[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preventive-intervention\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preventive-intervention":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100624765","the-stime-project-intersectoral-prevention-of-severe-youth-mental-health-difficulties-100624765",false,"NCT07413887","The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties","STIME","Each of the interventions has elaborate and narrowly defined inclusion and exclusion criteria. These are listed below for each intervention.\n\n'Signs of Internalizing'\n\nInclusion criteria\n\n* Adolescents aged 12-17 years\n* Mild to moderate impairment in daily functioning (e.g., reduced engagement in school, social life, or leisure activities compared to before symptoms)\n* Adolescents with well-managed ADHD or autism may be included if they demonstrate sufficient mentalizing abilities and can benefit from the intervention with parental support\n* Presence of both anxiety and depressive symptoms, neither of which dominates or meets full diagnostic criteria\n* The family is motivated to participate\n\nExclusion criteria\n\n* Symptoms of moderate to severe depression\n* Presence of OCD, PTSD, agoraphobia, panic disorder, or other psychiatric conditions\n* Low cognitive functioning\n* Moderate to severe functional impairment (e.g., school dropout, extreme social withdrawal, daily reliance on adult support, lack of motivation for treatment)\n* Recent unsuccessful psychological treatment\n* Primary problems related to family dynamics or a highly burdened family situation\n* Increased or acute suicide risk\n* Presence of self-harm or symptoms of disordered eating\n\n'Signs of Disordered Eating'\n\nInclusion criteria\n\n* Children and adolescents aged 10-17 years\n* High body dissatisfaction, preoccupation with food and\u002For body image, and\u002For early behavioral signs of an eating disorder\n* Stable physical condition, manageable in consultation with the adolescent's general practitioner\n* Able to consume food with guidance and support\n* The family is motivated to participate\n\nExclusion criteria\n\n* Previous treatment for an eating disorder\n* Symptoms meeting criteria for specialized psychiatric treatment\n* Low cognitive functioning\n* Significant weight loss\n* Solely restrictive or selective eating without other eating disorder symptoms\n* Severe comorbidity\n* Increased or acute suicide risk\n* Eating difficulties solely related to lifestyle factors\n\n'Signs of Self-Harm'\n\nInclusion criteria\n\n* Adolescents aged 12-17 years\n* Current thoughts of self-harm\n* At least one episode of direct (non-suicidal) self-harm within the past three months\n* The family is motivated to participate\n\nExclusion criteria\n\n* Increased suicide risk\n* Psychiatric disorder requiring further assessment or not adequately treated\n* Low cognitive functioning\n* Self-harm only in socially accepted contexts (e.g., piercings or tattoos)\n* Only indirect self-harm (e.g., excessive substance use)\n* Only self-harm by proxy (involving another person)\n\n'Take the Control Back'\n\nInclusion criteria\n\n* Children and adolescents aged 5-17 years\n* Experiencing obsessive thoughts and\u002For compulsive behaviors of mild to moderate severity\n* Experiencing self-perceived distress related to obsessive thoughts and\u002For compulsive behaviors\n* Experiencing obsessive thoughts as egodystonic, and thus aware that they are excessive (for the youngest participants, this criterion may be waived in cases of limited insight)\n* Functioning is impaired by obsessive thoughts and\u002For behaviors, e.g., reduced school functioning, social difficulties, or impaired functioning at home\n* The family is motivated to participate\n\nExclusion criteria\n\n* Symptoms meeting criteria for specialized psychiatric treatment\n* Has another psychiatric disorder that requires assessment or is not adequately managed\n* Has difficulties other than obsessive thoughts and behaviors that currently constitute the primary burden, and which must be addressed first\n* Has previously received OCD treatment within psychiatric care (may be offered STIME if assessed but not treated due to mild severity)\n* Has an increased or acute risk of suicide\n* Has low functioning for other reasons, e.g., significantly reduced cognitive functioning\n\n'the Parent Pilots'\n\nInclusion criteria\n\n* Parents of children aged 3-10 years who experience developmentally inappropriate difficulties with restlessness, hyperactivity, attention, and\u002For impulsivity\n* The symptoms must be present at home as a minimum, but may also occur across settings such as home, daycare, and school\n* The child's difficulties must be significant enough to affect overall daily functioning\n* The parents are motivated to participate\n\nExclusion Criteria:\n\n* Symptoms of attention difficulties that require psychiatric treatment\n* Presence of another psychiatric disorder that requires treatment\n* Previous treatment for ADHD within the psychiatric system\n* Low level of functioning due to other causes, such as significantly reduced cognitive functioning","ALL","3 Years","17 Years",{"count":20,"type":21},1200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial aims to evaluate the effectiveness of participation in five different STIME (Strengthened Cross-Sectoral Initiative for Children and Young People's Mental Health) interventions: 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-Harm', 'Take the Control Back', and 'The Parent Pilots'. The hypothesis is that participation in one of these interventions will be more effective than Management As Usual (MAU). Each intervention consists of three core components: early identification and screening, therapy based on evidence-informed manuals, and support within the child's learning environment.",[27,28],"Preventive Intervention","Mental Health Difficulties",[30,31,32,33,34,35],"Mental Health","Adolescents","Children","Preventive intervention","Sub-clinical symptoms","Randomized controlled trial","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":40},"2025-11-20",{"date":44,"type":21},"2028-02-01",{"name":46,"class":47},"Center for Clinical Research and Prevention","NETWORK",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100630353","anastomotic-leakage-prevention-by-endovascular-stenting-of-the-superior-mesenteric-artery-100630353","NCT07486570","Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery","ALPrES²MA","Inclusion Criteria:\n\n* Age \\>40 years.\n* Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).\n* Presence of an asymptomatic \\>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)\n\nExclusion Criteria:\n\n* All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain).\n* Presence of a \\>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament).\n* Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b\u002FT4c colon tumour resection, or a second colon anastomosis or a diverting stoma\n* History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries\n* Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.\n* Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.\n* Pregnancy","40 Years",{"count":58,"type":21},360,[24],"Rationale:\n\nAnastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \\>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \\\u003C .001).\n\nPrimary objective:\n\nThe ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \\>50% stenosed SMA origin reduces the risk of AL following colon surgery.\n\nSecondary objectives:\n\nClassification of severity of AL, incidence of delayed AL (\\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL.\n\nStudy design: Nationwide multicentre randomized controlled trail with a 1:1 fashion\n\nStudy population:\n\nPatients, 40 years and over, in the participating hospitals in the Netherlands with a \\>50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology.\n\nIntervention:\n\nIntervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the \\>50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months\n\nMain study parameters\u002Fendpoints:\n\nThe primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification\u002Fseverity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.",[62,63,27],"Mesenteric Vascular Disease","Colorectal Surgery",[65,66,33,67,68,69],"Anastomotic leakage","Colorectal surgery","Superior Mesenteric Artery Stenosis","Percutaneous transluminal angioplasty","Endovascular stenting","2026-03-17",{"date":72,"type":40},"2026-03-20",{"date":74,"type":40},"2026-02-01",{"date":76,"type":21},"2029-01-01",{"name":78,"class":79},"Medisch Spectrum Twente","OTHER",10]