[{"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:":712},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,124,0,25,[9,50,75,106,128,151,174,201,221,250,274,295,315,343,366,404,439,470,495,532,569,615,639,667,688],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054028","the-impact-of-a-diagnostic-strategy-for-acute-appendicitis-in-children-with-acute-abdominal-pain-in-primary-care-100054028",false,"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","ALL","4 Years","18 Years",{"count":22,"type":23},566,"ESTIMATED","INTERVENTIONAL",[26],"NA","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.",[29,30],"Appendicitis Acute","Acute Abdomen in Children",[32,33,34,35,36],"General practitioner","Appendicitis","Clinical prediction rule","C-reactive protein","Children","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2025-03-06",{"date":45,"type":23},"2029-03-01",{"name":47,"class":48},"University Medical Center Groningen","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"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":58,"type":23},100,"6 Months","OBSERVATIONAL","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.",[63,64],"Chronic Respiratory Failure","Non-invasive Ventilation",[66],"Monitoring","2026-07-01",{"date":69,"type":41},"2026-07-02",{"date":71,"type":41},"2024-12-01",{"date":73,"type":23},"2028-12-01",{"name":47,"class":48},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":49},"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":85,"type":23},680,[26],"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.",[89,90,91,92,93],"Neonatal Hyperbilirubinemia","Treatment Decisions","Neurodevelopmental Outcome","Phototherapy","Exchange Transfusion",[95,96],"neonatal jaundice","preterm infants \u003C 30 weeks GA","NOT_YET_RECRUITING","2026-06-24",{"date":100,"type":41},"2026-06-29",{"date":102,"type":23},"2026-08-01",{"date":104,"type":23},"2029-11-01",{"name":47,"class":48},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":113,"minAge":20,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"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":115,"type":23},261,[117],"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",[120],"Cervical Cancer",{"date":100,"type":41},{"date":123,"type":41},"2026-05-11",{"date":125,"type":23},"2039-02",{"name":47,"class":48},11,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":49},"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","70 Years",{"count":138,"type":23},655,[26],"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.",[142],"Mild Traumatic Brain Injury","2026-06-23",{"date":145,"type":41},"2026-06-26",{"date":147,"type":41},"2026-02-16",{"date":149,"type":23},"2027-12-31",{"name":47,"class":48},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":159,"sex":18,"minAge":20,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":49},"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.",true,"60 Years",{"count":58,"type":23},[26],"The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.",[165],"Depression in Remission","2026-06-15",{"date":168,"type":41},"2026-06-16",{"date":170,"type":41},"2020-06-19",{"date":172,"type":23},"2026-09-24",{"name":47,"class":48},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":24,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100641953","phase-2-in-vivo-fluorescence-molecular-bronchoscopy-of-dur-valumab-680lt-in-patients-with-unresectable-stage-iii-nsclc-after-chemoradiation-100641953","NCT07653438","In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation","In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation - 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 NSCLC.\n* Completion of concurrent platinum-based CRT\n* Eligibility for adjuvant durvalumab per standard of care.\n* At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscop-ic\u002Fendobronchial ultrasound, suitable for biopsy\u002FFNA and fluorescence measurement.\n* 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":183,"type":23},20,[185],"PHASE2","PulmoPrint is a clinical study at UMCG that investigates why some patients with unresectable stage III lung cancer stop responding to immunotherapy after chemoradiation. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an IV drip, after which a camera bronchoscopy is performed to visualize where and how much of the drug actually reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.",[188],"Stage III Non-small Cell Lung Cancer",[190,191,192],"Fluorescence molecular bronchoscopy","Durvalumab-680LT","Near-infrared fluorescence imaging","2026-06-11",{"date":195,"type":41},"2026-06-17",{"date":197,"type":23},"2026-09-01",{"date":199,"type":23},"2031-03-01",{"name":47,"class":48},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":113,"minAge":20,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":49},"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":209,"type":23},12,[211],"PHASE1","We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.",[214],"Cervical