[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Radboud University Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":670},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,95,0,25,[9,39,66,94,121,150,171,197,226,247,279,305,329,361,389,416,442,469,498,523,552,574,599,627,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100459804","an-european-multi-centre-cohort-study-for-unravelling-pharmacokinetic-and-genetic-factors-underlying-post-ercp-pancreatitis-100459804",false,"NCT05267379","An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis","G-PEP","Inclusion Criteria:\n\n* Age ≥ 18 years\n* written informed consent\n* Indication to undergo an ERCP\n\nExclusion Criteria:\n\n* Pancreatic cancer\n* Chronic pancreatitis\n* Ongoing acute pancreatitis\n* Altered anatomy, defined as anatomical variations in which gall and\u002For pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.","ALL","18 Years",{"count":20,"type":21},700,"ESTIMATED","OBSERVATIONAL","Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.",[25],"Post-ERCP Acute Pancreatitis","RECRUITING","2026-08-20",{"date":29,"type":30},"2026-08-21","ACTUAL",{"date":32,"type":30},"2022-03-01",{"date":34,"type":21},"2027-12-01",{"name":36,"class":37},"Radboud University Medical Center","OTHER",1,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100652860","pulsed-field-ablation-for-atrial-fibrillation-using-the-varipulse-catheter-100652860","NCT07779369","Pulsed Field Ablation for Atrial Fibrillation Using the VARIPULSE™ Catheter","VARI-POWER","Inclusion Criteria:\n\n* ≥18 years of age\n* AF and eligible for index PVI according to current ESC guidelines\n\nExclusion Criteria:\n\n* Unwilling or unable to give written informed consent\n* Prior left atrial ablation\n* Other left atrial arrhythmias including atrial flutters\n* Prior left atrial surgery\n* Severe mitral valve regurgitation\n* Contraindication for gadolinium-based contrast agents\n* Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)\n* Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin)",{"count":47,"type":21},40,"INTERVENTIONAL",[50],"NA","Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Pulsed field ablation (PFA) offers a non-thermal, tissue-specific alternative that may provide more durable isolation while also reducing procedural risks. While early data for the CE-marked VARIPULSE™ PFA system are promising, long-term lesion durability remains mostly unquantified. To obtain a definitive estimate of PFA effectiveness, a systematic invasive re-mapping approach is required. Advanced cardiac magnetic resonance (CMR) imaging can quantify atrial fibrosis after PVI across different ablation modalities, but it is unknown how well these imaging findings correspond with invasive electrical mapping. In the current study, CMR serves as a complementary modality to explore whether imaging-based tissue changes align with invasively confirmed long-term isolation.\n\nObjective: The primary objective is to evaluate the long-term durability of pulmonary vein isolation (PVI) using the VARIPULSE™ Pro PFA system, as defined by the rate of electrical reconnection during systematic invasive re-mapping at three months.\n\nStudy design: Prospective multicenter intervention study. Study population: Patients ≥ 18 years old, eligible for primary PVI according to ESC guidelines, without contraindications for gadolinium-based contrast-enhanced CMR imaging.\n\nIntervention: Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections.\n\nMain study parameters\u002Fendpoints: Primary outcome measure: Patient-level PV lesion durability. Secondary outcome measures: Percentage chronic isolation for each PV; Location of reconnection during re-map and lesion characteristics; Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure); Procedural fluoroscopy time and radiation dose; Percentage direct isolation for each pulmonary vein (PV); Acute PV reconnection for each PV; Percentage freedom from atrial achyarrhythmias at 12 months follow-up; Incidence of procedure related adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation involves standard PVI care with additional CMR imaging and an invasive re-map procedure. Early studies show that PFA with the VARIPULSE™ catheter is safe, and the extra imaging adds only minimal burden or risk. The re-map study carries the same risks as standard ablation. Overall, the study is expected to provide valuable insights that may further improve patient care and outcomes in atrial fibrillation.",[53],"Atrial Fibrillation (AF)",[55,56,57],"Atrial Fibrillation","Pulsed Field Ablation","LGE-CMR","NOT_YET_RECRUITING","2026-08-19",{"date":29,"type":30},{"date":62,"type":21},"2026-09",{"date":64,"type":21},"2028-09",{"name":36,"class":37},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":48,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100499457","a-multicomponent-intervention-program-to-prevent-and-reduce-icu-agitation-and-physical-restraint-use-100499457","NCT05783505","A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use","PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention","PRAISE","Inclusion criteria:\n\n* Adult ICU patients (aged ≥18) with an expected ICU stay of \\>24 hours\n* Patients who are (expected to become) agitated within the first 14 days of their ICU admission\n\nExclusion criteria:\n\n* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known\u002Fsuspected hypersensitivity);\n* Neurological patients with an (expected risk of) increased intracranial pressure;\n* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);\n* Support with Extracorporeal Membrane Oxygenation (ECMO);\n* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);\n* A high risk of physical aggression towards healthcare professionals;\n* No consent for long term follow up in the MONITOR-IC study;\n* Not able to read or understand the Dutch language and no relatives able to assist;\n* Enrolment in other sedation studies.",{"count":75,"type":21},480,[50],"Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.",[79],"Agitation,Psychomotor",[81,82,83,84,85],"ICU","Agitation","Physical Restraints","Non-pharmacologic interventions","Dexmedetomidine","2026-08-18",{"date":27,"type":30},{"date":89,"type":30},"2023-06-01",{"date":91,"type":21},"2026-10-01",{"name":36,"class":37},5,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":48,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":38},"100633713","phase-1-deposition-of-inhaled-liposomal-amphotericin-b-in-chronic-pulmonary-aspergillosis-cpa-100633713","NCT07530263","Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)","Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study","NIMBUS","Inclusion Criteria:\n\n* The patient is at least 18 years old on the day of inclusion.\n* The patients has been diagnosed with chronic pulmonary aspergillosis.\n* There is no significant interference with standard care and follow-up.\n\nExclusion Criteria:\n\n* The patient is breastfeeding, or of childbearing potential and is pregnant, planning to become pregnant within 3 months of the SPECT imaging, unable to provide a negative pregnancy test at screening, or unwilling to use effective contraception during the study and for at least 3 months after the last SPECT scan.\n* The patient is not able to lie supine in the scanner.\n* The patient has previously reported intolerance to inhalation medication.\n* The patient is unable to provide informed consent due to lack of decision-making capacity.",{"count":103,"type":21},18,[105],"PHASE1","This study evaluates and aims to optimize inhalation treatment with nebulized liposomal amphotericin B in patients with chronic pulmonary aspergillosis. The primary objective is to assess the pulmonary deposition and intrapulmonary distribution of liposomal amphotericin B after nebulization, using technetium-99m-labeled liposomal amphotericin B and SPECT\u002FCT imaging. The study also aims to generate data to inform optimization of inhalation treatment design.