[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Antonius Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":647},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,44,75,103,132,158,186,209,247,278,317,339,368,391,417,482,503,529,559,583,605],{"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":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645276","evalutation-of-a-hybrid-care-pathway-with-remote-monitoring-for-heart-failure-100645276",false,"NCT07680634","Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure","HARMONY-HF","Inclusion Criteria:\n\n* Adults (at least 18 years or older)\n* Diagnosed with heart failure according the prevailling ESC guideline\n* Treatment at the outpatient clinic at one of the seven participating hospitals\n* Sufficient digital literacy and adequate Dutch language proficiency by the patient or throught the informal caregiver.\n\nExclusion Criteria:\n\n* Inability or unwillingness to participate in home telemonitoring\n* Patients with end-stage heart failure or other terminal conditions","ALL","18 Years",{"count":19,"type":20},6000,"ESTIMATED","OBSERVATIONAL","Heart failure is a long-term condition in which the heart cannot pump blood as well as it should. People with heart failure often need to be admitted to hospital when their symptoms suddenly get worse, which affects their quality of life and places a heavy burden on the healthcare system.\n\nIn recent years, hospitals have started using home telemonitoring, in which patients measure values such as their weight, blood pressure, heart rate, and symptoms at home every day. These measurements are sent to a Medical Service Center (MSC), who can step in quickly when early warning signs appear - often before the patient feels seriously unwell.\n\nThe HARMONY-HF study looks at how well this hybrid care pathway works in everyday practice. The researchers will compare heart failure patients who take part in the home telemonitoring programme with patients who receive usual care without telemonitoring, across seven hospitals in the Netherlands. Because all care is part of routine treatment, patients are not asked to do anything extra for the study; the researchers use information that is already collected during normal care.\n\nThe main goal is to find out whether patients in the telemonitoring programme spend more days at home and out of the hospital. The study also looks at survival, hospital admissions, quality of life, and the use of recommended heart failure medication. The findings will help determine whether this approach should be offered more widely.",[24],"Heart Failure",[26,27,28,29,30],"heart failure","home telemonitoring systems","remote monitoring","hybrid care pathway","observational cohort study","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2023-05-01",{"date":39,"type":20},"2031-06",{"name":41,"class":42},"St. Antonius Hospital","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100582290","cryo-nerve-block-trial-100582290","NCT06861387","Cryo Nerve Block Trial","A Randomized Controlled Trial Studying the Effect of Additional Intercostal Cryo-analgesia (ICCA) to Standard Postoperative Pain Management in Patients Undergoing Minimally Invasive Lung Surgery","Inclusion Criteria:\n\n1. Patients are at least 18 years or older.\n2. Patients are electively scheduled to undergo minimally invasive (i.e., VATS or RATS) anatomical lung (i.e., pneumonectomy, (bi)lobectomy, or segmentectomy) resection for benign or malignant disease.\n3. Proficient understanding of the consequences of enrolment by the patients.\n4. Written informed consent by the patient.\n\nExclusion Criteria:\n\n1. Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.\n2. Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).\n3. Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)\n4. Patients with connective tissue disease.\n5. Patients with comorbidities or history contra-indicating ICCA.\n6. Patients who are pregnant.\n7. Participation in other clinical trial(s) that may interfere with the current trial.",{"count":52,"type":20},150,"INTERVENTIONAL",[55],"NA","Background:\n\nMinimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Current guidelines suggest using a combination of pain management strategies to reduce the use of opioids and their side effects. Intercostal cryo-analgesia (ICCA), a technique that uses cold to reduce nerve activity, may help lower pain and opioid use after surgery. However, there is limited research on ICCA, with most studies having small sample sizes and lacking randomized controlled trials. More research is needed to compare ICCA with standard pain management in patients undergoing minimally invasive lung surgery.\n\nObjective:\n\nThe goal of this study is to determine whether ICCA improves recovery compared to standard pain management after minimally invasive lung surgery. The investigators aim to measure recovery time and quality using the Quality of Recovery-15 (QoR-15) questionnaire. The investigators expect that ICCA will result in better recovery, less pain, reduced opioid use, and shorter hospital stays, without increasing the risk of nerve damage or other complications.\n\nStudy Design:\n\nThis will be a single-center, blinded, randomized controlled trial, along with an observational registry.\n\nStudy Population:\n\nThe study will include adults who are undergoing elective minimally invasive lung resections.\n\nIntervention:\n\nPatients in the intervention group will receive ICCA in addition to standard pain management after surgery. ICCA will be administered by the surgeon before closing the wound, targeting the intercostal nerves between ribs 3 and 7.