[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrosis-liver\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrosis-liver":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,53,87,118,140,164,193,221,249,282,313],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100492429","phase-1-coffee-and-metabolites-modulating-the-gut-microbiome-in-colorectal-cancer-100492429",false,"NCT05692024","COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER","Inclusion Criteria:\n\nParticipants must meet the following criteria on screening examination to be eligible to participate in the study:\n\n* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.\n* Age 18 years or older.\n* This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.\n* The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Subjects must be able and willing to follow study procedures and instructions.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nParticipants who exhibit any of the following conditions at screening will not be eligible for admission into the study.\n\n* Participants who are receiving any other investigational agents.\n* Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.\n* Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.\n* Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).\n* History of diagnosed conditions that may be worsen by coffee, including arrhythmias, insomnia, tremors, tics, generalized anxiety disorder, bipolar disease, panic attacks, Tourette's, epilepsy or overactive bladder.\n* History of adverse reactions to coffee or intolerance of coffee consumption.\n* Inability or unwillingness to swallow capsules.\n* History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.\n* Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.\n* Pregnant or breastfeeding. The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nShould a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with coffee. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.\n\n* Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.\n* Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.",[28,29,30,31,32,33,34],"Colorectal Cancer","Coffee","Gastrointestinal Microbiome","Stenosis","Fibrosis, Liver","Ultrasound Elastography","Proton Magnetic Resonance Spectroscopy",[36,37,38,29,39],"Liver fat","Gut microbiome","Colorectal cancer","Tumor biopsy","RECRUITING","2026-04-29",{"date":43,"type":44},"2026-05-05","ACTUAL",{"date":46,"type":44},"2024-03-21",{"date":48,"type":21},"2028-08-31",{"name":50,"class":51},"Massachusetts General Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":74,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":52},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994","NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition",{"count":62,"type":21},20,"OBSERVATIONAL","HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[66,67,68,69,70,71,32,72,73],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[75,76,77],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":80,"type":44},"2026-02-24",{"date":82,"type":44},"2025-09-24",{"date":84,"type":21},"2027-10",{"name":86,"class":51},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100561642","endoscopic-ultrasound-shear-wave-elastography-study-100561642","NCT06592820","Endoscopic Ultrasound Shear Wave Elastography Study","Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease","EUS-SWE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n5. BMI \\>\u002F=28\n6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and\u002For 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)\n\nExclusion Criteria:\n\n1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma\n2. Prior history of Hepatitis B or C infection\n3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)\n4. Histological evidence of other concomitant chronic liver disease on biopsy\n5. Inadequate liver biopsy\n6. Prior history of or current excess alcohol consumption (\\>140 g\u002Fweek and \\>210 g\u002Fweek for females and males, respectively) documented in EMR",{"count":96,"type":21},300,"This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\\[s\\] it aims to answer are:\n\n* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis\n* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).