[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cirrhosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,102,0,25,[9,43,69,126,150,173,207,235,263,290,317,343,365,395,421,451,478,504,538,562,595,622,654,678,696],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100495042","phase-2-empagliflozin-in-patients-with-cirrhosis-and-ascites-100495042",false,"NCT05726032","Empagliflozin in Patients With Cirrhosis and Ascites","Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites","EMPA Liver","Inclusion Criteria:\n\n1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +\u002F- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses\n2. eGFR \\>= 30mL\u002Fmin\u002F1.73 m2\n3. \\>=18 years old\n\nExclusion Criteria:\n\n1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)\n2. Direct bilirubin \\>=3 mg\u002FdL\n3. Systolic blood pressure \\\u003C 100 mmHg\n4. Active malignancy including hepatocellular carcinoma undergoing treatment\n5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections\n6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance\n7. Type 1 diabetes\n8. History of frequent hypoglycemic episodes\n9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.\n10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks\n11. Hepatic encephalopathy grade II or greater at the time of enrollment\n12. Patients who have had TIPS placed\n13. Previous liver transplant\n14. Participation in another trial with an investigational drug within the 30 days prior to informed consent\n15. Pregnancy or breastfeeding\n16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)\n17. Change in diuretic dose in the prior 2 weeks\n18. Patients with hospitalization for alcoholic hepatitis in the past 6 months\n19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks\n20. MELD-Na \\> or equal to 20\n21. Hemoglobin \\\u003C8","ALL","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.",[28,29],"Cirrhosis","Liver Failure","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2023-09-11",{"date":38,"type":22},"2026-12-01",{"name":40,"class":41},"Yale University","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100588124","phase-2-droxidopa-to-increase-mean-arterial-pressure-in-decompensated-cirrhosis-patients-with-acute-kidney-injury-100588124","NCT06937307","Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury","DROP-AKI","Inclusion Criteria:\n\n* Ability to provide informed consent by subject or legally authorized representative\n* Consent to blood and urine collection for biomarker analysis\n* Ability to take oral medications\n* At least 18 years of age\n* Hospitalized at Columbia University Irving Medical Center\n* Child-Pugh Score ≥ B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)\n* KDIGO Stage 1 AKI or greater, defined as:\n* ≥0.3 mg\u002FdL increase in serum creatinine within 48 hours OR\n* ≥50% increase in serum creatinine from outpatient baseline\n* Mean arterial pressure ≤85 mmHg averaged over 24 hours prior to randomization\n* For women of childbearing potential: negative pregnancy test and agreement to use effective contraception\n\nExclusion Criteria:\n\n* Serum creatinine \\>4.0 mg\u002FdL or current renal replacement therapy\n* Age \\>70 years\n* Severe cardiovascular disease, including:\n* Unstable angina\n* Congestive heart failure requiring escalating medical therapy\n* Symptomatic peripheral vascular disease\n* Any cardiovascular condition deemed severe by investigator\n* Active gastrointestinal bleeding, defined as requiring ≥ 2 units of packed red blood cells during the screening period\n* Acute respiratory failure requiring more than 6L of Nasal Canula\n* Use of medications that could interact with droxidopa including:\n* MAOI inhibitors\n* Norepinephrine reuptake inhibitors\n* Other investigational drugs\n* Pregnancy or breastfeeding\n* Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart\n* Prior liver transplantation","70 Years",{"count":52,"type":22},75,[25],"This study tests whether a medication called droxidopa can help improve blood flow to the kidneys in people with liver cirrhosis who develop kidney problems while in the hospital. When someone with cirrhosis experiences kidney injury, having better blood pressure can help their kidneys recover. Droxidopa is an oral medication that may help raise blood pressure without requiring intensive care or invasive treatments. The study will compare droxidopa to a placebo (inactive pill) in 75 people hospitalized with cirrhosis and kidney injury. Participants will take either droxidopa or placebo pills for 28 days and be monitored for an additional 30 days. Researchers will measure changes in blood pressure and kidney function to determine if droxidopa is effective and safe for these patients. This research could identify a new treatment option for a serious complication of liver disease.",[56,28,57],"Acute Kidney Injury","Decompensated Cirrhosis of Liver",[56,28,59],"Decompensated Cirrhosis","2026-08-17",{"date":62,"type":34},"2026-08-19",{"date":64,"type":34},"2025-05-27",{"date":66,"type":22},"2028-12-31",{"name":68,"class":41},"Giuseppe Cullaro, MD",{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":42},"100474891","inadvance-surveillance-prevention-and-interception-in-a-population-at-risk-for-cancer-100474891","NCT05463796","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer","Inclusion Criteria:\n\n* Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):\n\n  1-Hereditary risk for cancer including\n  * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes\n  * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)\n  * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)\n  * Hereditary Cancer Prediction Model-based elevated cancer risk\n  * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\\&N cancer for example), etc.\n* Exposed High Risk including\n\n  * Childhood cancer survivors with treatment exposures associated with increased risk of cancer\n  * Adult cancer survivors with treatment exposures associated with increased risk of cancer\n  * Documented high level exposure to group 1 IARC carcinogens\n  * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \\>50, Smoking history of \\>15 pack years, First-degree relative history of lung cancer or COPD\n  * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis\n* Precursor Lesions including\n\n  * Breast: ductal\u002Flobular carcinoma in situ (CIS) and atypical hyperplasia\n  * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia\u002Fadenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis\n  * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia\u002Fcarcinoma in situ,\n  * Lung: Adenomatous hyperplasia\n  * H\\&N: high-risk oral precancerous diseases\n  * Skin: Class II melanocytic lesions. Squamous dysplasia\n  * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas\n  * Thoracic: Lung nodules detected on screening CT that prompt further follow-up\n  * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia\n  * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.\n* FAMILY MEMBERS or healthy individuals\n\nExclusion Criteria:\n\nThere are no exclusion criteria for the study.\n\nNote: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.",true,{"count":78,"type":22},5000,"20 Years","OBSERVATIONAL","This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.\n\n* The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.\n* The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,28,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Cancer Risk","Cancer Predisposition Syndrome","Hereditary Cancer Prediction","Childhood Cancer Survivors","Adult Cancer Survivors","IARC Carcinogens","Smoking History","Lung Cancer","Ductal\u002FLobular Carcinoma","Barrett Esophagus","Pancreatic Precursor Lesions","Colonic Dysplasia\u002FAdenomata","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Steatohepatitis","High Grade Prostatic Epithelial Neoplasia","High-grade Bladder Urothelial Dysplasia\u002FCarcinoma in Situ","Adenomatous Hyperplasia","High-risk Oral Precancerous Diseases","Melanocytic Lesion, Adult","Hematologic Malignancy","Lung; Node","Serous Tubal Intraepithelial Carcinoma","Endometrial Intraepithelial Neoplasia","Cervical and Endocervical Carcinoma in Situ","Vulvar Intraepithelial Neoplasia","Nephrogenic Rests","Benign Bone Lesions With Risk of Malignant Degeneration","Giant Cell Tumor","Osteochondroma","Spitz Nevus",[114,115,116,117],"Hereditary Risk for Cancer","Childhood cancer survivors","Adult cancer survivors","Precursor Lesions","2026-08-13",{"date":60,"type":34},{"date":121,"type":34},"2023-04-25",{"date":123,"type":22},"2031-03-25",{"name":125,"class":41},"Dana-Farber Cancer Institute",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100609613","screening-cardiometabolic-opportunities-using-transformative-echocardiography-artificial-intelligence-scout-echo-ai-100609613","NCT07216859","Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI)","SCOUT Echo-AI","Inclusion Criteria:\n\n* Adults ≥18 years.