 3 months, and those with severe immunosuppression (neutrophil count \\\u003C 1.5×10⁶ cells\u002FL; CD4+ T cell count \\\u003C 2.0×10⁵ cells\u002FL)\n* Patients with malignant tumors of the liver or gastrointestinal tract, patients with spontaneous bacterial peritonitis, and patients with Budd-Chiari syndrome\n* Patients with severe heart, kidney, or lung dysfunction (NYHA III-IV grade or unstable heart failure; eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m² or requiring dialysis; respiratory failure or requiring long-term oxygen therapy)\n* Unstable vital signs (body temperature, heart rate, blood pressure, breathing)\n* History of gastrointestinal surgery within the past 3 months, such as colon resection\n* Patients planning to undergo liver transplantation within 6 months\n* Patients who have undergone FMT within the past 3 months\n* Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)\n* Other neurological and psychiatric disorders, including dementia, Parkinson's disease, and post-stroke sequelae\n* Pregnant or lactating subjects\n* Subjects considered to have poor compliance by the investigator",{"count":87,"type":21},26,[89],"EARLY_PHASE1","This is a single-center, prospective, open-label, parallel-group exploratory clinical study designed to evaluate the safety and preliminary efficacy of fecal microbiota transplantation combined with standard medical therapy in patients with refractory overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. The study also aims to explore whether adjunctive prebiotic supplementation may improve clinical outcomes and support gut microbiota reconstruction after fecal microbiota transplantation.\n\nA total of 26 participants with recurrent overt hepatic encephalopathy after TIPS despite standard therapy with rifaximin and lactulose will be enrolled. All participants will continue to receive standard medical therapy, including rifaximin and lactulose. During an episode of overt hepatic encephalopathy, all participants will receive fecal microbiota transplantation via a nasojejunal tube at a dose of 100 mL per administration, twice daily, for 3 consecutive days. Participants will be assigned in a 1:1 ratio to either the fecal microbiota transplantation group or the fecal microbiota transplantation plus prebiotic group. Participants in the combination group will receive dietary fiber prebiotic supplementation at 24 g\u002Fday for 4 weeks in addition to the same fecal microbiota transplantation and standard medical therapy.\n\nParticipants will be followed for up to 6 months. The primary efficacy assessment will focus on recurrence of hepatic encephalopathy, including recurrence rate, time to first recurrence, episode grade, and duration. Secondary assessments will include time to reversal of hepatic encephalopathy, West Haven grade, blood ammonia, liver and kidney function, inflammatory markers, liver function scores, neurocognitive function, and changes in gut microbiota composition. Safety assessments will include adverse events, fecal microbiota transplantation-related adverse events, infection, worsening hepatic encephalopathy, hospitalization, and serious adverse events. This study is expected to provide preliminary clinical evidence for a microbiota-based therapeutic strategy in patients with refractory overt hepatic encephalopathy after TIPS.",[27,92,93,94],"Fecal Microbiota Transplantation","TIPS","Refractory Hepatic Encephalopathy",[27,92,93,94],"2026-06-29",{"date":98,"type":44},"2026-07-06",{"date":100,"type":44},"2026-06-01",{"date":102,"type":21},"2028-06-01",{"name":104,"class":51},"Air Force Military Medical University, China",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100639849","underdilated-vcx-tips-versus-evl-plus-nsbb-for-secondary-prophylaxis-of-variceal-bleeding-in-cirrhosis-100639849","NCT07587671","Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis","Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial","U-TIPS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of sex.\n* Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and\u002For clinical manifestations.\n* Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.\n* Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.\n* Child-Pugh score of 5 to 13.\n* The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate.\n* The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent.\n\nExclusion Criteria:\n\n* Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.\n* A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.\n* Child-Pugh score greater than 13.\n* Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.\n* Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.\n* Non-cirrhotic portal hypertension.\n* Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible.\n* Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.\n* Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS.\n* Uncontrolled severe infection, sepsis, or multiple organ failure.\n* Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy.\n* Severe renal insufficiency requiring long-term renal replacement therapy.\n* Pregnancy or breastfeeding.\n* Absolute contraindication to EVL, NSBB, or TIPS.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.",{"count":114,"type":21},240,[24],"Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration.\n\nThe VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting.\n\nThis is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.",[68,118,119,120,27],"Portal Hypertension","Gastroesophageal Varices Bleeding","Esophageal Varices",[29,122,123,124,125,126,127,128],"Portal hypertension","Esophageal variceal bleeding","Secondary prophylaxis","Transjugular intrahepatic portosystemic shunt","Underdilation","Endoscopic variceal ligation","Hepatic encephalopathy","2026-05-07",{"date":131,"type":44},"2026-05-14",{"date":74,"type":21},{"date":134,"type":21},"2030-07-30",{"name":136,"class":51},"West China Hospital",3,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":52},"100635528","endoscopic-shunts-embolization-for-refractory-hepatic-encephalopathy-100635528","NCT07553858","Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy","Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial","Inclusion Criteria:\n\n1. Adults aged ≥18 years with known cirrhosis\n2. MRHE; defined as ≥2 episodes of hepatic encephalopathy, HE (as documented in an outpatient office visit or during an inpatient admission) within 6 months prior to enrollment despite medical therapy with lactulose and rifaximin\n3. Admission to inpatient hepatology floor at University Hospital-Newark with MRHE at the time of enrollment\n4. Presence of a spontaneous portosystemic shunt; confirmed on CT\u002FMRI at the index admission.\n\nExclusion Criteria:\n\n1. Severe\u002Frefractory ascites defined as ascites that does not recede after medical therapy or reoccurs shortly after fluid has been removed\n2. Refractory or recurrent bleeding from esophageal varices\n3. Presence of portal vein thrombosis with complete occlusion\n4. Hepatocellular carcinoma beyond Milan criteria or other advanced malignancy with limited life expectancy (\\\u003C6 months)\n5. Platelet count of less than 35,000 and\u002For INR of more than 2 which cannot be corrected for the EUS guided embolization procedure.\n6. Hepatic venous occlusion, or right heart failure as the etiology of cirrhosis.",{"count":146,"type":21},34,[24],"The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answer are:\n\n1. Does EUS guided embolization maintain an acceptable safety profile?\n2. Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?\n\nParticipants will:\n\n1. Receive EUS guided embolization or medical management.\n2. Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).\n3. Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.",[27,68,150],"Portal Shunt Systemic","2026-04-20",{"date":153,"type":44},"2026-04-28",{"date":155,"type":21},"2026-05-01",{"date":157,"type":21},"2028-11-01",{"name":159,"class":51},"Rutgers, The State University of New Jersey",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":137},"100633592","phase-2-microbiota-transplant-therapy-in-hepatic-encephalopathy-masterpiece-100633592","NCT07528690","Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)","Microbiota Transplant Therapy to Prevent HE Recurrence in a Phase 2B Multi-Center Trial of Veterans With Cirrhosis","MASTERPIECE","Inclusion Criteria:\n\n* 21 years of age\n\n  * Cirrhosis diagnosed by any of the following in a patient with chronic liver disease\n\n    * Liver Biopsy\n    * Radiologic evidence of varices, cirrhosis or portal hypertension\n    * Laboratory evidence of platelet count \\\u003C110,000 or AST\u002FALT ratio\\>1\n    * Endoscopic evidence of varices or portal hypertensive gastropathy\n  * Prior overt HE (patient can be on lactulose and\u002For rifaximin 4 weeks stable dosing)\n  * Able to give written, informed consent \\[mini-mental status exam (MMSE)\\]\\>25 at the time of consenting)\n  * For lactulose only group: Prior HE not on rifaximin\n\nExclusion Criteria:\n\n* Disease-related:\n\n  * MELD3.0 score\\>22\n  * WBC count\\\u003C1000\n  * non-elective hospitalization or overt HE episode within 1 month\n  * on dialysis\n  * known untreated, luminal GI cancer\n  * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease)\n* Safety-related:\n\n  * Current dysphagia\n  * History of aspiration, intestinal obstruction or non-medication induced gastroparesis\n  * Ongoing absorbable antibiotic use\n  * History of anaphylactic food allergy\n  * Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior FMT (7) ASA Class V\n* Pregnant or nursing patients\n* Acute illness or fever on the day of planned FMT\n* History of spontaneous bacterial peritonitis","21 Years",{"count":170,"type":21},162,[172],"PHASE2","The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.",[27,29],[32,33,176,177,178],"rifaximin","lactulose","microbiota transplant therapy","2026-04-09",{"date":181,"type":44},"2026-04-14",{"date":183,"type":21},"2026-10-30",{"date":185,"type":21},"2031-03-03",{"name":187,"class":188},"VA Office of Research and Development","FED",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":52},"100633026","phase-4-apixaban-pk-trial-preventing-portal-hypertension-complications-in-cirrhosis-100633026","NCT07521332","Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis","Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan","APIXABAN-PK","Inclusion Criteria:\n\n1. Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical\u002Fimaging findings.\n2. Evidence of portal hypertension, defined by:\n\n   Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia.\n3. Compensated or early decompensated cirrhosis (Child-Pugh B 7-10), with stable liver function defined as no change in Child-Pugh score \\>1 point in the preceding 3 months.\n4. Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale signs, or history of variceal bleeding) must undergo endoscopic variceal band ligation to obliteration before randomization.\n5. Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Active gastrointestinal bleeding within 6 weeks prior to enrollment.\n2. High bleeding risk:\n\n   * Platelet count \\\u003C50,000\u002FµL at baseline\n   * INR \\>1.8 (or \\>2.0 if secondary to cirrhosis without additional coagulopathy)\n   * Active peptic ulcer disease\n   * History of intracranial hemorrhage or hemorrhagic stroke\n   * Known bleeding diathesis\n3. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or on dialysis.\n4. Child-Pugh class C or Child-Pugh score ≥10.\n5. History of hypersensitivity to apixaban or carvedilol.\n6. Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.\n7. Concurrent anticoagulant or antiplatelet therapy (including aspirin, clopidogrel, warfarin, or other DOACs) that cannot be safely discontinued. A washout period of at least 5 half-lives is required before randomization.\n8. Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.\n9. Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.\n10. Current or planned liver transplantation.",{"count":198,"type":21},220,[200],"PHASE4","The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing portal hypertension-related complications in patients with cirrhosis. Conducted at the Gastroenterology and Hepatology Department and Clinical Trials Unit (CTU) of Asian Institute of Medical Sciences (AIMS) Hospital, Hyderabad, Pakistan, the trial will enroll eligible cirrhotic patients with portal hypertension. Participants will be followed for 12 months to monitor hepatic decompensation events, variceal bleeding, portal vein thrombosis, and mortality, while safety and tolerability of apixaban will be closely assessed. This study aims to provide local evidence for apixaban use in cirrhosis management in Pakistan.",[29,203,204,27,205,118],"Esophageal and Gastric Varices","Ascites","Portal Vein Thrombosis",[207,208,32,35,209,210,211,212,213,214,215,216,217,218],"apixaban","carvedilol","direct oral anticoagulant","variceal bleeding","hepatic decompensation","portal vein thrombosis","randomized controlled trial","Pakistan","Factor Xa Inhibitor","non-selective beta-blocker","prevention","liver disease","2026-04-03",{"date":179,"type":44},{"date":222,"type":44},"2026-04-01",{"date":224,"type":21},"2028-04-01",{"name":226,"class":51},"Asian Institute Of Medical Sciences",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":52},"100520100","phase-2-hepatic-encephalopathy-and-albumin-lasting-cognitive-improvement-100520100","NCT06052176","Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement","Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin","HEAL-LAST","Inclusion Criteria:\n\n* Age \\>18 years\n* Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count \\\u003C150,000\u002Fmm3 and AST\u002FALT ratio \\>1.\n* Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop\n* Prior HE controlled by lactulose or rifaximin for at least one month\n* Serum albumin \\\u003C4gm\u002Fdl\n\nExclusion Criteria:\n\n* Unclear diagnosis of cirrhosis\n* No prior overt HE\n* No cognitive impairment on the tests noted\n* Requiring regular albumin infusions within 3 months or anticipated during the study visit\n* Infection within a month\n* Allergies to albumin\n* Unlikely to be adherent to the study\n* Unable or unwilling to consent\n* West Haven Criteria\\>2\n* Alcohol abuse within 1 month\n* Serum albumin \\>4gm\u002Fdl\n* Congestive heart failure",{"count":236,"type":21},30,[172],"Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.