[{"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:":700},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,96,0,25,[9,48,79,110,142,173,198,222,249,269,294,322,344,375,397,428,454,479,503,537,560,590,620,649,671],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645314","promoting-response-to-immunotherapy-by-exercise-in-patients-with-advanced-renal-cell-carcinoma-100645314",false,"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","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Oncology",[27,29,30,31,32,33,34],"Exercise","immunotherapy","Renal cell carcinoma","immune-related adverse events","randomized controlled trial","immune function","NOT_YET_RECRUITING","2026-06-25",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":21},"2026-07-01",{"date":43,"type":21},"2028-09-01",{"name":45,"class":46},"Radboud University Medical Center","OTHER",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"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":57,"type":21},10,[59],"PHASE1","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.",[62,63,64,65],"Thyroid Cancer Stage IV","Anaplastic Thyroid Cancer","Differentiated Thyroid Cancer","Poorly Differentiated Thyroid Carcinoma",[67,68,69,70],"Drug repurposing","Thyroid cancer","Network pharmacology","Personalized therapy","2026-06-17",{"date":73,"type":39},"2026-06-22",{"date":75,"type":21},"2026-06-01",{"date":77,"type":21},"2027-09-01",{"name":45,"class":46},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":87,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"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":90,"type":21},735,[24],"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",[94],"Endometrial Cancer",[96,94,97,98,99,100,101],"ENDORISK","surgical staging","risk stratification","lymph node metastases","lymphadenectomy","sentinel node","RECRUITING",{"date":73,"type":39},{"date":105,"type":39},"2025-10-23",{"date":107,"type":21},"2032-10-16",{"name":45,"class":46},14,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"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.","35 Years","75 Years",{"count":121,"type":21},372,[123],"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.",[126],"Lynch Syndrome",[128,129,130,126,131,132],"Dendritic Cells","Cancer Vaccine","Hereditary Cancer","Prevention","Neoantigens","2026-05-20",{"date":135,"type":39},"2026-05-27",{"date":137,"type":21},"2026-10-01",{"date":139,"type":21},"2032-10-01",{"name":45,"class":46},1,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":170,"leadSponsor":172,"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":151,"type":21},60,[153,123],"PHASE2","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.",[156,157],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Chronic Fatigue",[159,160,161,162,163,164,165],"Modafinil","Inflammatory bowel disease","Crohn","Colitis","Fatigue","Remission","Pharmacological","2026-05-19",{"date":168,"type":39},"2026-05-22",{"date":75,"type":21},{"date":171,"type":21},"2027-06",{"name":45,"class":46},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":141},"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.",{"count":182,"type":21},13,[59,153],"The aim of this study is to assess safety, feasibility and immunogenicity 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.",[126],[187,188,189,126,131,132],"Dendritic cells","Cancer vaccine","Hereditary cancer","2026-04-30",{"date":192,"type":39},"2026-05-06",{"date":194,"type":21},"2026-08",{"date":196,"type":21},"2036-06",{"name":45,"class":46},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":205,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":208,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"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":207,"type":21},700,"48 Months","OBSERVATIONAL","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.",[212,213],"High Risk Localized Prostate Cancer","Synchronous Metastatic Hormone-Sensitive Prostate Cancer","2026-04-28",{"date":216,"type":39},"2026-05-01",{"date":218,"type":21},"2026-05",{"date":220,"type":21},"2030-05",{"name":45,"class":46},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":248,"locationsCount":141},"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":231,"type":21},18,[59],"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.",[235],"Chronic Pulmonary Aspergillosis",[237,238,239,240,241],"ambisome","liposomal amphotericin B","nebulization","chronic pulmonary aspergillosis","deposition","2026-04-09",{"date":244,"type":39},"2026-04-15",{"date":216,"type":21},{"date":247,"type":21},"2027-06-01",{"name":45,"class":46},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":266,"leadSponsor":268,"locationsCount":141},"100633891","phase-2-intranasal-insulin-to-prevent-intensive-care-unit-delirium-100633891","NCT07532577","Intranasal Insulin to Prevent Intensive Care Unit Delirium","Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n1. Age ≥65 years\n2. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG\n3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration)\n4. Informed consent from patient\n\nExclusion Criteria:\n\n1. Delirium at hospital admission\n2. Non-complex or off-pump cardiac surgery\n3. Known allergy\u002Fhypersensitivity to insulin or formulation excipients\n4. Contra-indication for nasal administration (severe nasal pathology, recent nasal\u002Fsinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)\n5. Participating in other investigational medication trial","65 Years",{"count":20,"type":21},[153,123],"This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass",[262],"Delirium - Postoperative",{"date":264,"type":39},"2026-04-16",{"date":244,"type":21},{"date":267,"type":21},"2026-08-15",{"name":45,"class":46},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":293,"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":278,"type":21},61,[24],"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.",[94,282],"Radiotherapy, Adjuvant",[284,285,286],"endometrial cancer","MR-guided radiotherapy","hypofractionation","2026-03-31",{"date":289,"type":39},"2026-04-07",{"date":216,"type":21},{"date":292,"type":21},"2033-03-01",{"name":45,"class":46},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":57},"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":303,"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).",[306,307],"Overweight , Obesity","Obesity (Disorder)",[309,310,311,312,313,314],"Obesity","Weightloss","Tirzepatide","Adults","Body composition","Dose escalation","2026-03-25",{"date":287,"type":39},{"date":318,"type":21},"2026-04-01",{"date":320,"type":21},"2026-08-01",{"name":45,"class":46},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":141},"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":151,"type":21},[123],"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",[333,334,335],"Parkinson's Disease (PD)","Freezing of Gait","Freezing of Gait Symptoms in Parkinson Disease","2026-02-24",{"date":338,"type":39},"2026-02-27",{"date":340,"type":39},"2026-01-01",{"date":342,"type":21},"2027-12-31",{"name":45,"class":46},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":47},"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\n* Patients who have used ONS in the past six months",{"count":151,"type":21},[24],"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.",[356],"Risk of Malnutrition",[358,359,360,361,362,363,364,365,366],"plant-based ONS","animal-based ONS","Risk of malnutrition","pilot feasibility","hospitalized patients","oral nutritional drinks","plant protein","sustainability","medical nutrition","2026-02-11",{"date":369,"type":39},"2026-02-17",{"date":371,"type":39},"2025-11-10",{"date":373,"type":21},"2026-11-01",{"name":45,"class":46},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":47},"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":384,"type":21},164,[123],"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.",[388],"Tuberculosis, Pulmonary","2026-01-16",{"date":391,"type":39},"2026-01-21",{"date":393,"type":39},"2024-01-16",{"date":395,"type":21},"2026-12-31",{"name":45,"class":46},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":427},"100601031","phase-4-shorter-weaning-from-invasive-ventilation-with-levosimendan-100601031","NCT07105202","Shorter Weaning From Invasive Ventilation With Levosimendan","Shorter Weaning From Invasive Ventilation With Levosimendan: a Randomized, Double-blind, Multicentre Study in Critically Ill Patients","WEANLESS","Inclusion Criteria:\n\n* Invasively ventilated \\> 48 hours.\n* Failed at least one spontaneous breathing trial (SBT).\n* Age above 18 years.\n* Female patients with age \\\u003C 60 must have a negative pregnancy test (blood or urine) prior to participation.\n\nExclusion Criteria:\n\n* Pre-existing neuromuscular disease (congenital or acquired)\n* Endotracheally intubated primarily for neurological reason (e.g., traumatic brain injury, intracranial haemorrhage, epilepsy, intracranial infection), or developed severe intracranial haemorrhage\u002Finfarction during ICU stay.\n* Contra-indications for levosimendan: severe renal failure (creatinine clearance \\\u003C30mL\u002Fmin) unless managed with appropriate continuous kidney replacement therapy (such as CRRT), severe liver failure (Child-Pugh class C), history of torsade des pointes; known significant mechanical obstructions affecting ventricular filling\u002F outflow or both; prolonged QTc interval (QTc \\> 470ms); breast feeding; known hypersensitivity to levosimendan.