[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Medical Center Groningen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":664},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,125,0,25,[9,48,82,104,133,158,183,210,236,259,288,311,341,362,384,406,426,455,479,499,518,546,569,606,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100467937","phase-3-hydrochlorothiazide-to-protect-polycystic-kidney-disease-patients-and-improve-their-quality-of-life-100467937",false,"NCT05373264","HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life","HYDRO-PROTECT","Inclusion Criteria:\n\n* ADPKD diagnosis (modified Ravine criteria)\n* ≥18 years old\n* eGFR \\> 25 mL\u002Fmin\u002F1.73m2\n* On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months\n\nExclusion Criteria:\n\n* Known intolerance to hydrochlorothiazide\n* Use of any diuretic\n* Orthostatic hypotension complaints or blood pressure \\\u003C105\u002F65mmHg during screening visit\n* Uncontrolled hypertension (blood pressure \\>160\u002F100mmHg)\n* Hypokalemia (\\\u003C3.5 mmol\u002FL)\n* History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and\u002For colchicine), defined as ≥2 episodes during the last year\n* History of skin cancer (basal cell, squamous cell and melanoma)","ALL","18 Years","80 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.\n\nTolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.",[28],"ADPKD",[28,30,31,32,33,34],"Tolvaptan","Hydrochlorothiazide","Quality of Life","Side effects","Polyuria","RECRUITING","2026-08-12",{"date":38,"type":39},"2026-08-14","ACTUAL",{"date":41,"type":39},"2024-07-31",{"date":43,"type":22},"2031-07",{"name":45,"class":46},"University Medical Center Groningen","OTHER",22,{"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":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100640555","establishing-a-reference-framework-for-outcomes-after-machine-preserved-liver-transplantation-in-europe-100640555","NCT07585890","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)","REFRAME-MP","Inclusion Criteria:\n\n* All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients \\>18 years at the time of liver transplantation.\n* All donor types (DBD, DCD)\n* Preservation either with static cold storage alone or combined with machine perfusion (MP).\n* Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.\n* Eligible MP protocols are:\n\n  1. end-ischemic single- or dual hypothermic oxygenated MP \\[e(D)HOPE\\],\n  2. end-ischemic (back-to-base) normothermic MP \\[eNMP\\],\n  3. continuous (device-to-donor) normothermic MP \\[cNMP\\],\n  4. e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP \\[e(D)HOPE-COR-NMP)\\],\n  5. e(D)HOPE followed by normothermic MP \\[e(D)HOPE-NMP\\], or\n  6. Normothermic regional perfusion followed by SCS or an ex situ MP protocol.\n* A minimum follow-up of 12 months after liver transplantation is required.\n\nExclusion Criteria:\n\n* Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.\n* Living donor liver transplantation",{"count":57,"type":22},10000,"OBSERVATIONAL","Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.",[61,62,63,64],"End-stage Liver Disease (ESLD)","Acute Liver Failure","Liver Cirrhosis","Liver Transplantation",[66,67,68,69,70,71,72],"machine perfusion","liver transplantation","hypothermic machine perfusion","normothermic machine perfusion","normothermic regional perfusion","organ preservation","machine preservation","2026-07-30",{"date":75,"type":39},"2026-08-03",{"date":77,"type":39},"2026-04-21",{"date":79,"type":22},"2030-12-31",{"name":45,"class":46},9,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100536601","perimetry-based-on-eye-movements-in-patients-with-suprasellar-tumors-100536601","NCT06266949","Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors","Inclusion Criteria:\n\n* Diagnosed with a (supra)sellar tumor\n* Visual field loss based on the most recent SAP; False positive rate \\\u003C15%; fixation losses \\\u003C20%\n* Informed written consent\n\nExclusion Criteria:\n\n* Neurological disorders\n* Eye disease not related to a (supra)sellar tumor",{"count":89,"type":22},30,"The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.",[92,93],"Pituitary Tumor","Visual Fields Hemianopsia","NOT_YET_RECRUITING","2026-07-22",{"date":97,"type":39},"2026-07-23",{"date":99,"type":22},"2026-12-01",{"date":101,"type":22},"2027-12-01",{"name":45,"class":46},1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100588010","respiratory-muscles-in-end-stage-lung-disease-pathophysiological-processes--clinical-consequences-100588010","NCT06935825","Respiratory Muscles in End-stage Lung Disease: Pathophysiological Processes & Clinical Consequences","Respiratory Muscles in End-stage Lung Disease: PAthophysiological Processes & Clinical Consequences","Re-MAP","In order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n* Age \\> 18 years old\n* Severe COPD defined as COPD GOLD stage III or IV (FEV1 \\\u003C 50% of predicted; FEV1\u002FFVC ratio \\\u003C 70%, no significant reversibility, smoking history of at least 10 pack-years).\n* Being on the lung transplant waiting list\n* Being able to understand the patient information and provide written informed consent for participation in the study\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Patients suffering from acute conditions at the time of inclusion or LTx\n* Patients using more than 20 mg of morphine, or an equivalent, or more than 20 mg oxazepam, or an equivalent, at the time of inclusion or LTx",{"count":113,"type":22},60,"Rationale: In patients with chronic lung diseases, the role of respiratory muscle dysfunction has been underestimated. Also, current treatment options, like chronic NIV and lung transplantation (LTx), might also have deleterious effects on the respiratory muscles, and the mechanisms are poorly understood.\n\nTherefore in this exploratory study the objectives are to:\n\n1. Determine in vivo respiratory muscle function and progression of respiratory muscle dys-function in end-stage COPD patients\n2. Establish the correlation between changes in the structure and contractility of respiratory myofibers and in vivo respiratory muscle function.\n3. Establish the effect of chronic NIV on structure and contractility of respiratory muscle fi-bers\n4. Determine whether the structure and contractility of respiratory muscles cells at the time of LTx predicts clinical recovery post-LTx.\n\nStudy design: The study will be an exploratory observational cohort study following patients on the LTx waiting list during the waiting period and afterwards until they showed functional recovery of respiratory muscle function.\n\nStudy population: Adult COPD patients on the LTx waiting list will be included. Intervention (if applicable): None\n\nMain study parameters\u002Fendpoints:\n\nTo assess clinical functioning of the respiratory muscles we will assess respiratory electrical activity as a measure of respiratory effort by surface EMG, and thickening fraction of the diaphragm and intercostal muscles and diaphragm excursions by ultrasound and maximal in- and expiratory pressure to assess muscle output; all before and after LTx. We will relate and correct these data for hyperinflation and degree of lung damage by using data from standard care lung function tests and CT scans, and will relate these measurements to prior treatment (NIV settings) and outcome after LTx, by retrieving these data from the EPD.\n\nTo assess contractility of respiratory myofibers and in vivo respiratory muscle function, biopsies will be taken during LTx surgery and the biopsies will be analyzed in the lab of Prof. Ottenheijm (AmsterdamUMC) for individual myofiber functioning (strength, calcium sensitivity, myofiber characteristics) and in the lab of Dr. Pouwels for extracellular matrix characteristics.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nOverall, risks are believed to be minimal. The clinical measurements are non-invasive and\u002For regular performed in clinical practice. Also, we decided to do those measurements during regular control visits, limiting the burden for the patients. Taking biopsies from the respiratory muscles during surgery has been extensively performed without any risk; the biobank of the Ottenheijm group contains \\> 500 samples and never any complication has been observed. Also, in preparation of the present study we performed a pilot study in 12 COPD patients of whom.. biopsies were taken at the UMCG without side effects or complications. The biopsies will be done with the patients being under full anesthesia, so participants will feel no discomfort.",[116],"COPD",[116,118,119,120,121,122,123,124],"NIV","Lung transplantation","Respiratory muscles","diaphragm","ultrasound","sEMG","MIP","2026-07-20",{"date":95,"type":39},{"date":128,"type":39},"2025-09-01",{"date":130,"type":22},"2029-09-01",{"name":45,"class":46},4,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":103},"100648144","pem-a-starting-point-to-investigate-mecfs-100648144","NCT07715838","PEM, a Starting Point to Investigate ME\u002FCFS","PEM, a Starting Point to Investigate and Understand ME\u002FCFS","PEM_CFS","Inclusion Criteria:\n\n* Willing and be able to complete all study procedures\n* Able to provide informed consent\n\nAdditional inclusion criteria for ME\u002FCFS patients\n\n* ME\u002FCFS patients have to meet the criteria of the ICC OR CCC.