[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mash\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mash":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,72,109,145,169,199,227,252,282,312],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":45,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751",false,"NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Obesity","Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[46,47,48,49,50,51,52,53,54,55,56,57,58],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)","RECRUITING","2026-06-23",{"date":62,"type":63},"2026-06-25","ACTUAL",{"date":65,"type":63},"2025-06-24",{"date":67,"type":20},"2028-06",{"name":69,"class":70},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":94,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":71},"100561325","phase-2-digoxin-in-nash-codin-100561325","NCT06588699","Digoxin In NASH (CODIN)","Clinical Trial of Oral Digoxin In NASH (CODIN)","CODIN","Inclusion Criteria\n\n* Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening\n* Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening\n* Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening\n* Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria\n\nLiver-related:\n\n* Documented causes of chronic liver disease other than NASH\n* History or clinical evidence of cirrhosis or portal hypertension\n* History of positive HBsAg, positive anti-HIV, positive HCV-RNA\n* AST or ALT \\> 5 times upper limit of normal (ULN) at screening\n* Total bilirubin \\> 1.5 mg\u002FdL at screening unless conjugated bilirubin is \\\u003C 1.5 × ULN\n* International normalized ratio (INR) \\> 1.3 at screening\n* Known or suspected alcohol use \\> 20 g\u002Fday for women or \\> 30 g\u002Fday for men\n* Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy\n* Treatment initiation or anticipated treatment (\\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy\n\nCardiac related:\n\n* Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)\n* Current diagnosis of severe aortic valve disease\n* History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)\n* History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device\n* Current diagnosis of permanent atrial fibrillation\n* Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker\u002Fimplantable cardiac device implantation, cardiac surgery, or stroke\n* Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.\n\nObesity related:\n\n* Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator\n* Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)\n* Recent surgical treatment (\\\u003C6 months of signing informed consent) for obesity\n\nGeneral safety related:\n\n* Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ\n* Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator\n* Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures\n* Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites\n* Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL at screening\n* Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.\n* Claustrophobia to an extent that would prevent tolerance of MRI\n* Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI","75 Years",{"count":82,"type":20},144,[84],"PHASE2","Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.",[87,88,89,90,91,32,92,93],"NASH","NAFLD","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Mash","MASH With Fibrosis","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[87,33,95,96,97,98,99,88],"Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","2026-05-22",{"date":102,"type":63},"2026-05-26",{"date":104,"type":63},"2025-06-05",{"date":106,"type":20},"2029-01",{"name":108,"class":70},"Yale University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100599366","routine-validation-and-reproducibility-testing-of-laboratory-assays-and-research-techniques-used-for-endocrine-cardiometabolic-and-musculoskeletal-disorder-research-vald-100599366","NCT07083557","Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)","VALD","Inclusion Criteria:\n\n* ≥18 and ≤100 years of age\n* body mass index ≥16.0 and ≤60 kg\u002Fm2\n\nExclusion Criteria:\n\n* \\\u003C18 and \\>100 years of age\n* body mass index \\\u003C16.0 or \\>60 kg\u002Fm2\n* allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians\n* use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay\u002Ftechniques being evaluated\n* engaged in regular structured exercise \\>150 min per week unless needed for validation of the assay\u002Ftechnique being evaluated\n* significant organ system dysfunction or diseases, except those that are sought for validation of the assay\u002Ftechnique being evaluated\n* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay\u002Ftechnique being evaluated\n* pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.",true,"100 Years",{"count":119,"type":20},100,"OBSERVATIONAL","The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.",[123,39,124,125,33,126,127,128,129,130,131,132,133,134],"Obesity