[{"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,103,0,25,[9,45,71,104,132,162,190,216,250,275,308,337,369,394,413,440,465,493,523,550,585,609,633,656,676],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643906","phase-3-evaluation-of-a-modified-bowel-preparation-regimen-in-cirrhotic-patients-undergoing-colonoscopy-100643906",false,"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","ALL","18 Years",{"count":21,"type":22},252,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Cirrhosis","Bowel Preparation",[31,28],"Inadequate bowel preparation","NOT_YET_RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":22},"2026-08-01",{"date":40,"type":22},"2027-10-30",{"name":42,"class":43},"Hospital do Divino Espírito Santo de Ponta Delgada","OTHER",4,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"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":53,"type":22},59,[55,56],"PHASE1","PHASE2","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.",[59,28,60,61],"Advanced Hepatocellular Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","RECRUITING",{"date":35,"type":36},{"date":65,"type":36},"2026-03-30",{"date":67,"type":22},"2031-03-04",{"name":69,"class":43},"Devalingam Mahalingam",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":70},"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":80,"type":22},60,[82],"NA","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.",[28,85],"Portal Hypertension",[87,88,89,90,91,92,93,94],"4D-Flow MRI","Hepatic Venous Pressure Gradient","Portal Hemodynamics","Noninvasive Liver Imaging","Hepatic Encephalopathy","Portal hypertension complications","TIPS","MASLD","2026-06-22",{"date":97,"type":36},"2026-06-24",{"date":99,"type":22},"2026-06-01",{"date":101,"type":22},"2028-05-01",{"name":103,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"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":112,"type":22},279,"OBSERVATIONAL","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.",[28,116,117,118],"Acute Hepatitis","Liver","mHLA-DR",[120,118,28,121],"liver","Acute hepatitis","2026-06-15",{"date":124,"type":36},"2026-06-17",{"date":126,"type":22},"2026-07-01",{"date":128,"type":22},"2030-07-01",{"name":130,"class":43},"Hospices Civils de Lyon",3,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":161},"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":142,"type":22},4700,[82],"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.",[146,28],"Carcinoma, Hepatocellular",[148,120,149,150,151,152],"hepatic, oncology","chronic diseases; health services and systems","prospective, randomized, clinical trial","magnetic resonance imaging; ultrasonography","cirrhosis; liver cancer",{"date":124,"type":36},{"date":155,"type":36},"2023-11-03",{"date":157,"type":22},"2031-09-01",{"name":159,"class":160},"VA Office of Research and Development","FED",34,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":70},"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":171,"type":22},500,[25],"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],[176,177,178,179,180],"cirrhosis","volume overload","diuresis","furosemide","bumetanide","2026-06-12",{"date":183,"type":36},"2026-06-16",{"date":185,"type":36},"2026-06-03",{"date":187,"type":22},"2029-03-31",{"name":189,"class":43},"Stacy Johnson",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":70},"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":198,"type":22},466,[82],"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],[176,203,204,205,206,207],"propranolol","decompensation","recompensation","survival","MELD","2026-06-11",{"date":183,"type":36},{"date":211,"type":22},"2026-06",{"date":213,"type":22},"2028-07",{"name":215,"class":43},"General Hospital of Shenyang Military Region",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":70},"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":225,"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.",[228,28,229,230],"Hepatocellular Carcinoma (HCC)","Risk Prediction for Liver Cancer","Epigenomics",[232,28,233,234,235,236,237,238,239,230,240],"Hepatocellular Carcinoma","mSEPT9 Biomarker","Epigenetics","Risk Prediction","Liver Cancer Surveillance","Prospective Cohort Study","Non-Invasive Biomarkers","Personalized Medicine","Risk Stratification","2026-06-08",{"date":243,"type":36},"2026-06-10",{"date":245,"type":36},"2025-06-03",{"date":247,"type":22},"2033-06-03",{"name":249,"class":43},"Central