\n\nParticipants will undergo:\n\n* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)\n* Liver biopsy\n* FibroScan",[99,100,32,101],"MASLD","MASH","Chronic Liver Disease",[103,104,105,106],"Shear Wave Elastography","Shear Wave","FibroScan","Attenuation Imaging","2025-09-11",{"date":109,"type":44},"2025-09-15",{"date":111,"type":44},"2025-09-03",{"date":113,"type":21},"2027-03-28",{"name":115,"class":116},"Olympus Corporation of the Americas","INDUSTRY",2,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":117},"100538633","safety-and-effectiveness-of-sulfasalazine-in-the-treatment-of-liver-fibrosiscirrhosis-100538633","NCT06293378","Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis\u002FCirrhosis.","Inclusion Criteria:\n\n1. Sign the informed consent form before the trial and be able to complete the study in accordance with the requirements of the trial protocol;\n2. The age is 18\\~70 years old (including boundary value), the weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) in the range of 18\\~32kg\u002Fm2 (including critical value);\n3. Enrolled patients also need to meet:\n\nA:Patients with PBC cirrhosis PBC patients who have been treated and show an inadequate response to UDCA：(1) according to the biochemical response criteria for 2021 PBC, Enrolled patients need to meet the criteria of ALP ≥1.67 × ULN as a poor biochemical response to UDCA after 12 months of UDCA treatment; (2) meeting the diagnostic criteria for primary cholangitis (PBC) , i.e. meeting at least two of the following criteria: 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive .3 liver biopsy consistent with PBC; Patients with newly diagnosed primary cholangitis (PBC-RRB- met the diagnostic criteria of at least two of the following): 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive 3. liver biopsy consistent with PBC; B:Patients with hepatitis B cirrhosis Diagnosis of hepatitis B cirrhosis based on clinical history, histology or imaging.\n\nC:Patients with hepatitis C cirrhosis Diagnosis of hepatitis C cirrhosis based on clinical history, histology or imaging.\n\nD:Alcoholic hepatitis cirrhosis Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging.\n\nExclusion Criteria:\n\n1. Those who have a history of allergies in the past, or the investigator suspects that they are allergic to the active ingredients of the drug or their excipients under study;\n2. Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid;\n3. Patients with intestinal obstruction or urinary tract obstruction;\n4. Patients with porphyria, such as sulfonamides, have been reported to cause acute attacks.\n5. Acute and chronic liver disease with clinical significance caused by infections other than HBV, HCV, PBC, and alcoholic liver disease;\n6. Primary liver cancer; alpha-fetoprotein (AFP) greater than 50 ug\u002FL or imaging suggests malignant liver mass; Those with other malignancies or a history of other malignancies in the 5 years prior to screening (except for complete remission of malignant tumors after treatment and no additional medical or surgical intervention within 3 years prior to screening);\n7. The investigator judged that there is impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent \\>Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhoea);\n8. Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, psychiatric, neurological, renal and other systems;\n9. Those who have had major trauma or undergone major surgery within 3 months before screening; or those who plan to undergo surgery during the study;\n10. Donated blood or lost blood ≥ 400mL within 3 months before screening, or received blood transfusion; or ≥ blood donation or blood loss within 1 month prior to screening 200mL；\n11. Those who are positive for AIDS antigen\u002Fantibody, positive for Treponema pallidum antibody and positive RPR test;\n12. History of drug dependence or drug abuse within 1 year prior to screening;\n13. Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use them Those who have medical devices;\n14. Those who have a positive pregnancy test during lactation or screening, or who have fertility requirements in the past two years;\n15. Subjects who the investigator believes have other factors that are not suitable to participate in this trial.","70 Years",{"count":126,"type":21},330,[128],"NA","This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, Observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.",[71,32],"2025-02-18",{"date":133,"type":44},"2025-02-20",{"date":135,"type":44},"2024-02-01",{"date":137,"type":21},"2028-10-10",{"name":139,"class":51},"The Second Affiliated Hospital of Chongqing Medical University",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":52},"100578692","prevalence-of-non-alcoholic-fatty-liver-disease-in-inflammatory-bowel-disease-patients-100578692","NCT06814600","Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients","Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: A Prospective Monocentric Study","PONI","Inclusion Criteria:\n\n* Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines\n* Willingness to provide informed consent for study participation\n\nExclusion Criteria:\n\n* Presence of established liver disease (including autoimmune hepatitis, primary biliary cholangitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, positive serology for viral hepatitis B or C)\n* History of hepatocellular carcinoma or liver transplantation\n* History of excessive alcohol