\n\nMain Study Parameters\u002FEndpoints:\n\nThe primary outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several domains, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool for measuring postoperative recovery.\n\nRisks and Benefits:\n\nThis trial will examine the effects of adding ICCA to the standard pain management protocol. Potential risks include numbness or nerve damage, neuropathic pain (pain caused by nerve injury), or complications such as bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include improved recovery, reduced opioid use, less pain, shorter hospital stays, and fewer respiratory complications after surgery.",[58,59,60],"Intercostal Nerve Block","Cryo Analgesia","Minimally Invasive Lung Surgery",[62,63,64,65],"cryo analgesia","intercostal nerve block","minimally invasive lung surgery","pain management","2026-06-25",{"date":68,"type":35},"2026-06-26",{"date":70,"type":20},"2026-09-01",{"date":72,"type":20},"2029-12-12",{"name":41,"class":42},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":53,"phases":85,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100460527","emr-versus-esd-for-barretts-neoplasia-100460527","NCT05276791","EMR Versus ESD for Barrett's Neoplasia","Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial","REMOVE-RCT","Inclusion Criteria:\n\n* Patients age: ≥ 18 years\n* Willingness to undergo both EMR or ESD\n* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation\n* BE with at least one visible lesion (\"target lesion\") with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee\n* Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study\n* Prior endoscopic resection is allowed\n\nExclusion Criteria:\n\n* Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee\n* Patients with HGD in at least one random biopsy, before inclusion (i.e. during endoscopy in the referring center \\\u003C3 months before imaging, or during imaging endoscopy)\n* History of esophageal surgery other than fundoplication\n* History of esophageal ablation therapy\n* In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site\n* Uncontrolled coagulopathy with INR \\>2.0, thrombocytopenia with platelet counts \\\u003C 50,000\n* Esophageal varix or varices\n* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines\n* Life expectancy \\\u003C2 years",{"count":84,"type":20},331,[55],"Rationale:\n\nThe optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity.\n\nObjective:\n\nThe investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus.\n\nStudy design:\n\nRandomized clinical trial\n\nStudy population:\n\nPatients with Barrett's esophagus and a visible lesion with dysplasia and\u002For early cancer. Suspicion for submucosal invasion is an exclusion criterion.\n\nIntervention:\n\nPatients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection.\n\nMain study endpoint:\n\nPrimary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.",[88,89,90],"Barretts Esophagus With Dysplasia","Barrett Adenocarcinoma","Esophageal Cancer",[92,93],"Barrett's esophagus","Esophagheal adenocarcinom","2026-06-24",{"date":96,"type":35},"2026-06-29",{"date":98,"type":35},"2023-01-17",{"date":100,"type":20},"2028-12-01",{"name":41,"class":42},6,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":53,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":74},"100529022","personalized-ct-guided-antithrombotic-therapy-versus-lifelong-single-antiplatelet-therapy-to-reduce-thromboembolic-and-bleeding-events-in-non-atrial-fibrillation-patients-after-transcatheter-aortic-valve-implantation-100529022","NCT06168370","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation: a Pragmatic, International, Multicentre, Randomized Clinical Trial","POP ATLANTIS","Inclusion Criteria:\n\n* Successful TAVI (according to the VARC-3 criteria)10 with any approved device\n* Ability to understand and to comply with the study protocol\n* Written informed consent\n\nExclusion Criteria:\n\n* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)\n* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)\n* Creatinine clearance \\\u003C15 mL\u002Fmin (based on the CKD-EPI formula) or on renal replacement therapy","110 Years",{"count":113,"type":20},2500,[55],"The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.\n\nAfter 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.",[117],"Severe Aortic Valve Stenosis",[119,120,121,122,123,124],"aortic stenosis","bleeding","tavi","ct","personalized antithrombotic therapy","tavr","2026-05-18",{"date":127,"type":35},"2026-05-19",{"date":129,"type":35},"2023-12-01",{"date":100,"type":20},{"name":41,"class":42},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100497547","the-effect-of-subclinical-leaflet-thrombosis-and-prosthesis-type-on-transcatheter-aortic-valve-degeneration-popular-pet-tavi-100497547","NCT05758662","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration","Inclusion Criteria:\n\n* Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago\n* Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Temporary or chronic oral anticoagulation use after TAVI\n* Known severe renal insufficiency\n* Known severe paravalvular regurgitation\n* History of valve-in-valve procedure\n* History of aortic valve re-intervention (including percutaneous paravalvular leak closure)",{"count":140,"type":20},180,"A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.",[143],"Aortic Valve Stenosis",[145,146,147,148,149,150],"TAVI","TAVR","Subclinical Leaflet Thrombosis","Bioprosthetic Valve Deterioration","Intra-annular","Supra-annular",{"date":127,"type":35},{"date":153,"type":35},"2023-11-16",{"date":155,"type":20},"2026-10-01",{"name":41,"class":42},4,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":53,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100431188","distal-gastric-bypass-outcome-in-revision-surgery-after-roux-en-y-gastric-bypass-100431188","NCT04894838","DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass","DISCOURSE","Inclusion Criteria:\n\n* Age 18-65 years;\n* BMI ≥40 kg\u002Fm2 or BMI ≥35 kg\u002Fm2 with obesity related comorbidity;\n* Weight regain or insufficient weight loss (EWL\\\u003C50% or TWL\\\u003C20%)15,16 following RYGB;\n* Multidisciplinary team screening at one of the bariatric centres;\n* Informed consent and willing to enter the follow-up program.