\n\nThis will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.",[29,27],[241,32,242,243],"albumin","inflammation","cognitive performance","2026-04-02",{"date":246,"type":44},"2026-04-08",{"date":248,"type":44},"2023-11-02",{"date":250,"type":21},"2026-12-01",{"name":252,"class":188},"Hunter Holmes Mcguire Veteran Affairs Medical Center",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":52},"100627882","phase-1-evaluation-of-the-outcome-of-fecal-microbiota-transplantation-100627882","NCT07454408","Evaluation of the Outcome of Fecal Microbiota Transplantation","A Clinical Randomized Controlled Study on the Prevention and Treatment of Drug-refractory Hepatic Encephalopathy After TIPS With Fecal Microbiota Transplantation","Inclusion Criteria:\n\n* Aged between 18 and 75 years old\n* Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery\n* Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention)\n* Provided written informed consent from the patient\n\nExclusion Criteria:\n\n* Malignant tumors of the liver, gastrointestinal tract or other systems\n* Uncontrolled severe active infection (\\>grade 2) or sepsis\n* Spontaneous bacterial peritonitis\n* Complicated with severe cardiac, renal or pulmonary insufficiency\n* Other neuropsychiatric diseases, including dementia\n* Budd-Chiari syndrome\n* Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)\n* History of gastrointestinal surgery (e.g., colectomy) within 3 months before enrollment\n* Pregnant or lactating subjects\n* Poor compliance judged by the investigator\n* Model for End-Stage Liver Disease (MELD) score \\>17\n* Tumor, immunodeficiency, or receiving immunosuppressive therapy within 3 months before enrollment\n* Patients who have used other prebiotics, probiotics or fecal microbiota transplantation (FMT) before enrollment",{"count":261,"type":21},40,[263,172],"PHASE1","This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.",[27,92,93],[27,92,93,267],"FMT","2026-03-05",{"date":270,"type":44},"2026-03-06",{"date":272,"type":21},"2026-03-07",{"date":274,"type":21},"2028-06-30",{"name":104,"class":51},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":284,"targetDuration":286,"studyType":64,"phases":4,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":52},"100625082","the-liver-cirrhosis-cognitive-decline-scale-liccos-100625082","NCT07418008","The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)","Development and Psychometric Validation of The Liver Cirrhosis Cognitive Decline Scale (LiCCoS)","LiCCoS","Inclusion Criteria:\n\n* Age 18-75 years.\n* Documented clinical diagnosis of liver cirrhosis based on imaging, histology, or validated clinical criteria.\n* Able to read and understand the language of the cognitive tests.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>75 years\n* Known case of Overt Hepatic Encephalopathy defined as Grade II or higher on the West Haven criteria \\[25\\].\n* Use of central nervous system depressants, anticholinergics, or psychotropics initiated or changed within the past 4 weeks.\n* Known case of Severe uncorrected visual or hearing impairment limiting ability to complete cognitive testing.\n* Known case of Any neurological and psychological disorders, substance use disorder and sleep disorders.\n* Known case of Severe systemic illness (e.g., end-stage renal disease, decompensated heart failure) that may independently impair cognition or limit participation.",{"count":285,"type":21},230,"1 Day","The goal of this observational study is to develop and test a new questionnaire called the Liver Cirrhosis Cognitive Decline Scale (LiCCoS) for adults with liver cirrhosis. This questionnaire is designed to help identify problems with thinking and daily mental functioning that are common in people with liver cirrhosis but are often missed during routine care.\n\nPeople with liver cirrhosis may experience problems such as forgetfulness, slowed thinking, trouble paying attention, or difficulty planning everyday tasks. These problems can affect daily life, safety, and treatment adherence. Existing cognitive tests often require special training or equipment and may not fully reflect how people experience these difficulties in daily life. This study aims to create a simple, patient-reported tool that captures these concerns in an easy and practical way.\n\nThe main questions this study aims to answer are:\n\n1. Can the LiCCoS questionnaire reliably measure cognitive difficulties in adults with liver cirrhosis?\n2. Does the questionnaire correctly reflect differences in cognitive function across levels of liver disease severity?