\n\nParticipants will receive two different doses of nebulized liposomal amphotericin B (12 mg and 24 mg) on separate study days. After each administration, participants will undergo SPECT\u002FCT imaging to assess pulmonary deposition. Blood samples will be collected on both study days and after study treatment to evaluate safety and measure systemic amphotericin B concentrations. Participants will also perform spirometry using a handheld device and complete a treatment satisfaction questionnaire on both study days.",[108],"Chronic Pulmonary Aspergillosis",[110,111,112,113,114],"ambisome","liposomal amphotericin B","nebulization","chronic pulmonary aspergillosis","deposition","2026-08-17",{"date":86,"type":30},{"date":91,"type":21},{"date":119,"type":21},"2027-06-01",{"name":36,"class":37},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":48,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":38},"100624635","phase-1-preventive-dendritic-cell-vaccination-for-lynch-syndrome-100624635","NCT07412197","Preventive Dendritic Cell Vaccination for Lynch Syndrome","Targeting Cancer Neoantigens Through Multi-Epitope Vaccination for Tumour Prevention in Lynch Syndrome: a Phase I\u002FII Clinical Trial.","PREVENT-Lynch","Inclusion Criteria:\n\n* a confirmed gPV in MLH1 or MSH2 and without a prior history of MMR-D cancer.\n* a confirmed gPV in MSH6, whether or not they have a history of MMR-D cancer. MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year.\n* previous surgical treatment may include any resection up to and including hemicolectomy; subjects who have undergone (sub)total colectomy are excluded due to the substantially reduced risk of cancer occurrence.\n* aged between 35 and 75 for subjects with gPV in MLH1 and MSH2; and aged between 40 and 75 for subjects with gPV in MSH6.\n* Lynch syndrome subjects without clinical signs of disease.\n* Lynch syndrome subjects with a prior history of colorectal premalignancies with at least 1 adenoma sample archived.\n* Lynch syndrome subjects without prior treatment for LS-associated cancer, except for MSH6 subjects who are \\>1 year disease-free and whose prior surgical treatment did not include subtotal colectomy.\n* Routine surveillance colonoscopy must be performed within 16 weeks prior to start of study, to exclude (pre)malignancy.\n* HLA-A02.01 genotype\n* Adequate hematologic, renal, and liver function as defined by laboratory values: WBC \\>3.0\\^109\u002Fl, lymphocytes \\>0.8\\^109\u002Fl, platelets \\>100\\^109\u002Fl, haemoglobin \\>7,0 mmol\u002Fl (9.0 g\u002Fdl), estimated glomerular filtration rate \\> 45 ml\u002Fmin\u002F1.73m2, AST\u002FALT \\\u003C3 x ULN, serum crea¬tinine \\\u003C150 µmol\u002Fl, serum bilirubin \\\u003C1.5 x ULN (exception: Gilbert's syndrome is permitted).\n* WHO performance status of 0 or 1\n* No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted.\n* No uncontrolled infectious disease, i.e., negative testing for HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and syphilis (Treponema Pallidum Hemagglutination Assay (TPHA)).\n* No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Subjects with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.\n* No serious (bleeding and clotting) condition that may interfere with safe leukapheresis.\n* No pregnant or lactating women. hCG tests will be performed regularly during the trial to confirm absence of pregnancy.\n* No Women Of Child-Bearing Potential (WOCBP) or male partners of WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \\[defined as amenorrhea \\> 12 consecutive months\\].\n* Subjects must have absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the subject before registration in the trial.\n* Expected adequacy of follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Individuals with a history of malignancy in the past. Allowed malignancies are adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ (e.g., DCIS\u002FLCIS\u002Fcervical CIS), papillary thyroid carcinoma, and low-risk prostate carcinoma; all locally resected with negative surgical margins and not treated with systemic therapy.\n* Organ allografts.\n* Known allergy to shellfish.\n* Inability to understand and communicate in Dutch.","35 Years","75 Years",{"count":132,"type":21},16,[105,134],"PHASE2","The aim of this study is to assess safety, immunogenicity and feasibility of vaccination with neopeptide-loaded dendritic cells in Lynch Syndrome subjects who are known to be carrier of a germline MMR-gene mutation without signs of disease.",[137],"Lynch Syndrome",[139,140,141,137,142,143],"Dendritic cells","Cancer vaccine","Hereditary cancer","Prevention","Neoantigens",{"date":59,"type":30},{"date":146,"type":21},"2026-10",{"date":148,"type":21},"2036-06",{"name":36,"class":37},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":48,"phases":160,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":38},"100593649","early-phase-1-tgw211-for-click-cleavable-imaging-in-her2-positive-cancers-100593649","NCT07009184","TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.","TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers, a Phase 0\u002FI Study.","CleavHER","Inclusion Criteria:\n\n1. Signed, written informed consent and willing and able to comply with study requirements.\n2. Male or Female aged ≥ 18 years.\n3. Histologically confirmed HER2-positive cancer (IHC 3+ or IHC 2+ AND FISH+) with at least 1 measurable target lesion of at least 10 mm on CT or MRI based on RECIST v1.1, assessed by the investigator to enable adequate SPECT\u002FCT imaging.\n4. WHO performance status (ECOG) of 0 or 1.\n5. Adequate organ and bone marrow function, evidenced by the following laboratory results:\n\n   1. Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002Fl;\n   2. Platelet count ≥ 100 x 10\\^9 \u002Fl;\n   3. Hemoglobin ≥ 9.0 g\u002Fdl or 5.6 mmol\u002Fl;\n   4. Total bilirubin ≤ 1.5 x the upper limit of normal (ULN);\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases);\n   6. Serum creatinine ≤ 1.5 x ULN; - Estimated Glomerular Filtration Rate (eGFR)\\* ≥ 60 ml\u002Fmin\u002F1.73 m2 ; \\*preferably calculated with CKD-EPI formula.\n\nExclusion Criteria:\n\n1. Medical history of myocardial infarction within 6 months before participation or symptomatic CHF (New York Heart Association Class III to IV).\n2. QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec on screening ECG or congenital long QT syndrome.\n3. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids or has current or suspected ILD\u002Fpneumonitis.\n4. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g, pulmonary embolism within 3 months of trial participation, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.).\n5. Has an uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals.\n6. Participation in another clinical study with an investigational product during the past 6 weeks.\n7. Concurrent enrolment in another clinical study unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.\n8. Pregnant or breastfeeding women, where pregnancy is defined as the time between conception and termination of gestation, confirmed by a positive urinary or serum pregnancy test.\n9. Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant and no evidence of post-menopausal status, unless they use highly effective methods of contraception or abstain from sexual activity for 30 days after investigational drug administration. Male partners of female patients should also use a condom during intercourse for 30 days after investigational drug administration to the partner to prevent them from fathering a child.\n10. Male patients in the reproductive age, not willing or able to use a condom or abstain from sexual activity for 30 days after investigational drug administration. WOCBP partners of sexually active male patients should also use a highly effective contraception method during intercourse for 30 days after investigational drug administration of the partner.\n11. Known allergy or hypersensitivity to any of the investigational drugs or its excipients.\n12. Any condition which, in the opinion of the investigator, would preclude participation in the study.