[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medisch Spectrum Twente\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":217},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,84,110,139,163,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100630353","anastomotic-leakage-prevention-by-endovascular-stenting-of-the-superior-mesenteric-artery-100630353",false,"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","ALL","40 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28],"Mesenteric Vascular Disease","Colorectal Surgery","Preventive Intervention",[30,31,32,33,34,35],"Anastomotic leakage","Colorectal surgery","Preventive intervention","Superior Mesenteric Artery Stenosis","Percutaneous transluminal angioplasty","Endovascular stenting","RECRUITING","2026-03-17",{"date":39,"type":40},"2026-03-20","ACTUAL",{"date":42,"type":40},"2026-02-01",{"date":44,"type":20},"2029-01-01",{"name":46,"class":47},"Medisch Spectrum Twente","OTHER",10,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100475258","coeliac-artery-release-or-sham-operation-100475258","NCT05468580","Coeliac Artery Release or Sham Operation","Coeliac Artery Release or Sham Operation in Patients Suspected of the Median Arcuate Ligament Syndrome","CARoSO","Inclusion Criteria:\n\n* Patients with a consensus diagnosis of MALS based on a multidisciplinary discussion in the two Dutch expert centers for Mesenteric Ischemia (Medisch Spectrum Twente and Erasmus Medical Centre). The multidisciplinary team contains of a vascular surgeon, gastroenterologist, radiologist as recommended in the guidelines.\n* Typical complaints: post-prandial pain and at least two of the following: dietary modification, unexplained weight loss, unexplained diarrhea.\n* Eccentric stenosis of ≥70% of the AC at the medial arcuatum ligament, demonstrated by two imaging techniques (duplex, MRA, CTA or DSA), including at least an inspiration and expiration CTA with 1mm sections. (Definition percent stenosis according to ECST 1998 formula: % stenosis = (1 - \\[diameter at the site of stenosis\u002Festimated original diameter at the site of the stenosis\\]) x 100).\n* Ultrasound Abdomen without other more common abnormalities.\n* Gastroscopy-duodenoscopy without abnormalities, unless appropriate for mucosal ischemia.\n\nExclusion Criteria:\n\n* Patient not suitable for endoscopic AC release (e.g. previous surgery in the operating area).\n* Pregnancy.\n* Previous (endovascular) intervention of the visceral arteries.\n* A significant stenosis in the superior or in the inferior mesenteric artery.","18 Years",{"count":59,"type":20},70,[23],"In patients with Median Arcuate Ligament Syndrome (MALS), significant external compression of the coeliac artery (CA) by the median arcuate ligament (MAL) increasing mucosal ischemia (1,2) is assumed to cause chronic disabling postprandial abdominal pain, weight loss, and consequently lethargy and social deprivation (3,8). The majority of these patients have had a long medical journey before the diagnosis MALS is considered resulting in a substantial burden of disease and high healthcare and societal costs.\n\nAlthough a Systematic Review have shown a sustainable symptom relief of 68% and a significant and durable improvement of quality of life after surgical treatment for MALS (4), there is still no (inter)national consensus on the existence and treatment of MALS (1, 5, 6, 7).\n\nTwo recent guidelines (3, 8) concluded that patients with MALS might be considered for surgical CA release (Recommendation 25 GRADE 2D; expert agreement 96%, Terlouw 2020). To end the ongoing debate and to enable the development of evidence-based guidelines for the management of MALS, both guideline committees recommend to perform a blinded, randomised controlled trial comparing a CA release with a sham operation. The proposed Coeliac Artery Release or Sham Operation study will either underline the usefulness of eCAR as a minimal invasive (cost)effective treatment for MALS or it will prohibit a meaningless intervention in patients with disabling abdominal symptoms.\n\nIf the CARoSO study proves that the treatment of MALS by eCAR is effective, to 490 patients with chronic disabling abdominal symptoms per year can be treated in the Netherlands. Effective treatment of MALS is expected to result in mean health gain of 6.05 Quality Adjusted Life Years (QALYs)\u002Fpatient and has the potency to reduce the substantial productivity loss and healthcare consumption caused by MALS, resulting in a saving up to M€4.3\u002Fyear. The outcome of the CARoSO study will be translated into strong recommendations in the coming updates of the relevant (inter)national multidisciplinary guidelines and will be adapted in daily practice.",[63,64,65,66,67],"Mesenteric Ischemia","Median Arcuate Ligament Syndrome","Dunbar Syndrome","Coeliac Artery Compression","Celiac Artery Compression Syndrome",[69,70,71,72,73,74],"MALS","Mesenteric ischaemia","Quality of Life","Coeliac Artery Release","Sham Operation","Healthcare Costs","2026-03-12",{"date":77,"type":40},"2026-03-16",{"date":79,"type":40},"2023-04-01",{"date":81,"type":20},"2028-11-01",{"name":46,"class":47},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":83},"100580953","investigating-the-impact-of-nudging-cardiologists-to-prescribe-guideline-directed-medical-therapy-in-heart-failure-patients-100580953","NCT06844006","Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients","Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial","ADMINISTER II","Inclusion Criteria:\n\n* All heart failure diagnoses\n* \\>18 years\n\nExclusion Criteria:\n\n* Not understanding the Dutch Language.