\n3. Do LiCCoS scores relate to results from commonly used cognitive screening tests?\n\nParticipants will be adults aged 18 to 75 years who have a confirmed diagnosis of liver cirrhosis and are attending outpatient clinics. Participation is voluntary.\n\nParticipants will:\n\nProvide basic background information, such as age and medical history\n\nComplete the LiCCoS questionnaire about their thinking and daily mental functioning\n\nComplete standard cognitive screening tests commonly used in clinical care\n\nThis study does not involve any treatment or change in medical care. The information collected will be used only for research purposes. The results are expected to help develop a reliable and easy-to-use tool that can support early recognition of cognitive difficulties in people with liver cirrhosis and improve communication between participants and health care providers.",[68,289,27,290],"Cognitive Dysfunction","Neurocognitive Disorders",[282,292,293,294,128,295,296,297,298,299],"Liver cirrhosis","Cognitive impairment","Cognitive dysfunction","Patient-reported outcome measure","Psychometric validation","Scale development","Cognitive assessment","Chronic liver disease","2026-02-10",{"date":302,"type":44},"2026-02-18",{"date":304,"type":44},"2025-12-15",{"date":306,"type":21},"2026-11-30",{"name":308,"class":51},"University of Malaya",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100548775","pilot-open-label-trial-of-resistant-potato-starch-in-patients-with-cirrhosis-and-overt-hepatic-encephalopathy-100548775","NCT06425380","Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy","Inclusion Criteria:\n\n* Able to provide consent, with signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation.\n* History of at least one episode of overt Hepatic Encephalopathy (HE) in the last year.\n\n  * Defined by West Haven Criteria Grades II to IV\n  * Can be precipitated Hepatic Encephalopathy (HE) episode.\n* Sexually active women of childbearing potential enrolled in the study must agree to use a highly-effective method of contraception (defined in the protocol) for the duration of the study.\n\nExclusion Criteria:\n\n* Hospitalization in the last 4 weeks\n* Current refractory ascites (requiring large volume paracentesis to manage ascites)\n* Gut-absorbable or intravenous antibiotic therapy in the last 4 weeks (rifaximin is permitted)\n* Anticipated antibiotics in the coming 4 weeks\n* Use of lactulose in the last 4 weeks\n* Alcohol or illicit drug intake in the last 4 weeks\n\n  * By history\n  * Alcohol use will be characterized as \\>1 alcoholic drink \u002F week\n* History of inflammatory bowel disease\n* History of primary sclerosing cholangitis\n* Total bilirubin in the last 3 months \\> 4 mg\u002FdL\n* Prior diagnosis of dementia or other primary neurocognitive disorder\n* Pregnancy or breast feeding\n* Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \\>3 months before enrollment)\n* Allergy to resistant potato starch","99 Years",{"count":317,"type":21},11,[24],"This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy.\n\nThe researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.",[27,29],[322],"Resistant Potato Starch","2026-01-28",{"date":325,"type":44},"2026-01-30",{"date":327,"type":44},"2024-07-12",{"date":329,"type":21},"2027-01-28",{"name":331,"class":51},"Mayo Clinic",2,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":349,"locationsCount":52},"100369874","late-evening-and-early-morning-protein-supplement-to-reduce-readmissions-for-hepatic-encephalopathy-100369874","NCT04096014","Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy","Inclusion Criteria:\n\n* \\> 18 years of age\n* cirrhosis diagnosed by clinical history and liver biopsy and\u002For clinical, biochemical and imaging evidence of cirrhosis\n* at least 1 hospitalization for documented HE within the last 12 months.\n* abdominal CT scan anytime in the past\n\nExclusion Criteria:\n\n* Patients with MELD score \\> 35\n* end stage organ failure (major dysfunction requiring organ support)\n* kidney injury defined by a creatinine \\> 2 mg\u002Fdl or rise in creatinine by 0.5 gm\u002Fdl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm\u002Fkg up to 100 gm\u002Fday)\n* active malignancy\n* uncontrolled diabetes mellitus with A1c\\>9.5 (to avoid altered muscle protein metabolism\n* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass\n* recent gastrointestinal surgery within past 12 months\n* ongoing infection (positive blood or other body fluid cultures)\n* active gastrointestinal bleeding.",{"count":261,"type":21},[24],"Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.",[27],"2025-11-24",{"date":345,"type":44},"2025-11-25",{"date":347,"type":44},"2019-09-16",{"date":183,"type":21},{"name":350,"class":51},"The