\n13. Second active malignancy.",{"count":159,"type":21},19,[161],"EARLY_PHASE1","In recent years, there is increasing interest in antibodies for imaging, antibody-drug conjugates (ADC) and targeted radionuclide therapy (TRT). With these techniques, antibodies are used as a vector to deliver a cytotoxic drug or radionuclide for therapy or nuclear medicine imaging. One such antibody-based vector suitable for delivering a cytotoxic drug or radionuclide is trastuzumab, which targets HER2 that is overexpressed in cancers such as breast, gastric and gastroesophageal junction carcinomas. Unfortunately, antibodies generally have a very long circulation time (\\>20-30 days) that often result in unfavorable background noise in the healthy organs in imaging or toxicity when trastuzumab is bound to a therapeutic radionuclide for radioimmunotherapy. There is thus a need to increase the speed of excretion of antibodies or release the antibody from its payload. Ideally, the clinician would like to appropriately time the elimination of radioactivity to achieve an optimal tumor to non-tumor ratio. To this aim, Tagworks Pharmaceuticals developed a new class of chemically cleavable radiolabeled conjugates that release the radiolabel on demand upon reaction with a small molecule \"the trigger\" (TRG001).",[164],"HER2 Positive Solid Tumor",{"date":86,"type":30},{"date":167,"type":30},"2026-04-02",{"date":169,"type":21},"2026-12",{"name":36,"class":37},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":48,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":93},"100646205","timing-of-immunotherapy-in-melanoma-100646205","NCT07696715","Timing of Immunotherapy in Melanoma","Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm","TIME-NL","Inclusion Criteria:\n\n* Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.\n* At least 18 years of age.\n* World Health Organization (WHO) Performance Status 0-1.\n* Measurable disease according to RECIST 1.1.\n* Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Uveal or mucosal melanoma (unknown primary melanoma is allowed).\n* Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.\n* Use of adrenal replacement medications, e.g. hydrocortisone.\n* Use of melatonin agonists.\n* Prior systemic therapy for irresectable\u002Fmetastatic melanoma (prior T-VEC is allowed)\n* Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago).\n* Use of investigational drugs.",{"count":180,"type":21},170,[50],"The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.",[184],"Melanoma",[186,187,188],"melanoma","chronoimmunotherapy","timing","2026-08-12",{"date":191,"type":30},"2026-08-13",{"date":193,"type":30},"2026-08-10",{"date":195,"type":21},"2033-09-30",{"name":36,"class":37},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":207,"studyType":22,"phases":4,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":38},"100613957","a-study-on-how-the-immune-system-responds-to-sepsis-and-its-long-term-effects-100613957","NCT07273344","A Study on How the Immune System Responds to Sepsis and Its Long-term Effects","A Systems Immunology Approach to Characterize the Immune Response in Sepsis and Its Long-term Complications","HEAL-SEPSIS","Inclusion Criteria:\n\n* Adults (≥18years).\n* Sepsis 3 criteria: defined as having a suspected or documented infection accompanied by organ dysfunction, represented by a total Sequential Organ Failure Assessment (SOFA-2) score 2 or more for new admissions or as 2 or more point-increase of the total SOFA-2 score for hospitalized patients.\n\nExclusion Criteria:\n\n* Known chemotherapy-induced or long-term neutropenia.\n* Known CD4 counts \\\u003C400 cells\u002FµL.\n* History of primary immunodeficiency\n* Chronic intake of corticosteroids (defined as total daily dose equal or greater than 0.4 mg\u002Fkg of equivalent prednisone for more than the last 15 days).\n* Current use of biologics.\n* Solid organ transplant recipients.\n* Recipients of allogeneic bone marrow transplants.",{"count":206,"type":21},400,"1 Year","Sepsis occurs when an infection, caused by bacteria, a virus, or a fungus, enters the body and throws the immune system out of balance. Instead of protecting the body, the immune response may become too strong and start damaging healthy organs, or it may become too weak and fail to control the infection. Both situations can be life-threatening. Even people who survive sepsis may experience long-term health problems, such as new infections, heart and blood vessel diseases, or early death.\n\nThis study aims to better understand how the immune system behaves during and after sepsis. We believe that there are different types of immune responses in sepsis, called immunotypes. We will identify these immunotypes by examining substances in the blood and changes in immune cells. We will then study which immunotypes help protect patients and which may cause short- or long-term harm.\n\nUnderstanding these immunotypes may make it possible in the future to quickly determine what type of immune response a patient with sepsis has. This could help doctors choose the best treatment for each individual patient.\n\nA total of 400 patients with sepsis from the intensive care unit will take part in this study. We will collect blood samples at several time points and gather information about their health. Participants will be followed from their intensive care admission until one year after they return home.",[210],"Sepsis",[212,213,214,215,216,217,218],"observational","sepsis","cohort study","immune endotypes","endotypes","immunotypes","post-sepsis syndrome",{"date":220,"type":30},"2026-08-14",{"date":222,"type":30},"2025-11-03",{"date":224,"type":21},"2028-12-01",{"name":36,"class":37},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":234,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":48,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":38},"100532201","vegetarian-diet-and-innate-immunity-in-patients-with-myocardial-infarction-and-in-healthy-volunteers-fresh-mi-study-100532201","NCT06209723","Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)","Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)","FRESH-MI","Inclusion Criteria for patients:\n\n* Acute myocardial infarction (STEMI\u002FNSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \\\u003C1 week before randomisation\n* Body mass index between 18.5 and 35 kg\u002Fm2\n* Written informed consent\n\nInclusion Criteria for healthy volunteers (life partners \u002F souses)\n\n* Body mass index between 18.5 and 35 kg\u002Fm2\n* Written informed consent\n\nExclusion Criteria for patients and healthy volunteers:\n\n* Already on a vegetarian or vegan diet\n* Previous myocardial infarction\n* Diabetes Mellitus\n* Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)\n* Use of immunomodulatory drugs\n* Vaccination less than one month before start of intervention\n* Clinically significant infections within 1 months prior to start of intervention (defined as fever \\>38.5 degrees Celsius)\n* Active malignant haematological disease\n* Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)\n\nExclusion Criteria for healthy volunteers\n\n\\- Use of lipid lowering therapy",true,{"count":236,"type":21},120,[50],"The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.",[240],"Myocardial Infarction",{"date":220,"type":30},{"date":243,"type":30},"2024-01-26",{"date":245,"type":21},"2027-09-01",{"name":36,"class":37},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":48,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100623688","plant-based-versus-animal-based-oral-nutritional-supplements-100623688","NCT07399886","Plant-based Versus Animal-based Oral Nutritional Supplements","PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study","PAVOS","Inclusion Criteria:\n\n* Clinical patients with cancer and lung diseases, cardiology patients, patients with cardiothoracic surgery, and orthopaedic patients age ≥18 years, and treated at Radboudumc or Maastricht UMC+.\n* Patients who have been advised at least 2 bottles of ONS daily based on a high risk of malnutrition (MUST≥2, PG-SGA-SF≥ 9) and\u002For by the dietitians expertise.\n* Written informed consent (IC)\n\nExclusion Criteria:\n\n* Patients who are or become dependent on tube or parenteral nutrition\n* Patients where life-extending therapy is no longer possible\n* Unable to follow up study instructions\n* Lactose intolerance\n* Soy allergy\u002Fintolerance\n* Vegan diet",{"count":256,"type":21},60,[50],"Background information:\n\nMany people who are admitted to the hospital are at risk of malnutrition. In some patient groups, this can be as high as 40%. When someone is not eating enough, the dietitian often recommends oral nutritional supplements (ONS). These are energy- and protein-rich drinks that help patients get enough nutrition. They can reduce complications, lower the chance of being readmitted to the hospital, and help improve body weight and physical functioning.