Carcinoma",{"date":195,"type":41},{"date":217,"type":41},"2026-01-05",{"date":219,"type":23},"2027-12-01",{"name":47,"class":48},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":49},"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":230,"type":23},49,[211],"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.",[234,235],"Barrett's Esophagus With or Without Dysplasia","Barrett Esophagus Adenocarcinoma",[237,238,239,240,241,242],"Glycan","Oncology","Fluorescent tracers","qFME","First-in-human","Lectin","2026-06-08",{"date":193,"type":41},{"date":246,"type":23},"2026-06-01",{"date":248,"type":23},"2028-10-31",{"name":47,"class":48},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},"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":58,"type":23},[26],"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.",[262],"Non Small Cell Lung Cancer Metastatic",[264,265],"brain metastasis","screening",{"date":267,"type":41},"2026-06-09",{"date":269,"type":41},"2024-05-13",{"date":271,"type":23},"2028-12-31",{"name":47,"class":48},3,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":294,"locationsCount":49},"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":281,"type":23},30,"• 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)",[284,285],"Dental Implants, Single-tooth","Crown",[287,288],"Implant placement","Immediate provisional",{"date":290,"type":41},"2026-06-05",{"date":67,"type":23},{"date":293,"type":23},"2027-07-01",{"name":47,"class":48},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":301,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":24,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":49},"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":303,"type":23},8,[26],"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.",[307],"Breast Cancer","2026-05-29",{"date":310,"type":41},"2026-06-04",{"date":246,"type":23},{"date":313,"type":23},"2030-08-01",{"name":47,"class":48},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":24,"phases":324,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"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":58,"type":23},[185],"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.",[327,328,329],"CKD","Cardiovascular Diseases","Heart Failure",[321,331,332,327,333,334],"Spironolactone","Vicadrostat","mineralocorticoid receptor antagonist (MRA)","aldosterone synthase inhibitor (ASi)","2026-05-28",{"date":308,"type":41},{"date":338,"type":41},"2026-05-12",{"date":340,"type":23},"2028-02",{"name":47,"class":48},2,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":351,"targetDuration":353,"studyType":60,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":49},"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":352,"type":23},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",[356,357],"Critically Ill","Organ Failure, Multiple","2026-05-21",{"date":360,"type":41},"2026-05-26",{"date":362,"type":41},"2022-01-01",{"date":364,"type":23},"2030-01-01",{"name":47,"class":48},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":377,"conditions":378,"keywords":381,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"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":375,"type":23},292,[26],"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.",[379,329,380],"Atrial Fibrillation (AF)","Cardiac Pacing",[382,383,384,385,329,386,387,388,389,390,391,372,392,393,394],"Conduction System Pacing","Cardiac Resynchronization","Atrial Fibrillation","AV Nodal Ablation","All-cause Mortality","Quality of Life","HF hospitalization","Unplanned\u002Furgent HF visit","Arterial Stiffness Index","Photoplethysmography","EQ-5D","AFEQT","Kansas City Cardiomyopathy Questionnaire (KCCQ)","2026-05-19",{"date":397,"type":41},"2026-05-22",{"date":399,"type":23},"2026-07",{"date":401,"type":23},"2030-06",{"name":47,"class":48},23,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":438,"locationsCount":273},"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","65 Years",{"count":414,"type":23},112,[185,416],"PHASE3","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",[419],"Patients Using Olanzapine, Quetiapine, Risperidone or Clozapine",[421,422,423,424,425,426,427,428,429,430,431,432],"Antipsychotics","Probiotics","Psychosis","Schizophrenia","Metabolic syndrome","HbA1c","Blood glucose","Weight gain","Olanzapine","Quetiapine","Risperidone","Clozapine","2026-05-18",{"date":360,"type":41},{"date":246,"type":23},{"date":437,"type":23},"2029-05-01",{"name":47,"class":48},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":449,"conditions":450,"keywords":455,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":342},"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":448,"type":23},10000,"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.",[451,452,453,454],"End-stage Liver Disease (ESLD)","Acute Liver Failure","Liver Cirrhosis","Liver Transplantation",[456,457,458,459,460,461,462],"machine perfusion","liver transplantation","hypothermic machine perfusion","normothermic machine perfusion","normothermic regional perfusion","organ preservation","machine preservation",{"date":464,"type":41},"2026-05-14",{"date":466,"type":41},"2026-04-21",{"date":468,"type":23},"2030-12-31",{"name":47,"class":48},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":159,"sex":18,"minAge":301,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":49},"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":281,"type":23},[26],"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.",[482],"Healthy