\n* A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise according to the DSQ-2. The persistent fatigue may have an acute onset or become progressively worse over 6 months.\n\nExclusion Criteria:\n\n* Use of immune-modulating drugs in the past 3 months.\n* A serious medical condition that may explain symptoms similar to ME\u002FCFS, such as cancer, coronary artery disease, uncontrolled diabetes, chronic infection (hepatitis B and C, tuberculosis, HIV), inflammatory diseases, autoimmune diseases (e.g. such as rheumatoid arthritis, lupus or polymyositis), severe COPD or other severe persistent respiratory disease, severe anemia, renal failure, Addison's or Cushing's disease or severe neurological disease (such as Parkinson's disease).\n* History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within last five years or lasting greater than 5 minutes at any point during their lifetime. Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.\n* Suspected, probable, or confirmed Lyme disease\n* Current or substance use disorder within last 5 years\n* A mood disorder or other psychiatric diagnosis prior to a diagnosis of ME\u002FCFS.\n* Pregnant, actively seeking to become or breastfeeding in the past 12 months.\n* BMI \\>35.\n* having cognitive or communication problems which reduces the capacity to understand instructions.\n* planned a change in medication during the testing period.\n* Use of medication that affects the blood pressure (e.g. Beta-blockers, fludrocortisone, vasoconstrictors).\n* Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.\n* Claustrophobia\n* Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the visits. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.\n* Use of B12 high dosage injections\n* Being colorblind\n\nAdditional exclusion criteria for control subjects:\n\n* performing high intensity or moderate intensity activities more than 30 minutes per week\n* substantial fatigue as determined using MFIS fatigue questionnaire \\>30",true,"65 Years",{"count":144,"type":22},100,"Exercise is an important contributor to general health and is considered a potential remedy for chronic diseases. This is in strong contrast with the observation that in most myalgic encephalomyelitis (ME\u002FCFS) patients exercise aggravates their symptoms. Recently, post-exertional malaise (PEM) is defined as the key symptom of ME\u002FCFS. The etiology and pathophysiological mechanisms underlying ME\u002FCFS are still unknown and objective diagnostic criteria are not available. Various hypotheses are postulated including disorders of several organ systems but the heterogenous presentation of symptoms in patients, and the multisystem deficits complicate reaching an all-encompassing hypothesis. It seems therefore reasonable to focus on the key symptom, i.e., PEM. PEM can be induced by minor cognitive or physical exertion and can be assessed with questionnaires. Acute physical activity triggers complex cardiovascular, metabolic, and molecular responses and for ME\u002FCFS, hence it is important to understand the relation between these acute processes and the prolonged presentation of aggravated symptoms (PEM). We therefore want to measure metabolites, cardiovascular responses, cognitive performance, muscle force and fatigability in 50 patients and 50 controls matched on group level for sex, age, and activity. To follow changes in these parameters we perform time-series analysis, including data obtained before, during and after task performance. Besides understanding these interactions, it is also essential to understand how these acute and prolonged responses affect behaviour and perception.",[147],"Myalgic Encephalomyelitis \u002F Chronic Fatigue Syndrome",[149],"Post exertional malaise","2026-07-14",{"date":152,"type":39},"2026-07-21",{"date":154,"type":39},"2024-05-01",{"date":156,"type":22},"2027-07-31",{"name":45,"class":46},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":103},"100647504","phase-1-a-phase-i-study-investigating-the-local-tolerability-and-pharmacokinetics-of-isoniazid-inh-inhalation-by-wet-nebulization-in-patients-with-tuberculosis-100647504","NCT07708779","A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis","INHalation-01","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of TB with known drug susceptibility, either by culture or molecular testing\n* Clinically stable or improving after at least 2 weeks of effective TB treatment\n* Obtained written informed consent\n\nExclusion Criteria:\n\n* Patients that are pregnant, or breast feeding\n* History of adverse events on previous or current INH use\n* FEV1 \\\u003C 30% predicted\n* Concurrent use of corticosteroids in varying dose (a stable dose one week before participating and during the study is allowed).\n* Concurrent use of aluminium containing medicines (i.e. antacids)\n* Concurrent use of carbamazepine, phenytoin or theophylline\n\nAdditionally, a potential subject with DS-TB (eliciting switch to levofloxacin) who meets any of the following criteria will be excluded from participation in this study:\n\n* History of epilepsy\n* History of adverse events on previous levofloxacin or other fluoroquinolone use\n* Risk of QTc prolongation (prolonged QTc-interval (\\>450 msec), long-QT syndrome (LQTS) or concurrent use of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose \\> 1000 mg) or sotalol)",{"count":166,"type":22},8,[168],"PHASE1","Rationale:\n\nTo halt the global tuberculosis (TB) crisis, and particular the ongoing threat of drug-resistant TB (DR-TB), it is essential to reduce transmission. This could be done by shortening the period that patients with pulmonary TB secrete viable bacilli, and are therefore contagious to others, by prompt initiation of effective treatment. Pulmonary administration of anti-TB drugs might play an important role since it yields higher local concentrations and lower systemic concentrations compared to systemic (oral or parenteral) administration. Isoniazid (INH) has very high bactericidal activity and is one of the most effective drugs in the treatment of TB. Although the occurrence of mutations leading to resistance to INH at systemic concentrations has hindered the use of this drug, INH can still be effective when administered in a high concentration at the site of infection even in case of drug resistance. This cannot easily be achieved by oral dosing because of the associated risk of systemic toxicity. However, pulmonary administration of INH may be a solution. The concept of inhalable antimicrobials is not new; for example it is a well-established therapy for the treatment of Pseudomonas aeruginosa infection in cystic fibrosis patients. INH has been used by inhalation before in patients with TB but only up to a dose of 200 mg\u002Fday. In this protocol, a local tolerability and pharmacokinetic study of higher doses of INH inhalations will be performed by wet nebulization in patients with TB. The hypothesis is that single doses up to 1200 mg INH are safe.\n\nFuture studies will demonstrate that high intrapulmonary concentrations enhance the initial reduction of the bacterial load in both drug-susceptible TB (DS-TB) as well as TB with reduced susceptibility to INH. If proven, this novel inhalation-based approach may lead to a massive decline in further spread of (drug resistant) TB.\n\nObjectives: The primary objective of this study is to investigate the local tolerability of isoniazid inhalation by wet nebulization at single ascending dosages. Secondary objective is systemic pharmacokinetics of inhaled isoniazid compared to intravenous dose administration.\n\nStudy design: single-center, single ascending dose tolerability study.\n\nParticipants will receive one intravenous dose of 300 mg INH and three inhaled doses of INH by using an eFlow nebulizer in ascending order (200 mg, 600 mg and 1200 mg) with at least 48 hours and maximum seven days in between doses. Before each INH administration, an indwelling venous cannula will be inserted and before and after each administration, serum samples will be collected for pharmacokinetic analysis. To investigate local tolerability, lung function tests will be performed once before and twice after inhalation of INH and the occurrence of adverse events will be scored. After every inhalation dose the study team will decide on escalation to the next dose step whereby a drop of forced expiratory volume in the first second (FEV1) of \\>15 % is considered critical next to specific other adverse events.