[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"constriction-pathologic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:constriction-pathologic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100502091","strategic-use-of-big-data-in-spine-surgery---testing-digital-prediction-of-outcome-in-clinical-praxis-100502091",false,"NCT05817747","Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis","Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis","Inclusion Criteria:\n\n* Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy\n* 18 years of age or older\n* Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician\n* Giving informed consent\n\nExclusion Criteria:\n\n* Another condition found to be the reason for the symptoms.\n* Not giving informed consent\n* Need for further investigation that prevents inclusion within one month of the doctor visit.","ALL","18 Years",{"count":19,"type":20},900,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice.\n\nThe main questions it aims to answer are:\n\n* Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis?\n* Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy?\n* How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery?\n\nEligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon.\n\nResearchers will compare participants with a matched control group from the Swedish Spine Register (\"Swespine\") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.",[26,27,28,29],"Constriction, Pathologic","Spine Degeneration","Surgery","Radiculopathy",[31,32,33,28,34,35,36],"Spine","Cervical radiculopathy","Lumbar spinal stenosis","Neck","Prognostic model","External validation","RECRUITING","2025-05-12",{"date":40,"type":41},"2025-05-13","ACTUAL",{"date":43,"type":41},"2022-03-01",{"date":45,"type":20},"2029-03-01",{"name":47,"class":48},"Sahlgrenska University Hospital","OTHER",10,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":72,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100480463","tavis-registry---trilogy-heart-valve-system-for-management-of-patients-with-aortic-valve-disease-100480463","NCT05536310","TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease","Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study","TAVIS","Inclusion Criteria:\n\n1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care\n2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for \"bail out\"\u002Fto address unfavorable circumstances if necessary\n3. Patients 18 years of age or older\n4. Patient is willing to participate in the study, provides signed Informed Consent\u002FData Authorization Form and authorizes the sharing of data in the study\n5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication\n2. Patients who have active bacterial endocarditis or other active infections\n3. Pediatric (\\\u003C18 years) and\u002For pregnant\u002Fnursing patients\n4. Congenital\u002Ffunctional unicuspid, bicuspid or quadricuspid native aortic valve morphology\n5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n6. Echocardiographic evidence of current left heart thrombus\n7. Hypertrophic cardiomyopathy with or without obstruction.\n8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \\\u003C7mm.",{"count":59,"type":20},600,"5 Years","OBSERVATIONAL","To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).",[64,65,66,26,67,68,69,70,71],"Aortic Valve Stenosis","Aortic Valve Regurgitation","Aortic Valve Stenosis With Insufficiency","Aortic Valve Disease","Heart Valve Diseases","Cardiovascular Diseases in Old Age","Ventricular Outflow Obstruction","Aortic Stenosis, Severe",[73,67,74,65],"Trilogy","Transcatheter aortic valve replacement (TAVR)","NOT_YET_RECRUITING","2023-01-10",{"date":78,"type":41},"2023-01-11",{"date":80,"type":20},"2023-03",{"date":82,"type":20},"2027-10",{"name":84,"class":85},"JenaValve Technology, Inc.","INDUSTRY",3]