\n* Underwent routine TTE within site defined recent timeframe and flagged as high risk for MASLD and\u002For cirrhosis by the AI model using pre specified threshold.\n* Able to provide informed consent; reachable for follow up.\n\nExclusion Criteria:\n\n* Inability to consent or communicate.\n* Enrollment in hospice or life expectancy so limited that additional evaluation would not be appropriate per clinician judgment.\n* Clinical circumstances where immediate alternative diagnostic pathways supersede study procedures (e.g., acute decompensation requiring urgent management).\n* Prior liver or kidney transplant.\n* Patient unwilling to undergo prospective testing for liver disease.",{"count":134,"type":22},2000,[136],"NA","The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and\u002For cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs).\n\nThe main question it aims to answer is to:\n\n1. Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment.\n2. Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.",[139,28],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","NOT_YET_RECRUITING","2026-08-11",{"date":118,"type":34},{"date":144,"type":22},"2028-01-01",{"date":146,"type":22},"2028-11-01",{"name":148,"class":41},"Kaiser Permanente",6,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":42},"100475926","adverse-outcomes-and-mortality-in-liver-transplant-100475926","NCT05477277","Adverse Outcomes and Mortality in Liver Transplant","Inclusion Criteria:\n\n1. All patients with end-stage liver disease undergoing evaluation for liver transplantation\n2. Patient clinically indicated for MRI during transplant candidacy evaluation\n3. Adult\n\nExclusion Criteria:\n\n1\\. Contra indication to MRI",{"count":157,"type":22},100,[136],"Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.",[161,162,163,28],"End Stage Liver DIsease","Sarcopenia","Sarcopenic Obesity","2026-08-03",{"date":166,"type":34},"2026-08-05",{"date":168,"type":34},"2022-11-02",{"date":170,"type":22},"2027-12-31",{"name":172,"class":41},"Mayo Clinic",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":42},"100596512","affect-of-melatonin-on-sleep-and-cognition-in-cirrhosis-100596512","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",{"count":182,"type":22},18,[136],"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.",[186,187,28,188],"Hepatic Encephalopathy","Covert Hepatic Encephalopathy","Sleep Disturbances and Insomnia",[190,191,192,193,194,195,196,197],"cirrhosis","hepatic encephalopathy","covert hepatic encephalopathy","portal hypertension","sleep disturbances","insomnia","sleep problems","wearable technology","2026-07-27",{"date":200,"type":34},"2026-07-29",{"date":202,"type":34},"2025-08-05",{"date":204,"type":22},"2026-12-31",{"name":206,"class":41},"Weill Medical College of Cornell University",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":76,"sex":18,"minAge":19,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":42},"100442753","phase-1-hepatic-impairment-with-cirrhosis-due-to-cholestatic-liver-disease-100442753","NCT05045482","Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","Inclusion Criteria:\n\nFor all subjects:\n\n1. Ability to comprehend and willingness to sign a written ICF for the study.\n2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.\n3. Body mass index within the range 18.0 to 48.0 kg\u002Fm2 (inclusive) at screening.\n4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.\n5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study.\n6. Ability to swallow and retain oral medication.\n\n   For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n7. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.\n8. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:\n\n   1. ALT\u002FAST value ≤ 10 × upper limit of normal (ULN)\n   2. Absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n   3. Platelets ≥ 25,000\u002Fmm3\n   4. Hemoglobin ≥ 8 g\u002FdL\n   5. α-fetoprotein \\\u003C 50 ng\u002FmL or 50-80 ng\u002FmL with negative imaging study (US, CT, MRI).\n\n   For Subjects in Groups 8D and 9D (normal hepatic function groups):\n9. Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in.\n10. Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT\u002FAST \\\u003C 1.2 × ULN at screening.\n\nExclusion Criteria:\n\nFor all subjects:\n\n1. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.\n2. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).\n3. History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).\n4. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.\n5. Any major surgery within 3 months of screening.\n6. Donation of blood or blood products within 3 months prior to screening.\n7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.\n8. Use or intend to use any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.\n9. Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.\n10. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2 by modification of diet in renal disease (MDRD) formula at screening.\n11. Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.\n12. Positive test for drugs of abuse at screening or admission. Subjects with a positive test based on a prescribed medication may be enrolled.\n13. Any subject with poor peripheral venous access\n14. Receipt of blood products within 1 month prior to check in.\n15. Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups.\n\n    For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n16. Other known cause of liver disease such as NASH, alcoholic steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records.\n17. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator.\n18. Subjects having -\n\n    1. History of gastrointestinal bleeding within 1 month prior to screening.\n    2. Current functioning organ transplant.\n    3. Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.\n19. Subjects who use or intend to use any over the counter (vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations) or prescription medications within 30 days or 5 half-lives (whichever is longer) prior to enrolment, with the exception of hormone replacement therapy and therapies for hepatic disease and treatments of associated disorders that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the Investigator (or designee).\n\n    For Subjects in Group 8A (Mild hepatic impairment group) and 8B (Moderate impairment group)\n20. Total bilirubin \\> 5×ULN\n\n    For Control with Normal Hepatic Function:\n21. Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 14 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen, hormonal contraceptive medications and\u002For any other over-the-counter product approved by the Investigator.","80 Years",{"count":216,"type":22},30,[218],"PHASE1","A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease",[221,28,222],"Hepatic Impairment","Cholestatic Liver Disease",[221,224,28,222],"Saroglitazar Magnesium","2026-07-24",{"date":227,"type":34},"2026-07-28",{"date":229,"type":34},"2021-10-21",{"date":231,"type":22},"2026-07-31",{"name":233,"class":234},"Zydus Therapeutics Inc.","INDUSTRY",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100541242","phase-1-evaluation-of-cirrhotic-cardiomyopathy-by-cardiac-mri-in-patients-waiting-for-liver-transplant-100541242","NCT06327308","Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.","Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. A Multicenter Prospective Pilot Study. (CARDIO-FIBROCIR)","CARDIOFIBROCIR","Inclusion Criteria:\n\n* Inclusion of cirrhotic patients who are candidates for liver transplantation and without documented contraindications to transplantation\n* Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)\n* Signature of an informed consent form indicating that the subject has understood the purpose and procedures required by the study and that he or she agrees to participate in the study and to comply with the requirements and restrictions inherent in the study\n* Patient with a social security system or beneficiary of such a system.