and Obesity-related Medical Conditions","Atherosclerotic Disease","Heart Failure","Sarcopenia","Osteoporosis","Hyperparathyroidism","Hypoparathyroidism","Ischemic Heart Disease","Cystic Fibrosis (CF)","Chronic Kidney Disease(CKD)","Osteopenia","Cachexia","2026-05-05",{"date":137,"type":63},"2026-05-07",{"date":139,"type":20},"2027-01-01",{"date":141,"type":20},"2030-07-01",{"name":143,"class":70},"Bettina Mittendorfer",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":116,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100632341","phase-1-phase-12-study-of-opk-88006-in-healthy-and-presumed-mash-participants-100632341","NCT07512427","Phase 1\u002F2 Study of OPK-88006 in Healthy and Presumed MASH Participants","Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants","Part A (SAD)\n\nInclusion Criteria:\n\n* Adults aged 18-65 years.\n* BMI ≥27 and ≤35 kg\u002Fm².\n* Good general health per investigator assessment.\n* Willing to comply with contraception, trial procedures, and stable diet\u002Fexercise.\n\nExclusion Criteria:\n\n* Significant uncontrolled medical or psychiatric history.\n* History of pancreatitis, cancer (within 5 years), or substance misuse.\n* Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.\n* Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).\n* Pregnant, lactating, or planning pregnancy.\n\nPart B (MAD)\n\nInclusion Criteria:\n\n* Adults aged 18-75 years.\n* Presumed MASH (defined by metabolic risk factors and specific liver tests).\n* BMI ≥27 and ≤40 kg\u002Fm² with stable weight.\n* Willing to comply with contraception, trial procedures, and stable diet\u002Fexercise.\n\nExclusion Criteria:\n\n* Significant uncontrolled medical or psychiatric history.\n* History of other liver diseases, cirrhosis, or hepatic decompensation.\n* History of pancreatitis, cancer (within 5 years), or substance misuse.\n* Clinically significant abnormal labs (e.g., elevated liver enzymes, HbA1c ≥9.5%) or ECG findings.\n* Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).\n* Pregnant, lactating, or planning pregnancy.",{"count":153,"type":20},30,[155,84],"PHASE1","Two-part Phase 1\u002F2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related pharmacodynamic changes compared to placebo.",[33],"NOT_YET_RECRUITING","2026-03-30",{"date":161,"type":63},"2026-04-06",{"date":163,"type":20},"2026-12",{"date":165,"type":20},"2027-12",{"name":167,"class":168},"OPKO Health, Inc.","INDUSTRY",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100625057","multicentric-approval-study-trans-duodenal-barrier-for-typ-2-diabetes-with-obesity-100625057","NCT07417683","Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity","Leistung Und Sicherheit Des Trans-Duodenal Barrier (LuST)","LuST","Inclusion Criteria:\n\n* Obese patients with type 2 diabetes mellitus,\n* Age ≥ 18 years,\n* The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28),\n* The patient has been informed and all written consents from the patient are available.\n\nExclusion Criteria:\n\n* The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial.\n* The patient is unwilling or unable to follow postoperative instructions.\n* The patient has been placed in an institution by court order or official order (MPDG §27).\n* The patient lives more than 100 km from the treatment site.\n* Pregnancy.\n* The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.",{"count":178,"type":20},126,[23],"Approval study Trans-Duodenal Barrier The goal of this clinical trial is to determin the safety and performance of the newly developed Trans-Duodenal Barrier in adult Tryp 2 diabetic and obese patients.\n\nThe Trans-Duodenal Barrier is an endoscopic implant which can be placed to the gastric outlet and the upper small bowel by interventional endoscopy. It consists of a 60 cm long foil tube , a transpyloric shaft and and two ringlike balloons to fix it at the pylorus. It will be removed after 6 months via gastroscopy.\n\nThe main questions it aims to answer are:\n\n* Does the Trans-Duodenal Barrier lower the HbA1c of the participants ?\n* How frequent are adverse side effects related to the device?\n* How much ist the excessive wight loss of treated patients ?\n* Show patients with Metabolic assiociated Hepatosteatitis (MASH) improvements in liver elasticity (elastography) ? Researchers implant the Trans-Duodenal Barrier to enclosed patients and follow up them till 4 weeks after explantation.\n\nParticipants will:\n\n* Get the Trans-Duodenal Barrier as an implant for 6 moths\n* Visit the clinic 3 times in the implant period and once for explant.