Participants",[484,485,486,487],"Schema Therapy","Virtual Reality","Imagination","Mental Imagery",{"date":489,"type":41},"2026-05-15",{"date":491,"type":41},"2026-01-29",{"date":493,"type":23},"2026-10-01",{"name":47,"class":48},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":24,"phases":505,"briefSummary":506,"conditions":507,"keywords":515,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":49},"100613651","surgical-versus-percutaneous-revascularization-in-patients-with-reduced-left-ventricular-function-stich-30-nl-100613651","NCT07269366","Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)","Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function","STICH 3*0-NL","Inclusion Criteria:\n\n* Age ≥ 18 years\n* LVEF≤ 40%\n* Angina pectoris, CCS≥2 and\u002For hospitalization for ACS or heart failure within 1 year prior to randomization\n* Multivessel CAD (2-3 vessel-disease with coronary lesions \\>70% and involvement of proximal LAD, and\u002For LM stenosis of \\>50%). Target vessels are determined by the local Heart Time\n* Clinical and angiographical characteristics suitable for isolated coronary revascularization both by CABG or PCI according to the judgment of the local Heart Team\n* Written informed consent\n\nExclusion Criteria:\n\n* ACS \\\u003C 48 hours before randomization\n* Valvular\u002Fstructural heart disease requiring intervention\n* Contra-indications to DAPT\n* Non-cardiac condition with life expectancy \\\u003C 1 year\n* Previous CABG\n* Decompensated HF at the time of inclusion",{"count":504,"type":23},358,[26],"This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.",[508,509,510,511,512,329,513,514],"Coronary Artery Disease","Coronary Artery Disease (CAD)","Multivessel Coronary Artery Disease","CABG","CABG in Low EF","PCI","Revascularization",[516,517,518,519,520,521,522,523,524],"coronary artery","coronary artery disease","heart failure","low ejection fraction","hfref","cabg","coronary artery bypass graft","pci","revascularization","2026-05-07",{"date":338,"type":41},{"date":528,"type":23},"2026-05",{"date":530,"type":23},"2034-05",{"name":47,"class":48},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":540,"minAge":20,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":49},"100478765","measuring-free-radicals-in-human-sperm-cells-related-to-microbiota-and-lifestyle-factors-100478765","NCT05514223","Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors","MeaSuring Free radIcals With Diamond magnetometrRy In hUman Single Sperm Cells Related to Microbiota and Lifestyle Factors","SIRIUS","Inclusion Criteria:\n\n* Males of couples visiting the CRM at the UMCG between 18-55 years old.\n* Planned semen-analysis as standard care.\n\nExclusion Criteria:\n\n* Males who receive(d) chemo- and\u002For radiotherapy, use(d) testosterone suppletion and\u002For anabolic steroids\n* Males who are azoospermic\n* Males who have an abnormal SA due to genetic causes.\n* Semen analysis with round cells \\>2x106 \u002Fml (as marker for infection)\n* Males who currently use antibiotics","MALE","55 Years",{"count":543,"type":23},80,"The cause of infertility can be due to a female factor or a male factor. In case of a male factor, it is often due to poor semen quality. However, the cause of poor quality is often unknown. In previous research, infertility problems in men were related to chemical processes in metabolism causing the formation of free radicals. Free radicals are physiological by-products of our body mechanisms. Free radicals are very reactive and can therefore react with a lot of molecules of cells within our body and cause damage. A balance between free radicals, which are also needed for physiological processes in the body, and antioxidants, which defuses the reactive free radicals, is most desirable. However, as stated in literature, there are a lot of factors that can influence extra free radical production, which causes overloading of the system, resulting in damage on cellular level. Free radicals in semen plasma and on the sperm cell could play a role in male infertility. Nonetheless, free radicals are not used as diagnostic markers due to the lack of detection systems, as free radicals are very short-lived. This study aims to introduce a new technique, called diamond magnetometry, to measure free radicals directly on the sperm cell and in serum. Diamond magnetometry involves very small diamond particles as magnetic sensors that engage a reaction with the free radicals on the sperm cell, causing signals that can be measured. To compare local free radical production with systemic free radical production, other diagnostic biomarkers are also measured in serum.