\n\nExclusion Criteria:\n\n* Minor or over 70 years old\n* Transplant Patient\n* Patient with a TIPS\n* Known heart disease including portopulmonary hypertension and coronary artery disease (history of ischemic heart disease with necrosis, history of cardiomyopathy or acute myocarditis)\n* Uncontrolled hypertension with interventricular septal thickness ≥ 15 mm\n* Hemodynamic instability\n* Type 1 diabetes\n* Current bacterial infection\n* HIV infection (or unknown HIV status)\n* Contraindications for MRI including pacemaker, implantable defibrillators, electrosystolic pacing probe, Swan-Ganz probe, postoperative epicardial electrodes, Starr-Ewards metal ball valves, insulin pumps, ferromagnetic vascular clips, ocular and otological implants, ocular ferromagnetic foreign bodies, renal failure with a GFR \\< 30 mL\u002Fmin\u002F1.73 m², contraindication to contrast media, patient unable to maintain apnea for a few seconds, claustrophobia\n* Inability to receive informed information in patients with severe encephalopathy who do not have a trusted person\n* Patient under guardianship, curatorship, Legal incapacity or limited legal capacity\n* Patient deprived of liberty\n* Pregnant woman or breastfeeding\n* Subject unlikely to cooperate in the study and\u002For low cooperation anticipated by the investigator\n* Subject being in the period of exclusion from another study or provided for by the \"national volunteer file\"",{"count":244,"type":22},60,[218],"The aim of this multicenter prospective interventional pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT). Through multimodal analysis of myocardial function and architecture, and analysis of specific markers of inflammation, we aim to explore the following hypotheses: 1) systemic inflammation promotes myocardial fibrosis in cirrhotic patients and could be an early marker of cirrhotic cardiomyopathy; 2) LT allows resolution of myocardial fibrosis by preventing the bacterial translocation that favors the development of deleterious systemic inflammation.",[28,248],"Registered on Transplant List",[28,250,251,252],"cirrhotic cardiomyopathy","Liver Transplantation","MRI","2026-07-20",{"date":255,"type":34},"2026-07-22",{"date":257,"type":34},"2025-03-11",{"date":259,"type":22},"2029-12-11",{"name":261,"class":41},"Centre Hospitalier Universitaire de Besancon",4,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":42},"100595191","prehab-and-creatinewhey-supplementation-in-frailty-among-patients-with-cirrhosis-100595191","NCT07029243","Prehab and Creatine\u002FWhey Supplementation in Frailty Among Patients With Cirrhosis","Physical Prehabilitation With and Without Creatine\u002FWhey Protein Supplementation Effects on Frailty In Patients With Cirrhosis","Inclusion Criteria:\n\n* Confirmed diagnosis of cirrhosis by ICD-10 code, liver biopsy, abdominal imaging, or transient elastography\n* Access to digital device and internet at home\n* Ability to provide written informed consent before any study-related activities\n* Ability to remain in study for at least 3 months\n\nExclusion Criteria:\n\n* Allergy to milk protein\n* On hemodialysis\n* No English language proficiency\n* Presence of condition or abnormality that in opinion of the Investigator will compromise safety of the patient or quality of the data\n* Concomitant severe underlying systemic illness that in the opinion of the Investigator would interfere with completion of study\n* Pregnant, breastfeeding, or intention of becoming pregnant during study time frame",{"count":157,"type":22},[136],"Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition\u002Fexercise prehabilitation app will maintain muscle health in patients with liver disease.",[28,274,162],"Frailty",[190,276,277,278,279,280],"liver","muscle","creatine","whey protein","frailty","2026-07-13",{"date":283,"type":34},"2026-07-15",{"date":285,"type":34},"2026-04-15",{"date":287,"type":22},"2026-12",{"name":289,"class":41},"University of California, San Francisco",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100481396","phase-1-intestinal-microbiota-transplant-in-alcohol-associated-liver-disease-100481396","NCT05548452","Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease","Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","IMPACT","Inclusion Criteria:\n\n-\\>18 years of age\n\n* Advanced liver disease\n* Able to give written, informed consent\n* Alcohol as a cause of advanced liver disease\n* Continued sustained drinking\n* Having previously declined a referral to traditional AUD therapy services or having failed such treatments\n\nExclusion Criteria:\n\n* Lack of sustained drinking\n* Recent or current alcoholic hepatitis\n* Alcohol withdrawal symptoms\n* Clinically significant use of illicit drugs\n* Uncontrolled mood disorders or primary psychotic conditions\n* MELD score\\>17\n* Unclear diagnosis of chronic liver disease\n* Current hepatic encephalopathy on lactulose and\u002For rifaximin\n* WBC count\\\u003C1000\n* Non-elective hospitalization within last month\n* on dialysis\n* known untreated, in-situ luminal GI cancers\n* chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)\n* Dysphagia within 2 weeks\n* History of aspiration, gastroparesis, intestinal obstruction\n* Ongoing absorbable antibiotic use\n* Severe anaphylactic food allergy\n* allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior IMT\n* ASA Class IV or V\n* Pregnant or nursing patients\n* acute illness or fever on the day of planned FMT\n* Immunosuppression\n* Other conditions which make patients are poor candidate for this study per investigator judgement",{"count":299,"type":22},80,[218,25],"The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.",[303,28,304],"Liver Disease; Alcohol-Related","Alcohol Use Disorder",[306,304,28,307],"Intestinal Microbiota Transplant","Chronic Liver Disease",{"date":309,"type":34},"2026-07-14",{"date":311,"type":34},"2022-11-21",{"date":313,"type":22},"2027-11",{"name":315,"class":41},"Virginia Commonwealth University",2,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":262},"100643906","phase-3-evaluation-of-a-modified-bowel-preparation-regimen-in-cirrhotic-patients-undergoing-colonoscopy-100643906","NCT07668778","Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy","Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy: a Multicentre Randomized Controlled Trial","CIRRHOPREP","Inclusion Criteria:\n\n* Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy\n* Age ≥ 18 years\n* Ability to follow verbal and written instructions in Portuguese\n\nExclusion Criteria:\n\n* Urgent procedures\n* Colonoscopies not intended to reach the caecum\n* History of any colonic surgery\n* Absolute contraindication to bowel preparation or colonoscopy\n* Active hepatic encephalopathy (West Haven grade ≥2) at the time of enrolment\n* Refractory ascites, defined as ascites unresponsive to maximum diuretic therapy or requiring repeated large-volume paracentesis\n* Severe hyponatraemia (serum sodium \\\u003C125 mEq\u002FL) at the time of enrolment\n* Subject refusal or inability to comprehend the trial",{"count":326,"type":22},252,[328],"PHASE3","Inadequate bowel preparation compromises colonoscopy quality and diagnostic accuracy, and cirrhosis is a recognized independent predictor of poor bowel cleansing. However, no bowel preparation regimen has been prospectively validated or specifically tailored for cirrhotic patients.\n\nThis multicenter, prospective, randomized, single-blind controlled clinical trial will evaluate whether the addition of adjunctive measures as an intensified bowel preparation protocol improves bowel cleansing quality in adult patients with cirrhosis undergoing elective outpatient colonoscopy.