[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494629":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":28,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":10,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":10,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"nonalcoholic steatohepatitis (NASH)",null,"Adult patients nonalcoholic steatohepatitis (NASH)",[13],"Other: Standard of care",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Standard of care","Participants will receive the standard of care for their condition",[9],[20],{"name":21,"affiliation":5,"role":22},"Mohammad S Siddiqui, MD","PRINCIPAL_INVESTIGATOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","804-828-4060","mohammad.siddiqui@vcuhealth.org",[29,54],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-92.4699,44.02163,{"lat":41,"lon":40},[44,48,52],{"name":45,"role":25,"phone":46,"phoneExt":10,"email":47},"Christopher Kigongo","507-266-1998","Kigongo.Christopher@mayo.edu",{"name":49,"role":25,"phone":50,"phoneExt":10,"email":51},"Mia Mahmoud","507-284-0361","Mahmoud.Mia@mayo.edu",{"name":53,"role":22,"phone":10,"phoneExt":10,"email":10},"Manal F. Abdelmalek, MD",{"facility":5,"status":31,"city":55,"state":56,"zip":57,"country":35,"countryCode":36,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Richmond","Virginia","23298",{"type":38,"coordinates":59},[60,61],-77.46026,37.55376,{"lat":61,"lon":60},[64,66],{"name":65,"role":25,"phone":26,"phoneExt":10,"email":27},"Mohammad Siddiqui, MD",{"name":65,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[70],{"name":71,"class":72},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100494629","predicting-outcomes-in-nonalcoholic-steatohepatitis-with-advanced-fibrosis-100494629",false,"NCT05720663","Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis","Inclusion Criteria:\n\nAdult patients with presence of NAFLD associated cirrhosis.\n\n* Cirrhosis: biopsy confirmed or Agile F (F4) score \\> 0.45\n* NAFLD as an etiology of liver disease will be determined based on presence of any of the following:\n\n  * Biopsy showing \\>5% steatosis or\n  * CAP \\> 280 dB\u002Fm or MR-PDFF\\>5%\n  * If CAP \\\u003C 280 dB\u002Fm or MR-PDFF \\\u003C5%, then must have type 2 diabetes and or 2 or more features of metabolic syndrome for 5 years (cryptogenic cirrhosis)\n\nExclusion Criteria:\n\n* Refusal to consent\n* Alcohol use \\> 14\u002F21 gm\u002Fweek cutoff\n* Other causes of chronic liver disease\n* MELD \\> 12\n* Hepatic and extrahepatic cancers expected to limit life expectancy \\\u003C 2 yrs\n* prior hepatic resections, TIPS, splenic embolization\n* prior decompensation events\n* inability to fit into MRI (failed hula-hoop test)\n* general contraindication for MRI contrast (GFR \\\u003C 30 ml\u002Fmin)\n* contraindications for MRI\n* pregnancy\n* acute kidney injury\n* reduced kidney function (GFR \\\u003C30ml\u002Fmin)","ALL","18 Years",{"count":82,"type":83},240,"ESTIMATED","OBSERVATIONAL","Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation.\n\nThe purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.",[87],"Nonalcoholic Steatohepatitis","2026-04-01",{"date":90,"type":91},"2026-04-02","ACTUAL",{"date":93,"type":91},"2023-04-19",{"date":95,"type":83},"2027-12",{"name":5,"class":6},2]