[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UMC Utrecht\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":692},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,51,76,102,125,150,178,206,235,257,287,313,337,362,388,418,439,463,484,539,562,593,619,648,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100643929","phase-3-cannabidiol-as-add-on-therapy-for-children-with-refractory-epilepsy-cbd-un1que-a-high-quality-individualized-approach-a-series-of-n-of-1-trials-100643929",false,"NCT07668856","Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials","CBD-uN1que","Inclusion Criteria:\n\n* Minimum age of 1 year old and maximum age of 18 years old.\n* Confirmed diagnosis of refractory epilepsy according to ILAE criteria\n* At least 4 countable seizures (not all in one week) of epileptic origin, during the 4-week baseline period while receiving care as usual.\n* All medication doses or other interventions for epilepsy must have been stable for one month prior to screening and the participants\u002Fparents and treating physicians are willing to maintain the current treatment regimen throughout the trial.\n* Informed consent\u002F of legal representative\u002F parents.\n* Presence of a consistently available patient caregiver for proxy-reports.\n\nExclusion Criteria:\n\n* Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (cannabis extract and refined peanut oil, generally safe for patients with peanut allergy)\n* History or current signs of significantly impaired liver function, such as bilirubin level ≥ 2 x upper limit of normal, or presence of liver damage as indicated by levels of alanine aminotransferase and\u002For aspartate aminotransferase ≥ 3 x upper limit.\n* Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment\n* Cardiac disease including: Structural heart disease with hemodynamic significance, heart failure, ischemic heart disease, Brugada syndrome, long-QT syndrome, cardiac arrythmia\n* Glaucoma\n* Ongoing evaluation for epilepsy surgery\n* Implementation of vagal nerve stimulation within 3 months prior to screening and unwillingness to delay inclusion until stable settings of vagal nerve stimulation are reached\n* Starting a ketogenic diet within 3 months prior to screening and unwillingness to delay inclusion until a stable ketogenic diet is reached\n* Unstable medical condition, other than refractory epilepsy, that is of significant influence on participation in the trial; significance to be determined with the treating physician\u002Fpediatric neurologist\n* History of recreational or medicinal cannabis use, or cannabinoid-based medications, within three months prior to screening and the patient is unwilling to abstain for the duration of the study\n* Planned intervention under general anesthesia interfering with the baseline period; or any planned major surgery within the duration of the trial\n* Expected inability to undergo blood sampling due to anxiety or resistance\n* Use of clobazam dosage of \\> 0,5 mg\u002Fkg\u002Fday in the last month","ALL","1 Year","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to learn if cannabidiol (\"CBD-oil\") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:\n\n* Does cannabidiol lower the number of seizure in children with severe epilepsy?\n* Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities?\n* What medical problems do participants have when taking cannabidiol?\n\nResearchers will compare cannabidiol to a placebo (a look-alike oil that contains no cannabidiol) to see if drug cannabidiol works to treat severe epilepsy. All participants will receive both the cannabidiol and the placebo during different periods. At the end of the trial, we will evaluate for each patient seperately, whether seizures were less or more frequent during cannabidiol periods or placebo periods, to see what works best for every patient seperately.\n\nParticipants will:\n\n* Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided\n* Take CBD oil during 2 to 3 periods. One period will last around 7 weeks.\n* Also take placebo oil during the other 2 to 3 periods\n* Have a blood test every 7 weeks to monitor for safety and possible adverse effects\n* Visit the clinic once every 15 weeks for checkups and tests\n* Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.",[28,29,30],"Refractory Epilepsy in Children","Refractory Epilepsy","Epilepsy",[32,33,34,35,36,37],"Refractory epilepsy","rare diseases","Cannabidiol.","bedrolite","n-of-1 trial","medicinal cannabis","RECRUITING","2026-06-19",{"date":41,"type":42},"2026-06-25","ACTUAL",{"date":44,"type":42},"2025-02-06",{"date":46,"type":22},"2027-12",{"name":48,"class":49},"UMC Utrecht","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100642753","innovative-brain-computer-interface-for-people-with-spinal-cord-injury-100642753","NCT07640711","Innovative Brain-Computer Interface for People With Spinal Cord Injury","Innovative Neurotechnology For Society - Brain-Computer Interface","INTENSE-BCI","Inclusion Criteria:\n\n* Clinical diagnosis of SCI at the cervical level C4 or higher (C1-C4)\n* Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis), i.e., level A or B at the American Spinal Injury Association (ASIA) Impairment Scale\n* Meeting surgical safety criteria, including surgical clearance by the study physicians\n* Meeting (neuro)psychological evaluation criteria\n* Ability to communicate reliably, via speech or other means\n* Willingness and ability to provide informed consent.\n* Lives within reasonable distance from UMC Utrecht\n* Participant consents to the study and still wishes to participate at the time of the study.\n* Vision and hearing largely intact.\n* For candidates who are not currently receiving invasive ventilation, and who have current respiratory problems (e.g., at night), there should be a clear and confirmed desire to proceed with tracheostomy ventilation whenever that would become necessary.\n\nExclusion Criteria:\n\n* Having a spinal cord injury with a degenerative or progressive etiology.\n* Having evident swallowing problems.\n* Having a significant current or recent anxiety disorder or depression or cognitive impairment that would interfere with obtaining informed consent or fully participating in study activities.\n* Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active infections, unexplained fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, cranioplasty, significant cardiovascular, metabolic, or renal impairments, chronic oral or intravenous use of steroids or immunosuppressive therapy, active cancer within the past year or requires chemotherapy, uncontrolled autonomic dysreflexia within the past 3 months, hydrocephalus with or without an implanted ventricular shunt or a medical contraindication to stop anti-coagulant medications during surgery, or a catabolic state, or strong and frequent spasms)\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations too challenging or incompatible with desired risk levels.\n* Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants or devices that deliver diaphragm pacing.\n* Anticipated need for MRI after implantation of the Brain InterChange system.","70 Years",{"count":50,"type":22},[62],"NA","The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury. The main question it aims to answer is efficient, independent, BCI-based control over digital devices in settings of daily living of an individual with SCI. In this project an advanced generation fully implantable BCI system will be used, the Brain InterChange (BIC) from CorTec.\n\nParticipants will be implanted with an electrode grid on the surface of the brain and an amplifier\u002Ftransmitter on the skull, under the skin. Participation includes visits of researchers for recording and training at home, 1-3 times per week for one year. Extension of participation after one year is possible. If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.",[65,66,67],"Spinal Cord Injury","Tetraplegia C1-C4","Quadriplegia","2026-06-05",{"date":70,"type":42},"2026-06-11",{"date":72,"type":22},"2026-08",{"date":74,"type":22},"2028-08",{"name":48,"class":49},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"100530771","fapi-molecular-imaging-for-diagnosis-of-the-cms4-unfavorable-colorectal-cancer-subtype-100530771","NCT06191120","FAPI Molecular Imaging for Diagnosis of the CMS4 Unfavorable Colorectal Cancer Subtype","FoCus","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Candidates for liver metastatectomy at the time of liver metastasis diagnosis as clinically indicated in the tumor board (RAKU).\n* Patients must have given written informed consent.\n* At least one liver metastasis should have a longest diameter of a least 1.5 cm as measured on routinely performed imaging (e.g. magnetic resonance imaging, CT-scan or ultrasound). This minimum diameter will guarantee sufficient tissue material for analysis and will prevent underestimation of \\[18F\\]-ALF-FAPI-74 uptake due to partial volume effects.\n* CRC patients who received prior treatment before clinical indication for surgical liver metastases resection (both synchronous and metachronous patients, as well as a re-resection of liver metastatic disease) are allowed to enter the study. This is because our prime interest is in the relation between FAPI uptake and the presence of CMS4 at the same point in time, which will likely not be biased by earlier therapies.\n* It is allowed for patients to receive concurrent radiofrequency ablation or other local treatments directed to other metastatic disease locations, if at least one liver metastasis of sufficient size is planned to be surgically removed and therefore available for tissue analysis.\n* It is allowed for patients to be treated with pre-surgical radiotherapy directed to the primary tumor (e.g. in rectal cancer patients).\n\nExclusion Criteria:\n\n* Pregnancy.\n* Patients treated with a pre-surgical chemotherapy regimen that does not include a fluoropyrimidine.",{"count":84,"type":22},45,[62],"Colorectal cancer (CRC) is the 3rd most common cancer worldwide and accounts for \\~14,000 new diagnoses and \\~5,000 deaths in the Netherlands yearly (1.9 million and 935 thousand on a global level). Large scale transcriptional profiling of primary CRC tumors has revealed the presence of four distinct consensus molecular subtypes (CMSs). The CMS4 subtype is associated with a poor prognosis, especially in early CRC, and may benefit less from several standard systemic treatments (e.g. oxaliplatin, 5-fluorouracil, cetuximab), while being relatively sensitive to irinotecan. This is relevant as in the metastatic setting often the first choice first-line systemic therapy regimen is oxaliplatin and not irinotecan-based. Furthermore, tumor cells can acquire a CMS4 phenotype following exposure to chemotherapy, which may contribute to therapy resistance.