\n\nIn the Netherlands, the Ministry of Health and the Dutch Federation of University Medical Centers have signed the Green Deal \"Working together on sustainable care.\" One of the goals is to make healthcare greener and climate-neutral by 2026. This also applies to medical and non-medical nutrition, including ONS.\n\nBecause of this, there is increasing attention on developing ONS that contain more plant-based proteins, which may be more sustainable.\n\nWhat do will the investigators find out?\n\nIt is unknown how plant-based ONS work when patients use them for a longer period of time. For example:\n\n* Do they help patients get enough energy and protein?\n* What are the effects on physical and clinical outcomes? Before a large study with many patients is started, it is important to first test whether this type of research is feasible.\n\nFeasibility in terms of\n\n* Recruitment rate\n* Drop-out rate\n* Adherence to the ONS advice\n* Study measurements (succesfull vs unsuccesfull measurements)\n\nTo answer these questions, a smaller pilot study will be conducted in which plant-based ONS will be compared to animal-based ONS.\n\nWhat does this study look like?\n\nInclusion criteria:\n\nPatients from the departments of medical oncology, lung diseases, cardiology, cardiothoracic surgery, and orthopedics at Maastricht UMC+ and Radboudumc. These are patients who are currently not eating enough.\n\nThese patients receive advice from the dietitian to take at least two bottles of ONS per day. If they want to participate in the study, they will be randomly assigned to one of two products:\n\n* Animal-based (milk protein): Fresubin YoDrink Raspberry©\n* Plant-based (soy protein): Fresubin Plant-Based Drink Vanilla©\n\nMeasurements will be performed at the start of the study and again after three months. In the meantime, the researcher will contact the patient twice by phone to ask how things are going.",[260],"Risk of Malnutrition",[262,263,264,265,266,267,268,269,270],"plant-based ONS","animal-based ONS","Risk of malnutrition","pilot feasibility","hospitalized patients","oral nutritional drinks","plant protein","sustainability","medical nutrition",{"date":272,"type":30},"2026-08-11",{"date":274,"type":30},"2025-11-10",{"date":276,"type":21},"2026-11-01",{"name":36,"class":37},2,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":48,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":278},"100604979","protein-supplementation-and-resistance-training-to-prevent-fat-free-mass-loss-following-metabolic-bariatric-surgery-100604979","NCT07156552","Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery","Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study","ENRICHED","Inclusion Criteria:\n\n* A scheduled metabolic-bariatric surgery (i.e. RYGB or Sleeve Gastrectomy)\n* Participation in the NOK care program\n* Able to understand and perform the study procedures\n\nExclusion Criteria:\n\n* Allergic or sensitive for milk proteins, or lactose intolerant\n* Diagnosed renal insufficiency\n* Diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease",{"count":206,"type":21},[50],"The goal of this clinical trial is to investigate the effects of daily protein supplementation and participation in a weekly supervised resistance training program on the prevention of excessive muscle mass loss following bariatric surgery. Patients treated at one of the participating centers will be invited to participate and will be randomly assigned to one of two groups.\n\nParticipants in group 1 will receive standard postoperative care as currently provided. Participants in group 2 will also receive standard care, but in addition, they will be asked to consume extra protein daily and take part in a supervised resistance training session once a week.\n\nPrevious research has shown that approximately one in five patients undergoing bariatric surgery experiences excessive muscle loss after the surgery. It is known that resistance training and protein intake can help maintain and even improve muscle mass. However, limited research has been conducted on the combined effects of protein supplementation and resistance training in patients after bariatric surgery. Therefore, the aim of this trial is to determine whether participants receiving the additional intervention experience less muscle mass loss compared to those receiving standard care alone.",[291,292],"Bariatric Surgery","Fat Free Mass",[294,291,295,296,297,298],"Metabolic-Bariatric Surgery","Sleeve Gastrectomy","Roux-en Y Gastric Bypass","Protein Supplementation","Resistance Training",{"date":272,"type":30},{"date":301,"type":30},"2025-06-20",{"date":303,"type":21},"2027-12-31",{"name":36,"class":37},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":48,"phases":317,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":38},"100551865","phase-4-methylphenidate-in-kbg-syndrome-n-of-1-series-100551865","NCT06465641","Methylphenidate in KBG Syndrome: N-of-1 Series","Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series","KBGS_N_of_1","Inclusion Criteria:\n\n* Age 6-20 years\n* Molecularly confirmed diagnosis of KBG syndrome (pathogenic ANKRD11 variant or a chromosome 16q24 deletion including ANKRD11)\n* Attention deficit or ADHD-related symptoms or a formal ADHD diagnosis, with a significant impact on daily life\\*\n* Presence of a subject's caregiver or supervisor for proxy-reports\n\nExclusion Criteria:\n\n* Family history of acute cardiac death that warrants further cardiac investigation\n* Cardiovascular disease in medical history (severe hypertension, heart failure, arterial occlusive disease, potentially life-threatening arrythmias, angina pectoris, hemodynamically significant congenital heart defect, cardiomyopathy, myocardial infarction and channelopathy)\n* Current or previous presence of hyperthyroidism, glaucoma or pheochromocytoma\n* Use of (psychotropic\u002Fstimulant) drugs which interact with MPH\n* Schizophrenic or psychotic disorder in medical history\n* Unstable epilepsy (not controlled with medication)\n* History of frequent drug and\u002For alcohol abuse\n* Excessive alcohol\u002Fdrug use and\u002For intoxication with one or both during the study\n* Pregnant or lactating women\n* Inability to understand or speak Dutch","6 Years","20 Years",{"count":316,"type":21},15,[318],"PHASE4","The goal of this clinical trial\\] is to learn about the effect of methylphenidate in children and adolescents with KBG syndrome. The main question it aims to answer is:\n\n• What is the effectiveness of methylphenidate on attention deficit and ADHD-related symptoms in children and adolescents with KBG syndrome?\n\nParticipants will receive multiple blocks of treatment with methylphenidate and placebo and fill out various questionnaires.",[321,322],"Kbg Syndrome","ADHD - Combined Type",{"date":272,"type":30},{"date":325,"type":30},"2024-11-13",{"date":327,"type":21},"2028-10-01",{"name":36,"class":37},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":337,"minAge":338,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":48,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100608354","individualised-endometrial-cancer-risk-stratification-by-bayesian-prediction-model-endorisk-optimizing-clinical-implementation-100608354","NCT07200466","Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation","ENDORISK Clinical Implementation Study","ENDORISK-I","Inclusion Criteria:\n\n* Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)\n* Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* No understanding of Dutch or English language\n* Rare types of endometrial cancer, such as endometrial stroma cell sarcoma","FEMALE","45 Years",{"count":340,"type":21},735,[50],"Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters\u002Fendpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating:\n\n* The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care\n* Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care\n* Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care\n* Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care\n* Patients' and doctors' use of and experiences with the ENDORISK-model\n* Impact of ENDORISK on regional care costs",[344],"Endometrial Cancer",[346,344,347,348,349,350,351],"ENDORISK","surgical staging","risk stratification","lymph node metastases","lymphadenectomy","sentinel node","2026-07-28",{"date":354,"type":30},"2026-07-29",{"date":356,"type":30},"2025-10-23",{"date":358,"type":21},"2032-10-16",{"name":36,"class":37},14,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":234,"sex":17,"minAge":18,"maxAge":338,"enrollmentInfo":369,"targetDuration":4,"studyType":48,"phases":371,"briefSummary":372,"conditions":373,"keywords":378,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":38},"100648220","clinical-performance-of-cadcam-occlusal-splints-fabricated-with-or-without-a-wax-bite-registration-in-healthy-adults-100648220","NCT07720453","Clinical Performance of CAD\u002FCAM Occlusal Splints Fabricated With or Without a Wax Bite Registration in Healthy Adults","Clinical Performance of CAD\u002FCAM Occlusal Splints Fabricated With or Without Wax Bite Registration: A Randomized Crossover Clinical Trial","Splint","Inclusion criteria:\n\n* Subjects aged 18-45 years\n* Subjects with an ASA physical status classification of I-III.