consumption defined as \\>3 units per day for women and \\> 5 units per day for men\n* Pregnancy at the time of recruitment\n* Failure to perform an elastography mesure or missing elastography data",{"count":149,"type":21},150,"Non-alcoholic Fatty Liver Disease (NAFLD) refers to a spectrum of disease characterized by the presence of more than 5% of steatosis in hepatocytes of individuals who consume little or no alcohol. It ranges from simple steatosis without evidence of inflammation, to the association of steatosis and inflammation with cellular necrosis, the so-called non-alcoholic steatohepatitis (NASH). NAFLD has become increasingly common in developed countries affecting up to 38% of the population. It is mostly but not exclusively associated with metabolic syndrome including obesity, insulin resistance, and hypertension. There is growing evidence of a close interaction between the gut and the liver \"Gut-liver axis\", particularly in the pathogenesis of NAFLD. The pathophysiological mechanism behind this association is not well understood but involves small intestinal bacterial overgrowth (SIBO), intestinal wall inflammation and increased permeability, all leading to systemic translocation of microbial metabolites including endotoxins and pro-inflammatory markers called Pathogen Associated Molecular Pattern (PAMPs). Thus, the gut-liver interaction, mediated by cytokines and inflammatory proteins seem to be the cornerstone of this complex liver disease.\n\nRecent studies underlined the increased prevalence of NAFLD in the Inflammatory Bowel Disease (IBD) population, accounting for almost 32% of hepatic extra-intestinal manifestations of the disease. Several hypotheses have been proposed to explain the pathophysiology behind this association, encompassing chronic intestinal wall inflammation, increased intestinal permeability and altered gut microbiota or dysbiosis. To our knowledge, no studies have been conducted so far to investigate the correlation between intestinal disease activity (IBD flare versus remission state) and NAFLD incidence and behavior (progression versus regression of steato-fibrosis). We therefore aim to conduct a prospective paired study, on IBD patients followed at Saint-Pierre University Hospital, aiming to explore this correlation.\n\nIn this paired study design, patients will be their own controls over the course of their disease: An evaluation of NAFLD will be done for all patients during both phases of their inflammatory bowel disease: In the active phase and in remission phase. Our primary outcome is to assess NAFLD prevalence in the IBD population followed at our institution. Secondary outcomes will be to explore NAFLD prevalence and behavior (progression versus regression of steato-fibrosis) according to IBD activity, IBD type, IBD duration and types of IBD treatments.",[152,153,154,32],"NAFLD","Inflammatory Bowel Diseases","Steatosis","2025-02-05",{"date":157,"type":44},"2025-02-07",{"date":159,"type":44},"2024-11-01",{"date":161,"type":21},"2025-12-01",{"name":163,"class":51},"Centre Hospitalier Universitaire Saint Pierre",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":52},"100523997","endoscopic-ultrasound-shear-wave-for-liver-fibrosis-in-masld-patients-the-rumipamba-trial-100523997","NCT06102980","Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial","Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography: The RUMIPAMBA Diagnostic Trial","Inclusion Criteria:\n\n* Patients referred for any kind of endoscopic procedure.\n* Without clinical suspicion of advanced liver fibrosis.\n* Acceptance to participate in the study.\n\nExclusion Criteria:\n\n* History of greater amounts of alcohol per week (140 g\u002Fweek and 210 g\u002Fweek for females and males respectively).\n* Significant or advanced fibrosis by Fibrosis-4 Index (FIB4) or the aspartate aminotransferase to platelet ratio index (APRI).\n* Any liver space-occupying lesion in the US.\n* Comorbidities or conditions related to avoidance of interventional procedures, namely: pregnancy or nursing, coagulopathy or any risk of bleeding, Anaesthesiology Society Association classification IV or higher, New York Heart Association functional class III or IV.","79 Years",{"count":173,"type":21},30,[128],"Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver fibrosis in patients with screening criteria of metabolic dysfunction-associated steatotic liver disease (MASLD), with absent-to-mild liver fibrosis. Similar research has been published but using vibration-controlled transient elastography (VCTE), recommended mainly due to its lower cost and less invasiveness. However, VCTE is limited to the anatomical proportions of the patient's body, and cannot assess the right hepatic lobe with less reliability, contrary to the EUS-SWE.",[177,32],"Liver Steatosis",[179,180,181,182,183],"Liver steatosis","Fatty