\n* Allergies that make uptitration impossible.\n* Admission to hospice or palliative care.\n* Severe psychological disorders.",{"count":93,"type":20},1320,[23],"This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.",[97],"Heart Failure",[99,100,97,101],"Digitial Care","Home monitoring","Nudging","2025-03-06",{"date":104,"type":40},"2025-03-07",{"date":106,"type":40},"2024-06-13",{"date":108,"type":20},"2028-08-31",{"name":46,"class":47},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":83},"100524978","rct-on-t-rex-twente-regimen-effects-on-quality-of-life-and-mobilisation-for-cardiac-surgery-patients-after-sternotomy-100524978","NCT06115759","RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy","A Randomized Clinical Trial to Study the \"T-REX Twente Regimen\" (Thoracic Surgery Rehabilitation Experts Twente) on Quality of Life and Mobilisation Activities for Cardiac Surgery Patients After Median Sternotomy, Compared to Usual Care","T-REX Twente","Inclusion Criteria:\n\n* Adult patients who are preoperatively included if they are undergoing a total median sternotomy at Thorax Centrum Twente (TCT)\n* Patients with their treating cardiologist also working for TCT.\n\nExclusion Criteria:\n\n* \\>72 hours of admission to the Intensive Care Unit (ICU)\n* Postoperative delirium (diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) version V\n* Patients with dementia (or other significant cognitive disorders)\n* Dutch language barriers\n* Patients with a cardiologist from a location other than TCT",{"count":119,"type":20},154,[23],"The goal of this study is whether the T-REX Twente precautions have a positive impact on the quality of life (MAcNew QLMI), level of physical activity, and reduction of fear of movement in heart patients after a total median sternotomy compared to the (current) standard precautions? Do these precautions also have no adverse effects on pain, wound healing, and\u002For postoperative complications?\n\nParticipants will be instructed by the physiotherapist to both groups immediately postoperatively and are constantly repeated by the involved disciplines during the hospital stay.\n\nThe control group is not allowed to lift, push, or pull for the first 6 weeks. There is little to no evidence for the current strict precautions currently implemented in the department.\n\nThe intervention group receives the new T-REX Twente precautions, allowing for more independent activities through the use of the tube model (keeping elbows close to the sides).\n\nAll patients receive three questionnaires (MacNew QLMI, Numeric Pain Rating Scale, and Tampa Scale for Kinesiophobia) preoperatively, on the 4th day postoperatively, on the first day of cardiac rehabilitation, and at the end of cardiac rehabilitation, taking approximately 10 minutes each time. Additionally, during the clinical admission immediately postoperatively, two AX3 accelerometers are placed on the patient, one lateroproximal on the right upper arm and one anterodistal on the right upper leg.\n\nResearchers will compare heart patients after a total median sternotomy with T-REX Twente precautions (intervention group) to the (current) standard precautions (control group).",[123,124,125,71,126],"Sternotomy","Cardiovascular Diseases","Physical Inactivity","Surgery",[123,128,129,130],"Cardiac Surgical Procedures","Cardiac Rehabilitation","Early Ambulation","2025-02-05",{"date":133,"type":40},"2025-02-07",{"date":135,"type":40},"2024-05-21",{"date":137,"type":20},"2026-03",{"name":46,"class":47},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":83},"100570091","the-rainbow-study---the-effect-of-feedback-on-asthmatic-symptom-perception-100570091","NCT06702735","The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception","The Rainbow Study - a Randomized Controlled Trial to Evaluate the Effect of Personalized Feedback on Symptom Perception in Asthmatic Children","Inclusion Criteria:\n\nSelection phase:\n\n* Pediatrician diagnosed asthma\n* Health care professional thinks perception might be poor\n* Age 7 until 15 years old\n* Adequate understanding of Dutch language\n\nIntervention phase:\n\n* Adequate number of lung function measurements + VAS scores during selection phase, defined as:\n* At least 4 measurements after exercise or when experiencing symptoms and\n* At least 2 standard measurements\n* Poor perception during selection phase, defined as:\n* At least 1 measurement in red zone on Perception Rainbow and\u002For\n* At least 2 measurements in orange zone on Perception Rainbow and\u002For\n* Average of all measurements after exercise or when experiencing symptoms in yellow zone (or orange\u002Fred)and\u002For\n* Average of all measurements in yellow zone (or orange\u002Fred)\n\nExclusion Criteria:\n\n* Severe comorbidity (for example psychomotor retardation or severe cardiopulmonary conditions)\n* Not able to fill in VAS score (for example due to blindness)\n* Not able to perform technically correct spirometry manoeuvres\n* Medication change in past 2 weeks\n* Exacerbation which required oral prednisone in the past 6 weeks\n* Exacerbation at the moment of inclusion\n* No device (computer, tablet or smartphone) with internet connection available at home","7 Years","15 Years",{"count":149,"type":20},39,[23],"Asthma is a common childhood disease that is characterized by chronic airway inflammation and episodic expiratory airflow obstruction. Asthma symptoms can impair participation in play and sports and have a negative impact on quality of life. It can be challenging for children to adequately feel and report their symptoms. Some children experience more symptoms than expected based on lung function during these symptoms, whereas others experience less symptoms than expected. This is also called 'symptom perception'.