\n* Treatment with intermittent haemodialysis.\n* Treatment limitation decision in place: do not reintubate\n* Previous treatment with levosimendan within 30 days.\n* Currently in another interventional trial that might interact with study drug or primary outcome.",{"count":406,"type":21},250,[408],"PHASE4","Prolonged weaning from mechanical ventilation is a common and serious challenge in the ICU, associated with increased morbidity, mortality, and length of stay. Diaphragm dysfunction plays a key role in weaning failure, and current strategies to support respiratory muscle function are limited. Levosimendan is a calcium sensitizer that enhances cardiac and skeletal muscle contractility, including the diaphragm, without increasing oxygen demand.\n\nThe investigators hypothesize that treatment with Levosimendan in difficult-to-wean ICU patients will improve diaphragm function and thereby shorten the duration of mechanical ventilation compared to placebo.",[411,412],"Mechanical Ventilation","Weaning Failure",[414,415,416,417,418],"mechanical ventilation","weaning","critically ill patients","levosimendan","diaphragm","2026-01-08",{"date":421,"type":39},"2026-01-09",{"date":423,"type":39},"2025-09-17",{"date":425,"type":21},"2028-08-01",{"name":45,"class":46},8,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":443,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":453},"100499159","multi-parametric-mri-in-patients-suspected-for-muscle-invasive-bladder-cancer-a-new-local-staging-paradigm-100499159","NCT05779631","Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm","Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)","BladParadigm","Inclusion Criteria:\n\n* Patients (18+ years of age)\n* Clinically suspected MIBC\n* No lymph node or distant metastases\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable or unwilling to undergo mpMRI\n* Unfit for TURBT\n* Unfit for definitive treatment with curative intent\n* A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment",{"count":437,"type":21},360,[24],"A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.",[441,442],"Bladder Cancer","Muscle-invasive Bladder Cancer",[444,445],"mpMRI + same-day biopsy","TURBT","2026-01-05",{"date":419,"type":39},{"date":449,"type":39},"2023-12-06",{"date":451,"type":21},"2031-06",{"name":45,"class":46},19,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":205,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":141},"100618642","detection-of-minimal-residual-disease-post-prostatectomy-100618642","NCT07334275","Detection of Minimal Residual Disease Post-prostatectomy","Pilot Study for the Detection of Minimal Residual Disease Post-prostatectomy and Early Disease Recurrence in Circulating Tumor DNA to Guide Future Adjuvant Therapy in High-risk Prostate Cancer Patients (MiRaDE)","MiRaDE","Inclusion Criteria:\n\n* Male aged 18 years or older;\n* High-risk prostate cancer, defined as:\n\n  1. High-risk localized prostate cancer, with PSA level \\>20 ng\u002FmL, Gleason score 8-10 (ISUP grade 4\u002F5) at prostate biopsies, or iT3a (based on multi-parametric MRI of the prostate); or\n  2. High-risk locally advanced prostate cancer, having any PSA level, any Gleason score\u002FISUP grade, iT3b-4 (based on multi-parametric MRI of the prostate) or iN1 (based on PSMA PET\u002FCT imaging);\n* Scheduled for robot-assisted radical prostatectomy;\n* Willingness to consent to both patient information sheets regarding tissue and liquid biobanking.\n\nExclusion Criteria:\n\n* Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.",{"count":463,"type":21},50,"The clinical objective for this pilot study is to determine whether minimal residual disease (MRD) detection in high-risk prostate cancer, utilizing a custom-made prostate-specific circulating tumor DNA (ctDNA) panel, may lead to more optimal prediction of disease recurrence following radical prostatectomy.",[466],"Prostate Cancer",[468,469,470],"Prostate cancer","Prostatectomy","Circulating tumor DNA","2025-12-31",{"date":473,"type":39},"2026-01-12",{"date":475,"type":39},"2025-09-16",{"date":477,"type":21},"2028-01",{"name":45,"class":46},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":141},"100605522","phase-2-obinutuzumab-induced-decreases-of-pla2r-antibodies-in-membranous-nephropathy-a-pilot-study-100605522","NCT07163611","Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study","Obinutuzumab Induced Decreases of PLA2Rab in MN: a Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of PMN, confirmed by:\n\n  1. Kidney biopsy or\n  2. Positive serum PLA2Rab test either by IFT and\u002For ELISA)\n* Serum PLA2Rab titer \\> 80 RU\u002Fml\n* Proteinuria ≥ 3.5 g\u002F24h despite supportive treatment for at least 6 months with a maximally tolerated and stable dose of ACE-i or ARB.