Cleveland Clinic",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":358,"enrollmentInfo":359,"targetDuration":361,"studyType":64,"phases":4,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":52},"100306314","vicis---vienna-cirrhosis-study-100306314","NCT03267615","VICIS - Vienna Cirrhosis Study","VICIS","Inclusion Criteria:\n\n* Age \\>18 years and \\\u003C100 years\n* Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG\\>5mmHg or Histology F3\u002FF4)\n* Written informed consent\n\nExclusion Criteria:\n\n* Withdrawal of written informed consent","100 Years",{"count":360,"type":21},10000,"10 Years","Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank.\n\nClinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.\n\nThis study is linked to a biobank with serum\u002Fplasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.",[68,118,204,364,27],"Variceal Hemorrhage",[68,118],"2025-09-22",{"date":368,"type":44},"2025-09-25",{"date":370,"type":44},"2017-02-01",{"date":372,"type":21},"2027-12-31",{"name":374,"class":51},"Medical University of Vienna",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":382,"enrollmentInfo":383,"targetDuration":385,"studyType":64,"phases":4,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":4},"100599319","mechanisms-of-perioperative-systemic-inflammation-in-the-development-of-pnd-in-cirrhotic-patients-100599319","NCT07082946","Mechanisms of Perioperative Systemic Inflammation in the Development of PND in Cirrhotic Patients","Mechanism of Perioperative Systemic Inflammation-Induced Postoperative Neurocognitive Disorders in Chronic Liver Disease Patients Via Blood-Brain Barrier Disruption","Inclusion Criteria:\n\n1. Age: 18-80 years\n2. Patients with or without liver cirrhosis scheduled for upper abdominal surgery due to various clinical indications\n3. Ability to comply with the study protocol and provide informed consent\n\nExclusion Criteria:\n\n1. Comorbid severe cardiac, pulmonary, or renal diseases\n2. Patients with mental status incompatible with study participation, including:\n\n   * Psychiatric disorders\n   * Inability to communicate clearly\n3. Any condition preventing effective communication or cooperation","80 Years",{"count":384,"type":21},148,"7 Days","Chronic Liver Disease (CLD) is associated with significant cognitive dysfunction, including hepatic encephalopathy (HE), which is driven by systemic inflammation and blood-brain barrier (BBB) disruption. Perioperative Neurocognitive Disorders (PND), comprising postoperative delirium (POD) and postoperative cognitive dysfunction (POCD), further exacerbate these impairments, particularly in cirrhotic patients undergoing major surgery. However, the mechanisms linking systemic inflammation, BBB dysfunction, and PND remain poorly understood. This study aimed to investigate perioperative cognitive changes and inflammatory markers in cirrhotic and non-cirrhotic patients undergoing major abdominal surgery, and to explore the effects of cirrhosis and surgical intervention on central nervous system inflammation and cognitive dysfunction using a rat model. The investigators conducted a prospective study on cirrhotic and non-cirrhotic patients undergoing major abdominal surgery. Perioperative cognitive function was assessed using validated tools, and inflammatory markers were analyzed using Olink Target protein detection and bioinformatics approaches. Additionally, the investigators established a cirrhosis model using bile duct ligation (CBDL) in rats, followed by exploratory laparotomy to evaluate behavioral performance, BBB integrity and levels of inflammatory cytokines in serum and brain tissue.",[27],"2025-07-16",{"date":390,"type":44},"2025-07-24",{"date":392,"type":21},"2025-07-20",{"date":394,"type":21},"2025-08-31",{"name":396,"class":51},"Sichuan Provincial People's Hospital",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":52},"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","65 Years",{"count":407,"type":21},336,[200],"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.",[27,411,67],"Decompensated Cirrhosis",[128,413,414,415,176],"Branched-chain amino acids","Computerized neurocognitive test battery","Double blind placebo controlled multicentric randomized controlled trial","2025-06-05",{"date":418,"type":44},"2025-06-10",{"date":420,"type":44},"2025-02-01",{"date":422,"type":21},"2027-08",{"name":424,"class":51},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":52},"100589400","correlation-between-serum-albumin-level-and-severity-of-hepatic-encephalopathy-in-patients-with-chronic-liver-disease-in-sohag-university-hospital-100589400","NCT06953921","Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital","Inclusion Criteria:\n\n* patients aged \\>18 years.