\n\nExclusion Criteria:\n\n* Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation \\>50 mL, gastro-gastric fistula, gastro-jejunostomy);\n* Distalisation of RYGB is technical infeasible (judgment by surgeon);\n* Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea;\n* Severe concomitant disease (such as carcinomas and neurodegenerative disorders);\n* Pregnant women;\n* Noncompliance in follow-up or unwilling to undergo surgery;\n* Inability of reading\u002Funderstanding and filling out questionnaires.","65 Years",{"count":52,"type":20},[55],"This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.",[170,171],"Obesity, Morbid","Weight Gain",[173,174,175,176],"Obesity","Weight regain","Failed RYGB","Distal gastric bypass","2026-04-24",{"date":179,"type":35},"2026-04-27",{"date":181,"type":35},"2021-05-01",{"date":183,"type":20},"2029-12",{"name":41,"class":42},8,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100454552","biomarkers-in-perioperative-management-100454552","NCT05199025","Biomarkers in Perioperative Management","Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery","BIGPROMISE","Inclusion Criteria:\n\n* Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery)\n* Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).\n* Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)\n* Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* Emergent surgery\n* No informed consent",{"count":195,"type":20},5000,"Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions.\n\nObjective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers.\n\nStudy design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery.\n\nIntervention (if applicable): Not applicable. Main study parameters\u002Fendpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.",[198,199,200],"Postoperative Complications","Quality of Life","Death","2026-04-22",{"date":179,"type":35},{"date":204,"type":35},"2021-10-12",{"date":206,"type":20},"2026-12-01",{"name":41,"class":42},2,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":217,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":53,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100623552","cryo-1-cryoablation-in-elderly-patients-with-early-stage-breast-cancer-100623552","NCT07398118","CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.","Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.","CRYO-1","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Histologically confirmed invasive breast cancer\n* Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status\n* Presence of concurrent DCIS is allowed if limited to \\\u003C25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component\n* Unifocal disease \\\u003C2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall\n* Ability and willingness to comply with project requirements\n* Preoperative endocrine therapy is allowed\n* Written informed consent given by the subject\n\nExclusion Criteria:\n\n* Pure DCIS lesions without invasive component\n* Extensive calcifications on imaging suggestive of widespread disease\n* Invasive lobular carcinoma (as assessed by IHC)\n* Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)\n* History of ipsilateral breast cancer or DCIS\n* Prior ipsilateral radiotherapy\n* Inability to communicate in Dutch or English language\n* Planned (e)migration or long-term stay abroad within one year after inclusion","FEMALE","70 Years",{"count":220,"type":20},61,[55],"This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation.\n\nOlder adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option.\n\nThe goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour.\n\nParticipants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment.\n\nAfter the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed.\n\nThis study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.",[224,225],"Breast Cancer Stage I","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[227,228,229,230,231,232,233,234,235,236],"Cryoablation","Early-stage breast cancer","Non-curative","Elderly","Minimally invasive treatment","Breast tumour","Local tumour control","Feasibility study","Cryotherapy","Non-surgical treatment","NOT_YET_RECRUITING","2026-03-20",{"date":240,"type":35},"2026-03-23",{"date":242,"type":20},"2026-04-01",{"date":244,"type":20},"2028-06-30",{"name":41,"class":42},3,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":53,"phases":257,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":277,"locationsCount":74},"100624808","non-invasive-detection-of-pulmonary-right-to-left-shunts-using-the-sonas-ultrasound-device-100624808","NCT07414446","Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device","Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts","SONAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT).\n* Incidentally: Patients who have experienced cryptogenic stroke\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known or suspected fracture(s) of the temporal \u002F parietal skull bones, or with open skin injuries in the anatomical area of the temporal \u002F parietal lobes.