\n* Serum albumin \\\u003C 30 g\u002Fl measured by BCP assay.\n* eGFR ≥ 30 ml\u002Fmin\u002F1.73m2.\n* Treatment with immunosuppression is warranted, as determined by the treating physician.\n\nExclusion Criteria:\n\n* Secondary MN (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).\n* RTX within 12 months prior to inclusion.\n* CNI within 2 months prior to inclusion.\n* Treatment with other immunosuppressive drugs within 6 months prior to inclusion.\n* Proteinuria must not have decreased by \\> 50% over 6 months whilst taking ACEi\u002FARB.\n* Life-threatening nephrotic syndrome resistant to treatment.\n* \\> 20% increase in serum creatinine not otherwise explained during antiproteinuric supportive treatment.\n* Pregnancy or breastfeeding. Women of childbearing age and male patients with female partners of childbearing potential not willing to use contraception throughout the study and for at least 6 months after the last dose of obinutuzumab.\n* Suspected or known hypersensitivity, allergy, and\u002For immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups.\n* Known active infection of any kind or recent major episode of infection.\n* Any disorder or condition which might pose an unacceptable risk to patient's safety and well-being that might interfere with completion of the study.\n* Inability to understand or comply with the requirements of the study.\n* Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative.\n* Use of an investigational agent.",{"count":487,"type":21},20,[153,123],"Objective: To assess the disappearance rate (half-life) of anti-PLA2R antibodies in high-risk primary membranous nephropathy (pMN) patients treated with obinutuzumab (OBI), and to evaluate immunological and clinical remission, adverse events, and quality of life.\n\nDesign: Open-label, single-center, prospective pilot intervention study conducted at Radboud University Medical Center.\n\nPopulation: 20 adult patients with high-risk PMN, defined by proteinuria ≥3.5 g\u002F24h despite 6 months of supportive treatment with ACE inhibitors or ARBs.\n\nIntervention: OBI 1000 mg on days 1 and 15, with two additional infusions after 6 months if anti-PLA2R antibody levels remain positive and proteinuria exceeds 2 g\u002F24h.\n\nFollow-up: Patients were monitored at baseline, and at weeks 1, 2, 4, 8, 12, 24, 37, and 52.",[491],"Membranous Nephropathy - PLA2R Induced",[493,494,495],"PLA2R antibody kinetics","membranous nephropathy","obinutuzumab",{"date":497,"type":39},"2026-01-06",{"date":499,"type":39},"2025-10-01",{"date":501,"type":21},"2028-04-01",{"name":45,"class":46},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100594648","lifestyle-intervention-for-symptoms-of-depression-with-app-support-in-general-practice-100594648","NCT07022184","Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice","A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial","LIDIAS","Inclusion Criteria:\n\n* Currently experiencing an episode of symptoms of depression and receiving treatment for this episode from their GP or GP-MHW for less than six months\n* Have a smartphone\n* Be proficient in Dutch\n\nExclusion Criteria:\n\n* Severe mental illness (such as psychosis or bipolar disorder)\n* Severe alcohol or drug addiction requiring specialized secondary care\n* High suicide risk\n* moderate to severe cognitive impairment (as determined by the GP)\n\nPatients who visit their GP for depressive symptoms but with a PHQ-9 of \\\u003C5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.",{"count":512,"type":21},216,[24],"The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression.\n\nThe main questions this study aims to answer are:\n\nDoes a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? Is this approach more cost-effective than regular care alone?\n\nResearchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes.\n\nParticipants who use the app will:\n\nComplete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity.\n\nSet personal goals based on their results and receive tailored lifestyle advice.\n\nTrack their depression symptoms regularly within the app to support ongoing care.\n\nHave follow-up conversations with their general practitioner or mental health nurse to discuss their progress.