\n\nParticipants will be randomized 1:1 to receive either a standard bowel preparation protocol, consisting of a 2-litre split-dose polyethylene glycol (PEG) regimen combined with a one-day low-residue diet and clear liquids the afternoon before the procedure (control), or the same split-dose regimen with the assigned adjunctive measures: 15 mg bisacodyl, a 3-day low-residue diet, and clear liquids the day before colonoscopy (intervention).\n\nThe primary outcome is the proportion of patients achieving adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥6 with no individual segment score \\\u003C2. Secondary outcomes include polyp, adenoma, advanced adenoma and colorectal cancer detection rates, caecal intubation rate, patient compliance, tolerability, and adverse events. Pre-specified subgroup analyses will evaluate the influence of etiology and severity of cirrhosis and portal hypertension complications.\n\nBy addressing a critical and unmet clinical need, this trial aims to generate high-quality evidence to optimize bowel preparation strategies in patients with cirrhosis, improve colonoscopy quality, and ultimately enhance colorectal cancer screening outcomes in this vulnerable population.",[28,331],"Bowel Preparation",[333,28],"Inadequate bowel preparation","2026-06-23",{"date":336,"type":34},"2026-06-25",{"date":338,"type":22},"2026-08-01",{"date":340,"type":22},"2027-10-30",{"name":342,"class":41},"Hospital do Divino Espírito Santo de Ponta Delgada",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":42},"100596243","phase-1-zanzalintinib-in-second-line-and-beyond-for-the-treatment-of-advanced-liver-cancer-100596243","NCT07042919","Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer","A Phase Ib\u002FII Study of Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 3.1.1 Patients with confirmed diagnosed HCC who are not amendable to curative treatments.\n* 3.1.2 Patients must have documented objective radiographic progression during or after treatment with any first or second line therapy, or intolerance to any first or second line therapy, which include immunotherapy-based combination, or non-immunotherapy-based treatment, except cabozantinib.\n* 3.1.3 Patients must have a Child-Pugh class A or Child-Pugh class B (B7 or B8) score for cirrhosis mortality. Child-Pugh class B, B9 is excluded. See Appendix A for Child-Pugh Class Scores.\n* 3.1.4 Patients must have measurable disease according to RECIST v1.1. See Section 7 for the evaluation of measurable disease. See Appendix B for RECIST v1.1 criteria.\n* 3.1.5 Patients may have had up to two prior lines therapy (not including cabozantinib) in the advanced metastatic setting. Palliative radiation or locoregional therapies are not considered a line of therapy.\n* 3.1.6 Patients must be age ≥ 18 years.\n* 3.1.7 Patients must exhibit a\u002Fan ECOG Status of 0-1 Refer to Appendix C; (Karnofsky ≥ 60%. See Appendix D.)\n* 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class A): Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL, Hemoglobin (Hgb) ≥ 9 g\u002FdL, Platelets (PLT) ≥ 75,000\u002FmcL, International Normalized Ratio (INR) ≤ 1.7 x upper limit of normal (ULN), activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN), Total bilirubin ≤ 3.0 mg\u002Fdl, Albumin ≥ 2.5 (g\u002FdL), AST (SGOT) ≤ 5 x institutional ULN, ALT (SGPT) ≤ 5 x institutional ULN, ALP ≤ 5.0 x institutional ULN, Creatinine Clearance \\> 40 mL\u002F minute if serum creatinine is elevated above 1.5 X ULN, Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg\u002Fmg (≤ 169.8 mg\u002Fmmol) creatinine.\n* 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class B): Absolute neutrophil count (ANC) ≥ 1,200\u002FmcL, Hemoglobin (Hgb) ≥ 8.5 g\u002FdL, Platelets (PLT) ≥ 60,000\u002FmcL, International Normalized Ratio (INR) ≤ 2.3 x upper limit of normal (ULN), activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN), Total bilirubin ≤ 3.0 mg\u002Fdl, Albumin ≥ 2.5 (g\u002FdL), AST (SGOT) ≤ 5 x institutional ULN, ALT (SGPT) ≤ 5 x institutional ULN, ALP ≤ 5.0 x institutional ULN, Creatinine Clearance \\> 40 mL\u002F minute if serum creatinine is elevated above 1.5 X ULN, Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg\u002Fmg (≤ 169.8 mg\u002Fmmol) creatinine.\n* 3.1.9 POCBP and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required.\n* 3.1.10 Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), refer to Appendix E, with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy.\n* 3.1.11 POCBP must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required.\n* 3.1.12 Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements.\n* 3.1.13 Patients must have the ability to swallow, retain, and absorb oral medications or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n\nExclusion Criteria:\n\n* 3.2.1 Patients with prior treatment with zanzalintinib.\n* 3.2.2 Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study Day 1 treatment.\n* 3.2.3 Patients who have received ≥ 3 prior therapies in the advanced setting.\n* 3.2.4 Patients with prior Cabozantinib use.\n* 3.2.5 Patients who have had chemotherapy, cytotoxic, biologic, radiation, or other systemic anticancer (including investigational) therapy within 4 weeks prior to study Day 1 treatment.\n* 3.2.6 Patients who have received palliative radiation therapy for bone metastasis within 14 days or any other radiation therapy within 4 weeks days before first dose of study treatment.\n* 3.2.7 Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment.\n* 3.2.8 Patients who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or trans arterial radioembolization (TARE) within 28 days prior to first dose of study treatment.\n* 3.2.9 Patients with any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE 5.0) Grade \\>1 at baseline, including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy (eg, physiological replacement of corticosteroid, from a previous anticancer therapy, with the following exceptions: Alopecia, vitiligo, and the laboratory values defined in the inclusion criteria., Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician., Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with zanzalintinib may be included only after consultation with the principal investigator.\n* 3.2.10 Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made: 1)For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage\n* 3.2.11 Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 28 days prior to first dose of study treatment. Note: Patients with an incidental finding of an isolated brain lesion \\\u003C 1 cm in diameter may be eligible after Principal Investigator approval if the lesion is radiographically stable for 28 days before first dose and does not require treatment per Investigator judgement. Note: Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed\n* 3.2.12 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib.\n* 3.2.13 Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following: a. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). b. Therapeutic doses of LMWH or anticoagulation with direct Factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in patients without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: Patients must have discontinued oral anticoagulants within 3 days or 5 halflives prior to first dose of study treatment, whichever is longer.\n* 3.2.14 Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study with in 2 weeks prior to cycle 1 day 1. Note: Taking complementary medications to treat symptoms of the cancer is allowed.\n* 3.2.15 Patient has uncontrolled, significant intercurrent or recent illness.\n* 3.2.16 Patients with clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration.\n* 3.2.17 Patients with symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n* 3.2.18 Patients with lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval. Patients with lesions invading the hepatic portal vasculature are eligible\n* 3.2.19 Patients with other clinically significant disorders that would preclude safe study participation\n* 3.2.20 Patients with Recent surgery within the following parameters: • Major surgery (e.g., GI surgery or removal\u002Fbiopsy of brain metastasis) within 8 weeks before first dose of study treatment. • Prior laparoscopic surgeries (i.e. nephrectomy) within 28 days prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. • Complete wound healing from major surgery and from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least prior to first dose of study treatment. • Patients with clinically relevant ongoing complications from prior surgery are not eligible. • Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 5 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n* 3.2.21 Patients with corrected QT interval calculated by the Fridericia formula (QTcF) \\>480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment. Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n* 3.2.22 Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because zanzalintinib is a next-generation TKI with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the nursing parent with zanzalintinib , breastfeeding should be discontinued if the nursing parent is treated with zanzalintinib. POCBP are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, POCBP \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required.\n* 3.2.23 Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or give informed consent, per the opinion of the treating investigator.\n* 3.2.24 Patients with other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* 3.2.25 Patients with documented hepatic encephalopathy (HE) within 6 weeks before first dose of study treatment. Patients with clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in diuretics) within 2 weeks prior to registration, C1D1.",{"count":351,"type":22},59,[218,25],"This phase Ib\u002FII trial tests the safety, side effects, and best dose of zanzalintinib and how well it works in treating patients with hepatocellular (liver) cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Zanzalintinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Giving zanzalintinib may be safe, tolerable, and\u002For effective in treating patients with advanced liver cancer.",[355,28,356,357],"Advanced Hepatocellular Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8",{"date":336,"type":34},{"date":360,"type":34},"2026-03-30",{"date":362,"type":22},"2031-03-04",{"name":364,"class":41},"Devalingam Mahalingam",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":42},"100635553","4d-flow-mri-assessment-of-portal-hypertension-and-tips-outcomes-in-cirrhosis-100635553","NCT07554183","4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis","Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI","PORTAL-4D","Inclusion Criteria:\n\nApplicable to both groups :\n\n1. Age ≥ 18 years\n2. Eligible to undergo MRI examination\n3. Prior clinical evaluation completed\n4. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)\n5. Patient informed and written informed consent obtained\n\n   Specific to the MASLD group :\n6. Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following:\n\n   * Refractory ascites\n   * Hepatic hydrothorax\n   * Failure of secondary prophylaxis of variceal gastrointestinal bleeding\n   * Preemptive TIPS\n   * Preoperative TIPS\n\n   Specific to the MASLD group :\n7. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)\n8. Liver stiffness \\> 15 kPa measured by transient elastography\n9. Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis\n10. Alcohol consumption \\\u003C 20 g\u002Fday for women and \\\u003C 30 g\u002Fday for men, assessed using validated routine clinical questionnaires\n\nExclusion Criteria:\n\nApplicable to both groups :\n\n1. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).\n2. Prior liver transplantation.\n3. Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.\n4. Individual under legal guardianship or trusteeship, or unable to provide informed consent.\n5. Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study.\n\n   Specific to the TIPS group\n6. Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group\n7. Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis",{"count":244,"type":22},[136],"PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).\n\nPortal hypertension is the main driver of hepatic decompensation and is associated with ascites, variceal bleeding, hepatic encephalopathy, and reduced survival. The current gold standard for assessing portal hypertension is the invasive hepatic venous pressure gradient (HVPG) measurement performed via the transjugular route. However, HVPG is invasive, operator-dependent, and limited to specialized centers. A reliable non-invasive alternative is therefore highly needed.\n\n60 adults patients with cirrhosis will be enrolled and divided into two parallel groups: MASLD group (n=24): Patients with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nTIPS group (n=36): Patients with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS) placement.\n\nThe primary objective is to assess the correlation between invasive HVPG values and 4D-flow MRI parameters. Secondary objectives include evaluating the prognostic value of 4D-flow MRI in predicting portal hypertension-related complications and post-TIPS outcomes within 6 months.\n\nThe study is expected to validate 4D-flow MRI as an non-invasive diagnostic and prognostic tool for portal hypertension, potentially improving patient selection for TIPS and reducing reliance on invasive procedures.",[28,377],"Portal Hypertension",[379,380,381,382,186,383,384,385],"4D-Flow MRI","Hepatic Venous Pressure Gradient","Portal Hemodynamics","Noninvasive Liver Imaging","Portal hypertension complications","TIPS","MASLD","2026-06-22",{"date":388,"type":34},"2026-06-24",{"date":390,"type":22},"2026-06-01",{"date":392,"type":22},"2028-05-01",{"name":394,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":404,"conditions":405,"keywords":409,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100641506","development-of-a-predictive-score-for-the-risk-of-infection-in-the-immediate-post-liver-transplant-period-100641506","NCT07647978","Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period","PREDITH","Inclusion Criteria:\n\nPatients awaiting liver transplantation for one of the following indications:\n\n* Compensated cirrhosis complicated by hepatocellular carcinoma\n* Chronically decompensated cirrhosis (recurrent gastrointestinal bleeding, refractory ascites, portopulmonary or hepatopulmonary syndrome, hepatic encephalopathy, chronic liver failure)\n* Acute decompensated cirrhosis, with or without associated multiple organ failure (ACLF)\n* Acute fulminant hepatitis\n\nFinal inclusion will be :\n\n* Patients receiving LT AND\n* Who provided their consent to participate during the initial enrollment visit AND\n* For whom the baseline sample (during the day of the LT) was collected\n\nExclusion Criteria:\n\n* Minors\n* Patients under legal guardianship or conservatorship\n* Pregnant or breastfeeding women\n* Patients deprived of their liberty\n* Patients not enrolled in the social security system\n* Refusal to participate in the study\n* Patients receiving immunosuppressive therapy prior to LT (with the exception of corticosteroids at a dosage of 40 mg per day for the treatment of alcoholic hepatitis)\n* Patient who is a candidate for a combined organ transplant\n* Patient receiving other immunomodulatory therapy (such as immune checkpoint inhibitors) prior to LT",{"count":403,"type":22},279,"Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases.\n\nThe expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (\\\u003C 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score \\> 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival.\n\nPREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.",[28,406,407,408],"Acute Hepatitis","Liver","mHLA-DR",[276,408,28,410],"Acute hepatitis","2026-06-15",{"date":413,"type":34},"2026-06-17",{"date":415,"type":22},"2026-07-01",{"date":417,"type":22},"2030-07-01",{"name":419,"class":41},"Hospices Civils de Lyon",3,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":450},"100476640","preventing-liver-cancer-mortality-through-imaging-with-ultrasound-vs-mri-100476640","NCT05486572","Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI","CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)","PREMIUM","Inclusion Criteria:\n\n1. Cirrhosis due to any underlying etiology diagnosed by one or more of the following:\n\n   * Histology of liver biopsy\n   * Radiologic criteria (nodular liver, evidence of portal hypertension)\n   * Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy)\n   * Vibration controlled transient elastography (VCTE, specifically Fibroscan, which is available in all participating sites) with liver stiffness \\>12.5kPa or magnetic resonance elastography \\>5.0 kPa\n2. High Risk of Liver Cancer: This will be defined by one or more of the following:\n\n   * Current HCV infection (detectable HCV RNA)\n   * FIB-4 score 3.25, within 6 months of randomization\n   * Estimated annual HCC incidence \\>2.5%, within 6 months of randomization, calculated by VA-specific models that the investigators developed (available on the national VA ALD Dashboard and at www.hccrisk.com).\n3. Age 18-75\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Prior diagnosis or of HCC\n2. Current suspicion of HCC\n3. Prior receipt of organ transplantation\n4. Currently listed for organ transplantation.\n5. Participation in a conflicting HCC screening trial\n6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \\>20, within 6 months prior to randomization\n7. Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\n8. Multiple comorbid conditions resulting in limited life expectancy, defined by a cirrhosis-specific comorbidity index (CirCom)112 score 3. Of note, early stage malignancies of the bladder, lung, or prostate will not be excluded.\n9. Estimated life expectancy \\\u003C5 years as determined by the clinical judgement of the Study Investigator\n10. Contraindications to undergoing contrast-enhanced MRI:\n\n    * Allergy to gadolinium-based contrast agents\n    * MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices)\n    * Implantable neurostimulation device\n    * Implantable cochlear implant\u002Fear implant\n    * Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps)\n    * Metallic foreign bodies in or around the eye\n    * Metallic fragments, such as bullets, shotgun pellets or shrapnel\n    * Metallic body piercings that cannot be removed\n    * Cerebral artery aneurysm clips\n    * Severe claustrophobia\n    * Unable to fit on MRI machine due to weight (weight \\>400lbs) or body habitus\n11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)\n12. Currently pregnant","75 Years",{"count":431,"type":22},4700,[136],"The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.",[435,28],"Carcinoma, Hepatocellular",[437,276,438,439,440,441],"hepatic, oncology","chronic diseases; health services and systems","prospective, randomized, clinical trial","magnetic resonance imaging; ultrasonography","cirrhosis; liver cancer",{"date":413,"type":34},{"date":444,"type":34},"2023-11-03",{"date":446,"type":22},"2031-09-01",{"name":448,"class":449},"VA Office of Research and Development","FED",34,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":42},"100588439","phase-3-bumetanide-vs-furosemide-in-cirrhosis-100588439","NCT06941415","Bumetanide vs. Furosemide in Cirrhosis","Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF Trial","BUFF","Inclusion Criteria:\n\n* History of liver cirrhosis\n* Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital\n\nExclusion Criteria:\n\n* Allergy to bumetanide or furosemide\n* Contraindication to diuretic administration (e.g. active bleeding, clinical suspicion of hepatorenal syndrome, hypotension)\n* Incarcerated or in custody of law enforcement\n* Diuretic ordered for purpose other than volume overload (e.g. hyperkalemia, continuation of home medication without clinical signs of volume overload)\n* Inpatient admission not anticipated\n* Not admitted to an inpatient hospital bed following initial evaluation in the emergency department",{"count":460,"type":22},500,[328],"Patients with cirrhosis are frequently hospitalized due to an acute decompensation of their liver disease including bleeding, jaundice, encephalopathy, and volume overload. Volume overload is associated with increased mortality from acute hypoxic respiratory failure, hemorrhage from esophageal varices, and spontaneous bacterial peritonitis.\n\nClinical practice guidelines describe sodium restriction and diuretics as first-line treatment, combined with regular body weight monitoring to assess response. In patients with suboptimal response to furosemide, alternative loop diuretics like torsemide or bumetanide may improve natriuresis. Bumetanide has a theoretic advantage over furosemide due to its more rapid and complete intestinal absorption, combined with a prolonged half-life in patients with hepatic dysfunction. In this pragmatic study, the aim is to compare the efficacy of diuresis with bumetanide versus furosemide among hospitalized patients with cirrhosis.",[28],[190,465,466,467,468],"volume overload","diuresis","furosemide","bumetanide","2026-06-12",{"date":471,"type":34},"2026-06-16",{"date":473,"type":34},"2026-06-03",{"date":475,"type":22},"2029-03-31",{"name":477,"class":41},"Stacy Johnson",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":42},"100642079","impact-of-propranolol-on-the-prognosis-of-patients-with-decompensated-cirrhosis-and-meld-score--9-100642079","NCT07652203","Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9","Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9: a Non-inferiority Randomized Controlled Trial","Inclusion Criteria:\n\n* patients' age ≥18 years;\n* patients with a definitive diagnosis of liver cirrhosis;\n* patients with a MELD score of \\>9;\n* patients with a history of decompensation or those who are experiencing their first decompensation, such as ascites, variceal bleeding, or hepatic encephalopathy (HE);\n* patients' informed consents.\n\nExclusion Criteria:\n\n* patients without a definite indication for NSBBs;\n* patients with an absolute contraindication of NSBBs (severe bronchospasm, asthma, severe psychosis, high-degree atrioventricular block, etc.);\n* patients with hypersensitivity to NSBBs;\n* patients who had been treated with NSBBs before 2 weeks of enrollment;\n* patients with occlusive portal vein thrombosis;\n* patients who had undergone liver transplantation;\n* patients who had undergone transjugular intrahepatic portosystemic shunt (TIPS);\n* patients with a definitive diagnosis of hepatocellular carcinoma;\n* patients with an estimated life time of \\\u003C12 months due to the presence of any comorbidities;\n* patients who are currently pregnant or breast-feeding.",{"count":486,"type":22},466,[136],"Non selective beta blockers (NSBBs), such as propranolol and nadolol, are mainstay therapies for portal hypertension in cirrhosis, but their efficacy and safety vary depending on the stage of the disease. Emerging evidence suggests that NSBBs may worsen the prognosis of advanced cirrhosis, especially in patients with a model for end-stage liver disease (MELD) score of \\>9. The purpose of this randomized controlled trial is to evaluate the effects of the use of propranolol as recommended by the guideline on the prognosis in cirrhotic patients with a MELD score of \\>9.",[28],[190,491,492,493,494,495],"propranolol","decompensation","recompensation","survival","MELD","2026-06-11",{"date":471,"type":34},{"date":499,"type":22},"2026-06",{"date":501,"type":22},"2028-07",{"name":503,"class":41},"General Hospital of Shenyang Military Region",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":514,"conditions":515,"keywords":519,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":42},"100575902","msept9-biomarker-for-predicting-hepatocellular-carcinoma-occurrence-in-patients-with-cirrhosis-100575902","NCT06778317","mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis","Evaluation of the Circulating Epigenetic Biomarker mSEPT9 for Predicting the Occurrence of Hepatocellular Carcinoma in Patients With Cirrhosis: A Prospective Multicenter Trial (SEPT9_SuRV)","SEPT9_SuRV","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients diagnosed with cirrhosis confirmed by clinical, biochemical, radiological, or histological criteria.\n* Cirrhosis attributable to one or more of the following etiologies: alcohol, hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or cryptogenic causes.