Hospital, Nancy, France",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":70},"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","70 Years",{"count":260,"type":22},50,[82],"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.",[28,264,265],"Refractory Ascites","TIPS Insertion",[267,268,28,264,265],"Personalized Nutritional Intervention","Overt Hepatic Encephalopathy",{"date":241,"type":36},{"date":122,"type":22},{"date":272,"type":22},"2029-12-15",{"name":274,"class":43},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":295,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":307},"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\\&amp;gt;2.67 or platelets \\&amp;lt;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 \\&amp;lt;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":284,"type":22},256,[56],"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.",[28,288,289,290,291,292,293,294],"Cirrhosis, Liver","Cirrhosis Early","Cirrhosis Due to Hepatitis B","Cirrhosis Advanced","Cirrhosis Infectious","Cirrhosis Alcoholic","Cirrhosis Due to Hepatitis C",[28,117,296],"Nonalcoholic Fatty Liver Disease","2026-05-29",{"date":299,"type":36},"2026-06-02",{"date":301,"type":36},"2023-12-07",{"date":303,"type":22},"2029-08-31",{"name":305,"class":306},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",13,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":316,"enrollmentInfo":317,"targetDuration":319,"studyType":113,"phases":4,"briefSummary":320,"conditions":321,"keywords":325,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":70},"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","80 Years",{"count":318,"type":22},30,"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 .",[28,322,323,324],"Splenectomy; Status","Hypersplenism","Kidney Function Issue",[28,85,326,327,323],"Splenectomy","Laparoscopy","2026-05-14",{"date":330,"type":36},"2026-05-18",{"date":332,"type":22},"2026-05-01",{"date":334,"type":22},"2029-02-28",{"name":336,"class":43},"Northern Jiangsu People's Hospital",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":349,"conditions":350,"keywords":354,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":70},"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":225,"type":22},[348],"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.",[351,352,353,28],"Cirrhotic Cardiomyopathy","Empagliflozin","Cardiometabolic Risk Factors",[355,356,357,358,359,360],"Empagliflozin in cirrhosis","Carvedilol in Cirrhosis","SGLT-2 inhibitor","Ascites","Diastolic heart failure","heart failure with preserved ejection fraction","2026-05-13",{"date":328,"type":36},{"date":364,"type":36},"2026-04-01",{"date":366,"type":22},"2029-06-30",{"name":368,"class":43},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":258,"enrollmentInfo":376,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":377,"conditions":378,"keywords":384,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"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":318,"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.",[28,379,380,381,382,383],"Microplastics","Portal Hypertension Related to Cirrhosis","Nanoplastics","Pollution","Cirrhosis and Chronic Liver Disease",[379,381,385,28,386],"Plastic pollution","Portal hypertension",{"date":388,"type":36},"2026-05-15",{"date":332,"type":36},{"date":391,"type":22},"2027-02-25",{"name":368,"class":43},2,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":316,"enrollmentInfo":402,"targetDuration":319,"studyType":113,"phases":4,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":411,"leadSponsor":412,"locationsCount":70},"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":318,"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.",[28,322,323,405],"Lipid Profiles",[28,326,327,405,323,407],"portal hypertension","2026-05-10",{"date":328,"type":36},{"date":332,"type":22},{"date":334,"type":22},{"name":336,"class":43},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":428,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":393},"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":422,"type":22},80,[55,56],"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.",[426,28,427],"Liver Disease; Alcohol-Related","Alcohol Use Disorder",[429,427,28,430],"Intestinal Microbiota Transplant","Chronic Liver Disease","2026-05-05",{"date":433,"type":36},"2026-05-06",{"date":435,"type":36},"2022-11-21",{"date":437,"type":22},"2026-12-30",{"name":439,"class":43},"Virginia