\n* Subjects with healthy complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)\n* Subjects willing and able to participate in the study\n* Subjects willing to provide written informed consent for their participation in the study\n\nExclusion Criteria:\n\n* Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints\n* Subjects with a history of autoimmune disorders\n* Subjects with known allergies to acrylic materials\n* Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment\n* Subjects who are pregnant or lactating\n* Subjects enrolled in another investigational clinical trial",{"count":370,"type":21},30,[50],"Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD\u002FCAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal intercuspation.\n\nThis randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required during insertion",[374,375,376,377],"Occlusion","Occlusal Splints","Occlusal Analysis","Comfort",[379,380],"Milled splints","Prospective clinical randomized crossover study","2026-07-24",{"date":383,"type":30},"2026-07-27",{"date":385,"type":21},"2026-09-01",{"date":387,"type":21},"2027-01-31",{"name":36,"class":37},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":48,"phases":398,"briefSummary":399,"conditions":400,"keywords":405,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":278},"100646625","phase-2-dietary-fiber-to-induce-gut-microbiota-mediated-response-to-immunotherapy-in-melanoma-100646625","NCT07686835","Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.","FIGURE-IM","Inclusion Criteria:\n\n* Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease\n* Measurable disease according to RECIST 1.1 criteria\n* Age ≥ 18 years\n* Starting standard-of-care treatment with ICI in first line\n* Written informed consent must be given\n* Able to read and understand Dutch or English\n* Able to comply with study procedures (e.g. willing to provide fecal samples)\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago\n* Use of systemic immunosuppressive medications\n* Use of laxatives up to 1 week prior to start of ICI\n* Use of supplements that alter bowel function or gut microbiota such as fibers\u002Fprebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI\n* Use of antibiotics up to 1 months prior to start of ICI\n* Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI\n* Pregnant or lactating\n* Current participation in another clinical trial requiring the use of study medication\n* Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.\n* Has a medical history of gastrointestinal resection (appendectomy is allowed)\n* Has active inflammatory bowel disease",{"count":397,"type":21},70,[134],"Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.",[401,402,403,404,184],"Melanoma (Skin) Stage IV","Melanoma (Skin Cancer)","Melanoma Metastatic","Melanoma Advanced",[406,407,408,409],"microbiota","gut microbiota","dietary fiber","life-style",{"date":383,"type":30},{"date":412,"type":21},"2026-07-31",{"date":414,"type":21},"2029-04-30",{"name":36,"class":37},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":48,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":278},"100645314","promoting-response-to-immunotherapy-by-exercise-in-patients-with-advanced-renal-cell-carcinoma-100645314","NCT07680556","Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma","PRIMER","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment.\n* Able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C6 months.\n* Unable to perform basic activities of daily living such as walking.\n* Presence of cognitive impairment or severe emotional instability (e.g. schizophrenia, Alzheimer's disease, alcohol addiction), at the discretion of the investigator.\n* Presence of other disabling comorbidities that may interfere with the ability to perform physical exercise (e.g., heart failure, chronic obstructive pulmonary disease (COPD, GOLD stage 3 or 4), orthopaedic conditions, or neurological disorders such as hernia, paresis, amputation or active rheumatoid arthritis), at the discretion of the investigator.\n* Current participation in structured vigorous aerobic and\u002For resistance exercise ≥ 2 times per week at a level comparable to the intervention",{"count":370,"type":21},[50],"The primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients with advanced renal cell carcinoma (RCC). The second aim is to generate preliminary data on the effects of exercise on the immune cell phenotype and function, gut microbiota composition, physical fitness, patient-reported outcomes and clinical outcomes.\n\nThis is a two-arm randomized controlled pilot trial in which 30 patients with advanced RCC scheduled to receive first-line nivolumab plus ipilimumab will be randomized in 1:1 ratio to an exercise intervention group or usual care group. The exercise intervention consists of two 60-minute supervised HIIT sessions per week, delivered by oncology-trained physiotherapists and one additional home-based moderate-intensity aerobic exercise sessions per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Participants in both groups will receive usual care and general exercise guidelines. Measurements include blood and stool sampling for microbiome and immune parameters analysis, physical fitness assessments, physical fitness monitoring, body composition measurements, and patient-reported outcomes related to quality of life, fatigue, depression, sleep and diet.",[427],"Oncology",[427,429,430,431,432,433,434],"Exercise","immunotherapy","Renal cell carcinoma","immune-related adverse events","randomized controlled trial","immune function","2026-07-23",{"date":381,"type":30},{"date":438,"type":21},"2026-07-01",{"date":440,"type":21},"2028-09-01",{"name":36,"class":37},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":48,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},"100648431","a-physical-activity-programme-focussed-on-step-volume-and-intensity-for-people-with-cardiovascular-disease-getting-active-and-staying-active-after-cardiac-rehabilitation-100648431","NCT07723274","A Physical Activity Programme Focussed on Step Volume and Intensity for People With Cardiovascular Disease: Getting Active and Staying Active After Cardiac Rehabilitation","Step Targets for Patients With Coronary Artery Disease: Towards Better Physical Activity Adherence Following Cardiac Rehab - A Randomised Controlled Trial","STEP COACH RCT","Inclusion Criteria:\n\n* Hospital admission for CAD (ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina pectoris (UAP), or stable angina pectoris (AP)) and\u002For having undergone a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);\n* Referral to cardiac rehabilitation;\n* 18 years of age or older;\n* Able to understand and perform study related procedures.\n\nExclusion Criteria:\n\n* Unable to give informed consent;\n* Wheelchair-bound \u002F not physically able to stand or walk;\n* Language barrier;\n* CABG surgery expected within 8 weeks after inclusion;\n* New York Heart Association class III or IV heart failure;\n* Participation in another interventional study targeting physical activity;\n* Already adhering to physical activity guidelines (i.e. on average \\>8,000 steps\u002Fday (smartphone) or \\>10,000 steps\u002Fday (smartwatch or smartband) in the 6 months prior to inclusion).",{"count":451,"type":21},334,[50],"The goal of this clinical trial is to learn about the effect of a physical activity program, focussing on increasing step volume and step intensity (STEP COACH program), compared to usual care in patients with coronary heart problems. The main question it aims to answer is: What is the effect of the STEP COACH program on physical activity levels in patients with coronary artery disease who participated in cardiac rehabilitation?