\n\nIt is hypothesized that the composition of seminal microbiome could influence the free radical concentration. Therefore, this study also aims to explore the microbiota composition and see if this has an influence in semen quality and free radical production. At last, this study also want to correlate standard semen parameters (defined by the World Health Organisation), lifestyle factors and food intake, to detect a role for lifestyle in the production of free radicals.",[546,547],"Infertility, Male","Infertility",[549,550,551,552,553,554,555,556,557,558,559,560,561],"Free radicals","Reactive oxygen species","Microbiota","Diet","Dietary patterns","Fertility","Semen analysis","Fertility clinics","Diamond magnetometry","Lifestyle","Semen","Oxidative stress","Food frequency questionnaire",{"date":563,"type":41},"2026-05-08",{"date":565,"type":41},"2024-06-01",{"date":567,"type":23},"2027-09-30",{"name":47,"class":48},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":587,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":614},"100576240","phase-2-psilocybin-therapy-for-psychological-distress-in-palliative-patients-100576240","NCT06782724","Psilocybin Therapy for Psychological Distress in Palliative Patients","The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.","PsyPal","Inclusion Criteria:\n\n1. Patient has to be diagnosed with one of the following four conditions, defined as:\n\n   COPD i) Diagnosis by medical specialist ii) Postbronchodilator FEV1\u002FFVC \\\u003C 0,7 and FEV1 \\\u003C80% pred iii) ≥ 40 years old iv) ≥ 10 years smoking\n\n   ALS i) ALS according to Goldcoast criteria (Shefner et al, Clin Neurophysiol, 2020) ii) ALS-FRS-R subscores of minimum 1 in item 2, 3 and 8, subscore of minimum 2 in item 1, 4 and 10 and a subscore of minimum 3 in item 11 and 12\n\n   MS i) Fulfilled diagnostic revised McDonald criteria for MS from 2017 (Thompson et al., 2018) ii) EDSS ≥ 1,0\n\n   APD i) Advanced to Late-Stage Parkinson's Disease - patients with a diagnosis of Parkinson's Disease per the MDS clinical diagnosis criteria with evidence of motor and non-motor fluctuations ii) Diseases in the spectrum of Progressive supranuclear palsy (PSP), fulfilling possible and probable criteria, according to the MDS diagnostic criteria iii) Clinically Established and Clinically Probable Multiple System Atrophy (MSA) according to the MDS diagnostic criteria\n2. Patient meets ICD-10 criteria for major depressive disorder documented through the com-pletion of the mood section of the Mini International Neuropsychiatric Interview by a screen-ing psychologist or physician.\n3. Patient has a MADRS score of \\> 19.\n4. Patient should have a life expectancy of at least 6 months (assessed by study physician).\n5. Patient is at least 18 years of age.\n6. Patient has an identified caregiver\u002Fsupport person. See specific conditions for Czechia in Appendix 5.\n7. Patient is able to read and understand the informed consent and all scales used in a local language. For those with ALS, MS, or APD, competency is ensured via neurologist assessment, cognitive screening, caregiver support during screening and interactive approaches where the screening clinician ask the patient to explain their understanding of consent elements, re-explaining potentially misunderstood information.\n8. Patient is able to and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.\n9. Patient is able to ingest capsules.\n\nExclusion Criteria:\n\n1. Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline).\n2. Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than depression \u002F distress.\n3. Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features (except substance\u002Fmedication-induced or due to another medical condition) or bipolar I\u002FII disorder.\n4. Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders.\n5. Patient has a first-degree relative with schizophrenia spectrum, bipolar I disorder or other psychotic disorders (expect substance\u002Fmedication-induced or due to another medical condition).\n6. Patients with a pre-existing psychiatric condition judged to be incompatible with safe exposure to psilocybin therapy.\n7. Significant suicide risk as defined by (1) suicidal ideation with intent to act (defined as ≥ 5 on MADRS item 10), (2) suicidal attempts within the past year, or (3) clinical assessment of significant suicidal risk during patient interview.\n8. Patient meets ICD-10 criteria for active\u002Fcurrent alcohol or drug use disorder.\n9. Patient has ongoing treatment with antipsychotic drugs. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug at the time of baseline (see Appendix 1a for Prohibited medications).\n10. Patient is unwilling or unable to pause formal psychotherapy (days 0-42).\n11. Patient has neurological conditions (e.g., intracranial tumour, epilepsy, brain injuries, or other neurological disorders) expected by the PIs to conflict with the treatment \u002F study protocol.\n12. Disease-specific exclusion criteria:\n\n    COPD: Unresolved exacerbation or pulmonary infection within last 4 weeks. ALS: Significant cognitive deficits (MoCa, see below). MS: Significant cognitive deficits (MoCa, see below), epilepsy or radiologically isolated syndrome.\n\n    APD: Dementia (MoCa, see below), or Schwab and England ADL scale with scores \\> 80% in the best functional state.