Commonwealth University",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":319,"studyType":113,"phases":4,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":70},"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":80,"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",[451,28,452],"Sarcopenia","Malnutrition",[454,176,455,456],"sarcopenia","malnutrition","skeletal muscle ultrasound","2026-04-27",{"date":332,"type":36},{"date":460,"type":36},"2024-05-06",{"date":462,"type":22},"2028-03-31",{"name":464,"class":43},"University Hospital, Antwerp",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":481,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":70},"100623164","psyliver-pilote-involvement-of-the-autonomic-nervous-system-in-hepatocellular-carcinoma-hcc-100623164","NCT07393074","PSYLIVER-PILOTE: Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC)","Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC): a Pilot Psycho-behavioral and Neurophysiological Study","PSYLIVER-PILOT","Inclusion Criteria:\n\nGroup A:\n\n* Over 18 years of age\n* Affiliated with a social security system\n* Sufficient command of the French language to hold a conversation and read\n* Signature of an informed consent form\n* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis or confirmation of cirrhosis, or for the etiological diagnosis of liver damage)\n* Liver biopsy scheduled as part of routine care for a diagnosis of cirrhosis without HCC\n\nGroup B:\n\n* Over 18 years of age\n* Affiliated with a social security system\n* Sufficient command of the French language to hold a conversation and read\n* Signature of an informed consent form\n* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis of cirrhosis or its confirmation; or for the etiological diagnosis of liver damage)\n* Liver biopsy scheduled as part of routine care for the diagnosis of suspected HCC (based on standard imaging criteria)\n\nExclusion Criteria:\n\n* Personal history of cancer in the broad sense (including HCC prior to inclusion in the study)\n* Pregnant or breastfeeding women\n* Adults subject to legal protection measures (guardianship, curatorship)\n* Contraindications to trans-parietal liver biopsy: clinical or radiological ascites, coagulation disorders, curative anticoagulation that cannot be suspended, dilation of the bile ducts\n* Persons deprived of their liberty by judicial or administrative decision\n* Wearers of electronic implants (pacemakers, implantable cardioverter defibrillators, cochlear implants, brain implants, etc.)\n* Psychotic disorders\n* Degenerative neurological disorders (Parkinson's disease and related disorders, dementia, Korsakoff's syndrome, etc.)\n* Antiarrhythmic treatment:\n\n  * Class Ia: Disopyramide and Quinidine\n  * Class Ic: Flecainide and Propafenone\n* Neuroleptic psychotropic treatment affecting the ANS (haloperidol, chlorpromazine, olanzapine, clozapine, quetiapine), tricyclic antidepressants (e.g., amitriptyline, amoxapine, clomipramine, etc.)",{"count":474,"type":22},100,[82],"Chronic liver diseases affect 1.5 billion people worldwide and can lead to cirrhosis and hepatocellular carcinoma (HCC), which ranks as the third leading cause of cancer-related mortality globally. Despite advances in the treatment of hepatitis B and C, metabolic diseases, and addiction, HCC incidence continues to rise. In France, between 2010 and 2015, the five-year survival rate for liver cancer (90% of which is HCC) was 18% for men and 19% for women. Treatment of HCC is based on the BCLC classification (Barcelona Clinic Liver Cancer), which evaluates both cancer progression and liver function (Child-Pugh classification). Patients at early stages (0 or A) have a survival rate of over 5 years, while those at more advanced stages (C or D) have significantly lower survival rates, highlighting the importance of better early detection tools.\n\nCurrent screening for HCC in cirrhotic patients involves biannual US-scan. However, ultrasound sensitivity for detecting tumors smaller than 2 cm is around 25%. Therefore, developing personalized strategies to predict and detect early-stage HCC is crucial to improving patient outcomes. Various clinical and biological scores have been developed to assess the risk of developing HCC in cirrhotic patients, but these scores remain imperfect. Molecular heterogeneity in HCC, as revealed by transcriptomic studies, could explain the variability in outcomes and treatment responses. This heterogeneity in occurrence, phenotype, and progression of HCC suggests individual singularities that are not yet well understood.