\n\nFill out questionnaires about their symptoms and experiences during the study.",[516,517],"Depressive\u002FAnxiety Symptoms","Depressive Disorder",[519,520,521,522,523,524,525,526,527],"Personalized lifestyle intervention","eHealth","Measurement-based care","Depression symptomatology","Cluster randomized trial","General practice","Lifestyle changes","Mental health support","Primary care","2025-12-19",{"date":530,"type":39},"2025-12-22",{"date":532,"type":39},"2025-06-17",{"date":534,"type":21},"2027-02",{"name":45,"class":46},3,{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":544,"targetDuration":546,"studyType":209,"phases":4,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":141},"100615534","optical-coherence-tomography-prognostic-value-and-artificial-intelligence-100615534","NCT07293858","Optical Coherence Tomography: Prognostic Value and Artificial Intelligence","ORANGE","Inclusion Criteria:\n\n* All consecutive patients undergoing intracoronary OCT imaging at the Radboud University Medical Center, and any additional centers that may join the study in the future.\n* OCT performed at the discretion of the treating physician, according to contemporary clinical guidelines.\n* Written informed consent obtained after the procedure.\n\nExclusion Criteria:\n\n* Patients who decline or are unable to provide informed consent. (Only patients who provide consent can be included.\n* Patients for whom follow-up or data collection is not feasible (e.g., no valid contact details).",{"count":545,"type":21},1000,"10 Years","This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. All patients who undergo OCT as part of their clinical care are invited to participate in this prospective registry.\n\nThe study will examine whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, or indicators of stent optimization-are associated with long-term clinical outcomes. Follow-up information on symptoms, medication use, hospitalizations, cardiac procedures, and major cardiac events will be collected through medical records, questionnaires, and national registry data over a period of up to 10 years.\n\nIn addition, pseudonymized OCT pullbacks will be used to support the development of an artificial intelligence (AI) algorithm for automated annotation of OCT images. This algorithm may help improve the clinical interpretation of OCT by identifying relevant imaging features in a consistent and efficient manner.\n\nParticipation is voluntary and includes permission to use clinical data, OCT images, and follow-up information for research purposes. Data are coded to protect participant privacy and stored securely according to applicable regulations. The results of this study may contribute to better understanding of coronary plaque characteristics and may support improved decision-making in interventional cardiology.",[549],"Coronary Arterial Disease",[551,552],"Optical Coherence Tomography","Artificial Intelligence","2025-12-08",{"date":528,"type":39},{"date":556,"type":39},"2021-11-26",{"date":558,"type":21},"2028-12-31",{"name":45,"class":46},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":568,"targetDuration":570,"studyType":209,"phases":4,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":141},"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":569,"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.",[573],"Sepsis",[575,576,577,578,579,580,581],"observational","sepsis","cohort study","immune endotypes","endotypes","immunotypes","post-sepsis syndrome","2025-11-27",{"date":584,"type":39},"2025-12-09",{"date":586,"type":39},"2025-11-03",{"date":588,"type":21},"2028-12-01",{"name":45,"class":46},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":606,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},"100464886","phase-3-personalized-elective-neck-irradiation-guided-by-sentinel-lymph-node-biopsy-in-larynx-and-pharynx-cancer-the-primo-study-100464886","NCT05333523","Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.","Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Patients With Squamous Cell Carcinoma of the Oropharynx, Larynx or Hypopharynx With a Clinically Negative Neck: (Chemo)Radiotherapy to the PRIMary Tumor Only. The PRIMO Study.","PRIMO","Inclusion Criteria:\n\n* Adult patients (≥18 years) with newly diagnosed cT1-4N0-2bM0 squamous cell carcinoma of the oropharynx (HPV-), larynx or hypopharynx, or cT1-4N0-1M0 oropharynx (HPV+) (AJCC TNM 8)\n* Histopathological diagnosis of squamous cell carcinoma.\n* Adequate staging of the neck including CT or MRI, and 18F-FDG-PET demonstrating no contralateral lymph node metastases.\n* Recommendation for curative intent external beam (chemo)radiotherapy made by a multidisciplinary head and neck oncology team (in case of chemoradiotherapy, only patients receiving concomitant platinum-based regimen are eligible).\n* Bilateral ENI is indicated according to Dutch consensus guidelines (LPHHRT) (see Appendix 13.1).