\n* Patients actively followed in one of the participating study centers.\n* Patients affiliated with a social security program or equivalent.\n* Patients with a body weight greater than 45 kg.\n* Patients who have been fully informed about the study procedures and have provided oral informed consent.\n\nExclusion Criteria:\n\n* History of hepatocellular carcinoma (HCC).\n* History of any other primary or secondary malignant liver tumor.\n* Diagnosis of malignancy or hematologic disorders within the past 5 years (without time limitation for hematologic malignancies).\n* Patients currently undergoing hemodialysis.\n* Pregnant or breastfeeding women.\n* Individuals under legal protection (e.g., guardianship, curatorship) or unable to provide consent.\n* Minors or individuals younger than 18 years.\n* Individuals deprived of liberty by judicial or administrative order.\n* Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1).\n* Patients unable to comply with the study protocol requirements.",{"count":513,"type":22},400,"This study aims to evaluate the role of the circulating epigenetic biomarker mSEPT9 in predicting the risk of hepatocellular carcinoma (HCC) in patients with cirrhosis. HCC is a primary liver cancer that frequently develops in individuals with cirrhosis, and early detection is critical for improving outcomes. This research involves 400 patients with cirrhosis who will be followed every six months for up to 60 months. During these visits, blood samples will be collected to analyze mSEPT9 levels. By identifying changes in this biomarker, the study seeks to improve early diagnosis and personalize surveillance strategies, potentially enhancing patient survival and quality of life.",[516,28,517,518],"Hepatocellular Carcinoma (HCC)","Risk Prediction for Liver Cancer","Epigenomics",[520,28,521,522,523,524,525,526,527,518,528],"Hepatocellular Carcinoma","mSEPT9 Biomarker","Epigenetics","Risk Prediction","Liver Cancer Surveillance","Prospective Cohort Study","Non-Invasive Biomarkers","Personalized Medicine","Risk Stratification","2026-06-08",{"date":531,"type":34},"2026-06-10",{"date":533,"type":34},"2025-06-03",{"date":535,"type":22},"2033-06-03",{"name":537,"class":41},"Central Hospital, Nancy, France",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":42},"100642920","personalized-nutritional-intervention-in-patients-undergoing-tips-insertion-for-refractory-ascites-to-prevent-overt-hepatic-encephalopathy-100642920","NCT07634237","Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy","Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)","SUPPRESS-HE","Inclusion Criteria:\n\n* Diagnosis of cirrhosis\n* TIPS planned for refractory ascites\n* Being at least moderately malnourished\n\nExclusion Criteria:\n\n* TIPS insertion for other reason than refractory ascites\n* Budd Chiari Syndrome\n* Complete or cavernomatous portal vein thrombosis\n* Pre-TIPS recurrent or persistent overt hepatic encephalopathy\n* Use of lactulose or rifaximin in the last 4 weeks\n* Liver failure (MELD \\> 18 or Child Pugh score \\> 12)\n* Heart failure (NYHA ≥ III or LVEF \\\u003C 50%)\n* Kidney failure (serum creatinine \\> 250µmol\u002FL)\n* Pregnancy or breastfeeding\n* Previous Liver transplantation\n* Unable to provide informed consent",{"count":547,"type":22},50,[136],"This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.",[28,551,552],"Refractory Ascites","TIPS Insertion",[554,555,28,551,552],"Personalized Nutritional Intervention","Overt Hepatic Encephalopathy",{"date":529,"type":34},{"date":411,"type":22},{"date":559,"type":22},"2029-12-15",{"name":561,"class":41},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":582,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":594},"100503205","phase-2-liver-cirrhosis-network-rosuvastatin-efficacy-and-safety-for-cirrhosis-in-the-united-states-100503205","NCT05832229","Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States","Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study","LCN RESCU","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)\n3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:\n\n   1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR\n   2. At least 2 of the following:\n\n   i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\\>2.67 or platelets \\<150\u002FmL within 6 months prior to consent or during Screening\n4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:\n\n   1. The first measure must be ≥ 15 kilopascal.\n   2. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.\n   3. The mean of two measurements must be ≥ 15 kilopascal.\n   4. Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa\n5. Compensated defined by:\n\n   1. Absence of ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.\n   2. If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and\u002For rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.\n   3. Child-Pugh score \\<8\n6. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Currently on a statin or any statin exposure within 24 weeks prior to consent.\n2. Known indication for statin therapy, defined as:\n\n   1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR\n   2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR\n   3. Fasting LDL-C ≥ 190 mg\u002FdL\n3. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.\n4. Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.\n5. Patients with limitations in attending study visits.\n6. Prisoners.\n7. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.\n8. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.\n9. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:\n\n   1. amiodarone\n   2. methotrexate\n   3. warfarin\n10. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:\n\n    1. fenofibrate\n    2. erythromycin\n    3. gemfibrozil\n    4. niacin (500 mg or more)\n    5. HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent\n    6. colchicine\n    7. cyclosporin\n    8. Additional medications that will be excluded:\n\n    atazanavir\u002Fritonavir capmatinib darolutamide dasabuvir\u002Fombitasvir\u002Fparitaprevir\u002Fritonavir ledipasvir\u002Fsofosbuvir elbasvir\u002Fgrazoprevir erythromycin glecaprevir\u002Fpibrentasvir lopinavir\u002Fritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir\u002Fvelpatasvir\u002Fvoxilaprevir sofosbuvir\u002Fvelpatasvir tafamidis teriflunomide\n\n    \\*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.\n11. Presence of portal or hepatic vein thrombosis\n12. Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism\n13. Receiving an elemental diet or parenteral nutrition\n14. Chronic pancreatitis or pancreatic insufficiency\n15. Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)\n16. Conditions which may confound study outcome:\n\n    1. Unstable or active inflammatory bowel disease\n    2. Active infection\n    3. Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years\n    4. Prior solid organ or hematopoietic cell transplant\n    5. Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks\n    6. Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.\n17. Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.\n18. The following laboratory abnormalities within 90 days of screening:\n\n    1. Hemoglobin \\\u003C10 g\u002FdL\n    2. Albumin \\\u003C3.0 g\u002FdL\n    3. Prolonged international normalized ratio (INR) \\>1.5\n    4. Total bilirubin ≥ 2.0 mg\u002Fdl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)\n    5. Direct bilirubin ≥ 0.9\n    6. Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.\n19. Kidney function abnormalities including:\n\n    1. Dialysis\n    2. Baseline eGFR \\\u003C 30 cc\u002Fmin with CKD-Epi equation\n    3. Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection\n20. Recent (within 48 weeks) or present hepatic decompensation with ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding\n21. Untreated chronic hepatitis B or C infection\n\n    1. HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12\n    2. HBV eligible if an HBV DNA \\\u003C100 IU\u002FmL within the last 48 weeks and on treatment\n22. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U\u002FL, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.