\n\nThese individual singularities are likely linked to the autonomic nervous system (ANS), particularly in the central nervous system (CNS), which regulates various physiological processes. The ANS consists of the sympathetic nervous system (SNS), mainly adrenergic, and the parasympathetic nervous system (PNS), mainly cholinergic. These two systems function antagonistically but with different temporal dynamics. A better understanding of the interaction between tumor cells and their environment through the ANS could lead to the identification of new biomarkers to predict HCC development and therapeutic targets.\n\nThe role of the ANS in cancer development has been explored in various cancers, including prostate, stomach, pancreatic, breast, and ovarian cancers, where the ANS regulates inflammation and immune responses. In chronic liver diseases, the liver is innervated by both sympathetic and parasympathetic fibers, and this innervation plays a role in regulating metabolism, liver regeneration, and fibrosis progression. Chronic liver disease etiologies, such as alcohol consumption, metabolic syndrome, and viral hepatitis, disrupt the balance between the SNS and PNS, contributing to liver dysfunction. The severity of liver damage is linked to autonomic dysfunction, and heart rate variability, a marker of PNS activity, is correlated with survival in patients with terminal-stage HCC.\n\nOur recent research has shown that patients with HCC exhibit a reconfiguration of the intrahepatic ANS, with a consistent cholinergic orientation at the neuro-hepatic synapse. Patients with parasympathetic orientation (as compared to sympathetic orientation) have more aggressive tumors, shorter survival, and, from a pharmacological perspective, anticholinergics increase sensitivity to targeted HCC therapies. Tumor cells and cytotoxic lymphocytes are most strongly associated with cholinergic receptor enrichment and depletion, respectively.\n\nIn this context, the PSYLIVER-PILOTE study builds on these findings by investigating the involvement of the ANS in HCC through non-invasive extra-hepatic measures. The SNS and PNS are connected to brain regions involved in cognitive, emotional, and social information processing, such as the anterior cingulate cortex, insula, ventromedial prefrontal cortex, amygdala, and hypothalamus. These brain areas are involved in cognitive control and emotional processing. Additionally, experimental data from polyvagal theory and neurovisceral integration theory highlight the role of the ANS in regulating cognitive, emotional, and social processes, as well as psycho-behavioral traits. For instance, confronting a person with cognitive tasks and emotional or social information alters the balance of sympathetic and parasympathetic activity. Similar changes are observed in psycho-behavioral disorders like depression, emotional dysregulation, stress, and aggression.\n\nThus, the PSYLIVER-PILOTE study aims to identify extra-hepatic markers of ANS activity associated with HCC, analyzing both electrophysiological indices (from the peripheral nervous system) and psycho-behavioral indices (from the central nervous system). This project could open new avenues for early HCC detection and the development of personalized treatments",[478,28,479,480],"Hepato Cellular Carcinoma","Autonomic Nervous System","Central Nervous System",[482,176,483,484],"HCC","ANS","NRS","2026-04-23",{"date":487,"type":36},"2026-04-29",{"date":489,"type":36},"2026-04-17",{"date":491,"type":22},"2028-04-17",{"name":130,"class":43},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":345,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":508,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":70},"100321996","a-randomized-controlled-study-evaluating-bariatric-surgery-as-a-treatment-for-severe-nash-with-advanced-liver-fibrosis-in-non-severe-obese-patients-100321996","NCT03472157","A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients","Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH","NASHSURG","Inclusion Criteria:\n\n* Provide written informed consent and agree to comply to the study protocol prior to enrolment.