\n13. Cardiovascular conditions: recent stroke (\\\u003C 1 year from signing of ICF), recent myocardial infarction (\\\u003C 1 year from signing of ICF), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg), clinically significant arrhythmia within 1 year of signing the ICF, or QTc prolongation exceeding 450ms (males) \u002F 470ms (females).\n14. Patient has moderate to severe hepatic impairment (Child-Pugh score ≥ 7).\n15. Patient has insulin-dependent diabetes or who are taking oral hypoglycaemic agents and have a current risk of hypoglycaemia that would require medical intervention.\n16. Patient has any physical or psychological symptoms, medications, blood test results or clinically significant findings at Screening or Baseline (based on the clinical judgement of clinical\u002Fmedical study personnel) that would make a patient unsuitable for the study.\n17. Patient has an allergy or intolerance to any of the materials contained in either drug product.\n18. Cognitive and Neuropsychological assessment: Patients will be excluded if they score below mean minus 1.5 Standard Deviation according to normative age and scholarity adjusted data on the Montreal Cognitive Assessment (MoCA) assessment.\n19. Recent (2 weeks) change or planned change in antidepressant medication during the intervention.\n20. Women who are pregnant, intend to become pregnant during the study or who are currently nursing, or are unwilling to use Highly Effective Contraceptive Methods",{"count":578,"type":23},108,[185],"The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are:\n\n* Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control?\n* Will the therapeutic effects be rapid and sustained over a 6-month period?\n\nResearchers will compare patients receiving two escalating doses of psilocybin (15mg followed by 25mg) against those receiving two low doses (1mg) to see if the higher doses lead to greater improvements in depression, anxiety, demoralization, and quality of life.\n\nParticipants will:\n\n* Attend three preparation sessions with psychotherapists (1-2 hours each)\n* Undergo two supervised psilocybin dosing sessions (6-8 hours each)\n* Complete five integration therapy sessions following the dosing sessions\n* Participate in follow-up assessments at 6 weeks, 3 months, and 6 months\n* Have access to a digital care platform and peer support groups during the 6-month follow-up period\n* Optional: Control group participants may receive one high-dose psilocybin session (25mg) after the initial study period",[582,583,584,585,586],"COPD (Chronic Obstructive Pulmonary Disease)","ALS (Amyotrophic Lateral Sclerosis)","MS (Multiple Sclerosis)","Major Depressive Disorder (MDD)","Atypical Parkinson Disease",[588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606],"psilocybin","therapy","palliative","care","palliative care","end-of-life distress","depression","psychological distress","psypal","copd","als","ms","apd","chronic obstructive pulmonary disorder","amyotrophic lateral sclerosis","multiple sclerosis","major depressive disorder","atypical parkinson disease","existential distress","2026-05-04",{"date":563,"type":41},{"date":610,"type":41},"2025-07-01",{"date":612,"type":23},"2028-01-01",{"name":47,"class":48},4,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":24,"phases":624,"briefSummary":625,"conditions":626,"keywords":629,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":638,"locationsCount":49},"100633492","phase-4-canagliflozin-in-dialysis-patients-100633492","NCT07527390","CANagliflozin In DIALysis Patients","CANIDIAP","Inclusion criteria:\n\n* Hemodialysis for more than 3 months (5 also with residual diuresis)\n* Age ≥18 years of age\n* Willing to sign informed consent\n\nExclusion criteria:\n\n* Mentally incapacitated subjects (i.e. not able to sign informed consent)\n* Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years.\n* Pregnant women and women of child-bearing potential who are not using reliable contraception\n* Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening\n* Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be inter-rupted 1 week prior to the first study day till the end of the second study day (as the half-life is 10-13 hours a wash-out of the study drug of at least 7-days should be considered)\n* History of hypersensitivity to canagliflozin or another SGLT2 inhibitor\n* Severe claustrophobia\n* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.\n* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:\n\n  * Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection\n  * Gastro-intestinal ulcers and\u002For gastrointestinal or rectal bleeding within last six months\n  * Pancreatic injury or pancreatitis within the last six months\n  * Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt\n  * Use of rifampicin and cholestryramine\n* Established peripheral arterial disease\n* Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous translu-minal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission \\\u003C 3 months before inclusion\n* People using digoxin and\u002For lithium\n* Patients with an active malignancy",{"count":623,"type":23},10,[117],"Rationale:\n\nSodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Secondary analyses from these trials demonstrated that these benefits were consistent in patients with or without type 2 diabetes and with or without chronic kidney disease (CKD) with a lower eGFR threshold of 20 mL\u002Fmin\u002F1.73m2. However, it is not yet clear if these drugs can also be used in patients with severe kidney disease who require dialysis. This is in part explained because SGLT2 inhibitors bind to a transporter which is located in the luminal side of proximal tubes in the kidney. If kidney function is low, and these patients have no or limited filtering capacity, it is possible that the efficacy of these drugs decrease. Notwithstanding, several animal experiments and preliminary clinical data have suggested that these drugs do have kidney and cardiac protective effects in case of severely decreased kidney function.