\n* Patients with known metal skull implants in the anatomical area of the temporal \u002F parietal bones, or with anatomical formation of the head or ear tha may interfere with proper headset placement.\n* Patients with known allergies or reactions to parabens, which are present in the gel pad material of the applied part.",{"count":256,"type":20},40,[55],"The goal of this clinical trial is to learn how well the SONAS ultrasound device can detect right-to-left shunts of adults with hereditary hemorrhagic telangiectasia (HHT) who are already scheduled for a contrast bubble echocardiogram (TTCE). The main questions it aims to answer are:\n\n1. How accurately does SONAS detect right-to-left shunts compared to the standard TTCE test?\n2. Can SONAS results help tell the difference between shunts in the heart and shunts in the lungs?\n\nParticipants will wear a headband with the SONAS device on the head while they undergo their routine TTCE bubble test. They will receive the usual contrast (agitated saline) through a vein, and both SONAS and TTCE signals will be recorded at the same time. There will be one examination in rest, and one during a breathing exercise (the Valsalva manoeuvre).",[260,261,262],"Hereditary Haemorrhagic Telangiectasia","PFO - Patent Foramen Ovale","Pulmonary Arteriovenous Malformation",[264,262,265,266,267,268,269,270],"Hereditary Hemorrhagic Telangiectasisa","Right-to-Left Shunt","Contrast Echocardiography","Transcranial Ultrasound","Microbubbles","Patent Foramen Ovale","Cryptogenic Stroke","2026-02-10",{"date":273,"type":35},"2026-02-17",{"date":275,"type":35},"2026-01-07",{"date":242,"type":20},{"name":41,"class":42},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":288,"conditions":289,"keywords":299,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":43},"100616764","hip-fracture-surgery-timing-and-blood-transfusion-risk-in-patients-on-doacs-100616764","NCT07309848","Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs","Blood Transfusion Risk After Early vs. Delayed Surgery in Hip Fracture Patients on Direct Oral Anticoagulants: A Natural Experiment","OPTIMIZEDOAC","Inclusion Criteria:\n\n* Isolated hip fracture classified as AO\u002FOTA 31A or 31B requiring surgical intervention.\n* Current DOAC use with the last dose taken ≤24 hours before emergency department (ED) presentation\n\nExclusion Criteria:\n\n* Pathologic or periprosthetic hip fractures.\n* Fracture sustained \\>24 hours before ED presentation.\n* Inter-hospital transfer.\n* Hematologic disorders (e.g., thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, leukemia).\n* Use of a non-EMA-approved DOAC (e.g., betrixaban).",{"count":287,"type":20},374,"This study looks at patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. In many hospitals, surgery for these patients is delayed because of concerns about bleeding, but waiting longer can also increase risks such as complications and longer hospital stays. The purpose of this study is to find out whether operating within 24 hours is as safe as delaying surgery beyond 24 hours. Specifically, the investigators want to know if early surgery does not lead to a higher need for blood transfusions compared to delayed surgery.",[290,291,292,293,294,295,296,297,298],"Blood Transfusion","Hip Fracture Surgeries","Geriatric","Bleeding Complications","Bleeding as Surgical Complication (Treatment)","Bleeding","Blood Transfusions","Blood Transfusion Complication","Direct Oral Anticoagulants (DOACs)",[300,301,302,303,304,305,120,306,307,308],"natural experiment","doac","direct oral anticoagulant","hip fracture","geriatric","surgery","blood transfusion","early","delayed","2025-12-15",{"date":311,"type":35},"2025-12-30",{"date":313,"type":35},"2025-11-01",{"date":315,"type":20},"2027-12-31",{"name":41,"class":42},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":324,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":53,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":43},"100606809","sequential-imaging-of-suspicion-of-prostate-cancer-reducing-overdiagnosis-and-unnecessary-biopsy-with-timely-diagnosis-of-significant-cancer-100606809","NCT07180381","Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer","SPROUT","Inclusion Criteria:\n\n* Life expectancy \\> 10 years\n* initial PSA \\\u003C 20 ng\u002Fml\n* No signs of extracapsular disease on digital rectal examination\n* Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\\\u003C 0.15\n* Mentally competent and able to comprehend the potential benefits and burdens of the study\n* Willing to undergo the follow-up protocol for a maximum of four years\n* written and signed informed consent\n\nExclusion Criteria:\n\n* Men who have previously undergone a prostate biopsy\n* Men who have a prior PCa diagnosis\n* using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors\n* Proven germline mutation for PCa (for example: BRCA1; BRCA2)\n* Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.\n* severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)","MALE",{"count":326,"type":20},503,[55],"The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,.\n\nThe main questions it aims to answer are:\n\n* Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed?\n* Does it reduce unnecessary biopsies and overtreatment?",[330],"Prostate Cancer","2025-11-26",{"date":333,"type":35},"2025-12-04",{"date":335,"type":35},"2025-05-14",{"date":337,"type":20},"2031-01",{"name":41,"class":42},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":346,"sex":16,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":53,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":74},"100605041","online-medical-hypnosis-exercises-to-improve-mental-health-in-primary-school-children-and-prevent-future-mental-health-issues-100605041","NCT07157358","Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues","Breinbaas","Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Fluent in Dutch\n2. Attending group 6 or 7 of a regular primary school in the Netherlands\n3. Permission of the parents to listen daily to one of the Breinbaas hypnosis exercises (maximum 20 minutes per day)\n4. Access to an electronic device to listen to the Breinbaas exercises (phone, tablet, computer) -\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Children treated with hypnotherapy in the three years preceding potential inclusion\n2. Children currently receiving psychological treatment",true,"9 Years","12 Years",{"count":350,"type":20},345,[55],"The goal of this trial is to learn if listening daily to online hypnosis exercises helps to improve mental health and self-esteem in primary school children. In the future we also hope to see if it can prevent feelings of depession or anxiety when these children have become teenagers.\n\nThe main questions it aims to answer are:\n\n1. can daily listening to these exercsies improve self-esteem, resilience and mental health of children 10-11 years compared to children who do not listen to these exercises?\n2. can listening to these exercsies prevent future metal health problems like feelings of depression or anxiety.\n\nResearchers will compare a group of children (10-11 years) who will listen daily to the exercises for 2 months with a group who will do that 6 months later.\n\nParticipants will:\n\nListen daily to a hypnosis exercise of maximum 15 minutes. Fill out questionnaires on self-esteem, resilience and mental health before during and after the study.",[354],"Healty Volunteers",[356,357,358,359,360],"mental health","primary school","hypnosis","self-esteem","resilience","2025-08-28",{"date":363,"type":35},"2025-09-05",{"date":365,"type":35},"2025-07-31",{"date":70,"type":20},{"name":41,"class":42},{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":74},"100481409","a-prospective-study-to-evaluate-the-implementation-of-shared-decision-making-strategy-for-renal-cell-cancer-rcc-100481409","NCT05548621","A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)","SDM-RCC","Inclusion Criteria:\n\n* Patients clinically diagnosed with RCC\n* Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients who are not able to fill in a questionnaire or undergo an interview individually",{"count":140,"type":20},"The aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (RCC) on the decision-making process and the quality of the decision.",[378,379],"Renal Cell Carcinoma","Renal Cell Carcinoma Metastatic",[381,382],"decision aid","renal cell carcinoma","2025-05-12",{"date":385,"type":35},"2025-05-15",{"date":387,"type":35},"2022-11-24",{"date":389,"type":20},"2025-12",{"name":41,"class":42},{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":53,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100589881","virtual-renality-assessing-the-impact-of-virtual-reality-on-preoperative-planning-in-renal-cancer-surgery-100589881","NCT06960174","Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery","Inclusion Criteria:\n\n* 18+\n* Suspected RCC and candidate for (partial) nephrectomy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)\n* Patients who are unable to give informed consent",{"count":398,"type":20},70,[55],"Rationale:\n\nPreoperative planning for both partial and radical nephrectomies using conventional CT imaging can be challenging due to complex renal anatomy and vascularization. 3D models in virtual reality (VR) may enhance anatomical understanding and improve preoperative planning. This study aims to prospectively evaluate the clinical impact of the use of 3D models in VR in the preoperative planning of partial and radical nephrectomies.\n\nObjective:\n\nThe primary objective is to assess the impact of VR on preoperative planning and thereby on the agreement between the preoperative plan and the performed surgery in renal surgery (both partial and radical nephrectomies). The secondary objectives focus on the urologist's understanding of the anatomy and how the intraoperative and postoperative outcomes are influenced by the use of VR in the preoperative planning.\n\nStudy design:\n\nThe Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein.\n\nStudy population:\n\nThe study population will consist of adult patients (18+) with a suspected RCC who are indicated for (partial) nephrectomy at St. Antonius Hospital Nieuwegein.\n\nIntervention:\n\nFor the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning. For the control group, only the CT scan will be used for preoperative planning, according to the current standard of care.\n\nMain study parameters\u002Fendpoints:\n\nThe primary study endpoint is the surgical concordance score, which describes the concordance between the actual performed surgery and the preoperatively determined surgical plan.