\n\nStudy population: 8 adult patients with tuberculosis with known drug susceptibility\n\nMain study parameters\u002Fendpoints: For the local tolerability, spirometry will be performed and adverse events will be recorded. The following serum pharmacokinetic parameters will be calculated: AUC24 (area under the concentration-time curve over 24 hours), Cmax (maximum serum concentration), Tmax (time to maximum serum concentration), actual dose inhaled.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients with DS-TB receive INH as part of usual care and this will temporarily be replaced by levofloxacin during the study period in order not to interfere with the intervention (this is not applicable for other forms of TB). From INH resistant TB (Hr-TB) it is known that this replacement does not impact on the efficacy of the treatment or its duration. An electrocardiogram will be performed before and after initiation of levofloxacin, because of the potential risk of QTc-interval prolongation.\n\nThere is no benefit with participation in the study. Taking part in the study takes extra time and the measurements such as spirometry and drawing of blood samples may give slight inconvenience. Participants may also experience adverse effects of isoniazid inhalations or levofloxacin tablets. Common adverse effects reported with administration of aerosolized antibiotics include wheezing, haemoptysis, and dyspnoea. After each inhalation dose the study team will determine if a drop of FEV1 \\> 15% or relevant adverse events have occurred and whether it is safe for the participant to move on to a higher dose. Halfway through the study a report will be made describing the withdrawals, spirometry results and the cumulative adverse events seen for judgement by the study team. Stop criteria are defined for premature ending of the study at thi",[171],"Tuberculosis",[173,174,175],"Inhalation","Pharmacokinetics","Isoniazid","2026-07-13",{"date":178,"type":39},"2026-07-16",{"date":180,"type":39},"2025-12-01",{"date":178,"type":22},{"name":45,"class":46},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100641953","phase-2-in-vivo-fluorescence-molecular-bronchoscopy-of-durvalumab-680lt-in-patients-with-unresectable-stage-iii-non-small-cell-lung-cancer-nsclc-after-chemoradiotherapy-100641953","NCT07653438","In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy","In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy - PulmoPrint","PulmoPrint","Inclusion Criteria:\n\n* Signed informed consent prior to participation in the study.\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed unresectable stage III non-small cell lung cancer.\n* Completion of concurrent platinum-based chemoradiotherapy\n* Eligibility for adjuvant durvalumab per standard of care.\n* At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscopic\u002Fendobronchial ultrasound, suitable for biopsy\u002Ffine-needle aspiration (FNA) and fluorescence measurement.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Patient is considered fit to undergo a research bronchoscopy (with or without addition of endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated).\n\nExclusion Criteria:\n\n* Known history of infusion reactions to durvalumab, other anti-PD-L1 antibodies, or other monoclonal antibodies, according to the patient's medical history.\n* Contraindication for bronchoscopy or endoscopic\u002Fendobronchial ultrasound (if applicable), including severe uncorrectable coagulopathy, pre-existing severe respiratory insufficiency, or any other clinical reason as judged by the investigator.\n* Medical or psychiatric conditions compromising the patient's ability to provide informed consent, according to the treating physician.\n* Pregnancy or breastfeeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration.\n* Use of an investigational medicinal product within 30 days prior to tracer administration.",{"count":192,"type":22},20,[194],"PHASE2","PulmoPrint is a clinical study at the University Medical Center Groningen (UMCG) that investigates why some patients with unresectable stage III lung cancer don't respond to immunotherapy after chemoradiotherapy. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an intravenous (IV) drip, after which a bronchoscopy is performed to visualize where and how much of the drug reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.",[197,198],"Stage III Non-small Cell Lung Cancer","Unresectable Stage III NSCLC",[200,201,202],"Fluorescence molecular bronchoscopy","Durvalumab-680LT","Near-infrared fluorescence imaging",{"date":204,"type":39},"2026-07-15",{"date":206,"type":22},"2026-09-01",{"date":208,"type":22},"2031-03-01",{"name":45,"class":46},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100612823","the-tasty-training-study-100612823","NCT07258589","The TASTY-training Study","Taste and Smell Training in Patients With Cancer Who Are Treated With Tyrosine Kinase Inhibitors: a Multicentre Randomized Intervention Trial","TASTY-training","Inclusion Criteria:\n\n* Age ≥18 and ≤70 years\n* Intention of being treated with tyrosine kinase inhibitors for next 12 weeks.\n* Experiencing taste alterations after starting treatment with tyrosine kinase inhibitors\n* Consuming solid foods and drinks is possible\n* ≤50% of recommended daily intake in kcal consisting of oral nutritional supplements\n* Oral mucositis grade ≤2 (Common Terminology Criteria for Adverse Events, version 5.0)\n* Ability to comply with all protocol-required actions\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of taste, smell, or saliva production dysfunction before treatment with tyrosine kinase inhibitors\n* Previous or current radiotherapy of head and neck region\n* Enteral feeding through tube or parenteral feeding\n* Participation in another clinical trial aimed at preventing or treating taste and\u002For smell alterations\n* Chronic (\\>1 month) high dose corticosteroids (\\>10 mg prednisone\u002Fday or equivalent)","70 Years",{"count":220,"type":22},90,[222],"NA","A multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste and smell training.\n\nTo examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.",[225,226],"Oncological Patients","Tyrosine Kinase Inhibitor",[228],"Taste alterations",{"date":204,"type":39},{"date":231,"type":39},"2025-11-10",{"date":233,"type":22},"2028-07",{"name":45,"class":46},11,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":252,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":235},"100612821","the-tasty-steering-study-100612821","NCT07258563","The TASTY-steering Study","Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial","TASTY-steering","Inclusion Criteria:\n\n* Age ≥18 and ≤70 years\n* Indication to start chemotherapy for:\n\n  * Metastatic triple negative breast cancer\n  * Metastatic testicular cancer\n  * Stage II-IV diffuse large B cell lymphoma\n* Chemotherapy scheduled to start in the next 6 weeks\n* Consuming solid foods and drinks is possible\n* ≤50% of recommended daily intake in kcal consists of oral nutritional supplements\n* Oral mucositis grade ≤2 (Common Terminology Criteria for Adverse Events, version 5.0)\n* Ability to comply with all protocol-required actions\n* Written informed consent\n* For the intervention phase only: subjective change in taste since start of chemotherapy\n\nExclusion Criteria:\n\n* Pregnancy\n* Currently experiencing taste or smell problems\n* Previous or current radiotherapy of head and neck region\n* Enteral feeding through tube or parenteral feeding\n* Participation in another clinical trial aimed at preventing or treating taste and\u002For smell alterations\n* Chronic (\\>1 month) high dose corticosteroids (\\>10 mg prednisone\u002Fday or equivalent).",{"count":245,"type":22},201,[222],"This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste steering.\n\nTo examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks.\n\nSome hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.",[249,250,251],"Metastatic Triple Negative Breast Cancer","Metastatic Testicular Cancer","Stage II-IV Diffuse Large B Cell Lymphoma",[253],"Taste Alterations",{"date":204,"type":39},{"date":256,"type":39},"2025-06-06",{"date":233,"type":22},{"name":45,"class":46},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":267,"maxAge":18,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":103},"100574668","the-impact-of-a-diagnostic-strategy-for-acute-appendicitis-in-children-with-acute-abdominal-pain-in-primary-care-100574668","NCT06762275","The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care","Optimizing Management of Children Presenting With Acute Abdominal Pain in Primary Care: a Cluster Randomized Controlled Trial Evaluating the Impact of a Clinical Prediction Rule Including C-reactive Protein for Appendicitis","ISAAK","Inclusion criteria:\n\n\\- Children aged 4 to 18 years with acute abdominal pain (onset ≤ 7 days) who present at the GP.