\n\nCMS4 accounts for \\~25% of all early-stage CRC patients and is more prevalent in advanced disease stages (\\~40% in stage IV CRC). Currently available CMS4 diagnostic tests require tumor tissue samples. The interpretation of biopsy-based CMS4 diagnosis is however complicated by large intra- and inter-lesion heterogeneity of CMS4 status. Extensive biopsy protocols could address the problem of CMS4 heterogeneity but are challenging in routine clinical practice. The development of CMS4-targeted therapy strategies therefore requires a more robust and clinically applicable diagnostic test for comprehensive quantitative assessment of CMS4 status of all lesions - primary and metastatic - in individual cancer patients.\n\nA promising solution for such a diagnostic test is to use a radiotracer that enables the quantitative assessment of CMS4 in vivo by whole body molecular imaging. This technique is particularly suited to assess biomarkers with heterogeneous expression: for diagnostic purposes, as a companion diagnostic for (targeted) therapies, or as part of a 'theranostic' strategy where patient selection using the diagnostic radiotracer is followed by treatment with the same tracer labeled to a therapeutic compound.\n\nRadiolabeled fibroblast activating protein inhibitor (FAPI) is an emerging diagnostic radiotracer that allows the comprehensive whole-body, whole-tumor assessment of fibroblast activation protein (FAP) expression in humans with a very low background uptake also at frequent CRC metastatic sites including the liver. FAP is an excellent candidate molecular imaging target for CMS4, as it is highly expressed on cancer-associated fibroblasts (CAF) that are abundantly present in this CRC subtype. Indeed, the investigators found that FAP gene-expression measured in tumor biopsies - as a single marker - accurately discriminates CMS4 from other CRC subtypes (area under the receiver operating characteristic curve (AUROC): 0.91; 95% confidence interval (CI): 0.90-0.93). The FoCus study will aim to take a next step by relating in vivo assessed FAP protein-expression by \\[18F\\]-ALF-FAPI-74 positron emission tomography (PET) \u002F computed tomography (CT) to CMS4 status in patients eligible for colorectal liver metastatectomy as a first proof of concept. Ultimately this will contribute to the development of a diagnostic tool for the comprehensive assessment of CMS4 load in patients with (metastatic) CRC by using \\[18F\\]-ALF-FAPI-74 PET\u002FCT molecular imaging, to guide CMS4 subtype-directed therapy decisions.",[88,89],"Metastatic Colorectal Cancer","Metastatic Cancer to Liver",[91,92,93],"CMS4","FAPI","Imaging","2026-05-12",{"date":96,"type":42},"2026-05-14",{"date":98,"type":42},"2024-08-05",{"date":100,"type":22},"2031-07",{"name":48,"class":49},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100549505","circulating-tumor-dna-based-adjuvant-chemotherapy-in-stage-ii-colon-cancer-patients-the-medocc-create-trial-100549505","NCT06434896","Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial","CrEATE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Informed consent for PLCRC with specific consent for:\n\n  * additional blood withdrawals\n  * collection and use of tissue for scientific research\n  * invitation for future (experimental) research within the cohort, including TwiCs studies\n* Inclusion in observational PLCRC -MEDOCC substudy\n* Histological confirmed stage II colon cancer\n* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician\n\nExclusion Criteria:\n\n* Indication for adjuvant chemotherapy according to treating physician\n* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma\n* Incomplete primary tumor resection (R1 or R2 resection)\n* Contra-indication for fluoropyrimidines or oxaliplatin\n* Pregnancy",{"count":110,"type":22},1320,[62],"Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).\n\nPatients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.",[114,115,116],"Circulating Tumor DNA","Recurrence","Colon Cancer Stage II","2026-05-07",{"date":94,"type":42},{"date":120,"type":42},"2020-03-05",{"date":122,"type":22},"2026-12",{"name":48,"class":49},29,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":148,"locationsCount":149},"100538031","phase-2-drug-rediscovery-for-rare-immune-mediated-inflammatory-diseases-100538031","NCT06285539","Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases","DRIMID","Inclusion Criteria:\n\n* Age 18 years of older\n* One of the following rare IMIDs:\n\n  * Diagnosis of Behçet's disease without refractory life, organ or sight-threatening symptoms with active disease, defined as a BDCAF \\>2 (new BDCAF) or \\>15 (old BDCAF) or with active disease, based on clinical grounds (e.g. the need to start new or additional medication\n  * Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria:\n\nDermatomyositis: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 201852 or anti-synthetase syndrome: Anti- synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 200353, both with active disease, defined as a CDASI score of ≥5 or abnormal levels of at least 1 of the following enzymes: creatine kinase (≥ 4× upper limit of normal \\[ULN\\]), aldolase (≥4 × ULN), lactate dehydrogenase (LDH ≥4 × ULN), aspartate transaminase (AST ≥4 × ULN), alanine aminotransferase (ALT ≥4 × ULN) or a MRI within the last 3 months indicative of active inflammation (e.g. edema signal pattern in affected proximal muscles) or active disease based on clinical grounds, e.g. the need to start new or additional medication\n\n* Diagnosis of IgG4-related disease, according to 2019 ACR\u002FEULAR guidelines, with active disease, defined as: IgG4-related disease responder index \\>10 or active disease based on clinical grounds, e.g. the need to start new or additional medication\n\n  * Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of glucocorticoid therapy as well as lack of response to at least one other immunosuppressive agent such as methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA) or rituximab or intolerance to standard-of-care treatment, as defined by the treating physician.\n  * No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: both a negative QuantiFERON-TB Gold (QFT-G) In-Tube test and a Mantoux tuberculin skin test performed at or within 3 months prior to screening and no signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care on a chest radiograph and no history of either untreated or inadequately treated latent or active TB infection.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Age ≥65 years\n* Life expectancy less than 6 months\n* Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM), inclusion-body myositis or cancer-associated myositis\n* End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity\n* Increased risk of major cardiovascular problems\n* Current smoker or smoked for a long time in the past\n* Pregnancy or lactation\n* Previous use of other JAK inhibitors\n* Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.\n* Human Immunodeficiency Virus (HIV) infection\n* Presence of an active infection or viral hepatitis type B or C\n* History of shingles or recurrent herpes simplex infection\n* Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)\n* Increased risk of cancer\n* Kidney injury with estimated glomerular filtration rate \\\u003C15mL\u002Fmin\u002F1.73m2\n* Liver failure Child Pugh C\n* Absolute neutrophil count \\\u003C1\\*109\n* Absolute leukocyte count \\\u003C0.5\\*109\n* Hemoglobin \\\u003C5mmol\u002FL - Inability to comply with study and\u002For follow-up procedures\n* Known recent substance abuse (drugs or alcohol).\n* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.\n* Previous non-adherence to immunosuppressants\n* Hypersensitivity to the active substance or to any of the excipients\n* Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption","65 Years",{"count":134,"type":22},60,[136],"PHASE2","Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation.",[139,140,141],"Behcet's Disease","Idiopathic Inflammatory Myopathies","IgG4-related Disease",[143],"JAK-inhibition",{"date":94,"type":42},{"date":146,"type":42},"2024-03-12",{"date":46,"type":22},{"name":48,"class":49},6,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":50},"100536884","personalized-live-remote-exercise-training-for-cancer-survivors-100536884","NCT06270628","Personalized Live-remote Exercise Training for Cancer Survivors","Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT","LION","Inclusion Criteria:\n\nTo be eligible to participate in this study, a subject must be:\n\n* 18 years of age or older\n* Diagnosed with any type of invasive cancer and have received systemic chemotherapy as part of their primary cancer treatment\n* Within the timeframe of 12 weeks to 1 year after the completion of their primary cancer treatment with curative intent. Primary treatment, in this context, includes surgery, radiotherapy, and\u002For chemotherapy. For patients undergoing endocrine, targeted, or immunotherapy, their treatment must not be scheduled to be discontinued within the next 6 months.\n* No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease in the regular clinical trajectory)\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2\n* Presence of at least one of the following side-effects: fatigue (measured using EORTC QLQ-C30 fatigue symptom scale, score \\>39), perceived low physical functioning in daily life (measured using EORTC QLQ-C30 physical functioning scale, score \\\u003C83), anxiety or depressive symptoms (measured using PHQ-ADS \\> 20), and\u002For CIPN (measured using 2 PRO-CTCAE items, score \\>0) for patients who received neurotoxic chemotherapy. Cut-off values are based on established thresholds.19-21\n* Access to good quality and stable internet connection to access the live-remote training sessions.\n* Able and willing to perform the exercise program and wear the activity tracker at least one week after T0 and before T2, T4, and T5 measurements and during training and online assessment sessions.\n* Able to read, speak and understand the main country language.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Too physically active (i.e., \\>210 minutes\u002Fweek of self-reported moderate-to-vigorous or leisure and sports activities; this threshold has also been used in other exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all participating countries) or participation in an exercise program comparable to the LION exercise program.