[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"minimal-hepatic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:minimal-hepatic-encephalopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100639822","a-prospective-cohort-study-on-the-epidemiological-investigation-diagnosis-and-treatment-of-hepatic-encephalopathy-100639822",false,"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,"ALL","18 Years","75 Years",{"count":20,"type":21},700,"ESTIMATED","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.",[26,27,28],"Hepatic Encephalopathy","Minimal Hepatic Encephalopathy","Liver Cirrhosis","NOT_YET_RECRUITING","2026-05-24",{"date":32,"type":33},"2026-05-29","ACTUAL",{"date":35,"type":21},"2026-06-01",{"date":37,"type":21},"2028-03-31",{"name":39,"class":40},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100613908","psychometric-hepatic-encephalopathy-score-in-prediction-of-minimal-hepatic-encephalopathy-in-compensated-cirrhotic-patients-100613908","NCT07272707","Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients","PHES-MHE","Inclusion Criteria:\n\n* Inclusion Criteria (Cirrhotic Patients):\n\n  1. Age 18-70 years.\n  2. Diagnosed compensated liver cirrhosis, regardless of etiology.\n  3. Able to read and write.\n  4. Adequate vision, hearing, and physical ability to perform the PHES tests.\n\n     Inclusion Criteria (Healthy Controls):\n\n  \u003C!-- -->\n\n  1. Age 18-70 years.\n  2. No chronic medical, neurological, psychiatric, renal, or cardiac disease.\n  3. Able to read and write.\n  4. Adequate cognition, hearing, vision, and physical ability.\n\n     Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. Chronic liver disease.\n  2. Neuropsychiatric illness.\n  3. Use of psychoactive medications.\n  4. Illiteracy.","70 Years",{"count":51,"type":21},150,"Minimal hepatic encephalopathy (MHE) is a covert form of hepatic encephalopathy associated with cognitive and psychomotor impairment in patients with compensated liver cirrhosis. Early detection of MHE is crucial to prevent progression to overt encephalopathy. The Psychometric Hepatic Encephalopathy Score (PHES) is a validated neuropsychological test battery for diagnosing MHE. This study aims to screen for MHE among compensated cirrhotic patients using PHES and to compare performance with healthy matched controls.",[27],[55,56],"Minimal hepatic encephalopathy","Psychometric Hepatic Encephalopathy Score","2025-11-26",{"date":59,"type":33},"2025-12-09",{"date":61,"type":21},"2025-12-01",{"date":63,"type":21},"2026-09-01",{"name":65,"class":40},"Sohag University",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":41},"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":76,"type":21},336,"INTERVENTIONAL",[79],"PHASE4","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.",[26,82,27],"Decompensated Cirrhosis",[84,85,86,87,88],"Hepatic encephalopathy","Branched-chain amino acids","Computerized neurocognitive test battery","Double blind placebo controlled multicentric randomized controlled trial","rifaximin","RECRUITING","2025-06-05",{"date":92,"type":33},"2025-06-10",{"date":94,"type":33},"2025-02-01",{"date":96,"type":21},"2027-08",{"name":98,"class":40},"Post Graduate Institute of Medical Education and Research, Chandigarh"]