\n* Confirmed chronic liver disease (by imaging ,\n* liver function tests , and clinical history).\n* Diagnosed with hepatic encephalopathy based on clinical criteria.\n* Patients able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients age less than 18 years old\n* Acute liver failure.\n* Chronic renal failure on dialysis.\n* Pregnant women.\n* Patients with active malignancy.",{"count":432,"type":21},100,"assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease.\n\nassess the impact of albumin level on clinical course and outcomes of HE.",[27],"2025-04-23",{"date":437,"type":44},"2025-05-01",{"date":439,"type":44},"2025-03-12",{"date":441,"type":21},"2025-09-12",{"name":443,"class":51},"Sohag University",{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":332},"100578190","phase-4-a-study-to-evaluate-role-of-inhaled-amikacin-to-prevent-ventilator-associated-pneumonia-in-patients-with-cirrhosis-100578190","NCT06808074","A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis","Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study","Inclusion Criteria:\n\n1. Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.\n2. Patient is aged ≥18 years.\n3. Written informed consent of the patient or a proxy.\n\nExclusion Criteria:\n\n1. Suspected or confirmed Pneumonia at the day of inclusion.\n2. Patients with Chronic kidney disease on maintenance hemodialysis\n3. Stage 2 or 3 Kidney Disease Improving Global Outcome (KDIGO) classification AKI the day of inclusion. Patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the KDIGO stage\n4. Pregnancy or breast-feeding.\n5. Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.\n6. Patients known to be allergic to aminoglycosides.\n7. Patients who received intravenous Amikacin before 7 days of inclusion in this study.",{"count":170,"type":21},[200],"The recent AMIKINHAL trial found that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in ICU patients. Since aspiration is a common complication of cirrhosis patients with HE (7 out of 10 patients develop some type of HE) who are hospitalized to the liver ICU also have an elevated risk of Ventilator associated pneumonia. Despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. This poses a significant challenge to physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.",[27,29,455],"Ventilator Associated Pneumonia (VAP)",[457,458,459],"Inhaled amikacin","Prophylaxis","Ventilator associated pneumonia","2025-04-03",{"date":462,"type":44},"2025-04-04",{"date":464,"type":44},"2025-02-12",{"date":466,"type":21},"2026-05",{"name":468,"class":51},"Asian Institute of Gastroenterology, India",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":382,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":485,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":496,"locationsCount":498},"100368129","phase-4-prevention-of-post-tips-hepatic-encephalopathy-by-administration-of-rifaximin-and-lactulose-100368129","NCT04073290","Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose","Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement: a Multi-centre Randomized, Double Blind, Placebo Controlled Trial.","PEARL","Inclusion Criteria:\n\n1. Elective TIPS placement for refractory ascites or recurrent variceal bleeding:\n\n   Recurrent tense ascites and one or more of the following criteria:\n\n   i. Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide).\n\n   ii. Kidney insufficiency (Creatinine \\> 135 umol\u002FL) induced by diuretics. iii. Electrolyte disturbances (Sodium \\\u003C 125 mmol\u002FL, Potassium \\> 5.5 mmol\u002FL) induced by diuretics.\n\n   iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps).\n\n   Recurrent variceal bleeding, not responsive to treatment with endoscopic band ligation and beta-blockers, with a high risk of failure of endoscopic treatment:\n\n   i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy\n2. Age ≥18 years\n3. Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Any absolute contraindications for TIPS placement\n2. Use of ciclosporin\n3. Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours\n4. Age \\> 80 years\n5. Non-cirrhotic portal hypertension\n6. Portal vein thrombosis (main trunk)\n7. HIV\n8. Current or recent (\\\u003C3 months) use of rifaximin\n9. Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease\n10. Pregnant or breastfeeding women\n11. Patients refusing or unable to sign informed consent",{"count":478,"type":21},238,[200],"Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.",[27,482,118,483,484],"Cirrhosis, Liver","Liver Diseases","Pathological Processes",[486,487,488,489],"Rifaximin","Lactulose","post-TIPS HE","Prevention","2025-01-27",{"date":492,"type":44},"2025-01-28",{"date":494,"type":44},"2020-01-21",{"date":48,"type":21},{"name":497,"class":51},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",6,{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":52},"100363607","safety-and-efficacy-of-fecal-microbiota-transplantation-100363607","NCT04014413","Safety and Efficacy of Fecal Microbiota Transplantation","Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study","Inclusion Criteria:\n\nConfirmed diagnosis of any of the following diseases:\n\n* Crohn's disease\n* Ulcerative colitis\n* Celiac disease\n* Irritable bowel syndrome\n* Functional dyspepsia\n* Constipation\n* Antibiotic-associated diarrhea or any antibiotic- associated complications\u002Fsymptoms\n* Metabolic syndrome such as diabetes mellitus and obesity\n* Multidrug-resistant infection\n* Hepatic encephalopathy\n* Multiple sclerosis\n* Pseudo-obstruction\n* Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection\n* Multiple organ dysfunction\n* Dysbiotic bowel syndrome\n* MRSA enteritis\n* Pseudomembranous enteritis\n* Alopecia, autism\n* Graft-versus-host disease\n* Idiopathic thrombocytopenic purpura (ITP)\n* Atopy or allergy\n* Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)\n* Alcohol dependence\n* Psoriatic arthropathy that has suboptimal control of disease despite standard treatment.\n\nExclusion Criteria:\n\n* Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema\n* Any conditions that may render the efficacy of FMT or at the discretion of the investigators\n* Current pregnancy",{"count":507,"type":21},450,[24],"The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.\n\nRecent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series\u002Freports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.\n\nDespite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.",[511,512,513,514,515,516,517,518,519,520,27,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536],"Crohn Disease","Ulcerative Colitis","Celiac Disease","Irritable Bowel Syndrome","Functional Dysphonia","Constipation","Clostridium Difficile Infection","Diabetes Mellitus","Obesity","Multidrug -Resistant Infection","Multiple Sclerosis","Pseudo-Obstruction","Carbapenem-Resistant Enterobacteriaceae Infection","Vancomycin Resistant Enterococci Infection","Multiple Organ Dysfunction Syndrome","Dysbiotic Bowel Syndrome","MRSA Enteritis","Pseudomembranous Enterocolitis","Alopecia","Autism","Graft-versus-host Disease","Idiopathic Thrombocytopenic Purpura","Atopy or Allergy","Liver Disease","Alcohol Dependence","Psoriatic Arthropathy","2024-08-21",{"date":539,"type":44},"2024-08-22",{"date":541,"type":44},"2019-07-15",{"date":543,"type":21},"2030-10-31",{"name":545,"class":51},"Chinese University of Hong Kong",{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":52},"100531606","revealing-engagement-patterns-among-hepatic-encephalopathy-patients-100531606","NCT06201988","Revealing Engagement Patterns Among Hepatic Encephalopathy Patients","Assessing Patient Engagement and Understanding in Hepatic Encephalopathy Clinical Research","Inclusion Criteria:\n\n* Signed Written Informed Consent\n* Aged ≥ 18 years old\n* No prior treatment for hepatic encephalopathy\n\nExclusion Criteria:\n\n* Participant is actively receiving study therapy in another\n* Inability to provide written informed consent\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating.",{"count":554,"type":21},500,"This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.\n\nIn essence, this trial aims to deepen understanding of the factors influencing participation in hepatic encephalopathy clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.",[27],[27],"2024-02-09",{"date":560,"type":44},"2024-02-12",{"date":562,"type":21},"2025-01",{"date":564,"type":21},"2027-01",{"name":566,"class":567},"Power Life Sciences Inc.","INDUSTRY",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":17,"minAge":575,"maxAge":405,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":52},"100374868","phase-3-efficacy-and-safety-of-nitazoxanide-in-preventing-recurrence-of-hepatic-encephalopathy-100374868","NCT04161053","Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy","Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy","Inclusion Criteria:\n\n* Cirrhotic patient with at least one previous episode of hepatic encephalopathy.\n* Adult Patients aging from 20 to 65 years old\n\nExclusion Criteria:\n\n* Active GIT bleeding.\n* Major psychiatric illness (psychosis \\& epilepsy).\n* Renal insufficiency (S.Cr 2mg\u002Fdl).","20 Years",{"count":577,"type":21},60,[579],"PHASE3","Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.",[27],"2019-11-12",{"date":584,"type":44},"2019-11-13",{"date":586,"type":44},"2018-11-01",{"date":588,"type":21},"2028-12",{"name":590,"class":51},"Tanta University"]