\n* Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication\n* Participated in the intervention group of an exercise study during cancer treatment\n* Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including:\n* Severe neurologic or cardiac impairment according to ACSM criteria\n* Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise\n* Uncontrolled pain All these exclusion criteria are formulated to ensure safe participation in the LION exercise program\n* Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the treating physician\n* More than 1 week not able to attend training sessions during the LION intervention period","100 Years",{"count":160,"type":22},350,[62],"Background\n\nMany people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.\n\nGoal of the study:\n\nThe main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and\u002For depressive symptoms, and 4) neuropathy.\n\nDesign of the study\n\nIn the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and\u002For depressive symptoms, and\u002For 4) neuropathy. Patients cannot participate in the study if they are already very active.\n\nThe exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.\n\nParticipants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.\n\nMeasurements\n\nThe main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.\n\nConclusion:\n\nThis study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.",[164],"Neoplasms",[166,167,168,169],"cancer survivors","exercise","live remote","personalized exercise training","2026-05-06",{"date":172,"type":42},"2026-05-11",{"date":174,"type":42},"2024-02-14",{"date":176,"type":22},"2027-10-31",{"name":48,"class":49},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":50},"100483460","randomized-trial-on-same-day-sbrt-and-surgical-stabilization-for-symptomatic-spinal-metastases-100483460","NCT05575323","Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases","Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)","BLEND","Inclusion Criteria:\n\n* Symptomatic (cervical, thoracic and\u002For lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and\u002For stabilization\n* Histologic proof of malignancy or radiographic\u002Fclinical characteristics indicating malignancy beyond reasonable doubt\n* Radiographic evidence of spinal metastases\n* Participation in PRESENT cohort, including consent for randomization into future trials\n* Fit for (radio)surgery\n* Age \\>18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain\n* Routine surgical decompression and\u002For stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and\u002For requiring radiotherapy on more than one location\n* Prior surgery or radiotherapy to the index level(s)\n* Multiple myeloma\n* Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)\n* Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy\n* Life expectancy of less than 3 months",{"count":187,"type":22},100,[62],"The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).",[191],"Spinal Metastases",[193,194,195,196,197],"Spinal metastases","SBRT","Surgery","Same-day treatment","RCT","2026-05-04",{"date":200,"type":42},"2026-05-08",{"date":202,"type":42},"2022-10-15",{"date":204,"type":22},"2027-06-30",{"name":48,"class":49},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":223,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100627470","comprehensive-invasive-physiological-evaluation-of-obstructive-coronary-artery-disease-100627470","NCT07449052","Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease","Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease","Inclusion Criteria:\n\n* Patients \\>18 years of age\n* Hemodynamically relevant obstructive coronary artery disease (as assessed by pressure wire evaluation) in the left anterior descending coronary artery amenable to percutaneous coronary intervention at the discretion of the operator.\n\nExclusion Criteria:\n\n* Prior coronary artery bypass graft surgery.\n* Stenosis \\>90% in the target vessel or a stenosis deemed unsafe for pressure wire instrumentation\n* Known severe left ventricular dysfunction (left ventricular ejection fraction by any imaging modality)\n* Severe valvular disease\n* Renal impairment (estimated glomerular filtration rate \\\u003C30mL\u002Fmin)\n* Contra-indications for the use of adenosine or acetylcholine\n* Expected inability to conform to the clinical follow-up\n* Unable or unwilling to use the ORBITA-app\n* Life expectancy of less than 12 months.",{"count":214,"type":22},450,[62],"The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is:\n\nDoes performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life?\n\nResearchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention.\n\nParticipants will:\n\n* Undergo percutaneous coronary intervention and coronary function testing in the intervention arm\n* Undergo percutaneous coronary intervention in the control arm",[218,219,220,221,222],"Coronary Artery Disease (CAD)","Obstructive Coronary Artery Disease","Coronary Microvascular Dysfunction (CMD)","Vasospasm, Coronary","Stable Angina Pectoris",[224,225,226],"Coronary Function Testing","Percutaneous Coronary Intervention","Stable Angina","NOT_YET_RECRUITING","2026-04-30",{"date":230,"type":42},"2026-05-01",{"date":230,"type":22},{"date":233,"type":22},"2029-03-01",{"name":48,"class":49},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":243,"minAge":4,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":50},"100553009","cancer-of-the-breast-asanas-study-cobra-100553009","NCT06480513","Cancer Of the BReast Asanas Study (COBRA)","The Effect of Yoga on Endocrine Therapy Induced Musculoskeletal Symptoms in Women With Breast Cancer: the COBRA Study","COBRA","Inclusion Criteria:\n\n* Be diagnosed with oestrogen-receptor positive stage I-III breast cancer,\n* Use of aromatase inhibitors or Tamoxifen (\\>4 months and will continue using it for at least six months),\n* Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least 12 weeks,\n* Experience musculoskeletal complaints (\\>3 months, which are at least mild in severity (i.e., score of ≥ 3 for worst pain item of a modified version of the Brief Pain Inventory \\[BPI\\](16, 42))., which started or exacerbated after initiation of endocrine treatment,\n* Be stabilized on menopausal symptom medication or antidepressants for at least three months and three weeks, respectively, if applicable, and\n* Be able to read, speak and understand Dutch or English.\n\nExclusion Criteria:\n\n* Too physically active (i.e., \\>150 minutes\u002Fweek of self-reported moderate-to-vigorous or leisure and sports activities)\n* Following (during the last 6 months), or planned to follow yoga classes on a structural base\n* Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication\n* Participated in the intervention group of an exercise study during breast cancer treatment\n* Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team\n* More than 3 weeks not able to attend training sessions during the intervention period\n* A body mass index (BMI) of \\>35 kg\u002Fm2","FEMALE",{"count":245,"type":22},140,[62],"Rationale: Women with hormone-receptor positive breast cancer are usually prescribed endocrine therapy for a period of 5-10 years. This treatment reduces the risk of recurrence and improves overall survival in these women. Musculoskeletal complaints are a common (\\~50%) negative consequence of endocrine treatment, which affects daily functioning and quality of life. These symptoms frequently result in early treatment discontinuation, which is associated with shorter disease-free survival. Musculoskeletal complaints are often pharmacologically treated with limited effect and accompanied by side-effects. Therefore, interventions to counteract musculoskeletal complaints are urgently needed in this population. A potential non-pharmacological option is yoga. In patients with osteoarthritis, there is emerging evidence that yoga is effective to reduce pain and stiffness and improve function. Yoga as treatment for musculoskeletal complaints that are associated with endocrine treatment is rarely investigated and mainly in small studies.\n\nObjective: The objective of the proposed study is to assess the effectiveness of a 4-month yoga program compared to a waiting list control group on musculoskeletal complaints in women with hormone-positive stage I-III breast cancer receiving endocrine treatment who report musculoskeletal complaints.\n\nStudy design: The COBRA study is a randomized controlled trial with two study arms: a yoga- and a waiting list control group.\n\nStudy population: For this study, 140 women with oestrogen-receptor positive stage I-III breast cancer on endocrine treatment (aromatase inhibitors or Tamoxifen; \\>4 months) will be recruited. These women experience musculoskeletal complaints (\\>3 months) which started or exacerbated after initiation of endocrine treatment. Furthermore, eligible women did not practice yoga in the last six months and are not planning to start yoga and are not highly physically active (i.e., \\>150 minutes per week moderate-vigorous exercise).\n\nIntervention: The intervention consists of two one-hour sessions\u002Fweek supervised yoga and once a week 30-minute yoga exercises at home. The 4-month yoga program will be an active form of yoga, such as Easy Vinyasa yoga, which is characterized by continuous slow movements linked with breathing. The waiting list control patients will be offered an online yoga program after the 4-month study period.",[249],"Breast Cancer","2026-04-29",{"date":170,"type":42},{"date":253,"type":42},"2024-10-08",{"date":255,"type":22},"2027-06",{"name":48,"class":49},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100636229","phase-1-focused-ultrasound-blood-brain-barrier-opening-in-pontine-diffuse-midline-glioma-to-enhance-temozolomide-therapy-pilot-feasibility-study-fides-100636229","NCT07562971","Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES)","Focused Ultrasound-mediated Blood-Brain Barrier Opening In Pontine Diffuse Midline Glioma (DMG) to Enhance Systemic Therapy With Temozolomide (FIDES) - an Exploratory Pilot and Feasibility Trial","FIDES","Inclusion Criteria:\n\n* Age ≥ 4 years.\n* Histologically\u002Fmolecularly verified de novo pontine H3K27-altered diffuse midline glioma.\n* Main localization ('center of mass') in the brainstem. NB: some degree of extension beyond the brainstem, e.g. cerebellar peduncles, is allowed.