\n23. Documented history of intolerance to statins\n24. Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks\n25. Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening\n26. Pregnancy, planned pregnancy or breastfeeding\n27. Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.\n28. Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.\n29. Failure or inability to provide informed consent.",{"count":571,"type":22},256,[25],"This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.",[28,575,576,577,578,579,580,581],"Cirrhosis, Liver","Cirrhosis Early","Cirrhosis Due to Hepatitis B","Cirrhosis Advanced","Cirrhosis Infectious","Cirrhosis Alcoholic","Cirrhosis Due to Hepatitis C",[28,407,583],"Nonalcoholic Fatty Liver Disease","2026-05-29",{"date":586,"type":34},"2026-06-02",{"date":588,"type":34},"2023-12-07",{"date":590,"type":22},"2029-08-31",{"name":592,"class":593},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",13,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":214,"enrollmentInfo":603,"targetDuration":604,"studyType":80,"phases":4,"briefSummary":605,"conditions":606,"keywords":610,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":42},"100639931","effect-of-laparoscopic-splenectomy-on-renal-function-in-cirrhotic-patients-with-hypersplenism-2-year-follow-up-100639931","NCT07585773","Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)","A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Renal Function in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism","LS-RF","Inclusion Criteria:\n\n1. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)\n2. Splenomegaly and hypersplenism\n3. No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )\n4. Age 18-80 years, male or female\n5. Child-Pugh Class A or B liver function\n6. No history of primary renal disease or acute kidney injury (AKI)\n7. Signed written informed consent\n8. Ability to complete 24-month follow-up\n\nExclusion Criteria:\n\n1. Child-Pugh Class C liver cirrhosis\n2. Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)\n3. Previous abdominal surgery precluding safe laparoscopic splenectomy\n4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders\n5. Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, refractory ascites) within 1 month before surgery\n6. Pregnancy or lactation\n7. Poor compliance, inability to complete follow-up",{"count":216,"type":22},"2 Years","Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .",[28,607,608,609],"Splenectomy; Status","Hypersplenism","Kidney Function Issue",[28,377,611,612,608],"Splenectomy","Laparoscopy","2026-05-14",{"date":615,"type":34},"2026-05-18",{"date":617,"type":22},"2026-05-01",{"date":619,"type":22},"2029-02-28",{"name":621,"class":41},"Northern Jiangsu People's Hospital",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":634,"conditions":635,"keywords":639,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":42},"100617716","phase-4-dice-study--diastolic-improvement-with-carvedilol--empagliflozin-in-patients-with-cirrhosis-100617716","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.","65 Years",{"count":513,"type":22},[633],"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.",[636,637,638,28],"Cirrhotic Cardiomyopathy","Empagliflozin","Cardiometabolic Risk Factors",[640,641,642,643,644,645],"Empagliflozin in cirrhosis","Carvedilol in Cirrhosis","SGLT-2 inhibitor","Ascites","Diastolic heart failure","heart failure with preserved ejection fraction","2026-05-13",{"date":613,"type":34},{"date":649,"type":34},"2026-04-01",{"date":651,"type":22},"2029-06-30",{"name":653,"class":41},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":661,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":662,"conditions":663,"keywords":669,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":675,"leadSponsor":677,"locationsCount":316},"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",{"count":216,"type":22},"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.",[28,664,665,666,667,668],"Microplastics","Portal Hypertension Related to Cirrhosis","Nanoplastics","Pollution","Cirrhosis and Chronic Liver Disease",[664,666,670,28,671],"Plastic pollution","Portal hypertension",{"date":673,"type":34},"2026-05-15",{"date":617,"type":34},{"date":676,"type":22},"2027-02-25",{"name":653,"class":41},{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":214,"enrollmentInfo":686,"targetDuration":604,"studyType":80,"phases":4,"briefSummary":687,"conditions":688,"keywords":690,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":694,"leadSponsor":695,"locationsCount":42},"100639930","effect-of-laparoscopic-splenectomy-on-lipid-profiles-in-cirrhotic-patients-with-hypersplenism-2-year-follow-up-100639930","NCT07588373","Effect of Laparoscopic Splenectomy on Lipid Profiles in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)","A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism","LS-LP-CH","Inclusion Criteria:\n\n1. Age 18-80 years, male or female\n2. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)\n3. Splenomegaly and hypersplenism\n4. Child-Pugh Class A or B liver function\n5. Signed written informed consent\n6. Ability to complete 24-month follow-up\n\nExclusion Criteria:\n\n1. Child-Pugh Class C liver cirrhosis\n2. No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )\n3. Previous abdominal surgery precluding safe laparoscopic splenectomy.\n4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders\n5. Metabolic\u002Fendocrine diseases: Familial hyperlipidemia; uncontrolled severe diabetes mellitus, thyroid dysfunction, nephrotic syndrome; use of lipid-lowering drugs, hormones, or other drugs affecting blood lipids within 1 month before surgery.\n6. Infections\u002Finflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.\n7. Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery\n8. Pregnancy or lactation\n9. Poor compliance, inability to complete follow-up",{"count":216,"type":22},"Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on lipid profiles over 2 years remains poorly characterized. This study will follow patients undergoing laparoscopic splenectomy to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether laparoscopic splenectomy can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.",[28,607,608,689],"Lipid Profiles",[28,611,612,689,608,193],"2026-05-10",{"date":613,"type":34},{"date":617,"type":22},{"date":619,"type":22},{"name":621,"class":41},{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":702,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":704,"targetDuration":604,"studyType":80,"phases":4,"briefSummary":705,"conditions":706,"keywords":708,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":713,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":718,"locationsCount":42},"100542644","muscle-mass-via-ultrasound-in-cirrhosis-mmuscle-100542644","NCT06345547","Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)","Prospective Observational Cohort Survey to Assess the Prevalence and Development of Sarcopenia and the Correlation of Muscle Mass and Outcome in Patients With Cirrhosis by Skeletal Muscle Ultrasound.","MMUSCLE","Inclusion Criteria:\n\n* diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp\n\nExclusion Criteria:\n\n* known patient will against participation in the study or against the measures applied in the study\n* a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours\n* no complete remission of malignancy including hepatocellular carcinoma within the past 12 months",{"count":244,"type":22},"The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\\[s\\] it aims to answer are:\n\n* what is the prevalence and development of sarcopenia in cirrhosis?\n* what is the role of malnutrition? Participants will\n\n  * undergo a muscle ultrasound of the lower and upper limb muscles\n  * handgrip strength will be measured\n  * malnutrition screening and assessment\n  * complete a questionnaire to assess quality of life",[162,28,707],"Malnutrition",[709,190,710,711],"sarcopenia","malnutrition","skeletal muscle ultrasound","2026-04-27",{"date":617,"type":34},{"date":715,"type":34},"2024-05-06",{"date":717,"type":22},"2028-03-31",{"name":719,"class":41},"University Hospital, Antwerp"]