\n\nExclusion criteria:\n\n* A history of appendectomy\n* Current pregnancy\n* Traumatic cause of abdominal pain","4 Years",{"count":269,"type":22},566,[222],"BACKGROUND Acute appendicitis (AA) in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% of non-AA cases among referrals.\n\nOBJECTIVE To evaluate the impact of the use of a diagnostic strategy for acute appendicitis (AA), which consists of a clinical prediction rule (cPR) including C-reactive protein point-of-care test (CRP POCT), on referral efficiency in children with acute abdominal pain in primary care, as compared to usual care.\n\nSTUDY DESIGN This is a cluster randomized controlled trial in primary care with a process evaluation. GPs in the intervention group will use an externally validated cPR based on symptoms and signs selectively followed by a CRP POCT in the medium risk group. GPs from general practices allocated to the control group will provide care and diagnosis as usual, i.e. following recommendations of the Dutch College of GPs guideline 'abdominal pain in children'.\n\nSTUDY POPULATION Children aged 4 to 18 years presenting to their general practitioner (GP) with acute abdominal pain.\n\nOUTCOME MEASURES Primary outcome: referral efficiency (proportion non-referrals in non-AA patients during 30 days follow-up).\n\nSecondary outcomes: safety (proportion of referrals in AA patients during the first consultation or planned reassessment), proportion of children with CRP-POCT, proportion of children with planned reassessment, child anxiety, parent or child satisfaction, quality of life, and costs.",[273,274],"Appendicitis Acute","Acute Abdomen in Children",[276,277,278,279,280],"General practitioner","Appendicitis","Clinical prediction rule","C-reactive protein","Children","2026-07-09",{"date":176,"type":39},{"date":284,"type":39},"2025-03-06",{"date":286,"type":22},"2029-03-01",{"name":45,"class":46},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":295,"targetDuration":296,"studyType":58,"phases":4,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":103},"100497372","improving-chronic-nocturnal-noninvasive-ventilation-a-multimodality-approach-100497372","NCT05756387","Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach","NOCTIVENT","Inclusion Criteria:\n\n* COPD patients indicated for chronic home NIV\n\nExclusion Criteria:\n\n* not able to read the written information and\u002For sign the informed consent form\n* no possibility to perfrom measurements at home",{"count":144,"type":22},"6 Months","The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.\n\nFor this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.",[299,300],"Chronic Respiratory Failure","Non-invasive Ventilation",[302],"Monitoring","2026-07-01",{"date":305,"type":39},"2026-07-02",{"date":307,"type":39},"2024-12-01",{"date":309,"type":22},"2028-12-01",{"name":45,"class":46},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":318,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":330,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":103},"100644802","bilirubin-thresholds-in-preterm-infants-on-neonatal-intensive-care-units-the-b-nice-trial-100644802","NCT07674537","Bilirubin Thresholds in Preterm Infants on Neonatal Intensive CarE Units: The B-NICE Trial","B-NICE","Inclusion Criteria:\n\n* Gestational age at birth \\\u003C30+0 weeks.\n* Admission to a participating NICU within 24 hours after birth.\n* Parental consent according to the approved consent procedure\n\nExclusion Criteria:\n\n* Major congenital anomalies, excluding intraventricular hemorrhage, expected to affect survival or neurodevelopmental outcome.\n* Antenatal diagnosis of immune hemolytic disease of the fetus or newborn (such as RhD antagonism) requiring protocolized alternative management.","24 Weeks","29 Weeks",{"count":321,"type":22},680,[222],"Rationale: Neonatal hyperbilirubinemia is highly prevalent in very preterm infants born \\\u003C30 weeks. Since 2008, uniform Dutch phototherapy thresholds for preterm infants have been used nationwide, largely based on consensus. Consequently, \\>80% of very preterm infants receive phototherapy for several days, accompanied by repeated blood sampling and reduced opportunities for skin-to-skin care. The corresponding UK National Institute for Health and Care Excellence (NICE) guideline applies higher (less strict) thresholds, which may reduce overtreatment, but comparative safety for very preterm infants has not been established in a randomized trial. The investigators hypothesize that using NICE thresholds is non-inferior to Dutch thresholds for survival without neurodevelopmental impairment (NDI) at two years' corrected age, while reducing treatment burden.\n\nObjective: Primary: To determine whether initiating phototherapy according to NICE thresholds is non-inferior to Dutch thresholds with regard to survival without NDI at two years' corrected age in infants born \\\u003C30 weeks of gestation. Secondary: To compare phototherapy exposure (incidence, duration and cumulative exposure) and monitoring burden (e.g., number of bilirubin blood samples, temperature instability, biomarkers of oxidative stress (subpopulation)), and to evaluate parent-infant outcomes (skin-to-skin contact time, parental stress\u002Fsatisfaction), and nursing workload (time dedicated to bilirubin-related care).\n\nStudy design: Nationwide multicenter, parallel-group, open-label randomized non-inferiority trial with 1:1 allocation, stratified by center and gestational age category (\\\u003C28 weeks and ≥28 weeks). Follow-up continues to the routine neurodevelopmental assessment at two years' corrected age. Planned project duration: 36 months.\n\nStudy population: Very preterm infants born \\\u003C30+0 weeks of gestation, admitted to a participating Dutch NICU within 24 hours after birth.\n\nIntervention: Bilirubin monitoring and phototherapy according to one of two threshold strategies: (1) current Dutch phototherapy thresholds (control) or (2) thresholds from the UK NICE guideline (intervention). Phototherapy is delivered using standard NICU devices.\n\nMain study parameters\u002Fendpoints: Primary endpoint: survival without NDI at two years' corrected age. NDI is defined as Bayley Scales of Infant and Toddler Development, fourth Edition, Dutch Version (BSID-IV-NL) cognitive and\u002For motor composite score \\\u003C85 and\u002For hearing impairment and\u002For visual impairment.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Both strategies reflect accepted standards of care with routine bilirubin monitoring. Incremental burden consists mainly of additional registration (phototherapy use, bilirubin sampling, skin-to-skin contact, temperature instability), parental questionnaires and, in selected centers, collection of stress-related biomarkers from urine, feces, or waste material from routine blood samples to explore the physiological impact of phototherapy. No biobanking for future unspecified research is planned. The investigators will also use routinely collected and stored monitor data to assess sleep (sleep-wake states and sleep fragmentation) in a subset of infants. Neurodevelopmental follow-up at two years corrected age is routine care in Dutch NICUs. Bilirubin levels above thresholds in both groups will be mitigated by routine monitoring and management according to this study protocol. The study is group-related because bilirubin management and potential neurotoxicity thresholds are specific to very preterm infants.",[325,326,327,328,329],"Neonatal Hyperbilirubinemia","Treatment Decisions","Neurodevelopmental Outcome","Phototherapy","Exchange Transfusion",[331,332],"neonatal jaundice","preterm infants \u003C 30 weeks GA","2026-06-24",{"date":335,"type":39},"2026-06-29",{"date":337,"type":22},"2026-08-01",{"date":339,"type":22},"2029-11-01",{"name":45,"class":46},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":348,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":235},"100643318","phase-4-pembrolizumab-registry-for-outcomes-and-treatment-evaluation-in-cervical-cancer-100643318","NCT07645625","Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer","PROTECx","Inclusion criteria for the observation cohort:\n\n\\- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.