\n* Procedures for SLNB (i.e. tumor accessible for tracer injection, imaging and surgery under general anesthesia) are deemed feasible by the head and neck surgeon.\n\nExclusion Criteria:\n\n* Recurrent disease or previous anticancer treatment to the head and neck area (e.g. radical attempt or tumor reductive surgery, neck dissection, neo-adjuvant chemotherapy or radiotherapy) except for endoscopic glottic laser micro surgery.\n* Well lateralized oropharyngeal cancers and early stage laryngeal cancers requiring no or unilateral ENI according to Dutch consensus guidelines (LPHHRT)\n* Patients receiving concomitant non-platinum-based systemic agents (e.g. cetuximab).\n* Patients that qualify for proton therapy and want to be treated accordingly.\n* Compromised airway or tracheostomy.\n* Any active invasive malignancy within the last 3 years except for early stage basal\u002Fsquamous cell carcinoma of the skin and incidental finding of stage T1N0M0 prostate cancer.\n* Any somatic, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.",{"count":599,"type":21},242,[123],"Rationale \\| Elective neck irradiation is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy. It is expected that elective neck irradiation can be omitted to one or both sides of the neck in 9 out of 10 patients with a clinically negative neck (cN0). For patients with clinically positive ipsilateral nodes (cN1-2b), it is expected that elective irradiation of the contralateral neck can be omitted in 7 out of 10 patients. This will enable better sparing of normal tissues from radiation and result in less permanent long-term radiation side effects with better quality of life.\n\nMethods\u002Fdesign \\| This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with sentinel lymph node biopsy guided neck irradiation versus standard bilateral elective neck irradiation in 242 patients with cN0-N2b squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral elective neck irradiation is indicated. Patients randomized to the experimental-arm will undergo sentinel lymph node biopsy. Based on the histopathologic status of the sentinel lymph nodes, patients will receive no elective neck irradiation (if no nodal metastases found at both sides of the neck), unilateral neck irradiation only (if no nodal metastases found at contralateral side of the neck only) or bilateral neck irradiation (if nodal metastases found at both sides of the neck). Patients randomized to the control arm will not undergo sentinel lymph node biopsy but will receive standard bilateral elective neck irradiation. The primary safety endpoint is the number of patients with recurrence in regional lymph nodes within 2 years after treatment. The primary efficacy endpoint is patient reported xerostomia-related quality of life at 6 months after treatment.\n\nDiscussion \\| If this trial demonstrates that the experimental treatment is non-inferior to the standard treatment in terms of regional recurrence and is superior in terms of xerostomia-related quality of life, this will become the new standard of care.",[603,604,605],"Laryngeal Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[607,608,609,610,611],"Head and neck cancer","Squamous cell carcinoma","Sentinel lymph node biopsy","Elective neck irradiation","FDG-PET","2025-11-20",{"date":614,"type":39},"2025-11-24",{"date":449,"type":39},{"date":617,"type":21},"2029-12-01",{"name":45,"class":46},9,{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":628,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":629,"targetDuration":631,"studyType":209,"phases":4,"briefSummary":632,"conditions":633,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":646,"leadSponsor":648,"locationsCount":4},"100611108","3d-printed-vs-milled-occlusal-splints-in-dentistry-100611108","NCT07236294","3D Printed vs. Milled Occlusal Splints in Dentistry","Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications","Splints","Inclusion Criteria:\n\n* Subjects being healthy (ASA \\\u003CIV)\n* Subjects with healthy, complete dentitions (except for 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 with dental issues other than the inclusion criteria\n* Subjects with a history of autoimmune disorder\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",true,{"count":630,"type":21},24,"6 Weeks","This crossover study aims to evaluate the wear comfort, retention, and stability of 3D-printed and milled occlusal splints in healthy subjects.\n\nThe main question it aims to answer is:\n\nResearch questions\n\n\\- How do healthy subjects experience the wear comfort, fitting, retention and stability of a printed and milled occlusal splint? and how do clinicians experience the fitting, retention and stability of the splints?