\n* Karnofsky Performance Score (KPS) or Lansky Performance Score (LPS) of ≥ 70\u002F KPS or LPS 60 and WHO\u002FECOG performance status ≤ 2.\n* ASA-score of I-III.\n* Intention to treat with (TMZ chemo-) radiation and maintenance TMZ as per consensus of the local multidisciplinary tumor board.\n* Feasible to schedule the first Exablate BBBO procedure preferably within 4-6 weeks, acceptably within 12 weeks, after successful completion of radiotherapy\u002F concomitant TMZ-chemoradiation, defined as completed treatment as planned without reported CTCAEv6.0 grade 3-4 toxicities or, in case of reported CTCAEv6.0 grade 3-4 toxicities, the toxicities must be resolved to grade 2 prior to inclusion.\n* If on steroids, stable or decreasing dose for at least 7 days prior to inclusion.\n* Able to attend all study visits.\n* Able and willing to give informed consent or have a legal guardian who is able and willing to do so.\n\nExclusion Criteria:\n\n* Previous or ongoing participation in other clinical trials with other than standard-of-care tumor-directed treatment(s) for H3K27-altered DMG.\n* Multifocal or leptomeningeal metastasized disease. Multifocal disease is defined as multiple FLAIR-hyperintense lesions, separated by normal-appearing brain tissue, with or without gadolinium enhancement. Multiple enhancing regions within one continuous FLAIR lesion can be considered as unifocal disease.\n* Signs\u002Fsymptoms of elevated intracranial pressure (ICP) (e.g. headache, vomiting, impaired vision\u002Fpapilledema, impaired consciousness), with corresponding radiographic findings on MRI at time of screening.\n* Severe dysphagia with feeding tube dependency.\n* Evidence of acute clinically significant intracranial hemorrhage. NB: minimal hemorrhagic foci without obvious related clinical symptoms will not serve as grounds for exclusion.\n* Tumor not visible on any pre-therapy or post-radiation imaging.\n* Presence of extracranial \u002F intracranial structures (e.g. metal prostheses, implants, calcifications) on pre-treatment CT-scan\u002F MRI-scan, significantly interfering with acoustic impedance as per judgement of the researchers.\n* Known co-occurring other malignancy that is progressing or has required active treatment within the past 3 years, with exception of: carcinomas in situ (CIS) and non-melanoma skin cancers.\n* Patients with right-to-left, bi-directional or transient right-to-left cardiac shunts.\n* Known LVEF \\\u003C 40 or unstable hemodynamics.\n* Severe hypertension, not adequately controlled with study compatible medication (Adults: RR systolic \\>180 and\u002F or RR diastolic \\>100; Children: \\>p95 + 12mmHg).\n* History of bleeding disorder and\u002For coagulopathy.\n* Treatment with anti-coagulant therapy.\n* Severely impaired renal function; creatinine clearance \\\u003C30 mL\u002F min.\n* Subjects with significant liver dysfunction; Child Pugh classification C.\n* Known diagnosis of active or untreated hepatitis B, hepatitis C, tuberculosis.\n* Any other illness or medical condition that in the investigator's opinion precludes participation in this study.\n* Pregnant or lactating women.\n* Expected uncontrollable therapy non-compliance\u002F non-cooperation that is likely to interfere with the study procedure, as per judgement of the investigators.\n* Head circumference ≤ 49 cm.\n* Weight ≥ 135 kg.\n* Patient ≥ 18 years old, who requires general anesthesia to undergo the Exablate BBBO procedure.\n* Contra-indication for MRI procedures.\n* Known sensitivity to gadolinium-based contrast agents.\n* Known sensitivity to the resonator agent (perflutren; Luminity®).","4 Years",{"count":267,"type":22},20,[269,136],"PHASE1","This study is for people (children and adults) with a rare and aggressive brain tumor called H3K27-altered diffuse midline glioma (DMG) located in the pons, a deep part of the brainstem. These tumors are very difficult to treat because they grow into surrounding brain tissue and cannot be fully removed with surgery. Most patients currently survive less than one year after diagnosis, and treatment options are limited.\n\nCurrent standard treatment The usual treatment is radiotherapy, sometimes combined with a chemotherapy drug called temozolomide (TMZ). This combination may slightly improve outcomes, but it is often not very effective for tumors in the pons. One possible reason is that the blood-brain barrier (BBB)-a natural protective filter in the brain-may be especially strong in this area, making it harder for medicines to reach the tumor.\n\nWhat this study is testing This study is exploring a new approach to help chemotherapy reach the tumor more effectively. It uses MRI-guided focused ultrasound (with the Exablate system) to temporarily and safely open the blood-brain barrier in the tumor area. This may allow more temozolomide to enter the tumor.\n\nStudy goal\n\nThe main goal is to find out:\n\n* Whether this technique is safe\n* Whether it may help slow tumor growth or extend survival\n\nWho can join\n\n* Adults and children aged 4 years and older\n* Diagnosed with H3K27-altered pontine DMG\n* Eligible for temozolomide after completing radiation therapy\n\nThe study will include 20 participants (about half children and half adults).\n\nWhat participants will do\n\nParticipants will:\n\n* Receive 6 cycles of temozolomide chemotherapy\n* Undergo focused ultrasound blood-brain barrier opening on the first day of each cycle\n* Have regular MRI scans and check-ups to monitor safety and tumor response\n\nEach treatment cycle includes 5 days of chemotherapy followed by a rest period of 23 days.\n\nWhat the study is measuring\n\nResearchers will look at:\n\n* Safety of the procedure and device\n* How long patients live without tumor progression (progression-free survival)\n* Overall survival\n* Tumor response to treatment\n* Whether the procedure is practical to use in clinical care\n\nThey will also compare results to data from previous patients in international brain tumor registries.\n\nWhy this study matters This study is testing whether temporarily opening the brain's natural barrier can help chemotherapy work better in a type of brain tumor that currently has very limited treatment options.",[272],"Diffuse Midline Glioma, H3 K27-Altered",[274,275,276,277,278],"DMG","DIPG","Focused ultrasound","Exablate","Temozolomide","2026-04-28",{"date":230,"type":42},{"date":282,"type":22},"2026-05",{"date":284,"type":22},"2031-11",{"name":48,"class":49},2,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":50},"100515479","use-of-a-putty-as-gap-filler-in-open-wedge-osteotomy-100515479","NCT05992038","Use of a Putty as Gap Filler in Open-wedge Osteotomy","A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy","AXOS","Inclusion Criteria:\n\n* indication for an open-wedge osteotomy of the femur, tibia or double level due to unicompartmental osteoarthritis (OA).\n* Comply with all aspects of the treatment, including CT scans, radiographs and 1-year follow-up\n* Informed consent\n\nExclusion Criteria:\n\n* Osteotomy for indication of cartilage treatment or other knee surgeries than unicompartmental OA\n* Correction using an open wedge above 10 mm\n* Pregnant women at time of enrollment or women who are planning to become pregnant during the duration of the study",{"count":296,"type":22},40,[62],"Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperative phase. This is probably due to a combination of bony cut (bone pain) and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to potentially reduce postoperative pain by reducing the bleeding from the bone gap.\n\nObjective: The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster accelerated rehabilitation\u002Fregaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and the occurrence of (serious) adverse events.\n\nStudy design: Single-blinded, prospective, randomized controlled trial.\n\nStudy population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy.\n\nIntervention: According to a randomization scheme, the osteotomy gap will be filled with either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional method).\n\nMain study parameters\u002Fendpoints: The main study endpoint is the Numeric Rating Scale (NRS) pain during the first week postoperative. The secondary study endpoints are faster rehabilitation\u002Fregaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and (serious) adverse events.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients may have the advantage of experiencing less pain postoperatively if they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation. Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone fusion and excessive bone growth. However, the preclinical studies and clinical studies show that the use of AttraX® Putty is safe for use in humans.",[300],"Osteo Arthritis Knee",[302,303,304,305,306],"Osteotomy","Gap filler","Postoperative pain","Randomized controlled trial","AttraX Putty",{"date":250,"type":42},{"date":309,"type":42},"2023-09-20",{"date":311,"type":22},"2026-12-01",{"name":48,"class":49},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},"100430162","additional-treatment-for-isolated-local-pancreatic-cancer-recurrence-using-stereotactic-body-radiation-therapy-100430162","NCT04881487","Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy","A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy","ARCADE","Inclusion Criteria:\n\n* Participation in the PACAP cohort with written informed consent for being randomized in future studies\n* Isolated local recurrence after primary PDAC resection\n* Minimum age of 18 years\n\nExclusion Criteria:\n\n* Distant metastases\n* Expected lifespan \\\u003C 3 months\n* Ineligibility for MRI or CT according to the protocol of the local radiology department;\n* Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.",{"count":322,"type":22},174,[62],"A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.",[326],"Recurrent Pancreatic Ductal Adenocarcinoma",[328],"Stereotactic body radiation therapy",{"date":330,"type":42},"2026-05-05",{"date":332,"type":42},"2021-07-05",{"date":334,"type":22},"2028-02",{"name":48,"class":49},3,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":344,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100632334","a-randomized-intra-patient-controlled-trial-of-magnetos-putty-vs-autograft-in-instrumented-posterolateral-spinal-fusion-in-idiopathic-scoliosis-patients-100632334","NCT07512336","A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis Patients","MAIS","AIS indicated for sugical treatment","12 Years","30 Years",{"count":245,"type":22},[62],"SUMMARY Rationale: Delayed union is a problem in adolescent idiopathic scoliosis (AIS) surgery, especially at the distal end of the construct. Surgeons therefore use local autograft or bone graft substitutes to prevent loss of correction and\u002For anchor failure and additionally restrict patients' activities during the first year. The concept of this study was developed after the promising results of the MaxA study (METC 18-311), where we compared the efficacy of BCP\\\u003Cμm ceramic granules (MagnetOs™ Granules) to autograft in posterolateral fusion (PLF). This randomized intra-patient-controlled trial indicated superior spinal fusion rates for the BCP\\\u003Cμm condition. The current investigational product (MagnetOs™ Putty) is made of the same MagnetOs™ Granules embedded in a fast-resorbing polymeric binder to improve surgical handling. If MagnetOs™ Putty allows better and faster fusion in scoliosis patients, it is possible to mobilize them faster and even abandon post-operative activity restrictions.