\n\nInclusion criteria for the early discontinuation cohort:\n\n* Previous inclusion in the observation cohort\n* Choice made to stop pembrolizumab for one of the following reasons:\n\n  1. Confirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR\n  2. Immune-related toxicity grade ≥ 3 OR\n  3. Patient's preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR\n  4. Confirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria)\n* Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)\n\nExclusion criteria for all cohorts are:\n\n* Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded\n* Any psychological, familial, sociological or geographical condition or a known psychiatric or substance abuse disorder potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. This comprises each and every condition or circumstance preventing the patient from showing up to the outpatient controls and\u002For undergoing the CT-scans, or preventing the patient from (adequately) filling out the questionnaires.","FEMALE",{"count":350,"type":22},261,[352],"PHASE4","This is a nationwide, multicenter, registry-based prospective cohort study to assess real-world effectiveness of treatment with a pembrolizumab containing regimen in persistent, recurrent, or metastatic cervical cancer. Patients in the observation cohort continue treatment according to standard of care. In the discontinuation cohort, patients discontinue their maintenance treatment with pembrolizumab (with or without discontinuation of bevacizumab). Patients may choose to discontinue pembrolizumab prematurely (with or without discontinuation of bevacizumab) if they achieve a confirmed CR or a confirmed PR to treatment, or on patient's request or due to toxicity. If an eligible patient chooses not to discontinue treatment early they will remain in the observation cohort. The duration of the trial for the individual patient will be until two years from the start of treatment. Survival follow-up will continue for a maximum of 10 years",[355],"Cervical Cancer",{"date":335,"type":39},{"date":358,"type":39},"2026-05-11",{"date":360,"type":22},"2039-02",{"name":45,"class":46},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":103},"100619165","multicenter-early-intervention-study-in-adults-with-complaints-after-mild-traumatic-brain-injury-100619165","NCT07341074","Multicenter Early Intervention Study in Adults With Complaints After Mild Traumatic Brain Injury","BRAin INjury REcovery After Symptom-guided Early Therapy","BRAIN-RESET","Inclusion Criteria:\n\n* Age 18-70 years\n* Seen at the ED within 24 hours after trauma\n* Loss of consciousness (\\\u003C30min.)\n* Post-traumatic amnesia (\\\u003C24hrs)\n* Glasgow Coma Scale (GCS) score of 13-15 after initial resuscitation at the ED\n* Comprehension of Dutch language\n\nExclusion Criteria:\n\n* Inability for follow-up\n* Chronic substance abuse (alcohol and\u002For drugs)\n* Severe psychiatric disease\n* Documented previous traumatic brain injury for which the patient was admitted\n* Dementia and\u002For other severe comorbidities\n* Current treatment by physical and\u002For occupational therapist for other indications\n* Language barriers or illiteracy prohibiting understanding and completion of questionnaires",{"count":371,"type":22},655,[222],"Rationale: In the Netherlands, traumatic brain injury (TBI) is one of the most frequent neurological diseases and one of the leading causes of disability. Presumably, about half of the total Dutch population will get a TBI during their lifetime. The majority, about 85%, of patients suffers from a mild TBI (mTBI). The incidence of mTBI is estimated at 68,000 patients each year, but this is an underestimation as patients seen at the general practitioner's offices are not taken into account. In general, the prognosis of mTBI is relatively good, however more than 70% of patient still have one or more post-traumatic complaints at six months post-injury influencing resumption of daily (social) activities and return to work\u002Fstudy. Considering the high annual incidence of mTBI the number of patients with incomplete recovery has high social impact accompanied with excessive health care related costs. Post-traumatic complaints in the chronic phase postinjury are considered therapy resistant and so far no evidence based treatment is available. Hence, the most appropriate strategy is to prevent complaints present in the (sub)acute phase after injury to become persistent to improve functional outcome and quality of life.\n\nObjective: The main aim of this study is to improve early care for patients suffering from post-traumatic complaints after mTBI through the development of effective symptom-guided tailored interventions. Nowadays, no effective therapy is available and care-as-usual consists of a wait-and-see policy. Early therapy will reduce posttraumatic complaints and facilitate earlier return to daily activities and work or study, consequently quality of life will be improved as well. This in turn will result in less healthcare consumption and lower societal costs.\n\nStudy design: The investigators propose a prospective three-arm multicenter open randomized controlled trial (RCT), randomizing participants between two interventions and care as usual. The end-point assessment is blinded.\n\nStudy population: Adults, aged 18-70 years, diagnosed with a mTBI at the Emergency Department (ED) of the participating hospitals within 24 hours after injury are eligible for inclusion.\n\nIntervention: At two weeks post-injury the presence, severity, and type of post-traumatic complaints are assessed using the Rivermead Postconcussive complaints Questionnaire (RPQ). If a predefined minimum of complaints is present, a participant is randomised for one of the two interventions or the control group. The first intervention arm consists of symptom-targeted treatment with assignment to physical and\u002For occupational therapy. The second intervention arm involves psychoeducation about the complaints through telephonic counselling. The interventions are offered during three weeks from week 3-6 week post-injury.\n\nMain study parameters\u002Fendpoints: The primary outcome measure is the total RPQ sum score at three months postinjury. The secondary outcome measures are functional outcome and quality of life.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants included in treatment arm 1 will undergo three to six therapy sessions with a physiotherapist and\u002For occupational therapist over a period of three weeks. This regimen may be potentially burdensome by its frequency but the risks associated with these treatments are low. Participants randomised to treatment arm 2 will receive three telephone calls over the course of three weeks, during which psychoeducation will be provided. This intervention is minimally burdensome and risk-free. All participants included in the interventional part of the study will complete questionnaires at three time points after injury and will receive two follow-up telephone calls three and six months post-injury for outcome assessment. This process is minimally burdensome and poses no risk. Finally, participants included in the registry will complete a limited set of questionnaires at three time points, which is also minimally burdensome and riskfree.",[375],"Mild Traumatic Brain Injury","2026-06-23",{"date":378,"type":39},"2026-06-26",{"date":380,"type":39},"2026-02-16",{"date":382,"type":22},"2027-12-31",{"name":45,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":141,"sex":17,"minAge":18,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":103},"100527301","mechanisms-of-change-of-positive-interventions-in-reducing-vulnerability-for-depression-100527301","NCT06145984","Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression","Understanding Mechanisms of Prevention of Depression: a Mechanistic Cross-over Trial of Mindfulness vs. Fantasizing to Reduce Perseverative Cognition Underlying Vulnerability for Depression","MINDCOG","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, all participants must meet all the following criteria:\n\n* Participants should be between 18 and 60 years old. Participants should not exceed 60 years of age in order to minimize aging-related decline in information processing;\n* Participants should display normal intelligence (IQ\\>85, as assessed with the Dutch Adult Reading Test and\u002For having finished an education on at least vocational level) in order to assure sufficient task comprehension.\n\nParticipants in the remitted Major Depressive Disorder group should meet the following criteria to make sure that participants are at high risk of depressive relapse and currently show no clinically relevant severity of depressive symptoms:\n\n* Remitted participants should have experienced at least two depressive episodes, according to criteria defined by the Diagnostic Statistical Manual, version 5 (DSM-5), experienced in past ten years;\n* Remitted participants should score 21 or lower on the Inventory of Depressive Symptomatology (IDS-SR30), indicative of the absence of clinically relevant depressive symptoms.