[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amsterdam UMC, location VUmc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":725},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,53,77,113,142,182,206,230,267,296,322,352,382,404,435,467,492,522,551,573,595,624,646,671,701],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100643351","vacstent-use-for-the-treatment-of-anastomotic-leakage-following-colorectal-surgery-100643351",false,"NCT07631702","VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery","VACStent Use for the Treatment of Anastomotic Leakage Following Colorectal Surgery: a Multicenter Prospective Efficacy Study","VACURE","Inclusion Criteria:\n\n* AL in the distal sigmoid, upper or mid rectum following a colorectal resection\n* ≥ 18 years old.\n* Signed a written informed consent\n\nExclusion Criteria:\n\n* Anastomosis that is not endoscopically accessible.\n* Contra-indications for VacStent GI therapy: (a) Significant tissue ischemia in the area of the wound cavity, larger than the length of the VacStent GI Colon; (b) Anastomotic defect located \\\u003C4 cm from the dentate line. This is considered a relative contraindication, as very distal placement may cause patient discomfort although not necessarily; (c) Severe coagulopathy; (d) Ileus that does not allow for endoscopic examination.\n* Anastomotic fistula to surrounding organs (vagina, bladder, small bowel)","ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL.\n\nMethods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.",[28,29,30,31,32,33,34],"Colorectal Surgery","Anastomotic Leak Rectum","Endoscopy, Digestive System","Vacuum Therapy","Stents","Anastomotic Leakage","Minimal Invasive",[36,37,38,39],"Postoperative Complications","Anastomotic Leak","Vacuum stent","Endoscopic vacuum therapy","NOT_YET_RECRUITING","2026-06-03",{"date":43,"type":44},"2026-06-08","ACTUAL",{"date":46,"type":22},"2026-07-01",{"date":48,"type":22},"2028-10-01",{"name":50,"class":51},"Amsterdam UMC, location VUmc","OTHER",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100640202","phase-1-comparing-intravenous-or-intradermal-administration-of-anti-ctla-4-in-combination-with-anti-pd1-treatment-in-patients-with-melanoma-100640202","NCT07615881","Comparing Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","Changes in the Tumour Microenvironment After Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","IpiD","Inclusion Criteria:\n\n* Patient must be of age ≥ 18 years, and have a histologically confirmed diagnosis of locally advanced, surgically incurable, or metastatic cutaneous melanoma.\n* European Cooperative Oncology Group (ECOG)\u002FWorld Health Organisation (WHO) performance status of 0 or 1.\n* Patient must be eligible for anti-PD-1 treatment with nivolumab (group 1) or with ipilimumab + nivolumab (group 2) according to the treating physician.\n* Patient must have one or more tumour lesions of which a biopsy can safely be obtained according to standard clinical practice.\n* Patients must have a life expectancy of 3 months or greater.\n* Patients must have measurable disease (according to RECIST v1.1) with at least one cutaneous metastasis. Note: measurable disease defined as: at least 1 visceral or nodal\u002Fsoft tissue melanoma lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by CT scan or MRI. Lymph nodes must measure ≥ 15 mm in their short axis to be considered measurable by CT-scan or MRI.\n* Adequate bone marrow, hepatic, renal and coagulation function (to be conducted within 7 days prior to start therapy, during the baseline period):\n\n  * Leukocyte count ≥ 3,5 × 109 \u002F L\n  * Platelets ≥ 100 × 109 \u002F L.\n  * Total bilirubin ≤ 3 × the upper limit of normal (ULN).\n  * ASAT and ALAT ≤ 3.0 × ULN; except patients with documented liver metastases ASAT and\u002For ALAT ≤ 5.0 × ULN.\n  * (Estimated) creatinine clearance ≥ 45 mL\u002Fmin\u002F1,73 m2.\n  * Albumin ≥ 30g \u002F L\n  * LDH ≤ 2 x ULN\n* Women of childbearing potential (WOCBP) must use contraception during the study and for 23 weeks after the last dose of nivolumab.\n* Men who are sexually active with WOCBP must use contraception during the study plus 7 months after the last dose of nivolumab.\n* Written and signed informed consent.\n\nExclusion Criteria:\n\n* Primary uveal or mucosal melanoma.