liver","Endosonography","Elastography","Liver fibrosis","2024-09-22",{"date":186,"type":44},"2024-09-24",{"date":188,"type":44},"2023-11-01",{"date":190,"type":21},"2025-04-01",{"name":192,"class":51},"Instituto Ecuatoriano de Enfermedades Digestivas",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":200,"maxAge":18,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":52},"100559485","stem-cell-applications-in-biliary-atresia-patients-100559485","NCT06564740","Stem Cell Applications in Biliary Atresia Patients","Umbilical Cord Derived Mesenchymal Stem Cell (UC-MSC) Transplantation in Infants with Biliary Atresia: a Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants were diagnosed with liver cirrhosis due to biliary atresia following Kasai's operation.\n* The patients two months old or older and exhibited signs of cirrhosis after the procedure, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (confirmed by endoscopy), and cirrhosis (confirmed by liver biopsy).\n\nExclusion Criteria:\n\n* Epilepsy\n* Neurological disorders\n* Coagulation disorders\n* Diabetes\n* Syndromic type biliary atresia\n* Allergies to anesthetic agents\n* Severe health conditions such as cancer or failure of the heart, lungs, liver, or kidneys, active infections, and severe psychiatric disorders.","2 Months",{"count":202,"type":21},64,[128],"Recently, mesenchymal stem cell (MSC) transplantation has emerged as a promising treatment for liver cirrhosis in adults. Additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (BA). This study aims to evaluate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA through a multicentric randomized controlled trial.",[206,32,207],"Biliary Atresia","Stem Cell",[209,210,211],"biliary atresia","liver fibrosis","stem cell","2024-09-03",{"date":214,"type":44},"2024-09-19",{"date":216,"type":44},"2024-06-01",{"date":218,"type":21},"2026-06-01",{"name":220,"class":51},"Necmi Kadıoğlu Hospital",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":229,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":232,"studyType":63,"phases":4,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":117},"100535188","find-hdv-and-determine-its-status-in-turkey-100535188","NCT06248580","Find HDV and Determine Its Status in Turkey","Find HDV and Determine Its Status in Turkey \"SITU(HD)VATION\"","SITUHDVATION","Inclusion Criteria:\n\n* Adults (Age≥18)\n* Being HBsAg positive for at least six months\n* Being a citizen of the Republic of Türkiye\n\nExclusion Criteria:\n\n* There are no exclusion criteria in this study.",true,{"count":231,"type":21},20000,"13 Months","The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV\u002FHCV and to detect liver fibrosis with a non-invasive method.",[235,32,70,71,236],"Chronic Hepatitis D Infection","Transmission Vertical",[238,70,239],"Chronic hepatitis D","Liver Cirrhosis","2024-08-08",{"date":242,"type":44},"2024-08-12",{"date":244,"type":44},"2024-03-11",{"date":246,"type":21},"2025-03-01",{"name":248,"class":51},"Yaşar Bayındır, MD",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":257,"enrollmentInfo":258,"targetDuration":260,"studyType":63,"phases":4,"briefSummary":261,"conditions":262,"keywords":269,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100489331","global-research-initiative-for-patients-screening-on-mash-100489331","NCT05651724","Global Research Initiative for Patients Screening on MASH","Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway","GRIPonMASH","Inclusion Criteria:\n\n* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.\n* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.\n\nStudy definitions:\n\nType 2 diabetes mellitus\n\n* At least 2 times a fasting glucose \\> 7,0 mmol\u002FL\n* Or elevated non-fasting glucose \\>11,1 mmol\u002FL 2 hrs after OGTT\n* Or HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider\n\nObesity\n\n* Body mass index (BMI) \\> 30\n* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian\u002FChinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm\n\nArterial hypertension\n\n* Systolic BP ≥ 140 mmHg and\u002For diastolic BP ≥ 90 mmHg\n* Or being actively treated for previously diagnosed arterial hypertension by a health care provider\n\nMetabolic syndrome\n\n\\- Central obesity defined as waist circumference (see above), if BMI is \\>30 kg\u002Fm2, central obesity can be assumed and waist circumference does not need to be measured\n\nAND any two of the following:\n\n* Raised triglycerides: ≥ 150 mg\u002FdL (1.7 mmol\u002FL), or specific treatment for this lipid abnormality\n* Reduced HDL cholesterol: \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in males, \\\u003C 50 mg\u002FdL (1.29 mmol\u002FL) in females, or specific treatment for this lipid abnormality\n* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension\n* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg\u002FdL (5.6 mmol\u002FL), or previously diagnosed type 2 diabetes (if above \\>5.6 mmol\u002FL or 100 mg\u002FdL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)\n\nExclusion Criteria:\n\n* The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);\n* The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;\n* The patient engages in (excessive) alcohol use: \\> 3 units\u002Fday in males \\[30 grams\u002Fday\\] and \\> 2 units\u002Fday in females \\[20 grams\u002Fday\\];\n* The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;\n* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;\n* The patient is not able to understand the details of the protocol and\u002For is not able to provide written informed consent;\n* The patient is pregnant or breastfeeding.\n* The patient underwent bariatric surgery in the last 12 months.","75 Years",{"count":259,"type":21},10000,"5 Years","GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.",[100,99,263,32,264,265,266,267,268],"MASH With Fibrosis","Steatosis of Liver","Type 2 Diabetes","Obesity","Metabolic Syndrome","Arterial Hypertension",[99,100,270,271],"Screening","Patient care pathway","2024-07-30",{"date":274,"type":44},"2024-08-01",{"date":276,"type":44},"2023-06-30",{"date":278,"type":21},"2031-03-31",{"name":280,"class":116},"Julius Clinical",13,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":300,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":117},"100504953","the-liver-care-trial-100504953","NCT05855031","The Liver Care Trial","The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study","Inclusion Criteria:\n\n* Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde\n* Informed written consent\n\nExclusion Criteria:\n\n* Not speaking Danish or English\n* Severe liver disease (known by the participant)","110 Years",{"count":291,"type":21},408,[128],"The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units\u002Fweek) throughout the last months, and assessed 6 months after randomization.",[295,296,297,298,32,299],"Alcoholic Liver Disease","Alcohol Use Disorder","Alcohol Abuse","Alcoholism","Alcohol-Related Disorders",[270,301,302,303],"Fibroscan","Liver stiffness measurement","abstinence","2023-05-15",{"date":306,"type":44},"2023-05-17",{"date":308,"type":44},"2023-05-08",{"date":310,"type":21},"2027-05-01",{"name":312,"class":51},"Zealand University Hospital",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":319,"enrollmentInfo":320,"targetDuration":321,"studyType":63,"phases":4,"briefSummary":322,"conditions":323,"keywords":330,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100396456","the-european-nafld-registry-100396456","NCT04442334","The European NAFLD Registry","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinically suspected NAFLD based on any of:\n\n   1. Patient with historical liver biopsy providing histological evidence of NAFLD or,\n   2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and\u002For radiological findings consistent with NAFLD or,\n   3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':\n\n      * Increased waist circumference by ethnically adjusted criteria (e.g. Europid male\u002Ffemale ≥94cm\u002F80cm) or overweight\u002Fobese (BMI ≥25);\n      * Raised fasting glucose ≥100 mg\u002FdL \\[5.6 mmol\u002FL\\], HbA1c ≥48mmol\u002Fmol (6.5%) or previously diagnosed insulin resistance\u002Ftype 2 diabetes mellitus (or on treatment);\n      * Dyslipidaemia (fasting TG level ≥150 mg\u002FdL \\[1.7 mmol\u002FL\\]; or fasting HDL \\\u003C40 mg\u002FdL \\[1.03 mmol\u002FL\\] in males and \\\u003C50 mg\u002FdL \\[1.29 mmol\u002FL\\] in females; or on treatment);\n      * Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).\n3. Average alcohol consumption less than 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n\nExclusion Criteria\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than approximately 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD.\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose\u002Fregimen or introduction of Vitamin E (at a dose ≥400 IU\u002Fday), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-English speaking\u002Funable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.\n9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.","100 Years",{"count":259,"type":21},"10 Years","The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and\u002For from NAFL through NASH to fibrosis and cirrhosis.",[152,324,325,32,264,70,326,265,327,328,266,329],"NASH","NASH - Nonalcoholic Steatohepatitis","Cardiovascular Diseases","Dyslipidaemia","Hypertension","Other Associated Comorbidities",[152,324,331,332,333,334],"Steatohepatitis","Liver","Cirrhosis","Non-alcoholic fatty liver disease","2023-01-05",{"date":337,"type":44},"2023-01-06",{"date":339,"type":44},"2015-05-01",{"date":341,"type":21},"2030-12-31",{"name":343,"class":51},"Newcastle University",37]