\n\nObjective: The primary objective is to demonstrate superiority and safety of MagnetOs™ Putty compared to autograft regarding the posterolateral spinal fusion rate, in instrumented PLF in AIS patients. The secondary objectives encompass comparisons of posterolateral spinal fusion rates on different levels at various points in time, monitoring the changes in trunk rotation, evaluating quality of life and patient's experiences as well as improving the reliability of Hounsfield unit measurements.\n\nStudy design: Multicenter, randomized, controlled superiority trial with intra-patient comparisons over a 1-year follow-up.\n\nStudy population: 140 patients between 12 to 30 years with AIS qualified for scoliosis surgery with lowest instrumented vertebrae T12-L4.\n\nIntervention: According to a randomization scheme, one side of the caudal PLF will be grafted with the MagnetOs™ Putty and the other side with local bone. The rest of the surgical procedure will be according to standard care.\n\nMain study parameters\u002Fendpoints: The fusion rate of MagnetOs™ Putty compared to standard fusion with local autograft, assessed locally and centrally through a three plane assessment tool at the caudal segment on CT scans at 3 or 6 months. The complication rate will be compared to the rate in control populations from literature.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness: The study population includes AIS patients between 12 to 30 years with an indication for PLF. Patient burden and risks are expected to be minimal. The post-operative follow-up will be according to standard care. Additional study procedures include the completion of patient-reported outcome measures (PROM) at four time points and a limited CT scan. Based on pre-clinical investigations and the results of the MaxA study, we expect MagnetOs™ Putty to perform better than the current treatment. This may benefit the patient as currently about 5% experience problems of delayed union in our own series.",[350],"Adolescence Idiopathic Scoliosis",[352,353,354],"bone healing","bone graft","autograft","2026-03-30",{"date":357,"type":42},"2026-04-06",{"date":230,"type":22},{"date":360,"type":22},"2030-05-01",{"name":48,"class":49},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":371,"studyType":372,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":50},"100236481","prospective-evaluation-of-interventional-studies-on-bone-metastases---the-present-cohort-100236481","NCT02356497","Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort","PRESENT","Inclusion Criteria:\n\n* Histologic proof of malignancy;\n* Radiographic or histologic proof of metastatic bone disease;\n* Undergoing radiotherapy;\n* Age \\> 18 years;\n* Informed consent - at least - for use of routinely collected clinical data.\n\nExclusion Criteria:\n\n* Mentally incompetent patients;\n* Life expectancy \\\u003C 1 week indicated by the treating physician.",{"count":370,"type":22},2500,"3 Years","OBSERVATIONAL","Bone metastases are frequent distant manifestations of cancer, with pain as a common and devastating consequence. The primary treatment for painful bone metastases, external beam radiation therapy, is moderately effective: about 60% of patients who undergo conventional radiotherapy experience (partial) pain relief. Several factors associated with treatment failure have been identified, but no attempts have been made to collapse these factors into a clinically useful prediction tool to predict treatment response. In addition, to aid in therapy selection based on expected survival time, development of survival models is essential. Finally, we need innovative treatments as alternatives or additive to standard treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT cohort study, recruiting patients at the departments of radiation oncology and orthopedic surgery.\n\nWe aim to provide detailed information about clinical data, create an infrastructure for efficient, fast and pragmatic evaluation and implementation of innovative interventions, as well as development of accurate new prediction tools.",[375],"Bone Metastases",[377,378,379],"Bone metastases","Metastatic bone disease","Multi-trial facility","2026-03-18",{"date":382,"type":42},"2026-03-19",{"date":384,"type":42},"2013-06",{"date":386,"type":22},"2035-12",{"name":48,"class":49},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100630308","coronary-sinus-reducer-therapy-for-persisting-angina-100630308","NCT07485985","Coronary Sinus Reducer Therapy for Persisting Angina","Impact of the Coronary Sinus Reducer on Invasive Hemodynamics and Angina in Patients With Advanced Coronary Artery Disease","REDUCE ANGINA","Inclusion Criteria:\n\n* Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.Hemodynamically significant epicardial coronary artery disease in the LAD, defined as an FFR≤0.80 and\u002For NHPR≤0.89.\n* No conventional revascularization options or considered unsuitable as determined by the local heart team.\n* Anatomically suitable for instrumentation of the left anterior descending coronary artery with a coronary pressure wire and infusion microcatheter.\n* Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Absence of symptoms reported on the ORBITA-app during the 2-week screening period.\n* Mean right atrial pressure ≥15 mmHg\n* Severe pulmonary hypertension.\n* Coronary sinus anatomy not suitable for CSR implantation.\n* Pregnancy or planned pregnancy within the next 12 months.\n* Recent acute coronary syndrome (within 3 months).\n* Recent revascularization with PCI (within 6 months).\n* Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (\\>100bpm despite medication).\n* Indication for cardiac resynchronization therapy.\n* Severe left ventricular impairment (left ventricular ejection fraction \\\u003C30%).\n* NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.\n* Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure).\n* Presence of a pacemaker lead in the coronary sinus.\n* Severe valvular heart disease.\n* History of tricuspid valve replacement or repair.\n* Kidney failure (estimated glomerular filtration rate \\\u003C30ml\u002Fmin)\n* Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment.\n* Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.\n* Unable or unwilling to use the ORBITA app\n* Known inability to tolerate contrast medium.\n* Life expectancy \\\u003C1 year.",{"count":7,"type":22},[62],"Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless-steel mesh device designed to create a controlled narrowing of the coronary sinus (CS). By increasing CS pressure, CSR implantation may improve myocardial perfusion and reduce anginal symptoms, although the physiological mechanisms underlying this effect remain incompletely understood.\n\nREDUCE-ANGINA is a prospective observational study investigating the hemodynamic effects of CSR implantation in 25 patients with refractory angina and advanced CAD. The study evaluates the interaction between coronary sinus hemodynamics and coronary arterial blood flow before and after CSR implantation. The main study endpoints include changes in coronary sinus pressure, coronary flow reserve, microvascular resistance reserve, and absolute microvascular resistance from baseline to 6 months, measured using continuous flow thermodilution during saline-induced coronary hyperemia.",[400,401],"Coronary Artery Disease","Angina (Stable)",[403,404,400,405,406,407,408,409],"Coronary Sinus Reducer","Refractory Angina","Coronary Sinus Hemodynamics","Coronary Flow Reserve","Microvascular Resistance","Continuous Flow Thermodilution","Coronary Physiology","2026-03-17",{"date":412,"type":42},"2026-03-20",{"date":414,"type":22},"2026-04-01",{"date":416,"type":22},"2028-07-01",{"name":48,"class":49},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":425,"targetDuration":427,"studyType":372,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100630011","multicenter-registry-of-patients-with-subarachnoid-hemorrhage-100630011","NCT07482124","Multicenter Registry of Patients With Subarachnoid Hemorrhage","MEASURE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Spontaneous subarachnoid hemorrhage with blood in the basal cisterns and\u002For major fissures on non-contrast head computed tomography (CT), or xanthochromia of cerebrospinal fluid confirmed by spectrophotometric analysis.