\n* Prior treatment with CTLA-4 inhibitor or agonist, or anti-PD1, except for adjuvant nivolumab \\> 6 months ago.\n* Prior radiotherapy is permitted except on RECIST v1.1 target lesions within 2 weeks of start of trial treatment. Irradiated lesions without progression before start of treatment cannot be target lesions. Note: Patients must have recovered from all radiation-related toxicities, and not require corticosteroids.\n* Patient has 12-lead ECG significant findings during screening, per Investigator's as sessment.\n* History of another malignancy (that is progressing or requires active treatment) within the previous 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cancer that has undergone potentially curative therapy.\n* Patient has a confirmed active SARS-CoV-2 infection.\n* Patient has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Active systemic infections requiring therapy, or signs or symptoms of a systemic infection within two weeks prior to baseline.\n* Patient has used systemic corticosteroids to treat inflammatory or autoimmune symptoms within 15 days or other immunosuppressive drugs within 30 days prior to screening. Exceptions:\n\n  * Patients that require intermittent use of inhalation or topical corticosteroids are eligible for the study.\n  * Patient has received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) that, in the opinion of the Investigator, will not compromise protocol objectives.\n* Patient has had treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor agents) within 2 weeks prior to baseline.\n* Patient has had treatment with systemic immunostimulatory agents (including but not limited to interferons \\[IFNs\\] or interleukin-2 \\[IL-2\\]) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to baseline.\n* Known history or evidence of immunodeficiency states (e.g., organ transplant, leukaemia, human immunodeficiency virus (HIV), hepatitis B, hepatitis C or known acquired immunodeficiency syndrome (AIDS)). NOTE: Testing for HIV must be performed at sites were mandated locally.\n* Patient has had any major surgery within 4 weeks prior to enrolment or major surgery is scheduled during the study, with the exception of procedures that are part of the study site IIS.\n* Patient has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the patient at high risk from complications.\n* Patient has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and\u002For the proposed ICI therapy.\n* Pregnancy or breastfeeding.\n* Patient has a history of alcohol or drug abuse within the last year.\n* Currently participating in or has participated in a study of an investigational agent within 30 days of baseline or has not recovered from adverse events due to agents administered more than 4 weeks earlier, except A Phase 1a\u002F1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients with Solid Tumor Malignancies to Evaluate GEH200520 Injection \u002F GEH200521 (18F) Injection Safety and Tolerability, Positron Emission Tomography Imaging, Pharmacokinetics, and Changes in Imaging after Treatment; NCT05629689, EU Trial number: 2024-515218-42-00.\n* For any reason, patient is considered by the local investigator to be an unsuitable candidate to participate in this study.",{"count":62,"type":22},18,[64,65],"PHASE1","PHASE2","This study investigates whether a single intradermal (i.d.) injection of low-dose anti-CTLA-4 (ipilimumab), given at the tumour site, can enhance immune activation when combined with standard intravenous (i.v.) anti-PD-1 therapy in patients with advanced melanoma. While combined checkpoint inhibition is effective, it is associated with high toxicity, creating a need for strategies that maintain efficacy with fewer side effects.\n\nPreclinical and early clinical data suggest that local (intradermal) CTLA-4 blockade can stimulate systemic anti-tumour immune responses with reduced toxicity, potentially by reactivating suppressed T cells in tumour-draining lymph nodes. This study compares systemic immune effects of intradermal versus standard intravenous CTLA-4 administration, both combined with nivolumab.