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness:\n\nParticipation in this study will not require any additional physical examinations, blood samples, hospital visits, or questionnaires beyond standard clinical care. The only difference for participants in the intervention group is that a 3D model will be created from the existing CT scan and reviewed in VR during preoperative planning by the urologist.",[402],"Renal Cell Carcinoma (Kidney Cancer)",[378,404,405,406,407,408],"Partial nephrectomy","Radical nephrectomy","Preoperative planning","3D virtual model","Virtual Reality","2025-04-28",{"date":411,"type":35},"2025-05-07",{"date":413,"type":20},"2025-06-02",{"date":415,"type":20},"2026-01-31",{"name":41,"class":42},{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":425,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":53,"phases":429,"briefSummary":430,"conditions":431,"keywords":448,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100577382","the-primary-objective-of-this-study-is-to-determine-whether-positively-framed-information-pfi-on-side-effects-compared-to-negatively-framed-and-extensive-information-nfi-can-reduce-the-number-and-severity-of-reported-adverse-events-caused-by-adhd-medication-in-children-aged-7-to-17-years-100577382","NCT06797570","The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.","Nocebo Effecten Verminderen in Kinderen Met ADHD: the NOVA Study","NOVA","Inclusion Criteria:\n\n* Children aged 7 to 17 years\n* Recently diagnosed with ADHD or ADD by a psychologist\n* Desire to start ADHD\u002FADD medication expressed by both the child and the parents\n\nExclusion Criteria:\n\n* Previous use of stimulants\n* 1st or 2nd degree family member using stimulants for ADHD\u002FADD within the last two years","7 Years","17 Years",{"count":428,"type":20},130,[55],"The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the number and severity of reported adverse events caused by ADHD medication in children aged 7 to 17 years. The main questions it aims to answer are:\n\n1. Does PFI reduce the percentage of children suffering from decreased appetite in the first 4 weeks after starting medication compared to NFI?\n2. Does PFI reduce the total number of adverse events compared to NFI?\n3. Does PFI lower the total score on the Pittsburgh Side Effects Rating Scale (PSRS) compared to NFI?\n4. Does PFI lead to higher parental satisfaction with the explanation of adverse events compared to NFI?\n5. Does PFI reduce the number of patients who discontinue medication due to adverse events compared to NFI?\n6. Does PFI decrease the number of patients needing melatonin for sleeping problems due to the use of methylphenidate compared to NFI?\n7. What is the relationship between baseline factors such as age, ADHD or ADD diagnosis, and gender on the number of adverse events?\n\nResearchers will compare children who receive positively framed, concise information (PFI) to those who receive negatively framed, detailed information (NFI) to determine if the framing of information affects the prevalence and severity of reported side effects, medication adherence, and parental satisfaction.\n\nParticipants in this study will:\n\n* Be randomly assigned to receive either PFI or NFI about the side effects of methylphenidate.\n* Start taking methylphenidate according to standard care protocols.\n* Complete a Pittsburgh Side Effects Rating Scale (PSRS) questionnaire 4 weeks after starting medication to report any adverse events and their severity.\n* Parents will provide feedback on satisfaction with the explanation of side effects using a short questionnaire.\n\nThis trial aims to inform best practices for communicating potential side effects to improve medication adherence and the overall treatment experience for children with ADHD and their families.",[432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447],"Attention Deficit Disorder","Attention Deficit Disorder (ADD)","Attention Deficit Disorder with Hyperactivity","ADHD","ADD","ADHD-not Other Specified","ADHD or ADHD Traits","ADHD Predominantly Hyperactivity Type","ADHD Predominantly Inattentive Type","ADHD with Sleep Onset Insomnia","ADHD, ADD","ADHD, Predominantly Hyperactive - Impulsive","ADHD, Predominantly Inattentive Type","Hyperactivity","Hyperactivity Disorder","Inattention",[449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473],"attention deficit hyperactivity disorder","attention deficit disorder","hyperactivity","inattention","adverse drug reaction","adverse events","side effects","nocebo effect","medication side effects","patient education","communication methods","communication strategies","pediatric care","parental satisfaction","pharmacological treatment","treatment","medication adherence","medication","child health","side effect management","treatment compliance","pediatric pharmacology","positive framing","negative framing","side effect reporting","2025-01-22",{"date":476,"type":35},"2025-01-28",{"date":478,"type":20},"2025-01-25",{"date":480,"type":20},"2027-01-06",{"name":41,"class":42},{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":489,"targetDuration":491,"studyType":21,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":74},"100529003","future-optimal-research-and-care-evaluation---aortic-stenosis-100529003","NCT06168123","Future Optimal Research and Care Evaluation - Aortic Stenosis","FORCE-AoS","Inclusion Criteria:\n\n* Older than 18 years of age\n* Severe or moderate aortic stenosis\n\nNo exclusion criteria are applicable to this registry",{"count":490,"type":20},800,"4 Years","In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.\n\nObjective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.",[117,494],"Moderate Aortic Valve Stenosis","2024-11-28",{"date":497,"type":35},"2024-12-03",{"date":499,"type":35},"2023-11-27",{"date":501,"type":20},"2027-08-01",{"name":41,"class":42},{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":346,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":53,"phases":512,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":74},"100510425","phase-2-popular-guilty-pilot-genotype-guided-clopidogrel-monotherapy-100510425","NCT05926271","POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy","POPular GUILTY","Inclusion Criteria:\n\nPatients aged 18 years or older are eligible for inclusion if all of the following criteria are met:\n\n* Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)\n* Successful PCI (according to the treating physician) with implantation of new generation drug eluting stents.