\n* Receive a telefon interview 4 weeks after explant",[182,26,183,33],"Typ 2 Diabetes","Obesity Type 2 Diabetes Mellitus",[185,186,187,188],"gastroduodenal liner","endoscopic implant","wight management","glycemic control","2026-02-10",{"date":191,"type":63},"2026-02-18",{"date":193,"type":20},"2026-03",{"date":195,"type":20},"2028-04",{"name":197,"class":168},"Trans-Duodenal Concepts GmbH",8,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":71},"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":208,"type":20},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",[32,33,211,212],"Fibrosis, Liver","Chronic Liver Disease",[214,215,216,217],"Shear Wave Elastography","Shear Wave","FibroScan","Attenuation Imaging","2025-09-11",{"date":220,"type":63},"2025-09-15",{"date":222,"type":63},"2025-09-03",{"date":224,"type":20},"2027-03-28",{"name":226,"class":168},"Olympus Corporation of the Americas",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":237,"studyType":120,"phases":4,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":144},"100596929","prospective-cohort-and-biobank-of-patients-with-nonalcoholic-fatty-liver-disease-100596929","NCT07051863","Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease","Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)","NAFLD Cohort","Inclusion Criteria:\n\n1. Participant must be ≥ 18 years of age at the time of signing the informed consent\n2. Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits\n3. To have a diagnosis of NAFLD\u002FNASH\u002FMAFLD followed at Epatocentro Ticino and collaborating\u002Freferring clinicians based on:\n\n   1. Liver biopsy with a histological evidence of NAFLD\u002FNASH\u002FMAFLD OR\n   2. Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR\n   3. Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:\n\n      * Abdominal obesity: a waist circumference of more than 35 inches (\\>89cm) for women and more than 40 inches (\\>102 cm) for men;\n      * High blood pressure of 130\u002F80 mm Hg or higher. Normal blood pressure is defined as less than 130 mm Hg for systolic pressure, and less than 80 mm Hg for diastolic pressure\n      * Impaired fasting blood glucose. This means a level equal to or greater than 100 mg\u002FdL (\\>5.6 mmol\u002FL)\n      * High triglyceride levels of more than 150 mg\u002FdL (\\> 1.7mmol\u002FL).\n      * Low HDL (good) cholesterol: less than 40 mg\u002FdL (\\\u003C 1.04 mmol\u002FL) for men and less than 50 mg\u002FdL (\\\u003C 1.29 mmol\u002FL) for women\n4. alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine\n\nExclusion Criteria:\n\n1. To have a diagnosis of type I diabetes mellitus\n2. To have a concomitant liver disease\n3. To take or have taken in the last 12 months before enrolment, on more than 50% of days, drugs that may cause liver steatosis (long-term high dose systemic corticosteroids (\\> 20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens and valproic acid)\n4. Pregnancy and breast feeding.",{"count":236,"type":20},200,"6 Months","The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD\u002FNASH\u002FMAFLD, according to standardized criteria.\n\nThis will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.",[88,33,240],"NASH\u002FMASH",[88,33,87,242],"Steatoepatitis","2025-07-04",{"date":245,"type":63},"2025-07-09",{"date":247,"type":63},"2023-07-19",{"date":249,"type":20},"2030-12",{"name":251,"class":70},"Fondazione Epatocentro Ticino",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":116,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":262,"conditions":263,"keywords":267,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":279,"locationsCount":281},"100559302","early-phase-1-a-microdose-trial-investigating-binding-of-68gaga-dota-cys-ath001-in-healthy-subjects-and-different-patient-groups-100559302","NCT06562361","A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.","A First-In-Human, Microdosing, Clinical Trial to Investigate Binding of the PET Tracer [68Ga]Ga-DOTA-CYS-ATH001 Targeting PDGFRβ in Healthy Subjects as Compared to Patients With MASH, PSC and CD","Inclusion Criteria:\n\n1. Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.\n2. Male or female participant aged 18 to 75 years, inclusive, at the screening visit.\n3. Body mass index (BMI) ≥ 19 and \\\u003C 40.0 kg\u002Fm2 at the time of the screening visit.\n4. Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of \\\u003C 1 % to prevent pregnancy from at least 2 weeks prior to administration of tracer for at least 1 week after the PET imaging examination (or for at least 1 weak after the last PET imaging examination for those participants undergoing test\u002Fretest PET imaging). In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom during the same time period.\n\n   The following are considered highly effective methods of contraception:\n   * combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),\n   * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),\n   * intra-uterine device \\[IUD\\]or intra-uterine hormone-releasing system \\[IUS\\]) WOCBP must refrain from donating eggs until 3 months after the last tracer administration.