\n* BMI and Brunt Fibriosis score:\n\n  * For F3 fibrosis patients: 35\\>BMI≥ 30kg\u002Fm² ; Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 fibrosis score grade within 1 month before inclusion or F3 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n  * For F4 fibrosis patients: 50\\>BMI≥ 30kg\u002Fm² ; Fibroscan ≥ 15kPa predicting a F4 fibrosis score grade within 1 month before inclusion or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n* Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 or F4 fibrosis score grade within 1 month before inclusion Or F3 or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n* Patient should agree to have one liver biopsy during the screening period (before randomization, the randomization will be permitted after at least a second reading performed by pathologist of CHRU Lille to confirm the histological diagnosis of NASH with advanced fibrosis (F3-F4)) for the diagnosis purpose (if no histological biopsy within 1 month before inclusion is available) and one at the end of the treatment period for assessment of the treatment effects.\n* For patients with cirrhosis, patients must fulfil all the following criteria: Platelets \\> 125 000, PT \\> 80 %, Albumin \\> 35 g\u002FL, MELD score at inclusion \\\u003C 9, CPT score \\\u003C 6, No history of previous decompensation, No oesophageal varices (endoscopy), No vascular shunt, ASA score ≤ III, Alcohol consumption lower than 20g\u002Fday for women and 30g\u002Fday for men.\n* For hypertensive patients, hypertension must be controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).\n* Female participating in the study must be either of non-child bearing (surgically sterilized at 6 month prior to screening or postmenopausal) or using an efficient contraception: hormonal contraception (including patch, contraceptive ring etc) intra-uterine device or other mechanical contraception\n* Patient agrees to come to the study visits within the protocol-specified delay\n\nExclusion Criteria:\n\n* Previous history of bariatric surgery (except gastric ring removed for more than 3 years).\n* Decompensated cirrhosis (MELD\\> 7 CPT score\\> 5, previous history of decompensation (encephalopathy, ascites, jaundice, varicose vein rupture)\n* Hepatocellular carcinoma\n* Platelets \\\u003C125 000; TP \\\u003C80%; bilirubin \\\u003C20 mmol \u002F l; albumin \\\u003C35 g \u002F L.\n* Other liver disease: alcohol consumption exceeding 20 g \u002F day for women and 30g \u002F day in men, HBV, HCV, CBP, CSP, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin.\n* Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)\n* HIV positive patients\n* Patients who had an acute cardiovascular episode, coronary Heart Disease (Angina pectoris, myocardial infarction, revascularization procedure), stroke or TIA (Transient Ischemic Attack) within the 6 months prior to screening Recent cardiovascular events (stroke, myocardial infarcts, etc…) in the past 6 months.\n* Severe chronic respiratory disease.\n* Severe chronic cardiac insufficiency (grade III and IV of NYHA classification).\n* Pregnant or breastfeeding women.\n* Simultaneous enrollment in another clinical trial.\n* Drug abuse within the past year.\n* Patient with contra-indication for bariatric surgery\n* Gastic Banding, Biliopancreatic diversion and all the new bariatric surgery techniques are forbidden because the study design allow only the laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric Bypaass.\n* History of cancer, except:\n\n  * Patients considered in remission for at least 5 years after onset of treatment.\n  * Patients Treated and believed to be cured basal or squamous cell carcinoma of the skin or resected carcinoma of the cervix",{"count":474,"type":22},[82],"The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg\u002Fm² \\> BMI ≥ 30 kg\u002Fm²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).",[505,506,507,28],"Surgery","Obesity","NASH - Nonalcoholic Steatohepatitis",[509,510,511,512,513,28],"Gastric bypass","Sleeve gastrectomy","Lifestyle therapy","NASH","Advanced fibrosis","2026-04-21",{"date":516,"type":36},"2026-04-22",{"date":518,"type":36},"2018-06-20",{"date":520,"type":22},"2028-06-20",{"name":522,"class":43},"University Hospital, Lille",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":531,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":131},"100633592","phase-2-microbiota-transplant-therapy-in-hepatic-encephalopathy-masterpiece-100633592","NCT07528690","Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)","Microbiota