[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476106":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":26,"armGroups":22,"interventions":27,"overallOfficials":22,"centralContacts":22,"locations":31,"responsibleParty":51,"collaborators":22,"id":55,"slug":22,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":22,"enrollmentInfo":63,"targetDuration":22,"studyType":66,"phases":22,"briefSummary":67,"conditions":68,"keywords":22,"overallStatus":34,"whyStopped":22,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Flare I","Evaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods.","within 1 year",[14,18],{"measure":15,"description":16,"timeFrame":17},"Flare II","Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods.","within 2 years",{"measure":19,"description":20,"timeFrame":21},"Flare III","Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods.","within 3 years",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"COHORT","PROSPECTIVE","This is a prospective cohort of a total of 400 UC patients with an active flare",[28],{"type":6,"name":29,"description":30,"armGroupLabels":22,"otherNames":22},"Deep learning model","Use of deep learning model to predict individual patients disease course",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":36,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Gastrounit, medical section, Copenhagen University Hospital Hvidovre","RECRUITING","Hvidovre","Denmark","2650","DK",{"type":40,"coordinates":41},"Point",[42,43],12.47708,55.64297,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":22,"email":50},"Bobby ZS Lo, M.D.","CONTACT","+45 28580410","bobby.lo@regionh.dk",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Bobby Lo","Principal Investigator","100476106",false,"NCT05479617","Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project","Presager II","Inclusion criteria:\n\n* Signed informed consent\n* Diagnosis of UC for at least 1 year\n* Relapse due to UC.\n* First endoscopic and histological evaluation of the flare Exclusion criteria\n* Well-founded doubt that the flare is due to other than the patients UC","ALL","18 Years",{"count":64,"type":65},400,"ESTIMATED","OBSERVATIONAL","In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8.\n\nSecondary endpoints:\n\n* An artificial intelligence model's precision in predicting a new flare within 2 and 3 years\n* An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year",[69],"Ulcerative Colitis","2025-02-25",{"date":72,"type":73},"2025-02-27","ACTUAL",{"date":75,"type":73},"2022-06-20",{"date":77,"type":65},"2026-07",{"name":5,"class":6},1]