\n\n   WOCBP with an exclusive male partner who has undergone vasectomy may choose not to use contraceptives.\n\n   Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle-stimulating hormone \\[FSH\\] \\>25 IU\u002FL is confirmatory).\n\n   Male participants must be willing to use condom or be vasectomized or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of tracer until 3 months after the administration of tracer. Any female partner of a non-vasectomized male participant who is of childbearing potential must use contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (see above) from at least 2 weeks prior to administration of tracer to 4 weeks after administration of tracer.\n\n   Cohort-specific inclusion criteria:\n\n   Cohort 1 (healthy participants)\n5. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.\n\n   Cohort 2 (presumed MASH patients) MASH diagnosis based on non-invasive assessments. Participants should have a high level of disease activity with regards to pro-peptide of type III collagen (ProC3) as a marker of ongoing fibrogenesis.\n6. Steatosis according to biopsy, radiology, or controlled attenuation parameter (CAP) (≥ 280 dB\u002FM 8), assessments ≤ 24 weeks prior to the screening visit.\n7. At least 1 cardiometabolic criteria from the following list:\n\n   A. BMI ≥ 25 kg\u002Fm2 \\[23 Asia\\] OR waist circumference (WC) \\> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol\u002FL \\[100 mg\u002FdL\\] OR 2-hour post-load glucose levels ≥ 7.8 mmol\u002FL \\[≥ 140 mg\u002FdL\\] OR HbA1c ≥ 5.7% \\[39 mmol\u002FL) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130\u002F85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol\u002FL \\[150 mg\u002FdL\\] OR lipid-lowering treatment, E. Plasma high-density lipoprotein (HDL)-cholesterol ≤ 1.0 mmol\u002FL \\[40 mg\u002FdL\\] (M) and ≤ 1.3 mmol\u002FL \\[50 mg\u002FdL\\] (F) OR lipid-lowering treatment.\n8. ProC3 ≥ 12.6 ng\u002FmL. Cohort 3 (verified MASH patients) MASH diagnosis based on historical liver biopsy. Participants should have a high level of disease activity with regards to ProC3 as a marker of ongoing fibrogenesis, to allow for correlation to PET-tracer uptake.\n9. Evidence of steatosis according to biopsy, radiology, or CAP (≥ 280 dB\u002FM) or MRI-PDFF, assessments ≤ 24 weeks prior to the screening visit.\n10. At least 1 cardiometabolic criteria from the following list:\n\n    A. BMI ≥ 25 kg\u002Fm2 \\[23 Asia\\] OR WC \\> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol\u002FL \\[100 mg\u002FdL\\] OR 2-hour post-load glucose levels ≥ 7.8 mmol\u002FL \\[≥ 140 mg\u002FdL\\] OR HbA1c ≥ 5.7% \\[39 mmol\u002FL) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130\u002F85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol\u002FL \\[150 mg\u002FdL\\] lipid-lowering treatment, E. Plasma HDL-cholesterol ≤ 1.0 mmol\u002FL \\[40 mg\u002FdL\\] (M) and ≤ 1.3 mmol\u002FL \\[50 mg\u002FdL\\] (F) OR lipid-lowering treatment.\n11. Historical liver biopsy 24 weeks to 4 weeks prior to inclusion with histologically proven metabolic dysfunction-associated steatotic liver disease (MASLD).\n12. ProC3 ≥ 12.6 ng\u002FmL. Cohort 4 (fibrostenotic CD patients)\n13. Fibrostenotic CD as evidenced by persistent luminal narrowing with or without obstructive symptoms as assessed with MRI, ≤ 24 weeks prior to the screening visit OR fibrostenotic CD by positive colonoscopy up to 24 weeks prior to the screening visit.\n14. Crohn's disease activity index (CDAI) \\\u003C 150\n15. Calprotectin \\\u003C 250\n16. C-reactive protein (CRP) \\\u003C 20 Cohort 5 (PSC patients)\n17. Large duct PSC, including intrahepatic bile duct involvement, according to MRI\u002FMRCP.\n18. ProC3 ≥ 12.6 ng\u002FmL\n\nExclusion Criteria:\n\n1. Any contraindication for MRI according to a standard checklist used in clinical practice, including claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, cardiac pacemaker, defibrillator, artificial valves in heart, aneurysm clips or coils, etc.), inability to stay in supine position for 90 minutes, and permanent makeup or tattoos which in the Investigator's opinion might jeopardize the participant's safety or interfere with the imaging assessments.\n2. Having worked as a metal worker or welder.\n3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.\n4. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the screening visit.\n5. Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no interventions scheduled during the period of trial participation.\n6. Any planned major surgery within the duration of the trial participation.\n7. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.\n8. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B or C antibodies and\u002For human immunodeficiency virus (HIV).\n9. Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc.).\n10. Poor peripheral venous access, as judged by the Investigator.