\n\nExclusion Criteria:\n\nFurthermore, individuals who meet any of the following criteria will be excluded from participation in this study:\n\n* Fulfilling criteria for any current DSM-5 diagnosis as objectified with the Structured Clinical Interview for DSM-5 (SCID-5);\n* Daily use of anti-depressive medication, benzodiazepines, methylphenidate, beta blockers or other medication potentially influencing electrocardiogram currently or in the last four weeks;\n* Recent engagement (defined as in their last episode, or as one year prior to inclusion in case the last episode was more than a year before inclusion) in preventive cognitive therapy including the positive fantasizing technique and\u002For have recent experiences (defined as daily practice in the past two years for at least two weeks) with mindfulness, meditation, or mindful yoga. This criterion prevents underestimation of true effects of mindfulness and\u002For positive fantasizing and maximizes treatment effects;\n* Participation in another clinical intervention study at the moment of inclusion in the study to prevent overlapping intervention effects.\n\nIndividuals for the Never-Depressed control group who additionally meet any of the following criteria will be excluded from participation of this study:\n\n* Presence of symptoms of depression according to the IDS-SR30 (score \\> 13), to make sure participants are not currently experiencing clinically relevant depressive symptoms;\n* Any life-time psychopathology of any disorder as objectified with the SCID-5.","60 Years",{"count":144,"type":22},[222],"The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.",[397],"Depression in Remission","2026-06-15",{"date":400,"type":39},"2026-06-16",{"date":402,"type":39},"2020-06-19",{"date":404,"type":22},"2026-09-24",{"name":45,"class":46},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":348,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":103},"100641774","phase-1-neoadjuvant-lymph-node-targeted-immunotherapy-in-cervical-cancer-a-feasibility-study-neolync-100641774","NCT07653503","Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)","NEOLYNC","Inclusion Criteria:\n\n* Female participants with uterus and cervix in situ who are at least 18 years of age on the day of signing informed consent with histologically confirmed primary diagnosis of cervical cancer and are intended to be treated with standard-of-care surgery (\\\u003C FIGO IB3). Only female participants with reproductive organs still in situ are eligible because this ensures the highest chance of the correct lymph(node) anatomy needed for the administration of the IMP;\n* The participant is not pregnant, not breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to follow contraceptive guidance as described in 9.2.1. during the treatment period and at least until SoC surgery;\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n\nExclusion Criteria:\n\n* WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to allocation.\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (defined as \\>10 mg prednisone equivalent per day) or other systemic immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of systemic corticosteroids and other immunosuppressants prior to initiation of study treatment should be avoided due to potential interference with the pharmacodynamic activity of nivolumab. Use of immunosuppressive agents after initiation of treatment is allowed when clinically indicated for the management of immune-related adverse events.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Any contraindication to MRI, including but not limited to the presence of non-MRI-compatible implants (e.g., pacemakers, cochlear implants, neurostimulators), ferromagnetic metal fragments, or severe claustrophobia unmanageable with standard precautions.\n* Prior surgical intervention in the inguinal region with potential disruption of lymphatic drainage.\n* Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Any condition, as assessed by the research physician and\u002For medical oncologist, that in their clinical judgment makes the patient unsuitable for participation in the study. This may include, but is not limited to, poor physical condition, abnormal laboratory values, or other medical or psychosocial factors that could compromise patient safety or study integrity. Patients that are excluded based on this criterium will always be reported to the DSMB.",{"count":414,"type":22},12,[168],"We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.",[418],"Cervical Carcinoma","2026-06-11",{"date":421,"type":39},"2026-06-17",{"date":423,"type":39},"2026-01-05",{"date":101,"type":22},{"name":45,"class":46},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":103},"100643087","phase-1-development-of-fluorescent-lectin-tracers-with-dedicated-technology-for-in-vivo-detection-of-esophageal-dysplasia-in-barrett-patients-100643087","NCT07643727","Development of Fluorescent Lectin Tracers With Dedicated Technology for in Vivo Detection of Esophageal Dysplasia in Barrett Patients","Glycan Near-Infrared Imaging Using Fluorescently Labeled Wheat Germ Agglutinin (WGA): Evaluation of Safety and Feasibility in a Prospective Pilot Study","GRAIN","Inclusion Criteria:\n\n* Patients with confirmed Barrett's esophagus, esophageal dysplasia, or superficial esophageal ade-nocarcinoma.\n* Patients scheduled for gastroscopy procedure within the UMCG.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to wheat.\n* Celiac disease.\n* Dermatitis herpetiformis.\n* Pregnancy or breastfeeding.",{"count":435,"type":22},49,[168],"The goal of this clinical trial is to evaluate the feasibility of WGA-800CW with dedicated imaging systems for detection of invisible esophageal dysplasia in patients with Barrett's esophagus.\n\nThe main questions it aims to answer are:\n\n* What is the optimal dose of WGA-800CW that maximizes the tumor-to-background ratio and enables clear visualization of the tumor?\n* Can fluorescence endoscopy with WGA-800CW in combination with qFME detect dysplastic esophageal lesions?\n\nIn this non-randomized, non-blinded, prospective, feasibility intervention study, 49 participants with Barrett's esophagus will be included. Patients will undergo the combined procedure (qFME and\u002For OCT-NIRF and HD-WLE). WGA-800CW will be topically administered via a spray catheter during gastroscopy procedures and fluorescent signal will be assessed with qFME and\u002For OCT-NIRF.",[439,440],"Barrett's Esophagus With or Without Dysplasia","Barrett Esophagus Adenocarcinoma",[442,443,444,445,446,447],"Glycan","Oncology","Fluorescent tracers","qFME","First-in-human","Lectin","2026-06-08",{"date":419,"type":39},{"date":451,"type":22},"2026-06-01",{"date":453,"type":22},"2028-10-31",{"name":45,"class":46},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"100505700","value-of-screening-mri-brain-in-stage-iv-non-small-cell-lung-cancer-100505700","NCT05864794","Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer","ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial","VULCAN","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.\n* Fit for systemic treatment (PS 0-2) according to standard of care.\n* No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.\n\nExclusion Criteria:\n\n* Prior\u002Fconcomitant therapy for stage IV disease.\n* Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.\n* Contraindications for MRI scan with contrast as per standard of care protocol of the institution.",{"count":144,"type":22},[222],"Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.",[467],"Non Small Cell Lung Cancer Metastatic",[469,470],"brain metastasis","screening",{"date":472,"type":39},"2026-06-09",{"date":474,"type":39},"2024-05-13",{"date":476,"type":22},"2028-12-31",{"name":45,"class":46},3,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":103},"100639159","immediate-loading-of-implants-in-the-aesthetic-zone-using-three-dimensionally-printed-provisional-crowns-a-1-year-prospective-case-series-study-100639159","NCT07629752","Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study","Inclusion Criteria:\n\n* The patient is 18 years or older;\n* The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;\n* Sufficient healthy and vital bone after alveolar ridge preservation to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability \\> 45 Ncm;\n* The implant site must be free from infection;\n* Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);\n* Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic crown;\n* The provisional crown can be designed free from occlusal contact;\n* The patient is capable of understanding and giving informed consent.\n\nExclusion Criteria:\n\n* Medical and general contraindications for the surgical procedures;\n* Presence of an active and uncontrolled periodontal disease;\n* Bruxism;\n* Smoking\n* A history of local radiotherapy to the head and neck region.",{"count":89,"type":22},"• Background There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes. It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation\u002Freconstruction in the maxillary esthetic zone.