Transplant Therapy to Prevent HE Recurrence in a Phase 2B Multi-Center Trial of Veterans With Cirrhosis","MASTERPIECE","Inclusion Criteria:\n\n* 21 years of age\n\n  * Cirrhosis diagnosed by any of the following in a patient with chronic liver disease\n\n    * Liver Biopsy\n    * Radiologic evidence of varices, cirrhosis or portal hypertension\n    * Laboratory evidence of platelet count \\\u003C110,000 or AST\u002FALT ratio\\>1\n    * Endoscopic evidence of varices or portal hypertensive gastropathy\n  * Prior overt HE (patient can be on lactulose and\u002For rifaximin 4 weeks stable dosing)\n  * Able to give written, informed consent \\[mini-mental status exam (MMSE)\\]\\>25 at the time of consenting)\n  * For lactulose only group: Prior HE not on rifaximin\n\nExclusion Criteria:\n\n* Disease-related:\n\n  * MELD3.0 score\\>22\n  * WBC count\\\u003C1000\n  * non-elective hospitalization or overt HE episode within 1 month\n  * on dialysis\n  * known untreated, luminal GI cancer\n  * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease)\n* Safety-related:\n\n  * Current dysphagia\n  * History of aspiration, intestinal obstruction or non-medication induced gastroparesis\n  * Ongoing absorbable antibiotic use\n  * History of anaphylactic food allergy\n  * Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior FMT (7) ASA Class V\n* Pregnant or nursing patients\n* Acute illness or fever on the day of planned FMT\n* History of spontaneous bacterial peritonitis","21 Years",{"count":533,"type":22},162,[56],"The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.",[91,28],[176,538,539,540,541],"hepatic encephalopathy","rifaximin","lactulose","microbiota transplant therapy","2026-04-09",{"date":544,"type":36},"2026-04-14",{"date":546,"type":22},"2026-10-30",{"date":548,"type":22},"2031-03-03",{"name":159,"class":160},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":565,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":70},"100633026","phase-4-apixaban-pk-trial-preventing-portal-hypertension-complications-in-cirrhosis-100633026","NCT07521332","Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis","Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan","APIXABAN-PK","Inclusion Criteria:\n\n1. Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical\u002Fimaging findings.\n2. Evidence of portal hypertension, defined by:\n\n   Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia.\n3. Compensated or early decompensated cirrhosis (Child-Pugh B 7-10), with stable liver function defined as no change in Child-Pugh score \\>1 point in the preceding 3 months.\n4. Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale signs, or history of variceal bleeding) must undergo endoscopic variceal band ligation to obliteration before randomization.\n5. Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Active gastrointestinal bleeding within 6 weeks prior to enrollment.\n2. High bleeding risk:\n\n   * Platelet count \\\u003C50,000\u002FµL at baseline\n   * INR \\>1.8 (or \\>2.0 if secondary to cirrhosis without additional coagulopathy)\n   * Active peptic ulcer disease\n   * History of intracranial hemorrhage or hemorrhagic stroke\n   * Known bleeding diathesis\n3. Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or on dialysis.\n4. Child-Pugh class C or Child-Pugh score ≥10.\n5. History of hypersensitivity to apixaban or carvedilol.\n6. Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.\n7. Concurrent anticoagulant or antiplatelet therapy (including aspirin, clopidogrel, warfarin, or other DOACs) that cannot be safely discontinued. A washout period of at least 5 half-lives is required before randomization.\n8. Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.\n9. Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.