\n* CYP2C19 extensive or ultra-rapid metabolizer\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* CYP2C19 poor or intermediate metabolizer\n* Known allergy or contraindication for aspirin or clopidogrel.\n* Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)\n* Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)\n* High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length \\>60 mm\n* Recent stroke, transient ischemic attack (TIA) or intracranial bleeding\n* Severe hepatic impairment (Child Pugh class C)\n* Planned surgical intervention within 6 months of PCI\n* Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)\n* Pregnant or breastfeeding women at time of enrolment\n* Participation in another trial with an investigational drug or device",{"count":511,"type":20},200,[513],"PHASE2","The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). The main questions it aims to answer are:\n\n* Is genotype-guided clopidogrel monotherapy effective in reducing ischemic risk during the first six months following successful PCI?\n* Is genotype-guided clopidogrel monotherapy safe in terms of reducing bleeding risk during the first six months following successful PCI?\n\nParticipants will be given genotype-guided clopidogrel monotherapy after their successful PCI procedure and will be monitored for any bleeding or ischemic complications over the next six months.\n\nResearchers will compare these results to the typical outcomes associated with traditional Dual antiplatelet therapy (DAPT) to see if genotype-guided clopidogrel monotherapy provides similar or improved protection from ischemic events, but with fewer bleeding complications.",[516,517],"Acute Coronary Syndrome","CYP2C19 Polymorphism",[519,520,521,522],"Acute coronary syndrome","Monotherapy","P2Y12 inhibitor","Aspirin free strategy",{"date":497,"type":35},{"date":525,"type":35},"2023-07-15",{"date":527,"type":20},"2027-01-15",{"name":41,"class":42},{"id":530,"slug":531,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":53,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":157},"100434595","safety-and-cost-efficincy-of-new-imaging-techniques-in-patients-suspected-of-coronary-artery-disease-100434595","NCT04939207","Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease","Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis","iCORONARY","Inclusion Criteria:\n\n* The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up\n* The subject is clinically suspected of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.\n* The subject has had ≥64 multidetector row coronary CTA or will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row coronary CTA.\n\nExclusion Criteria:\n\n* The subject is suffering from unstable angina pectoris.\n* The subject is suffering from decompensated congestive cardiac failure.\n* The subject is suffering from a known non-ischemic cardiomyopathy.\n* The subject has a history of PCI or CABG.\n* The subject has had pacemaker or internal defibrillator leads implanted.\n* The subject has a prosthetic heart valve.\n* There is a severe language barrier.\n* The subject participates in any other clinical trial that interferes with the current study.\n* Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.\n* The subject is or might be pregnant.\n* The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:\n\n  * The subject is suffering from a cardiac rhythm other than sinus rhythm.\n  * The subject is morbidly obese (Body Mass Index (BMI) \\> 40).\n  * The subject is not able to sustain a breath-hold for 25 seconds.\n  * The subject is unable to remain in supine position for at least 30 minutes.\n  * The subject has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin\u002F1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR \\\u003C 60 ml\u002Fmin\u002F1,73m2.",{"count":538,"type":20},825,[55],"Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.\n\nMost patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan.\n\nSubjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period.\n\nThe investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.",[542],"Coronary Artery Disease",[544,545,546,547,548,549,550],"Coronary artery disease","Angina pectoris","Coronary arteriosclerosis","CT scan","Cardiac catheterization","Coronary angiography","Myocardial fractional flow reserve","2024-11-27",{"date":553,"type":35},"2024-12-02",{"date":555,"type":35},"2022-03-22",{"date":557,"type":20},"2025-04-01",{"name":41,"class":42},{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":74},"100542976","dutch-cholecystitis-snapshot-study-100542976","NCT06349863","Dutch Cholecystitis Snapshot Study","Variation in Cholecystitis Treatment and Outcome in the Netherlands; a Nation-wide Cohort Study","Dutch CHESS","All patients \\>18 years with a calculous cholecystitis as primary reason for their hospital admittance. Location of diagnosis may the emergency department, the ward during admittance for diagnostics, or during diagnostic laparoscopy. Cholecystitis is defined according to the TG18 diagnostic criteria for a definitive diagnosis of cholecystitis: A. Local signs of inflammation (Murphy's sign and or RUQ mass\u002Fpain\u002Ftenderness) + B. Systemic signs of inflammation (Fever, elevated CRP and\u002For elevated WBC count) + C. Imaging findings characteristic of acute cholecystitis. Patients with a suspected diagnosis (one item in A + one item in B + C), of which the diagnosis is confirmed by peroperative findings, are also included. Patients will be identified by a local study investigator, e.g. a surgeon or surgeon in training.","120 Years",{"count":569,"type":20},3000,"Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.