\n\nOne recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional three-dimensionally printed provisional crowns and allows for rapid additive production of prosthetic restorations.\n\nUntil date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction.\n\n* Main research question The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns.\n* Design (including population, confounders\u002Foutcomes) The study design is a prospective, single-arm observational study for evaluation of 30 patients with a failing tooth in the maxillary aesthetic region to be treated with an implant-supported provisional and definitive restoration by means of a provisional and definitive crown. Outcomes: registration of time\u002Fcomplications during the diagnostic\u002Fplanning\u002Fmanufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.\n* Expected results Satisfying results for patients and professionals (VAS-scores and PES\u002FWES-scores)",[488,489],"Dental Implants, Single-tooth","Crown",[491,492],"Implant placement","Immediate provisional",{"date":494,"type":39},"2026-06-05",{"date":303,"type":22},{"date":497,"type":22},"2027-07-01",{"name":45,"class":46},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":505,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":103},"100639782","late-scan-time-point-optimalisation-of-18f-fluoroestradiol-for-the-large-field-of-view-lafov-petct-scanner-100639782","NCT07627269","Late Scan Time-point Optimalisation of 18F-Fluoroestradiol for the Large Field-of-view (LAFOV) PET\u002FCT Scanner.","Inclusion Criteria:\n\n* Patients who are referred for PET\u002FCT imaging with 18F-Fluoroestradiol will be included in this study.\n\nExclusion Criteria:\n\n* Patients who are not able to lay down in supine position for up to one hour.","16 Years",{"count":166,"type":22},[222],"Currently, in routine patient care PET\u002FCT scan protocols used on high sensitivity large field of-view (LAFOV) PET\u002FCT systems are based on protocols that historically were developed for standard field-of-view (SAFOV) PET\u002FCT systems with a much lower sensitivity profile. In the current SAFOV-based imaging protocols, the maximum delay between injection and actual scanning is limited by increasing noise (due to radioactive decay) resulting in bad image quality. A major advantage of later time-point imaging in general is, that the target-to background ratio improves. With the high-sensitive LAFOV PET\u002FCT scanner later time-point imaging becomes possible, and higher tumour-to background ratios can be obtained. Specifically for the 18F-Fluoroesradiol tracer, used to image estrogen receptor positive tumors, high physiological uptake in the liver and intestines hampers the visualization and quantification of liver metastases and peritoneal metastases. The aim of this study is to evaluate whether late time point imaging with the 18F-Fluoroestradiol tracer on the LAFOV PET\u002FCT improves visualization and quantification of liver metastases and peritoneal metastases.",[510],"Breast Cancer","2026-05-29",{"date":513,"type":39},"2026-06-04",{"date":451,"type":22},{"date":516,"type":22},"2030-08-01",{"name":45,"class":46},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":533,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},"100616377","phase-2-comparative-study-on-the-mode-of-action-of-vicadrostat-and-spironolactone-on-protein-profiles-and-renal-hemodynamic-effects-compare-vs-100616377","NCT07304817","Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)","Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients Chronic Kidney Disease With Cardiovascular Disease \u002FHeart Failure","COMPARE-VS","Inclusion Criteria:\n\n1. Provided written and dated informed consent for participation prior to trial admission,\n2. Age ≥18 years, female or male\n3. Patients with\n\n   * Heart failure\\*1 (any LVEF) and eGFR\\*2 between 25-90 mL\u002Fmin\u002F1.73m2 OR\n   * Established cardiovascular disease\\*3 and eGFR between 25-60 mL\u002Fmin\u002F1.73m2 OR\n   * Established cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL\u002Fmin\u002F1.73m2\n4. Serum potassium ≤ 5.0 mmol\n5. Currently treated or eligible for treatment with Empagliflozin\\*4\n6. Not using a MRA or AS inhibitor in the last 6 months prior to enrollment\n7. On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment\n8. Outpatient.\n\n   * 1 HF is defined as the definition used in the most recent ESC guidelines for HF.\n   * 2 eGFR as assessed by the 2009 CKD-EPI without the race coefficient\n   * 3 Cardiovascular disease is defined as a history of a myocardial infarction, coronary bypass surgery, PCI, or proven coronary artery disease (e.g. by coronary angiography, CT-scan, etc.)\n   * 4 If switching from another SGLT2i to Empagliflozin subjects can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8.\n\nExclusion Criteria:\n\n1. Inability to understand and sign informed consent\n2. Absolute contra-indication for aldosterone antagonist\n3. Absolute contra-indication for a SGLT2-inhibitor\n4. Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment\n5. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.",{"count":144,"type":22},[194],"In this study, investigators will compare the effect of vicadrostat combined with empagliflozin with the effect of spironolactone combined with empagliflozin on renal function and changes in protein profiles in blood and urine.\n\nThe hypothesis is that the renal and cardiac responses between vicadrostat and spironolactone differ due to mechanistic differences in their mode of action. Spironolactone is a mineralocorticoid receptor antagonist (MRA) and exerts its effect on a receptor, or a type of \"receiver,\" found on various cells. Vicadrostat is an aldosterone synthase inhibitor (ASI) and inhibits aldosterone production. Therefore, both drugs affect aldosterone.\n\nHowever, studies evaluating the differences between MRAs (such as spironolactone) and ASI (such as vicadrostat) and examining their effects on the kidneys in patients with chronic kidney disease with concurrent cardiovascular disease, and\u002For heart failure are still lacking.\n\nFor this study, all participants will be divided into two groups:\n\n* Group 1. Participants in this group will receive one tablet of vicadrostat (10 mg) and one tablet of empagliflozin (10 mg) daily for 26 weeks.\n* Group 2. Participants in this group will receive one tablet of spironolactone (25 mg) and one tablet of empagliflozin (10 mg) daily for the first four weeks. Participants in this group will then receive two tablets of spironolactone (50 mg) and one tablet of empagliflozin (10 mg) daily for the remaining 22 weeks. The spironolactone dosage may be adjusted during the study period (from 12.5 to 50 mg) based on blood test results.",[530,531,532],"CKD","Cardiovascular Diseases","Heart Failure",[524,534,535,530,536,537],"Spironolactone","Vicadrostat","mineralocorticoid receptor antagonist (MRA)","aldosterone synthase inhibitor (ASi)","2026-05-28",{"date":511,"type":39},{"date":541,"type":39},"2026-05-12",{"date":543,"type":22},"2028-02",{"name":45,"class":46},2,{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":554,"targetDuration":556,"studyType":58,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":103},"100401074","heterogeneity-of-critical-illness-a-cohort-study-100401074","NCT04502511","Heterogeneity of Critical Illness: a Cohort Study","Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study","HEALICS","Inclusion Criteria:\n\n* Adults Definition: age ≥18 years.\n* Emergency admission to the ICU Definition: patients who are acutely admitted to the ICU due to acute or unexpected critical illness, either from the emergency department or the ward or transferred from an ICU (or a ward) from another hospital.\n\nExclusion Criteria:\n\n* Planned admission\n* Absence of an invasive arterial or venous line for blood sampling.\n* Any continued cardiopulmonary resuscitation efforts upon admission which limit access to the patient for research activities.\n* Main ICU admission reason chronic (non-invasive) home ventilation\n* Main ICU admission reason normothermic treatment after cardiac arrest\n* Main ICU admission reason ischemic stroke, intracerebral bleeding, or isolated neurotrauma\n* Main ICU admission reason Coronavirus Disease 2019 (COVID-19)\n* Solid organ or hematopoietic stem cell transplant during current hospital admission\n* Strict isolation due to any contagious disease\n* No informed consent",{"count":555,"type":22},5000,"1 Year","Rationale: There is large heterogeneity in disease states of critically ill patients at ICU admittance and there is also large heterogeneity in their disease severity during ICU stay. Still, some patients may show remarkable similarities in disease patterns. There is a lack of understanding of causal mechanisms that lead to divergent outcomes in critically ill patients, and at the same time different diseases may share common underlying, yet unidentified, causal pathways that could explain similarities between different diseases.