\n11. After 10 minutes of supine rest at the screening visit, any vital signs values outside the following ranges:\n\n    * Systolic blood pressure: \\\u003C 90 or \\>165 mmHg, or\n    * Diastolic blood pressure \\\u003C 50 or \\>100 mmHg, or\n    * Pulse \\\u003C 40 or \\> 90 bpm\n12. The participant has a change in body weight ≥5%, 3 months before the screening visit.\n13. The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.\n14. Clinically significantly abnormal 12-lead ECG recording result or cardiac symptoms as judged by the Investigator.\n15. The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.\n16. Current use of any hormone therapy at doses that may cause metabolic interference as judged by the Investigator. Stable hormonal replacement therapy is allowed.\n17. Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit or previous participation in another PET imaging trial within the last 12 months.\n18. Positive screening result for alcohol at the screening visit (cohorts 1a and 1b only).\n19. Ongoing or previous alcohol abuse, or long-standing excessive intake of alcohol, as judged by the Investigator.\n20. Presence or history of drug abuse, as judged by the Investigator.\n21. History of, or current use of anabolic steroids, as judged by the Investigator.\n22. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.\n23. The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.\n\n    Additional exclusion criteria for all participants (cohorts 2-5):\n24. The participant is receiving treatment with vitamin E, thiazolidinediones, or glucagon-like peptide-1 receptor agonists unless on a stable dose for 3 months before the screening Visit and is anticipated to maintain the same dosing regimen throughout trial participation.\n25. Participants with HbA1c ≥48 mmol\u002Fmol (6.5%) at screening without a previous diagnosis of T2D must not take part in the study. Participants with a previous diagnosis of T2D are permitted to enter the study if on a stable regimen of antidiabetic therapy for at least 3 months before screening. Participants who are on a stable regimen of antidiabetic therapy for at least 3 months before screening and have HbA1c of ≥ 63 mmol\u002Fmol (9%) at screening should be excluded.\n26. Clinically significant disease, apart from T2D, which in the opinion of the Investigator might interfere with the interpretation of the trial results and\u002For the safety of the participant, or in any other way unsuitable for participation in this clinical trial.\n27. The participant has a severe immune-mediated inflammatory disease (IMID) (e.g., rheumatoid arthritis, spondylarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions such as psoriasis, atopic dermatitis, hidradenitis suppurativa, asthma, multiple sclerosis). Participants with inactive IMID or active IMID of mild to moderate severity are permitted to enter the trial.\n\n    Additional exclusion criteria for MASH and PSC participants (cohorts 2-3, and 5)\n28. Liver stiffness \\> 25 kPa by transient elastography or any sign of decompensation. For cohorts 2 and 3, based on the FibroScan® evaluation on the screening visit, and for cohort 5 based on routine elastography performed ≤ 12 months.\n29. For participants with biopsy-confirmed fibrosis stage F2 or F3, the participant has any of the following during the screening period:\n\n    * Aspartate aminotransferase (AST) levels \\> 5 x the upper limit of normal (ULN).\n    * Alanine aminotransferase (ALT) levels \\> 5 x ULN.\n    * Alkaline phosphatase (ALP) ≥ 2 x ULN (cohorts 2 and 3) and ALP ≥ 10 (cohort 5).\n    * Serum creatinine ≥1.5 x ULN or has an estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73m2 (the revised Lund-Malmö GFR estimating equation will be used).\n    * International normalized ratio (INR) \\>1.3.\n    * Total TBL ≥ULN (except for patients with a documented history of Gilbert's syndrome if direct bilirubin is within the normal reference range).\n    * Direct bilirubin ≥ 3 x ULN.\n    * Platelet count \\\u003C 60 x 109\u002FL.\n    * Presence or history of ascites, hepatic encephalopathy, or variceal bleeding.\n    * Presence or history of Child-Pugh \\> 6 (Class B or C), unless due to therapeutic anticoagulation.\n    * Presence or history of Model for End-Stage Liver disease (MELD) score \\>12 (only for cohorts 2-3).\n\n    Note: It is the Investigator's decision, in consultation with the Sponsor, to allow participants to enter the study who have clinically meaningful rising tendencies in liver chemistries or significantly elevated liver chemistries that do not yet satisfy but could be interpreted as clinically concerning (i.e., AST or ALT \\> 4 x ULN) at any visit during the screening period.