\n10. Current or planned liver transplantation.",{"count":559,"type":22},220,[348],"The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing portal hypertension-related complications in patients with cirrhosis. Conducted at the Gastroenterology and Hepatology Department and Clinical Trials Unit (CTU) of Asian Institute of Medical Sciences (AIMS) Hospital, Hyderabad, Pakistan, the trial will enroll eligible cirrhotic patients with portal hypertension. Participants will be followed for 12 months to monitor hepatic decompensation events, variceal bleeding, portal vein thrombosis, and mortality, while safety and tolerability of apixaban will be closely assessed. This study aims to provide local evidence for apixaban use in cirrhosis management in Pakistan.",[28,563,358,91,564,85],"Esophageal and Gastric Varices","Portal Vein Thrombosis",[566,567,176,407,568,569,570,571,572,573,574,575,576,577],"apixaban","carvedilol","direct oral anticoagulant","variceal bleeding","hepatic decompensation","portal vein thrombosis","randomized controlled trial","Pakistan","Factor Xa Inhibitor","non-selective beta-blocker","prevention","liver disease","2026-04-03",{"date":542,"type":36},{"date":364,"type":36},{"date":582,"type":22},"2028-04-01",{"name":584,"class":43},"Asian Institute Of Medical Sciences",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":70},"100551812","microbiome-modulation-with-prebiotics-in-ptsd-and-cirrhosis-100551812","NCT06464952","Microbiome Modulation With Prebiotics in PTSD and Cirrhosis","Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)","RESIST-PTSD","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Ability to provide informed written consent\n3. Cirrhosis diagnosis\n4. Willing to comply with all study procedures and be available for the duration of the study.\n5. Ability to take oral medication.\n6. Willing to provide study-related samples\n7. Meeting the PCL-5 definition of PTSD and have a chart diagnosis of PTSD made by a mental health provider\n\nExclusion Criteria:\n\n1. Known SARS-CoV-2 infection in the last 60 days using medical records\n2. Subjects identified as, or appearing to, lack consent capacity\n3. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)\n4. Active illicit drug use (marijuana is allowed)\n5. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.\n6. Individuals who are pregnant, lactating or planning on becoming pregnant during the study\n7. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac disease\n8. Unstable psychiatric illness (psychosis)\n9. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)\n10. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days\n11. Systemic antibiotics in the last 30 days\n12. Fecal microbiota transplant in the last 30 days\n13. Active dysphagia\n14. Allergies to any of the ingredients in assigned products\n15. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.\n16. On treatment for hepatic encephalopathy.\n17. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.",{"count":318,"type":22},[82],"Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation.\n\nPrebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.",[28,597],"PTSD",[599,600,601,577],"microbiome","prebiotic","gut-brain",{"date":542,"type":36},{"date":604,"type":36},"2024-07-31",{"date":606,"type":22},"2027-09-25",{"name":608,"class":160},"Hunter Holmes Mcguire Veteran Affairs Medical Center",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":618,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":70},"100520100","phase-2-hepatic-encephalopathy-and-albumin-lasting-cognitive-improvement-100520100","NCT06052176","Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement","Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin","HEAL-LAST","Inclusion Criteria:\n\n* Age \\>18 years\n* Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count \\\u003C150,000\u002Fmm3 and AST\u002FALT ratio \\>1.\n* Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop\n* Prior HE controlled by lactulose or rifaximin for at least one month\n* Serum albumin \\\u003C4gm\u002Fdl\n\nExclusion Criteria:\n\n* Unclear diagnosis of cirrhosis\n* No prior overt HE\n* No cognitive impairment on the tests noted\n* Requiring regular albumin infusions within 3 months or anticipated during the study visit\n* Infection within a month\n* Allergies to albumin\n* Unlikely to be adherent to the study\n* Unable or unwilling to consent\n* West Haven Criteria\\>2\n* Alcohol abuse within 1 month\n* Serum albumin \\>4gm\u002Fdl\n* Congestive heart failure",{"count":318,"type":22},[56],"Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.