\n\nParticipants will be randomised in 2 groups:\n\n1. Control group who receives usual care (i.e., a 3-month cardiac rehabilitation program);\n2. STEP COACH group who receives usual care and the 9-month STEP COACH program.\n\nObjectively measured changes in physical activity time from pre to post STEP COACH program will be compared between groups to see if participants in the STEP COACH group are able to increase their daily physical activity time more compared to participants in the control group.",[455],"Coronary Artery Disease",[457,458,459,142,460,461],"Cardiac rehabilitation","Cardiovascular disease","Physical activity","Consumer wearables","Step metrics","2026-07-20",{"date":435,"type":30},{"date":385,"type":21},{"date":466,"type":21},"2028-08-31",{"name":36,"class":37},4,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":48,"phases":479,"briefSummary":480,"conditions":481,"keywords":486,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":4},"100630276","phase-1-drug-repurposing-in-thyroid-carcinoma-a-feasibility-trial-100630276","NCT07485569","Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial","Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial","REPOTHYROID-II","Inclusion Criteria:\n\n* Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.\n* Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).\n* Measurable disease per RECIST 1.1\n* ECOG performance status ≤ 2\n* Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to obtain a (new) biopsy for molecular profiling\n* Pregnancy or breastfeeding.\n* Other active malignancies requiring therapy.\n* Neutropenia (ANC \\\u003C 1.5 × 10⁹\u002FL).\n* Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).",{"count":478,"type":21},10,[105],"This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.",[482,483,484,485],"Thyroid Cancer Stage IV","Anaplastic Thyroid Cancer","Differentiated Thyroid Cancer","Poorly Differentiated Thyroid Carcinoma",[487,488,489,490],"Drug repurposing","Thyroid cancer","Network pharmacology","Personalized therapy","2026-06-17",{"date":493,"type":30},"2026-06-22",{"date":495,"type":21},"2026-06-01",{"date":245,"type":21},{"name":36,"class":37},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":129,"maxAge":130,"enrollmentInfo":506,"targetDuration":4,"studyType":48,"phases":508,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":522,"locationsCount":38},"100637101","phase-3-preventive-dendritic-cell-vaccination-for-lynch-syndrome-carriers-100637101","NCT07609901","Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers","Prevention of Tumour Occurrence by Targeting Emergent Cancer Neoantigens Through Therapeutic Vaccination in Lynch Syndrome Carriers: a Phase III Clinical Trial.","PROTECT-Lynch","Inclusion Criteria:\n\n* a confirmed gPV in MLH1 or MSH2 and without a prior history of MMR-D cancer.\n* a confirmed gPV in MSH6, whether or not they have a history of MMR-D cancer. MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year.\n* previous surgical treatment may include any resection up to and including hemicolectomy; subjects who have undergone (sub)total colectomy are excluded due to the substantially reduced risk of cancer occurrence.\n* aged between 35 and 75 for subjects with gPV in MLH1 and MSH2; and aged between 40 and 75 for subjects with gPV in MSH6.\n* Lynch syndrome subjects without clinical signs of disease.\n* Lynch syndrome subjects without prior treatment for LS-associated cancer, except for MSH6 subjects who are \\>1 year disease-free and whose prior surgical treatment did not include subtotal colectomy.\n* Routine surveillance colonoscopy must be performed within 16 weeks prior to start of study, to exclude (pre)malignancy.\n* HLA-A02.01 genotype\n* Adequate hematologic, renal, and liver function as defined by laboratory values: WBC \\>3.0\\^109\u002Fl, lymphocytes \\>0.8\\^109\u002Fl, platelets \\>100\\^109\u002Fl, haemoglobin \\>7,0 mmol\u002Fl (9.0 g\u002Fdl), estimated glomerular filtration rate \\> 45 ml\u002Fmin\u002F1.73m2, AST\u002FALT \\\u003C3 x ULN, serum crea¬tinine \\\u003C150 µmol\u002Fl, serum bilirubin \\\u003C1.5 x ULN (exception: Gilbert's syndrome is permitted).\n* WHO performance status of 0 or 1\n* No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted.\n* No uncontrolled infectious disease, i.e., negative testing for HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and syphilis (Treponema Pallidum Hemagglutination Assay (TPHA)).\n* No autoimmune disease such as, but not limited to, inflammatory bowel disease, multiple sclerosis, and lupus. Subjects with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.\n* No serious (bleeding and clotting) condition that may interfere with safe leukapheresis.\n* No pregnant or lactating women. hCG tests will be performed regularly during the trial to confirm absence of pregnancy.\n* No Women Of Child-Bearing Potential (WOCBP) or male partners of WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 8 weeks after the last administration of the treatment. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \\[defined as amenorrhea \\> 12 consecutive months\\].\n* Subjects must have absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions must be discussed with the subject before registration in the trial.\n* Expected adequacy of follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Individuals with a history of malignancy in the past. Allowed malignancies are adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ (e.g., DCIS\u002FLCIS\u002Fcervical CIS), papillary thyroid carcinoma, and low-risk prostate carcinoma; all locally resected with negative surgical margins and not treated with systemic therapy.\n* Organ allografts.\n* Known allergy to shellfish.\n* Inability to understand and communicate in Dutch.",{"count":507,"type":21},372,[509],"PHASE3","The primary objective is to assess the effect of vaccination with neopeptide-loaded dendritic cells on disease-free survival (DFS) compared to placebo in LS subjects who are known to be carrier of a germline MMR-gene mutation with no signs of disease.",[137],[513,514,515,137,142,143],"Dendritic Cells","Cancer Vaccine","Hereditary Cancer","2026-05-20",{"date":518,"type":30},"2026-05-27",{"date":91,"type":21},{"date":521,"type":21},"2032-10-01",{"name":36,"class":37},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":531,"targetDuration":4,"studyType":48,"phases":532,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":4},"100639369","phase-2-modafinil-for-debilitating-fatigue-in-quiescent-inflammatory-bowel-disease-modifi-ibd-trial-100639369","NCT07582458","Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)","Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)","MODIFI-IBD","Inclusion Criteria:\n\n* Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study\n* Age between 18 to 75 years at screening.