\n30. The participant has a change in body weight ≥ 5% after qualifying liver biopsy. Additional criteria for fibrostenotic CD participants (cohort 4)\n31. MRI findings consistent with only inflammation, i.e., edema, hyperemic intestinal wall, restricted diffusion, mesenteric lymphadenopathy etc.",{"count":153,"type":20},[261],"EARLY_PHASE1","The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer \\[68Ga\\]Ga-DOTA-Cys-ATH001 in the liver and\u002For gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga\\]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are:\n\n* What does the uptake of the \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?\n* What does the uptake of the \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects, and that of patients with fibrostenotic CD?\n* How much \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection?\n* How is \\[68Ga\\]Ga-DOTA-Cys-ATH001 uptake distributed in the body?\n* What medical problems do participants have when receiving \\[68Ga\\]Ga-DOTA-Cys-ATH001?\n\nParticipants will:\n\nReceive one administration of \\[68Ga\\]Ga-DOTA-Cys-ATH001, after which examination with PET is performed. Magnetic Resonance Imaging (MRI) is also used in the study to create a detailed picture of the body and its function which will facilitate the interpretation of the results of the PET examination. A subset of participants will have blood samples collected after the tracer administration to assess the blood levels of the tracer over time.\n\nA subset of participants will come back for a second visit where they will receive a second administration of \\[68Ga\\]Ga-DOTA-Cys-ATH001, followed by PET and MRI.\n\nA health check-up is performed before dosing, and a safety assessment will be performed after dosing. A remote follow-up visit is performed the day after the dosing visit.",[33,264,265,266],"PSC","Fibrostenotic Crohn's Disease","Healthy Volunteers",[268,269,270,33,264,271,272],"PET","Tracer","PDGFRB","MRI","Crohn´s Disease","2024-08-28",{"date":275,"type":63},"2024-08-29",{"date":277,"type":20},"2024-08",{"date":193,"type":20},{"name":280,"class":168},"Antaros Medical",3,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":290,"targetDuration":292,"studyType":120,"phases":4,"briefSummary":293,"conditions":294,"keywords":299,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"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.",{"count":291,"type":20},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.",[33,32,91,211,295,296,26,297,298],"Steatosis of Liver","Type 2 Diabetes","Metabolic Syndrome","Arterial Hypertension",[32,33,300,301],"Screening","Patient care pathway","2024-07-30",{"date":304,"type":63},"2024-08-01",{"date":306,"type":63},"2023-06-30",{"date":308,"type":20},"2031-03-31",{"name":310,"class":168},"Julius Clinical",13,{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100550425","acceptability-and-feasibility-of-a-new-approach-to-engage-patients-with-steatotic-liver-disease-in-physical-activity-100550425","NCT06446908","Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity","Inclusion Criteria:\n\n* \\>18 years of age,\n* confirmed MASLD or MASH without cirrhosis\n* access to a computer with an internet connection\n\nExclusion Criteria:\n\n* liver disease from another cause,\n* the existence of cirrhosis on imaging or clinically,\n* weekly alcohol consumption over 50g,\n* having a contraindication to PA without medical clearance (the Get Active questionnaire from the Canadian Society for Exercise Physiology is used to determine if medical clearance is needed),\n* being already enrolled in a supervised exercise intervention or PA behaviour change intervention or currently meeting PA guidelines of 150 mins\u002Fweek\n* the need for a wheelchair, cane, walker, or other support(s) to move",{"count":319,"type":20},12,[23],"Steatosis is the building of fat in the liver. Steatotic liver disease (SLD) regroups MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH. MASH is a leading cause of liver transplantation in Canada. There is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA).\n\nIs a counselling intervention to help patients progressively engage in more PA a feasible and acceptable approach? Objectives. This proposal has three primary objectives: 1) To assess the feasibility of our PA counselling intervention (to be delivered online) with SLD patients; 2) To evaluate the acceptability of our intervention; 3) To evaluate the feasibility of the study methods\u002Fprocedures.\n\nMethodology. This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.\n\nPA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.\n\nBased on past studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.\n\nThe primary outcomes of the project are to evaluate the feasibility and acceptability of the trial and intervention. The secondary outcomes are Daily PA time and biological\u002Fimaging data evolution",[323,33,32],"Liver Steatosis",[325,326,327,328],"Physical activity","coaching","telehealth","liver","2024-05-31",{"date":331,"type":63},"2024-06-06",{"date":304,"type":20},{"date":334,"type":20},"2027-03-31",{"name":336,"class":70},"Hopital Montfort"]