\n\nPurpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.\n\nMethods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \\>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.\n\nConclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.",[572,573,574],"Cholecystitis","Cholecystitis; Gallstone","Cholecystitis; Choledocholithiasis","2024-08-08",{"date":577,"type":35},"2024-08-12",{"date":579,"type":35},"2024-04-01",{"date":581,"type":20},"2025-10-30",{"name":41,"class":42},{"id":584,"slug":585,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":53,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":208},"100527428","phase-2-prophylactic-tributyrin-supplementation-in-acute-pancreatitis-100527428","NCT06147635","Prophylactic Tributyrin Supplementation in Acute Pancreatitis","Prophylactic Tributyrin Supplementation in Acute Pancreatitis; a Phase IIa (Proof of Concept) Double-blind Randomized Placebo-controlled Food Supplement Trial","PARROT","Inclusion Criteria:\n\n* First episode of acute pancreatitis (AP)\n* Able to read and\u002For understand the study procedures\n* Able to give informed consent (or their legal representatives)\n* \\\u003C24 hours after diagnosis of AP\n* \\\u003C72 hours after onset of symptoms of AP\n\nExclusion Criteria:\n\n* Pancreatitis due to endoscopic retrograde cholangiopancreatography (ERCP), malignancy or trauma\n* Post-operative pancreatitis\n* Intra-operative diagnosis\n* Immunocompromised patients (history or current immunosuppressive treatment such as chemotherapy, radiotherapy, longer use of immunosuppressive medication or recent high doses, immunocompromised illness' such as AIDS, leukemia, lymphoma)\n* Pregnancy and\u002For lactation\n* Age \\\u003C18 years old\n* History of recurrent or chronic (MANNHEIM criteria25) pancreatitis (see Appendix 15.1 for definition)",{"count":592,"type":20},92,[513],"The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is:\n\n• The effect of oral tributyrin supplementation on the plasma endotoxin level\n\nParticipants will be randomized between two groups: intervention and control group. They will receive:\n\n\\- three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. placebo), for a total of 14 days\n\nIn total 92 adult patients with a first episode of acute pancreatitis will be included.",[596],"Acute Pancreatitis","2024-06-17",{"date":599,"type":35},"2024-06-20",{"date":601,"type":35},"2024-02-12",{"date":603,"type":20},"2027-01",{"name":41,"class":42},{"id":606,"slug":607,"hasResults":11,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":53,"phases":615,"briefSummary":617,"conditions":618,"keywords":627,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":646},"100396044","phase-4-what-is-the-optimal-antithrombotic-strategy-in-patients-with-atrial-fibrillation-undergoing-pci-100396044","NCT04436978","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?","WOEST-3","Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. Undergoing successful PCI (either ACS or elective PCI)\n3. History of or newly diagnosed (\\\u003C72 hours after PCI\u002FACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC\n\nExclusion Criteria:\n\n1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors\n2. Current indication for OAC besides atrial fibrillation\u002Fflutter (e.g. venous thromboembolism)\n3. \\\u003C12 months after any stroke\n4. CHADSVASc score ≥7\n5. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)\n6. Mechanical heart valve prosthesis\n7. Intracardiac thrombus or apical aneurysm requiring OAC\n8. Poor LV function (LVEF \\\u003C30%) with proven slow-flow\n9. History of intracranial haemorrhage\n10. Active bleeding on randomization\n11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved\n12. Recent (\\\u003C1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.\n13. Known coagulopathy\n14. Severe anaemia requiring blood transfusion or thrombocytopenia \\\u003C50 × 109\u002FL\n15. BMI \\>40 or bariatric surgery\n16. Kidney failure (eGFR \\\u003C15)\n17. Active liver disease (ALT, ASP, AP \\>3x ULN or active hepatitis A, B or C)\n18. Active malignancy excluding non-melanoma skin cancer\n19. Life expectancy \\\u003C1 year\n20. Pregnancy or breast-feeding women",{"count":614,"type":20},2000,[616],"PHASE4","The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy.\n\nHowever, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest.\n\nThe WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.",[516,619,620,621,622,623,295,624,625,626,542],"Myocardial Infarction","Atrial Fibrillation","Atrial Flutter","STEMI - ST Elevation Myocardial Infarction","NSTEMI - Non-ST Segment Elevation MI","Stroke","Stent Thrombosis","Embolism",[516,619,620,621,622,623,628,629,630,631,632,633,634,295,635,624,625,636,637,544],"Oral Anticoagulant","NOAC - Novel Oral Anticoagulant","DOAC - Direct Oral Anticoagulant","DAPT - Dual Antiplatelet Therapy","Antithrombotic Therapy","Dual Therapy","Triple Therapy","Thrombosis","Systemic Embolism","Percutaneous coronary intervention","2023-12-14",{"date":640,"type":35},"2023-12-15",{"date":642,"type":35},"2023-01-11",{"date":644,"type":20},"2027-12-01",{"name":41,"class":42},20,""]