\n* ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria\n* Chronic fatigue for at least six months\n* Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F\n* Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) \\\u003C5 for CD patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with UC or IBD-unclassified\n* Faecal calprotectin \\\u003C250 µg\u002Fg\n* Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months\n\nExclusion Criteria:\n\n* Contraindications for the use of modafinil, such as:\n\n  * Uncontrolled hypertension\n  * Cardiac arrhythmia\n  * A history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse who have previously developed mitral valve prolapse syn-drome during treatment with central nervous system stimulants\n  * Patients with hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption\n* Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \\& Drug class'\n* Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines\n* Surgery before or during study period that impacts ability to participate in this study, per investigator judgement\n* Participation in another intervention study (excl. registries and post marketing studies)\n* Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose\n* People with a diagnosis of drug or alcohol dependence syndrome will be excluded\n* Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to:\n\n  * Anaemia (Hb \\\u003C7.0 mmol\u002Fl for women and \\\u003C8.0 mmol\u002Fl for men) and which is judged as clinically significant by the investigator\n  * Folate deficiency (\\\u003C6.0 nmol\u002Fl)\n  * Iron deficiency (ferritin \\\u003C20 g\u002Fl for women and \\\u003C25 g\u002FL for men)\n  * Vitamin B12 deficiency (\\\u003C148 pmol\u002Fl)\n  * Liver insufficiency defined by an ALT or AST \\>2x ULN or total bilirubin \\> 2 mg\u002FdL\n  * Renal insufficiency defined by an estimated glomerular filtration rate \\\u003C 45 mL\u002Fmin, calculated using the Chronic Kidney Disease-Epidemiology Collaboration equation and\u002For a serum creatinine \\>178 μmol\u002FL (2mg\u002FdL)\n  * Auto-immune disorders such as primary sclerosing cholangitis, rheumatoid ar-thritis, systemic lupus erythematosus or coeliac disease\n  * Uncontrolled or recently diagnosed depression\n  * Active suicidal ideation\n  * Bipolar disorder\n  * Schizophrenia or other psychotic disorders\n  * Other psychiatric disorders that may interfere with the study as judged by the investigators\n  * History or current anxiety or sleep disorders\n  * Substance dependence disorders (e.g. alcohol, cannabis, drugs)\n  * Evidence, history, or suspicion of infectious diseases that may interfere with the study as judged by the investigators\n  * Active Epstein-Barr virus or cytomegalovirus infection\n  * Endocrinological disorders such as uncontrolled diabetes mellitus, untreated hy-pothyroidism, hypoadrenalism or hypogonadism\n  * Neurological disorders such as multiple sclerosis, dementia, Parkinson's disease or myasthenia gravis\n  * Heart failure\n  * Chronic obstructive pulmonary disease\n  * Obstructive sleep apnoea\n  * Active malignancy (exception of malignancies adequately treated with resection for non-metastatic basal cell carcinoma)\n  * Long\u002Fpost-COVID\n* Patients who are not able to complete the Dutch questionnaires in an online form\n* Has a clinically significant concurrent disease or relevant laboratory abnormality or a history of illness or medical condition that in the investigator's opinion could confound the study results or increase the participant's risk by taking part in the study",{"count":256,"type":21},[134,509],"The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are:\n\nDoes modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue?\n\nResearchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes.\n\nParticipants will:\n\nattend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.",[535,536],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Chronic Fatigue",[538,539,540,541,542,543,544],"Modafinil","Inflammatory bowel disease","Crohn","Colitis","Fatigue","Remission","Pharmacological","2026-05-19",{"date":547,"type":30},"2026-05-22",{"date":495,"type":21},{"date":550,"type":21},"2027-06",{"name":36,"class":37},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":559,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":561,"studyType":22,"phases":4,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":4},"100636058","prospective-prostate-cancer-infrastructure-100636058","NCT07560748","Prospective Prostate Cancer Infrastructure","ProPCI","Inclusion Criteria:\n\n* Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA \\> 20 ng\u002FmL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET\u002FCT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.\n* Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate\n* Age ≥ 18 years at the time of inclusion.\n* Written informed consent\n* Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.\n\nExclusion Criteria:\n\n* Not currently living in the Netherlands.","MALE",{"count":20,"type":21},"48 Months","The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.",[564,565],"High Risk Localized Prostate Cancer","Synchronous Metastatic Hormone-Sensitive Prostate Cancer","2026-04-28",{"date":568,"type":30},"2026-05-01",{"date":570,"type":21},"2026-05",{"date":572,"type":21},"2030-05",{"name":36,"class":37},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":337,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":48,"phases":584,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":596,"leadSponsor":598,"locationsCount":4},"100632487","mr-guided-adaptive-stereotactic-radiotherapy-for-endometrial-cancer-100632487","NCT07514325","MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer","MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer (MASTEC)","MASTEC","Inclusion criteria\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n* Women aged 18 years or older with histologically proven carcinoma of the endometrium, treated with curative hysterectomy with or without bilateral salpingo-oophorectomy. All histologies may be included (endometrioid, clear cell carcinoma, de-\u002Fundifferentiated carcinoma, carcinosarcoma, other non-endometrioid)\n* Candidate for adjuvant EBRT as decided by multidisciplinary tumour board, amongst others:\n\n  * FIGO IB grade 3 endometrioid carcinoma\n  * FIGO stage II endometrioid carcinoma\n  * FIGO stage IIIA-C1 endometrioid carcinoma\n  * FIGO IB-II clear cell carcinoma\n  * FIGO IA-III carcinosarcioma\n* Patients receiving adjuvant systemic therapy are eligible when these therapies will not be administered concurrently\n* Patients receiving vaginal vault brachytherapy are eligible\n* Capable of giving informed consent\n\nExclusion criteria\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Contra-indications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrofobia\n* Presence of para-aortic lymph node metastases (FIGO stage IIIC2)\n* Prior pelvic radiotherapy\n* WHO performance score \\> 2",{"count":583,"type":21},61,[50],"Rationale: External beam radiotherapy (EBRT) is an important cornerstone in treatment to reduce locoregional relapse in high(-intermediate) risk endometrial cancer (EC) patients. MR-guided adaptive radiotherapy (MGART) allows for more accurate delivery of radiation beams to the patients by visualizing and correcting for interfraction motion, with subsequent reduction of safety margins around the radiotherapy plan. Objective: The MASTEC study will investigate the safety of hypofractionated MR-guided adaptive radiotherapy in five fractions for elective pelvic nodal and vaginal vault irradiation in endometrial cancer.\n\nStudy design: Phase II multicentre intervention study Study population: Patients with endometrial cancer that receive adjuvant EBRT to the pelvic nodal areas and vaginal vault (with or without vaginal brachytherapy).\n\nIntervention (if applicable): MR-guided adaptive radiotherapy (MGART) with reduced PTV margins, including 5 times 6Gy to the vaginal vault and pelvic nodal areas, 2 times a week .\n\nMain study parameters\u002Fendpoints: The primary endpoint is acute gastrointestinal and genitourinary toxicity, scored by the Common Terminology Criteria Adverse Events version 6.0. Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and disease free survival; disease-specific survival; overall survival and metastasis-free survival.",[344,587],"Radiotherapy, Adjuvant",[589,590,591],"endometrial cancer","MR-guided radiotherapy","hypofractionation","2026-03-31",{"date":594,"type":30},"2026-04-07",{"date":568,"type":21},{"date":597,"type":21},"2033-03-01",{"name":36,"class":37},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":609,"conditions":610,"keywords":613,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":478},"100631706","real-world-effectiveness-and-dosing-patterns-of-tirzepatide-in-people-with-obesity-100631706","NCT07504172","Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity","Real-world Effectiveness and Dosing Patterns of Tirzepatide: A Multicentre Retrospective Observational Study in the Netherlands","TIRZ-DOSE-NL","Inclusion Criteria:\n\n* Adults (age ≥18 years old)\n* A BMI of ≥ 30 kg\u002Fm2 or a BMI ≥ 27 kg\u002Fm2 with at least one obesity complication (e.g., hypertension, dyslipidaemia)\n\nExclusion Criteria:\n\n* Pregnant women or pregnancy during treatment\n* Previously treated for obesity (with pharmacotherapy, endoscopic treatment or metabolic-bariatric surgery)\n* Patients with diabetes",{"count":608,"type":21},1700,"Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice.\n\nIn this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are:\n\n* How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching?\n* How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).",[611,612],"Overweight , Obesity","Obesity (Disorder)",[614,615,616,617,618,619],"Obesity","Weightloss","Tirzepatide","Adults","Body composition","Dose escalation","2026-03-25",{"date":592,"type":30},{"date":623,"type":21},"2026-04-01",{"date":625,"type":21},"2026-08-01",{"name":36,"class":37},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":48,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":647,"locationsCount":38},"100617259","phase-3-pharmacologically-modulating-the-noradrenergic-arousal-system-to-reduce-freezing-of-gait-in-parkinsons-disease-a-multi-centre-and-multi-modal-approach-100617259","NCT07316296","Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach","AnTi-FREEZE","Inclusion Criteria:\n\n* Aged 18 years or older;\n* Diagnosis of idiopathic PD according to MDS Diagnostic Criteria;\n* Stabilised on optimal dopaminergic PD treatment for a minimum of four weeks prior to the baseline visit (Visit 1) and for the duration of the trial;\n* Presence of FOG symptoms on a daily basis;\n* Ability to walk for 10-meters unaided in the dopaminergic ON-state;\n* Ability to provide written informed consent in accordance with ICH-GCP and local regulations;\n* Willing and able to undergo all clinical trial assessments.\n\nExclusion Criteria:\n\n* Current and\u002For previous (within 3 months) participation in a clinical trial;\n* Any contra-indications for undergoing MRI-scanning (e.g. claustrophobia or metal parts within the body such as DBS, an infusion pump or a pacemaker);\n* Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments);\n* Severe cognitive impairment hampering the ability to comply with the study protocol;\n* Active psychosis that would impact the ability to comply with the study protocol;\n* Severe cardiovascular disorders: severe hypertension (Sustained (Sitting) hypertension of ≥180 mmHg systolic or ≥110 mmHg diastolic, defined by the average of three observations, each at least 3 minutes apart, with the participant having assumed the required position for at least 3 minutes), heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, long QT interval syndrome (QTc \\> 500ms Bazett-formula) and channelopathies that in the opinion of the study PI would significantly compromise participant safety;\n* Severe cerebrovascular disorders: cerebral aneurysm or recent\u002Fsignificant stroke;\n* Hepatic or renal insufficiency that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate;\n* Narrow angle glaucoma;\n* (History of) pheochromocytoma;\n* Use of noradrenergic agents;\n* Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine);\n* Use of high dose salbutamol (or other beta2 agonists) that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate;\n* Pregnancy and\u002For breastfeeding;\n* Known hypersensitivity to atomoxetine.",{"count":256,"type":21},[509],"The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is:\n\nDoes atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait?\n\nResearchers will compare atomoxetine to a placebo to see if atomoxetine can improve freezing of gait in people with Parkinson's disease.\n\nParticipants will:\n\nVisit the study site for measurements Take atomoxetine or placebo Perform walking assessments and undergo MRI Complete questionnaires about anxiety, stress, and quality of life",[638,639,640],"Parkinson's Disease (PD)","Freezing of Gait","Freezing of Gait Symptoms in Parkinson Disease","2026-02-24",{"date":643,"type":30},"2026-02-27",{"date":645,"type":30},"2026-01-01",{"date":303,"type":21},{"name":36,"class":37},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":48,"phases":658,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":278},"100520511","phase-3-pragmatic-optimized-rifampicin-trial-100520511","NCT06057519","Pragmatic Optimized Rifampicin Trial","Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients","PORT","Inclusion Criteria:\n\n* The patient has provided informed consent for study participation prior to all trial-related procedures.\n* The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria.\n* The patient is aged 18 years or older at the day of informed consent.\n* No known allergic reactions or toxicity to rifampicin in the past.\n* Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice an effective method of birth control during the study. And they should not be lactating during the trial (female participants of childbearing potential only). Effective birth control for female patients has to include two methods, including methods that the patient's sexual partner(s) use. At least one must be a barrier method. Female patients are considered not to be of childbearing potential if they are post-menopausal with no menses for the last 12 months, or surgically sterile (this condition is fulfilled by bilateral oophorectomy, hysterectomy, and by tubal ligation which is done at least 12 months prior to enrolment).\n* The patient will be compliant to the study schedule, in the discretion of the investigator.\n\nExclusion Criteria:\n\n* The patient has tuberculosis which is assessed to receive high dose rifampicin according to the local standard of care.\n* The patient started current TB treatment more than 4 weeks ago.\n* The patient has TB meningitis.\n* The patient is in a coma.\n* Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. in a prisoner or mentally handicapped person)\n* The patient is not able to give consent personally.\n* Poor general condition or comorbidities where delay in treatment cannot be tolerated or death within three months is likely. Or if there is concurrent treatment that may interfere.\n* The patient is pregnant or breast-feeding.\n* Patient infected with a rifampicin-resistant strain of M. tuberculosis.\n* Known allergy or intolerance for rifamycins.\n* The participant has a known or suspected, current alcohol or drug or amphetamine abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient.\n* The patient has a known allergy or intolerance, or concomitant disorders or conditions for which rifamycins or other standard TB treatment drugs are contraindicated.\n* The patient has had treatment with any other investigational drug within 1 month prior to enrolment, or enrolment into other clinical (intervention) trials is planned in the upcoming 6 months\n* Laboratory: at screening one or more of the following abnormalities were observed for the patient in screening laboratory:\n\n  * Serum amino aspartate transferase (AST) and\u002For serum alanine aminotransferase (ALT) activity \\>3x the upper limit of normal\n  * Serum total bilirubin level \\>2.5 times the upper limit of normal\n  * Creatinine clearance (CrCl) level lower than 30 mls\u002Fmin\n* Acute or severe or life-threatening liver disease induced by drugs in the past\n* The patient has a chronic disorder such as liver disease or renal disease.\n* The patient has icterus.\n* Previous anti-TB treatment: the patient ended a previous TB treatment (episode) within last 3 months.",{"count":657,"type":21},164,[509],"The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 mg if patient \\\u003C50 kg and 600 mg if patient \\>50kg) of rifampicin in tuberculosis patients.\n\nThe main questions it aims to answer are:\n\n* To compare the incidence of hepatotoxicity occurs in the optimized dose vs standard dose arm\n* To compare any adverse events occur in the optimized dose vs standard dose arm\n* To compare final treatment outcome at the end of treatment according to WHO definitions of cure in the optimized dose regimen versus the standard dose regimen.\n* To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen.\n* To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen.\n\nParticipants will be given an optimized dose of 1800 mg of rifampicin daily. Researchers will compare the optimized and standard dose to see if more hepatotoxicity occurs.",[661],"Tuberculosis, Pulmonary","2026-01-16",{"date":664,"type":30},"2026-01-21",{"date":666,"type":30},"2024-01-16",{"date":668,"type":21},"2026-12-31",{"name":36,"class":37},""]