\n* Eligible etiologies\u002Fpatterns:\n\n  * Aneurysmal SAH\n  * SAH from other intracranial vascular malformation (e.g. AVM, dural AVF)\n  * Perimesencephalic SAH\n  * Non-perimesencephalic angiogram negative SAH\n  * SAH from intracranial artery dissection\n\nExclusion Criteria:\n\n* Traumatic, neoplastic, infection related (except mycotic aneurysms), or iatrogenic SAH\n* Isolated convexity SAH",{"count":426,"type":22},1000,"18 Months","The purpose of this registry is to collect detailed information on the characteristics, treatment, and outcomes of patients with a subarachnoid hemorrhage. This information will enable research aimed at improving the safety and effectiveness of current and future treatments. By studying these data, the investigators aim to identify which treatment strategies offer the best results and which factors are most important in the care of patients with a subarachnoid hemorrhage. The knowledge gained from this research will help improve patient care in the future.",[430],"Subarachnoid Hemorrhage, Spontaneous","2026-03-15",{"date":382,"type":42},{"date":434,"type":42},"2024-02-12",{"date":436,"type":22},"2028-02-01",{"name":48,"class":49},9,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":447,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":50},"100428602","erectile-function-preservation-for-prostate-cancer-radiation-therapy-erect-100428602","NCT04861194","EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT)","EREctile Function Preservation for Prostate Cancer Radiation Therapy (ERECT); a Prospective Phase II Trial","ERECT","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically proven adenocarcinoma of the prostate\n* Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score ≤6, and PSA \\\u003C10 µg\u002FL; intermediate risk: T2b-T2c or Gleason score 7 or PSA 10-20 µg\u002FL)\n* Patients with pT1a\u002Fb tumor diagnosis after transurethral resection of the prostate (TURP)\n* Domain score of 17-25 on the International Index of Erectile Function-5 (IIEF-5) questionnaire\n* Karnofsky score of 70-100\n* Written informed consent\n\nExclusion Criteria:\n\n* Use of (neo-)adjuvant androgen deprivation therapy\n* High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA \\>20 µg\u002FL)\n* Patients with \"bulky\" iT3 tumor diagnosis\n* Previous pelvic irradiation or radical prostatectomy\n* Clinical evidence of metastatic disease\n* Patients who are unable to undergo MRI\n* Patients who are incompetent to sign written informed consent","MALE",{"count":449,"type":22},70,[62],"Single-arm phase II trial of 70 men with low- or intermediate-risk prostate cancer receiving magnetic resonance guided adaptive radiotherapy (MRgRT) in 5 fractions of 7.25 Gy, additionally sparing the neurovascular bundles, the internal pudendal arteries, the corpora cavernosa, and the penile bulb for erectile function preservation.",[453,454],"Prostate Cancer","Erectile Dysfunction Following Radiation Therapy","2026-03-03",{"date":457,"type":42},"2026-03-05",{"date":459,"type":42},"2021-07-14",{"date":461,"type":22},"2027-08-10",{"name":48,"class":49},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":447,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":472,"studyType":372,"phases":4,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":286},"100380025","utrecht-prostate-cohort-for-cancer-treatment-intervention-studies-and-long-term-evaluation-100380025","NCT04228211","Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation","UPC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with newly diagnosed histologically proven prostate cancer, referred for radiation treatment to the Radiotherapy Department of the UMC Utrecht or for prostatectomy, watchful waiting or active surveillance to the Urology Department of St. Antonius hospital or the Urology Department of the UMC Utrecht.\n* Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires.\n\nExclusion Criteria:\n\n* Mentally incompetent patients.\n* Inability to understand the Dutch language.",{"count":471,"type":22},1500,"10 Years","Rationale: Prostate cancer is the most common cancer in men worldwide. Survival rates are high due to the typically non-aggressive nature of disease and effective treatments. Radical treatments such as surgery and radiotherapy often cause toxicity and long term side effects. Based on current available literature, the choice for primary therapy for clinically localised prostate cancer has a negative impact on cancer-specific quality of life (QOL). New interventional treatments are being developed. The investigators aim to build a multidisciplinary prostate cancer cohort which will serve as a multi-trial facility for interventional treatment studies. The Trials within Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled Trial design (cmRCT) will be conducted and as a prospective registry for assessment of long-term safety, performance and effectiveness new treatment interventions.\n\nObjective: To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer.\n\nStudy design: Observational, prospective cohort study, according to the 'Trials within Cohorts' (TwiCs) design.\n\nStudy population: All patients with newly diagnosed histologically proven prostate cancer.\n\nMain study parameters\u002Fendpoints: Clinical parameters (e.g. co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (e.g. toxicity, and survival outcomes) and patient reported outcomes (e.g. QOL).",[453],[476,477],"prostate cancer","trials within cohorts (TwiCs) design",{"date":457,"type":42},{"date":480,"type":42},"2020-02-05",{"date":482,"type":22},"2033-02-05",{"name":48,"class":49},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":494,"studyType":372,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":538},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":493,"type":22},8000,"2 Years","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[497,249,453,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,164,526,527,528,529,530,531],"Oncology","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Cancer","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Cancer","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Bladder Cancer","Bladder Neoplasm","Liver Cancer","Liver Neoplasms","Liver Metastases","Oligometastases",{"date":457,"type":42},{"date":534,"type":42},"2019-02-01",{"date":536,"type":22},"2030-08-01",{"name":48,"class":49},18,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":561,"locationsCount":286},"100490129","phase-2-treatment-of-ectopic-calcification-in-fahrs-disease-or-syndrome-100490129","NCT05662111","Treatment of Ectopic Calcification in Fahr's Disease or Syndrome","A Randomized, Placebo-controlled, Double-blind Trial to Study the Effects of Etidronate on Ectopic CALCIfication in FAhr's Disease or Syndrome","CALCIFADE","Inclusion criteria are:\n\n1. Age of 18 years or over,\n2. Clinical diagnosis of Fahr's disease or syndrome. No international accepted diagnostic criteria for Fahr's disease or syndrome exist yet. It is diagnosed mostly based on the clinical presentation. For the present study the following criteria are used:\n\n   1. Clinical symptoms consistent with a clinical diagnosis of Fahr's disease or syndrome.\n   2. Bilateral calcifications of the basal ganglia as seen on the computed tomography (CT) scan of the head. To rule out basal ganglia calcifications due to aging, a CT based calcification score will be used as proposed by Nicolas et al. Calcification is graded from 0 (no calcification) to 5 (serious and confluent) in specific locations of the brain; lenticular, caudate, thalamus nuclei, subcortical white matter, cortex, cerebellar hemispheres, vermis, midbrain, pons, and medulla. The total calcification score (ranging from 0 to 80) is obtained by adding all location-specific points, where a score higher than the age-specific threshold points at Fahr's disease or syndrome.\n\n      Furthermore, the next criteria are supportive for the clinical diagnosis of PFBC:\n   3. Frequently, the family history is consistent with autosomal dominant inheritance. A positive family history with at least one relative in the first or second degree with symptoms of PFBC is supportive for the clinical diagnosis of PFBC.\n   4. The presence of a (likely) pathogenic mutation in one of the PFBC-related genes is supportive for the clinical diagnosis of PFBC. Mutations in up to now 4 known genes are associated with an autosomal dominant pattern of inheritance: solute carrier family 20 member 2 (SLC20A2) (OMIM#213600), xenotropic and polytropic retrovirus receptor 1 (XPR1) (OMIM#616413), platelet-derived growth factor b (PDGFB) (OMIM#615483), and platelet-derived growth factor receptor b (PDGFRB) (OMIM#615007). Autosomal recessively inherited PFBC is associated with mutations in two genes: myogenesis-regulating glycosidase (MYORG) (OMIM#618317) and junctional adhesion molecule 2 (JAM2) (OMIM#618824).\n\nExclusion criteria are:\n\n1. unable or unwilling to sign an informed consent,\n2. severe renal impairment (estimated glomerular filtration rate (eGFR) of \\\u003C30 ml\u002Fmin\u002F1.73m2 calculated using CKD-EPI equation),\n3. contraindication to receiving oral medication (for example severe dysphagia),\n4. known abnormality of the oesophagus that would interfere with the passage of the drug (for example oesophageal strictures or achalasia),\n5. known sensitivity to etidronate,\n6. pregnancy, women with an active pregnancy wish \\\u003C1 year, or women who are breastfeeding at the time of inclusion,\n7. inability to undergo a Dutch neuropsychological assessment (for example, non-fluent Dutch speakers or severe visual, hearing or motor impairment),\n8. any other medical or social condition that puts the subject at risk of harm during the study or might adversely affect the interpretation of the study data,\n9. use of bisphosphonates during the last 5 years,\n10. hypocalcaemia (calcium \\\u003C2.20 mmol\u002FL),\n11. 25-OH vitamin D deficiency \\\u003C35 nmol\u002FL. After correction of hypocalcaemia or vitamin D deficiency, a participant is again suitable for participation.",{"count":548,"type":22},98,[136],"Fahr's disease or syndrome are neurodegenerative diseases in which patients present with bilateral vessel associated calcifications in the basal ganglia. The clinical penetration of Fahr's disease or syndrome is incomplete and heterogeneous comprising of neuropsychiatric signs, cognitive decline, movement disorders, and various other signs (migraine, speech disorders, pain, seizures). The symptoms start between 30 and 50 years and are (slowly) progressive. Symptomatic patients have an increased risk for dependence in activities of daily living and impaired quality of life.\n\nCurrently, disease-modifying therapies are not available for patients with Fahr's disease or syndrome. However, in a small case series it was shown that alendronate was effective in the clinical treatment of several patients with Fahr's disease or syndrome. Now the time has come to investigate the effectiveness of treatment with bisphosphonates in patients with Fahr's disease or syndrome in a randomized controlled trial.",[552,553,554],"Fahr Disease","Fahr Syndrome","Primary Familial Brain Calcification","2026-02-26",{"date":557,"type":42},"2026-03-02",{"date":559,"type":42},"2023-04-03",{"date":46,"type":22},{"name":48,"class":49},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":570,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":50},"100625532","predicting-the-right-advice-at-the-right-time-in-patients-with-hip-and-knee-osteoarthritis-the-e-coach-cross-over-100625532","NCT07423858","Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: the e-cOAch Cross-over.","Developing Data Driven Algorithms for Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: The e-cOAch Cross-over Study","e-cOAch","Inclusion Criteria:\n\n1. Have a hip or knee joint that, self-administered through a questionnaire, meets the National\n\n   Institute for Health and Care Excellence clinical criteria for osteoarthritis:\n   1. Aged 45 years or over and;\n   2. Activity-related pain at the joint and;\n   3. Joint morning stiffness that lasts no longer than 30 minutes or no morning stiffness at the joint;\n2. History of pain at the joint for at least 3 months;\n3. Have access to a smartphone with internet connection and an email address;\n4. Able to give informed consent and willing to commit to all study evaluation and assessment procedures\n5. Able to read and understand texts in Dutch at B1 level.