\n\nThe investigators hypothesize that SGLT2 inhibitors are distributed to several tissues in the body on top of the kidney and therefore the investigators would like to investigate the specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis.",[627,628],"Dialysis","Chronic Kidney Disease (Stages 4 and 5)",[630,631],"SGLT2 inhibitors","PET imaging","2026-04-29",{"date":634,"type":41},"2026-05-06",{"date":246,"type":23},{"date":637,"type":23},"2027-01-30",{"name":47,"class":48},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":24,"phases":649,"briefSummary":650,"conditions":651,"keywords":656,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":49},"100438208","cpap-or-bipap-for-motion-mitigation-during-radiotherapy-100438208","NCT04986293","CPAP or BiPAP for Motion Mitigation During Radiotherapy","Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy","SISTER","Inclusion Criteria:\n\n* Age ≥18 years\n* Stage III\u002FIV (N)SCLC, esophageal cancer or malignant lymphoma that will be treated with curative intent\n* WHO 0-2.\n* Written informed consent\n\nExclusion Criteria:\n\n* Facial deformations so that facial mask is impossible to fit\n* Noncompliance with any of the inclusion criteria.\n* Planned for radiotherapy with fraction dose ≥3 Gy.\n* Severe heart failure (LVEF\\\u003C30%)",{"count":648,"type":23},31,[26],"When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent.\n\nWith Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.",[652,653,654,655],"Radiotherapy Side Effect","NSCLC","Esophageal Cancer","Malignant Lymphoma",[657,658,659],"BiPAP","CPAP","Mechanical ventilation","2026-04-28",{"date":607,"type":41},{"date":663,"type":41},"2021-06-01",{"date":665,"type":23},"2027-12",{"name":47,"class":48},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":673,"targetDuration":674,"studyType":60,"phases":4,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":682,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":49},"100241475","standard-follow-up-program-sfp-for-lung-cancer-patients-treated-with-radiotherapy-or-chemoradiation-100241475","NCT02421718","Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation","Inclusion Criteria:\n\n* Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)\n* Patients receiving radiotherapy dose \\> 40 Gy\n\nExclusion Criteria:\n\n* Failure to comply with any of the inclusion criteria",{"count":448,"type":23},"5 Years","Motive:\n\nIn order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients.\n\nGoal:\n\nTo set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.\n\nA standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.",[677],"Lung Cancer",[679,680,681],"Acute toxicity","Late toxicity","Prediction models",{"date":632,"type":41},{"date":684,"type":41},"2013-03",{"date":686,"type":23},"2031-12",{"name":47,"class":48},{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":694,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":696,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":697,"conditions":698,"keywords":700,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":49},"100570040","change-in-task-related-oxygen-uptake-after-ebv-treatment-100570040","NCT06702072","Change in Task-related Oxygen Uptake After EBV Treatment","Change in Task-related Oxygen Uptake After Bronchoscopic Lung Volume Reduction With Endobronchial Valves","CROCODILE","Inclusion Criteria:\n\n1. Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;\n2. Patient read, understood and signed the Informed Consent Form.\n\nExclusion Criteria:\n\n1\\) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).",{"count":183,"type":23},"Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.\n\nPatients report that it is easier to perform ADLs after EBV treatment. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before.\n\nPotentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.\n\nObjective: To investigate the change in exercise physiology during daily activities after EBV treatment.\n\nStudy design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.\n\nStudy population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.\n\nIntervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.",[699],"COPD",[699,701,702,703,704],"Emphysema","lung volume reduction","endobronchial valves","bronchoscopy","2026-04-24",{"date":632,"type":41},{"date":708,"type":41},"2025-06-02",{"date":710,"type":23},"2028-08-01",{"name":47,"class":48},""]