\n\nObjective: To explore the association between patient characteristics and the severity of organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort study Study population: Adult critically ill patients in the ICU Intervention (if applicable): not applicable Main study parameters\u002Fendpoints: Maximum severity of organ failure observed during ICU stay measured by the maximum SOFA score and quality of life at one year follow-up",[559,560],"Critically Ill","Organ Failure, Multiple","2026-05-21",{"date":563,"type":39},"2026-05-26",{"date":565,"type":39},"2022-01-01",{"date":567,"type":22},"2030-01-01",{"name":45,"class":46},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":605},"100638160","av-nodal-ablation-with-conduction-system-pacing-versus-cardiac-resynchronization-for-symptomatic-heart-failure-patients-with-atrial-fibrillation-100638160","NCT07604727","AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation","AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation: The APAF-CSP All-cause Mortality and Quality of Life Trial","APAF-CSP","Inclusion Criteria:\n\n* Age 18 years or above.\n* Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment.\n* Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room\u002Furgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy.\n* Willing and capable to provide informed consent.\n\nExclusion Criteria:\n\n* NYHA functional class IV.\n* Severe concomitant non-cardiac disease.\n* Patient who require any cardiac surgical intervention.\n* Previously implanted pacing devices (pacemaker\u002FICD\u002FCRT) with ≥40% pacing burden.\n* Any of the following within the 3 months prior to enrollment:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Percutaneous coronary intervention\n  * Stroke or TIA\n  * Significant bleeding\n  * Pericarditis\u002Feffusions\n* Coronary artery bypass surgery\u002Fatriotomy within 6 months prior to enrolment.\n* Women who are pregnant or breastfeeding.",{"count":578,"type":22},292,[222],"The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control.\n\nThe main question it aims to answer is:\n\nIs AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life?\n\nParticipants will undergo:\n\n* An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT.\n* Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure.\n* Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly.\n* Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year\n* At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.",[582,532,583],"Atrial Fibrillation (AF)","Cardiac Pacing",[585,586,587,588,532,589,32,590,591,592,593,575,594,595,596],"Conduction System Pacing","Cardiac Resynchronization","Atrial Fibrillation","AV Nodal Ablation","All-cause Mortality","HF hospitalization","Unplanned\u002Furgent HF visit","Arterial Stiffness Index","Photoplethysmography","EQ-5D","AFEQT","Kansas City Cardiomyopathy Questionnaire (KCCQ)","2026-05-19",{"date":599,"type":39},"2026-05-22",{"date":601,"type":22},"2026-07",{"date":603,"type":22},"2030-06",{"name":45,"class":46},23,{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":638,"locationsCount":478},"100637611","phase-2-no-guts-no-glory-probiotics-100637611","NCT07606014","No Guts No Glory Probiotics","Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial","NGNGP","Inclusion Criteria:\n\n1. About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine\\*, clozapine or risperidone for treating psychosis\n2. Aged between 18 - 65\n3. No exposure to these four antipsychotic medications for longer than one week continuously in the last 6 months (except starting the treatment with the current medication 8 weeks prior to the inclusion)\n4. The participant understands the study and is able to provide written informed consent.\n\n   * Quetiapine prescribed in a low dose for use as a sleep aid does not apply\n\nExclusion Criteria:\n\n1. Critically ill patients (e.g. ICU), diagnosed comorbid eating disorders, chronic GI-disorders, disorders of the liver or pancreas, pre-existing diagnosed diabetes mellitus or metabolic syndrome\n2. Current use of medications known to target metabolism or weight (e.g, diabetes medication and GLP-1 agonists, proton pump inhibitors and diuretics\u002Fbeta blockers) or use of antibiotics or probiotics (such as Yakult, Activia, or other probiotic supplements containing ≥10⁹ CFUs) in the past 4 weeks\n3. Pregnancy or breastfeeding\n4. Inability to follow the intervention or other conditions that according to the investigator might interfere with the evaluation of the study objectives as judged by the treating physician",{"count":615,"type":22},112,[194,25],"The goal of this clinical trial is to learn if probiotics work to prevent or reduce metabolic side effects caused by antipsychotic medication in adults.\n\nThe main question it aims to answer is:\n\nDo probiotics reduce weight gain, blood sugar levels, and blood fat levels in people using antipsychotics?\n\nResearchers will compare a probiotic (Ecologic® Barrier) to a placebo (a look-alike powder without active bacteria) to see if the probiotic is effective.\n\nParticipants will:\n\nTake either probiotics or a placebo daily for 12 weeks (3 months) Dissolve two sachets in water and drink them each morning Visit the clinic (or receive home visits) four times: at the start, after 6 weeks, and after 12 weeks, plus an initial screening visit Undergo physical measurements (e.g., weight, blood pressure), complete questionnaires, and perform a cognitive test at specific visits Provide blood samples and stool samples at the beginning and end of the study Complete two 3-day food diaries during the study",[619],"Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine",[621,622,623,624,625,626,627,628,629,630,631,632],"Antipsychotics","Probiotics","Psychosis","Schizophrenia","Metabolic syndrome","HbA1c","Blood glucose","Weight gain","Olanzapine","Quetiapine","Risperidone","Clozapine","2026-05-18",{"date":563,"type":39},{"date":451,"type":22},{"date":637,"type":22},"2029-05-01",{"name":45,"class":46},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":141,"sex":17,"minAge":505,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":648,"briefSummary":649,"conditions":650,"keywords":652,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":103},"100606144","virtual-reality-assisted-schema-therapy-100606144","NCT07171736","Virtual Reality Assisted Schema Therapy","VRAST: Virtual Reality Assisted Schema Therapy","VRAST","Inclusion Criteria:\n\n* Undergraduate student\n* 16 years or older\n* A score of ≥ 3 on (at least) one of the schema modes (Demanding Parent, Punitive Parent, and\u002For Vulnerable Child)\n\nExclusion Criteria:\n\n* Insufficient command of the Dutch Language",{"count":89,"type":22},[222],"Schema therapy helps people understand which emotional needs were not met during childhood, and how they can take care of those needs now. One important part of the therapy is the chairwork exercise, where people imagine talking to different parts of themselves (like the strict parent or the hurt child) using empty chairs. These exercises can be very helpful, but they can also be difficult for people who find it hard to imagine things in their mind.\n\nVirtual Reality (VR) can make these exercises easier and more powerful. VR creates a 3D world that feels real, using special equipment like a headset. In this world, people can see and interact with virtual characters that represent different parts of themselves. This can make the therapy more concrete and easier to understand, especially for people who struggle with imagination.\n\nIn this study, the investigators want to compare the regular imagination-based exercise with the chairwork exercise done in Virtual Reality. Everyone who joins the study will do both versions of the exercise-one with imagination and one with VR. The order will be random. Before and after each exercise, a short assessment will be conducted to see how people feel. At the end, there will also be a short interview about their experience. The whole session will take about 1.5 to 2 hours.\n\nThe investigators want to know if people experience the VR exercise differently than the regular imagination exercise. The investigators also want to know if these differences depend on how well someone can imagine things in their mind.",[651],"Healthy Participants",[653,654,655,656],"Schema Therapy","Virtual Reality","Imagination","Mental Imagery",{"date":658,"type":39},"2026-05-15",{"date":660,"type":39},"2026-01-29",{"date":662,"type":22},"2026-10-01",{"name":45,"class":46},""]