\n\nExclusion Criteria:\n\n1. Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms;\n2. Scheduled for lower limb joint surgery within the next year or underwent lower limb joint surgery (total hip, total knee) the last year as surgical interventions could affect outcomes and confound the assessment of treatment effects.","45 Years",{"count":572,"type":22},600,[62],"This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. In the future, these models may help give people with OA the right self-care advice at the right time through a web application called ArtroseCoach.\n\nPeople with OA will take part in this study for one year. Every two weeks, they will fill in online questionnaires covering various aspects of their health and daily functioning, such as pain, daily activities, and participation in life. During the year, participants will be randomly assigned to one of several self-care programs in the ArtroseCoach web app. These programs focus on physical activity, weight management, or sleep. Each program lasts 12 weeks. At four points during the year (weeks 3, 15, 27, and 39), participants will receive one of these programs or no program at all. No one will receive the same program twice.\n\nThe ArtroseCoach web app provides education about OA, lifestyle advice, and tips to support behavior change. The study will help researchers understand which factors are linked to changes in pain and physical functioning over time. This knowledge will be used to improve the ArtroseCoach and other future tools that support people with OA in managing their condition on their own.",[576],"Osteo Arthritis Knee and Hip",[578,579,580,581,582,583,584],"Stepped care","Self-management","Lifestyle behaviours","Movement behaviour","Sleep behaviour","Weight management","Hip and knee osteoarthritis","2026-02-17",{"date":587,"type":42},"2026-02-20",{"date":589,"type":42},"2025-09-01",{"date":591,"type":22},"2027-02",{"name":48,"class":49},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":618,"locationsCount":50},"100556397","phase-1-treatment-of-cancer-with-immune-checkpoint-inhibition-therapy-boosted-by-high-intensity-focused-ultrasound-histotripsy-100556397","NCT06524570","Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy","Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy; the iFOCUS Study","iFOCUS","Inclusion Criteria:\n\n1. Histologically confirmed metastatic or unresectable cancer that progressed under standard of care treatment options.\n2. Age ≥ 18 years.\n3. Has signed and dated written informed consent before performing any study procedure, including screening.\n4. Anticipated life expectancy ≥ 12 weeks by investigator judgement.\n5. At least one tumor lesion (primary tumor or metastasis) which is amenable to application of high intensity focused ultrasound histotripsy (determined by a radiologist with HIFU-expertise).\n\n   * The lesion must have a distance of ≤30 mm to the skin.\n   * At least part of the lesion must have a distance of ≥10 mm to the skin and other vulnerable structures (e.g. large blood vessels). This part should be sufficient to be able to select at least one HT focus in an area of solid tumor.\n\n   Most liver metastases cannot be treated currently (due to their depth, overlying ribs and movement during breathing), some superficial large left-sided and caudally located right-sided liver metastases excepted\n\n   • If the target lesion contains cystic or necrotic regions: the solid component should be ≥10 mm in diameter, sufficient to be able to select at least one HIFU-HT focus in an area of solid tumor with ≥10 mm distance to the skin.\n6. Sonication will be performed on tumors that have not previously directly been treated with radiation therapy or surgery unless they showed significant mass regrowth.\n7. Measurable disease (at least one lesion besides the HIFU-HT treated lesion) on CT according to RECIST V 1.1 criteria (or on PET-CT according to PERCIST criteria) as assessed by investigator and local radiology review.\n8. Performance status of 0 or 1 on the WHO Performance Scale.\n9. Screening laboratory values must meet the following criteria:\n\n   * WBC ≥ 2.0x109\u002FL,\n   * Neutrophils ≥1.5x109\u002FL\n   * Platelets ≥100 x109\u002FL\n   * Hemoglobin ≥5.5 mmol\u002FL\n   * Serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL\u002Fminute (≤Grade 1)\n   * Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN; AST\u002FALT \\\u003C5 x ULN if liver involvement\n   * Serum bilirubin ≤1.5 x ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels \\>1.5xULN, except in subjects with Gilbert's Syndrome\n10. Patients must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of study medication.\n11. Patients must be willing to undergo tumor biopsy.\n12. Sufficient proficiency in the Dutch language to provide informed consent or comply with study procedures\n\nExclusion Criteria:\n\n1. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for ≥4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone ≤10 mg\u002Fday or equivalent.\n2. Patients currently participating and receiving study therapy or patients who participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of the study treatment.\n3. Prior chemotherapy, targeted small molecule therapy or monoclonal antibodies within 4 weeks prior to the first dose of the study treatment.\n4. Prior radiotherapy within 8 weeks prior to the first dose of the study treatment. The patient will be excluded from the study if the only targetable lesion has directly been treated with radiation therapy in the past with an exception for lesions that showed massive regrowth.\n5. Prior surgery or ablative therapy within 4 weeks prior to the first dose of the study treatment. The patient will be excluded from the study if the only targetable lesion has directly been treated with ablative therapy in the past.\n6. Ongoing adverse events \\> Grade 1 due to a previously administered therapy. Subjects with ≤ Grade 2 neuropathy, vitiligo, thyroid disorders, hypocortisolism or alopecia of any grade are an exception to this criterion and may qualify for the study.\n7. History of other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years.\n8. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids; exceeding prednisolone 10 mg or equivalent.\n9. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, high-dose corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n10. Active infection requiring systemic therapy.\n11. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n12. Known history of active Tuberculosis.\n13. Receipt of a live vaccine within 4 weeks prior to the first dose of the study treatment.\n14. Hypersensitivity to any of the study drugs or their excipients.\n15. Contra-indications to MR imaging (e.g. certain pacemakers or severe claustrophobia). Contra-indications to gadolinium-based contrast agents are not an exclusion criterion, as a different brand of gadolinium can be used or if necessary the MRI can be performed without contrast.\n16. Pregnancy or lactation.\n17. Any other medical or social condition that, in the opinion of the Principal Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.",{"count":602,"type":22},24,[269],"This phase 1 clinical trial aims to evaluate the safety, tolerability and feasibility of combination treatment of High Intensity Focused Ultrasound Histotripsy (HIFU-HT) and immune checkpoint inhibitors (ICI) in adult patients with metastatic or unresectable cancer that have progressive disease after regular treatment. Patients will undergo one single session of HIFU-HT during treatment with ipilimumab and nivolumab. Safety, tolerability and feasibility endpoints will be studied as well as radiologic, immunologic and clinical response.",[606,607],"Cancer","Metastatic Cancer",[609,610,611],"Metastasized","Unresectable","Progressive after regular treatment","2026-02-13",{"date":614,"type":42},"2026-02-18",{"date":616,"type":42},"2024-07-26",{"date":536,"type":22},{"name":48,"class":49},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":634,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":50},"100620576","phase-1-mr-guided-radiotherapy-dose-escalation-trial-for-esophageal-squamous-cell-carcinoma-100620576","NCT07359417","MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma","Improving Outcome of Patients With Squamous Cell ESophageal CArcinoma by Dose escaLATion Using High-prEcision Mr-guided Radiotherapy (ESCALATE): a Phase 1 Dose Finding Trial","ESCALATE","Inclusion criteria\n\nIn order to be eligible for this study, a subject must meet all of the following criteria:\n\n* Histologically confirmed squamous cell carcinoma of the esophagus or GE- junction (Siewert I\u002FII)\n* Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT\n* Scheduled to receive neoadjuvant chemoradiotherapy according to CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week), followed by esophagectomy (as judged by the multidisciplinary tumor board)\n* Tumor length ≤ 10 cm\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Signed informed consent\n* Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion criteria\n\nA subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Adenocarcinoma of the esophagus\n* Non-resectable, inoperable or metastatic squamous cell carcinoma of the esophagus or GE-junction\n* Siewert type III\n* Squamous cell carcinoma of the cervical esophagus\n* Prior (chemo)radiotherapy to the mediastinum\n* Prior esophageal surgery that impedes the ability to perform an esophagectomy\n* Patients with multiple primary carcinomas of the esophagus\n* Patients who meet exclusion criteria for MRI\n* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy\n* Pregnant or breast-feeding patients\n* Patients in whom it is not in their best interest to participate (in the judgment of the PI)",{"count":628,"type":22},30,[269],"SUMMARY Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis. Poor disease outcome after surgery alone (5-yr overall survival between 25-40%) prompted many researchers to explore neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant or perioperative chemotherapy (nCT\u002FpCT) approaches. nCRT has led to pathological complete response (pCR) rate in squamous cell EC of almost 50%. Patients with a pCR have a favorable prognosis with 5-year OS \\>50%. In addition, patients who will achieve a pCR might be candidates for an organ preserving treatment strategy. Current standard nCRT consists of a relatively low dose of radiation compared to other tumors in the same area. The investigators hypothesize that increasing the dose of radiation will lead to increased local tumor control and pCR rates.