\n\nThis will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.",[28,91],[622,176,623,624],"albumin","inflammation","cognitive performance","2026-04-02",{"date":627,"type":36},"2026-04-08",{"date":629,"type":36},"2023-11-02",{"date":631,"type":22},"2026-12-01",{"name":608,"class":160},{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":393},"100628473","vagus-nerve-guided-laparoscopic-splenectomy-and-azygoportal-disconnection-100628473","NCT07462091","Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection","VNLSD","Inclusion Criteria:\n\n1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology\n2. Splenomegaly with secondary hypersplenism\n3. Bleeding portal hypertension\n4. No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT\n5. Informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Delayed gastric emptying\n2. Diarrhea\n3. Hepatocellular carcinoma or any other malignancy,\n4. Hypercoagulable state other than the liver disease related\n5. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n6. Child - Pugh C\n7. Recent peptic ulcer disease\n8. History of Hemorrhagic stroke\n9. Pregnancy.\n10. Uncontrolled Hypertension\n11. Human immunodeficiency virus (HIV) infection",{"count":641,"type":22},15,[82],"This study aimed to evaluate the effectiveness and safety of vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection, and to assess its impact on postoperative digestive complications and quality of life.",[28,323,645],"Hypertension, Portal",[327,647,28,648,326],"Vagus nerve","Azygoportal disconnection","2026-03-26",{"date":364,"type":36},{"date":652,"type":36},"2026-03-25",{"date":654,"type":22},"2027-03-31",{"name":336,"class":43},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":665,"briefSummary":666,"conditions":667,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":70},"100513576","cirrhosisrx-cds-system-100513576","NCT05967273","CirrhosisRx CDS System","Pragmatic Randomized Controlled Trial to Evaluate the Effect of CirrhosisRx, a Novel Clinical Decision Support System, on Guideline-adherence and Clinical Outcomes for Patients With Cirrhosis","Inclusion Criteria:\n\n* All adult (age ≥ 18 years) patients who have cirrhosis identified based on 1+ chronic liver disease and 1+ cirrhosis (or its complications) International Classification of Diseases, Revision 10 diagnosis codes OR mention of cirrhosis or portal hypertension (or their complications) in clinical documentation admitted at our institution.\n\nExclusion Criteria:\n\n* Children (age \\\u003C 18 years)\n* patients who do not meet the cirrhosis definition criteria as noted above\n* ambulatory patients",{"count":664,"type":22},2106,[82],"The aim of the study is to compare the effect of CirrhosisRx, a novel clinical decision support (CDS) system for inpatient cirrhosis care, versus \"usual care\" on adherence to national quality measures and clinical outcomes for hospitalized patients with cirrhosis.",[28,668],"Decision Support Systems, Clinical",{"date":364,"type":36},{"date":671,"type":36},"2025-01-14",{"date":673,"type":22},"2027-01",{"name":675,"class":43},"University of California, San Francisco",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":686,"conditions":687,"keywords":688,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":693,"leadSponsor":695,"locationsCount":70},"100628431","efficacy-of-apixaban-in-the-treatment-of-portal-vein-thrombosis-occurring-more-than-one-year-after-ls-100628431","NCT07461545","Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS","Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy","Inclusion Criteria:\n\n1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.\n2. Splenomegaly with secondary hypersplenism.\n3. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.\n4. Underwent laparoscopic splenectomy at our center.\n5. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.\n6. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3\n7. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.\n8. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.\n9. Developed portal vein thrombosis after 12 months post-surgery.\n10. Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma or any other malignancy.\n2. Hypercoagulable state other than the liver disease related.\n3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n4. Portal hypertension bleeding .\n5. Child - Pugh C\n6. Recent peptic ulcer disease\n7. History of Hemorrhagic stroke\n8. Pregnancy.\n9. Uncontrolled Hypertension\n10. Human immunodeficiency virus (HIV) infection",{"count":684,"type":22},20,[82],"The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy.",[28,326,564,645],[28,564,85,689,326,327],"Apixaban",{"date":691,"type":36},"2026-03-31",{"date":364,"type":22},{"date":694,"type":22},"2027-09-30",{"name":336,"class":43}]