\n\nA tool was developed to visualize symptoms, lung function and accessory symptom perception: The Rainbow tool. The aim of this study was to identify asthmatic children with a poor perception and investigate if their symptom perception could be improved by regular lung function measurements and personal feedback based on the Rainbow Tool.\n\nHypothesis: Measuring lung function en symptoms and provide personal feedback on perception based on the Rainbow tool has a positive effect on perception of asthma-related symptoms in asthmatic children.",[153,154],"Asthma in Children","Exercise Induced Asthma","2024-11-22",{"date":157,"type":40},"2024-11-25",{"date":159,"type":40},"2023-10-16",{"date":161,"type":20},"2025-05-01",{"name":46,"class":47},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":170,"maxAge":57,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":83},"100552976","prevalence-of-eilo-among-children-with-asthma-100552976","NCT06480084","Prevalence of EILO Among Children With Asthma","The Prevalence of Exercise-Induced Laryngeal Obstruction (EILO) Amongst Children With Asthma' - a Prospective Cross-sectional Study","Inclusion Criteria:\n\n* Age 12 to 18 years\n* Paediatrician diagnosed asthma confirmed with at least one of the following during the last two years: Positive ECT (post-exercise fall in FEV1 \\> 10%) \u002F Positive methacholine test (PC20 value of ≤8 mg\u002FmL) \u002F Bronchodilator reversibility (increase in FEV1 ≥12% and\u002For ≥200 mL following inhalation of 200-400 μg short-acting β2-agonists)\n\nExclusion Criteria:\n\n* Other severe cardiopulmonary disease\n* Inability to perform ECT or CLE test\n* Inability to perform technically acceptable spirometry\n* Asthma exacerbation or respiratory tract infection in the last 2 weeks\n* Short-acting β2-agonists or long-acting β2-agonists use less than respectively 8 and 24 hours before the ECT or CLE test\n* Oral corticosteroid use in the 4 weeks before the ECT or CLE test","12 Years",{"count":172,"type":20},200,[23],"The goal of this cross-sectional study is to investigate the prevalence of Exercise Induced Laryngeal Obstruction (EILO) in children with asthma.\n\nThe hypothesis is that the prevalence will be around 15%, which is higher than the prevalence of 5-8% among the general adolescent population. This is based on the increased prevalence of EILO among adult asthmatics.\n\nParticipants who are referred for an Exercise Challenge Test will perform an additional Continuous Laryngoscopy during Exercise Test with expiratory FEV1 curves, and fill in the Borg scale for dyspnea, Asthma Control Test, EILODI questionnaire and DISCO-RC questionnaire.",[176,153,177,178,179,180],"Exercise Induced Laryngeal Obstruction","Exercise-Induced Bronchospasm","Exercise-Induced Bronchoconstriction","Dyspnea","Larynx","NOT_YET_RECRUITING","2024-06-26",{"date":184,"type":40},"2024-06-28",{"date":186,"type":20},"2024-08-01",{"date":188,"type":20},"2026-04-30",{"name":46,"class":47},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100519841","early-cessation-of-sedation-and-ttm-in-patients-with-a-favourable-eeg-after-cardiac-arrest-100519841","NCT06048796","Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest","Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study","SELECT","Inclusion Criteria:\n\n* Patients after cardiac arrest admitted to the ICU for treatment with sedation, TTM and mechanical ventilation.\n* Age 18 years or older.\n* Continuous EEG measurement started within 12 hours after cardiac arrest.\n* Favourable EEG pattern within 12 hours after arrest, defined as a continuous background pattern (NVN, 2019; Ruijter et al., 2019).\n* Possibility to stop sedative treatment within three hours after identification of a favourable EEG pattern.\n* Written informed consent (deferred).\n\nExclusion Criteria:\n\n* A known history of another medical condition with limited life expectancy (\\\u003C6 months).\n* Any progressive brain illness, such as a brain tumour or neurodegenerative disease.\n* Pre-admission Glasgow Outcome Scale Extended score of 4 or lower.\n* Reason other than neurological condition to continue sedation and\u002For ventilation.\n* Follow-up impossible due to logistic reasons.",{"count":199,"type":20},40,[23],"The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\\\u003C 12 h) favourable EEG pattern (indicating no or mild postanoxic encephalopathy).",[203,204],"Hypoxia-Ischemia, Brain","Heart Arrest",[206,207],"EEG","targeted temperature management (TTM)","2024-05-10",{"date":210,"type":40},"2024-05-13",{"date":212,"type":40},"2024-03-12",{"date":214,"type":20},"2026-10",{"name":46,"class":47},2,""]