\n\nObjective: The main objective of this study is to determine the maximum tolerated dose (MTD) of 2-fraction boost MRI-guided radiotherapy (MRgRT) for patients with SCC following CROSS therapy. The secondary objectives are feasibility, non-dose limiting toxicity, oncological outcomes and to explore variables for early response evaluation.\n\nStudy design: 6+3 dose-escalation design with 3 radiotherapy dose levels. Study population: Patients with a resectable squamous cell esophageal carcinoma who are eligible for nCRT, surgery and MRgRT.\n\nIntervention: 2 sequential, homogenous boost fractions of 4-7 Gy on the gross tumor volume (GTV) in the week following CROSS using MR-guided online adaptive radiotherapy on the MR-linac. Start in dose level 0, of 2 x 5Gy boost per patient, and if safe this is increased step-wise to a maximum dose level 2 of 2 x 7Gy per patient.\n\nMain study parameters\u002Fendpoints: The primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula\u002F perforation\u002F hemorrhage\u002F necrosis or tracheal, bronchial or bronchopleural fistula\u002Ftracheal or bronchopulmonary hemorrhage grade ≥ 3 or any non-hematological grade 4 toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 14 weeks after the start of radiotherapy and before surgery or the postponing of surgery \\> 14 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and\u002For postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis ≥ 3b according to Clavien-Dindo. Secondary endpoints are non-DLT toxicity, the technical feasibility of dose delivery, perioperative complications, and oncological outcomes including R0 resection rate, histopathological tumor response, local and regional recurrence and death from any cause.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefits for the patients may include higher probability of complete pathological response that initially leads to increased survival and could eventually result in organ-sparing treatment programs. Compared to standard treatment, the CROSS regimen including the sequential boost will take 2 days extra in the final week of CROSS. Possible risks include higher radiation toxicity and surgical complication rates. However, it is expected this increase to be minor, for the investigators will use dose constraints on organs at risk, which are associated with low radiation-induced toxicity, and they will not be exceeded.",[632,633],"Esophageal Squamous Cell Carcinoma (ESCC)","Esophageal Cancer, Squamous Cell",[635,636,637,638,639],"MR-Guided Radiotherapy","Adaptive Radiotherapy","MR-Linac","Dose Escalation","Phase 1 Trial","2026-01-13",{"date":642,"type":42},"2026-01-22",{"date":644,"type":42},"2025-05-30",{"date":646,"type":22},"2028-05-01",{"name":48,"class":49},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":664,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":50},"100620578","phase-1-combination-of-chemotherapy-and-adaptive-mr-guided-radiotherapy-to-improve-outcomes-in-patients-with-esophageal-adenocarcinoma-100620578","NCT07359443","Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma","Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma (MERGE): A Phase 1 Dose-Finding Trial","MERGE","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the esophagus or GE- junction (Siewert I or II)\n* Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT\n* Eligible for neoadjuvant treatment: followed by esophagectomy (as judged by the multidisciplinary tumor board)\n* Eligible for pCT FLOT\n* Tumor length ≤ 10 cm\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Signed informed consent\n* Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)\n* Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Non-resectable, inoperable or metastatic adenocarcinoma of the esophagus or GE junction\n* Siewert type III tumors\n* Prior (chemo)radiotherapy to the mediastinum\n* Prior esophageal surgery that impedes the ability to perform an esophagectomy\n* Patients with multiple primary carcinomas of the esophagus\n* Patients who meet exclusion criteria for MRI according to the MRI contraindications screening list of the imaging and oncology division of the UMC Utrecht\n\n  \\* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy\n* Pregnant or breast-feeding patients\n* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration. Patients in whom it is not in their best interest to participate (in the judgment of the PI)",{"count":657,"type":22},39,[269],"Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis. Poor disease outcome after surgery alone (5-yr overall survival between 25-40%) prompted many researchers to explore neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant or perioperative chemotherapy (nCT\u002FpCT) approaches.\n\nIn the Netherlands, neoadjuvant chemoradiation has become standard of care for esophageal cancer since publication of the CROSS trial showing a benefit of nCRT over surgery alone for both adenocarcinoma (AC) and squamous cell carcinoma (SCC) (van Hagen et al., 2012). However, the benefit of nCRT was less pronounced in AC, which was also reflected by pathologic complete response (pCR) rates: 23% in AC vs. 49% in SCC. Furthermore, SCC and AC differ in patterns of recurrence after nCRT or chemotherapy. AC is more likely to develop distant metastases while SCC has a predisposition for locoregional recurrences. This difference in response to nCRT and in recurrence pattern indicates that histology-tailored treatment strategies should be explored. In the modern multidisciplinary discussion on the optimal approach to locally advanced adenocarcinoma of the esophagus and junction, both a trimodiality approach or perioperative chemotherapy are acceptable and evidence based. Therefore both are viable options within current guidelines.\n\nAs mentioned above, patients with an AC of the esophagus are especially prone to develop distant recurrences. In addition, response to nCRT is only moderate in AC. Therefore, the investigators hypothesize that the ideal neoadjuvant treatment should consist of adding MR-guided radiotherapy to standard pCT in order to achieve maximum systemic control and achieve maximum local control.\n\nObjective: The main objective of this study is to determine the maximum tolerated dose (MTD) of 5 fractions MRgRT for patients with AC following FLOT therapy. The secondary objectives are feasibility, non-dose limiting toxicity, oncological outcomes and to explore variables for early response evaluation.\n\nStudy design: 6+3 dose-escalation design with 4 radiotherapy dose levels. Study population: Patients with a resectable esophageal adenocarcinoma who are eligible for nCRT and surgery and who are eligible for MRgRT.\n\nIntervention: 5 sequential, homogenous fractions of 4-8 Gy within 2 weeks on the gross tumor volume (GTV) following preoperative FLOT (as part of standard perioperative chemotherapy) using MR-guided online adaptive radiotherapy on the MR-linac. Start in dose level 0, of 5 x 5Gy per patient, and if safe this is increased step-wise to a maximum dose level 3 of 5 x 8Gy per patient.\n\nMain study parameters\u002Fendpoints: The primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula\u002F perforation\u002F hemorrhage\u002F necrosis or tracheal, bronchial or bronchopleural fistula\u002Ftracheal or bronchopulmonary hemorrhage grade ≥ 3 or any non-hematological grade ≥ toxicity, assessed clinically significant and related to the radiotherapy, according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 16 weeks after the start of radiotherapy and before surgery or postponing of surgery \\> 16 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and\u002For postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis ≥ 3b according to Clavien-Dindo.\n\nSecondary endpoints are non-DLT toxicity, the technical feasibility of dose delivery, perioperative complications. and oncological outcomes including R0 resection rate, histopathological tumor response, local and regional recurrence and death from any cause.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefits for the patients may include higher probability of complete primary tumor and lymph node metastases response that initially lead to increased survival and could eventually result in organ-sparing treatment programs. Possible risks are mainly esophageal fistula\u002Fperforation and broncho-esophageal fistula or hemorrhage.",[661,662,663],"Esophageal Adenocarcinoma","Esophageal Adenocarcinoma (EAC)","Adenocarcinoma - Gastroesophageal Junction (GEJ)",[635,636,637,638,639],{"date":642,"type":42},{"date":667,"type":42},"2025-05-21",{"date":646,"type":22},{"name":48,"class":49},{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":50},"100545882","artificial-intelligence-in-anoca-100545882","NCT06387693","Artificial Intelligence in ANOCA","Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease","(AI)NOCA","Inclusion Criteria:\n\n1. Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.\n2. Absence of obstructive coronary artery disease with an indication for revascularization, documented by means of recent coronary computed tomography angiography (CCTA) or invasive coronary angiography (with invasive coronary pressure measurements if clinically indicated).\n3. Patient is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Absence of chest discomfort after initiation of medical therapy.\n2. Language barrier preventing sufficient understanding and communication in Dutch.",{"count":679,"type":22},250,[62],"Angina pectoris is diagnosed in \\>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.\n\nThe origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.\n\nDuring CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.",[683],"Angina, Stable","2026-01-08",{"date":686,"type":42},"2026-01-12",{"date":688,"type":42},"2024-12-03",{"date":690,"type":22},"2028-12",{"name":48,"class":49},""]