\n\nBy systematically assessing self-reported outcomes, this research seeks to contribute valuable insights into the practical applications of both technologies. The findings may not only enhance our understanding of patient preferences but also guide future developments in the design and manufacturing of occlusal splints, ultimately improving patient care in dental practice.",[634,635,636],"Wear Comfort","Retention","Stability",[638,639,640,635,636,641],"3D printed splints","Milled splints","Prospective clinical randomized crossover study","comfort","2025-11-14",{"date":644,"type":39},"2025-11-19",{"date":340,"type":21},{"date":647,"type":21},"2026-09-01",{"name":45,"class":46},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":22,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":4},"100610626","phase-4-doxycycline-boosted-therapy-in-lyme-borreliosis-dobo-study-100610626","NCT07230028","Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.","A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.","DoBo","Inclusion Criteria:\n\n* Patients who are 18 years of age or older\n* Patients with probable or possible signs and symptoms attributed to Lyme borreliosis\n* Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)\n* Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).\n\nExclusion Criteria:\n\n* Known contra-indication for used study medication.\n* Women who are pregnant or lactating",{"count":463,"type":21},[408],"The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:\n\nDoes addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.\n\nParticipants will:\n\nTake hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.",[661],"Lyme Borreliosis, Nervous System",[663],"Hydroxychloroquine",{"date":665,"type":39},"2025-11-17",{"date":667,"type":21},"2026-03-01",{"date":669,"type":21},"2027-11-01",{"name":45,"class":46},{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":677,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":681,"conditions":682,"keywords":685,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":694,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":141},"100608609","peep-induced-effects-on-respiratory-drive-and-effort-100608609","NCT07203781","PEEP-induced Effects on Respiratory dRivE and EFfort","Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study","REEF","Inclusion Criteria:\n\n* Age \\> 18 years\n* Acute hypoxemic respiratory failure (AHRF) with a PaO2\u002FFiO2-ratio ≤ 200\n* Patient on invasive assisted mechanical ventilation in pressure support mode exhibiting valid inspiratory efforts (occlusion pressure \\> 5 cmH2O).\n\nExclusion Criteria:\n\n* Pre-existent neuromuscular disease\n* History of chronic respiratory failure requiring long-term oxygen therapy\n* Muscle paralysis\n* Pneumothorax\n* Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)\n* Contra-indications for EAdi or oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known\u002Fsuspected varices).",{"count":487,"type":21},[24],"Rationale:\n\nIn patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. While spontaneous breathing improves gas exchange and limits diaphragm atrophy, strong inspiratory efforts may worsen lung and diaphragm injury. Balancing these factors requires refined and tailored strategies, such as the modulation of PEEP. However, the impact of PEEP on neural respiratory drive and inspiratory effort is very heterogenous, and these two entities have only been studied separately in limited subsets of patients and healthy subjects. Additionally, it remains unclear whether the major determinant of PEEP-induced changes in respiratory drive and effort is represented by variations in diaphragm geometry, lung compliance, or by the presence of expiratory muscles recruitment, which may counteract its effect.\n\nObjective:\n\nThe primary objective is to determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation. The secondary objective is to determine the major physiological contributors to PEEP-mediated changes in diaphragm neuromechanical efficiency.\n\nStudy design: Prospective, physiological study. Study population: Invasively mechanically ventilated adult patients admitted to the ICU.\n\nIntervention:\n\nFor each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected.\n\nMain study parameters\u002Fendpoints:\n\nThe primary outcome of the study will be the evaluation of PEEP-mediated changes in diaphragm neuromechanical efficiency (NME).",[683,684],"ARDS (Moderate or Severe)","Acute Hypoxemic Respiratory Failure",[686,687,688,689,690,691,692,418,693],"PEEP","effort","drive","PSV","pressure support ventilation","AHRF","ARDS","NME",{"date":665,"type":39},{"date":696,"type":39},"2025-09-02",{"date":698,"type":21},"2026-09",{"name":45,"class":46},""]