\n\nThe primary objective is to assess systemic immune activation by measuring changes in CD4+ and CD8+ T-cell frequencies and ICOS expression in peripheral blood. Additional immune monitoring includes blood sampling, tumour biopsies, and advanced imaging using FDG-PET\u002FCT and a novel CD8-targeted PET tracer. The study is a prospective, open-label pilot trial in patients with metastatic melanoma, with follow-up for clinical outcomes and immune response over approximately 13 weeks.",[68],"Melanoma (Skin Cancer)","2026-05-22",{"date":71,"type":44},"2026-05-29",{"date":73,"type":22},"2026-07",{"date":75,"type":22},"2029-07",{"name":50,"class":51},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":101,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":52},"100565589","p4o2-ild-extension-100565589","NCT06644144","P4O2 ILD Extension","Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.","P4O2-ILD","Inclusion Criteria:\n\n* Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).\n* Meeting all the following criteria during the screening period:\n\n  1. FVC ≥45% predicted.\n  2. FEV1\u002FFVC ≥0.7.\n  3. DLco corrected for Hb ≥40% predicted.\n* Able to provide written informed consent as approved by the independent ethics committee.\n* Able to undergo a CT scan and perform PFT.\n* Age \\> 18 years and \\< 80 years.\n* Understanding of the Dutch or English language.\n\nExclusion Criteria:\n\n* Combined pulmonary fibrosis and emphysema (CPFE) diagnosis\n* Chronic obstructive lung disease (COPD) with an FEV1\u002FFVC \\<70%.\n* Uncontrolled severe asthma.\n* Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.\n* Pregnancy or lactating.","80 Years",{"count":87,"type":22},450,"OBSERVATIONAL","The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in participants with interstitial lung diseases (ILDs). The participant population includes adults diagnosed with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic ILDs, and interstitial lung abnormalities (ILA).\n\nThe main questions it aims to answer are:\n\n* What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients?\n* What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD?\n* What biomarkers and risk factors can help identify ILA patients who may develop significant ILD?\n* What biomarkers and risk factors can predict how well ILD patients will respond to treatment?\n\nResearchers will compare the outcomes between participants diagnosed with IPF\u002FFPF, other fibrotic ILDs, and ILA to see if early detection biomarkers differ among these groups.\n\nParticipants will:\n\n* Undergo blood sampling.\n* Perform lung function tests.\n* Have CT scans.\n* Perform breath analysis\n* Participate in exposome and microbiome analyses.\n* Complete questionnaires.\n* A subgroup of participants will be offered bronchoscopy.",[91,92,93,94,95,96,97,98,99,100],"Interstitial Lung Disease","Pulmonary Fibrosis","Interstitial Lung Fibrosis","IPF","Pulmonary Fibrosis, Idiopathic","Pulmonary Fibrosis Idiopathic Familial","Chronic Hypersensitivity Pneumonitis","Unclassifiable ILD","Idiopathic NSIP","CTD-ILD",[91,102,103],"Interstitial Lung Abnormalities","Progressive Pulmonary Fibrosis","RECRUITING","2026-05-05",{"date":107,"type":44},"2026-05-11",{"date":109,"type":44},"2024-11-01",{"date":111,"type":22},"2031-10-01",{"name":50,"class":51},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":52},"100634690","transgender-analysis-of-nephrological-studies-focused-on-renal-metrics-100634690","NCT07542964","Transgender Analysis of Nephrological Studies Focused on Renal Metrics","TRANSFORM","Inclusion Criteria:\n\n* Diagnosed with gender dysphoria according to DSM-V\n* Expected to start gender-affirming hormone treatment in the upcoming month\n\nExclusion Criteria:\n\n* Current or prior use of gender-affirming hormone therapy\n* Participation in other studies\n* Concomitant use of medication (specifically: antihypertensive agents, products, antidepressants, antipsychotic agents)\n* Known kidney disease (eGFR \\\u003C 60 ml\u002Fmin; UACR \\> 2.5 mg\u002Fmmol)\n* Diabetes mellitus\n* A history of cardiovascular disease (myocardial infarction; cardiac surgery or revascularization, unstable angina, heart failure, transient ischemic attack, cerebrovascular disease, or a previously undiagnosed arrhythmia)\n* Known iodine-related allergies\n* Metal in the body (such as pacemaker, ICD, neurostimulator, cochlear implant, or other metal)\n* Pregnancy\n* Claustrophobia","40 Years",{"count":122,"type":22},60,"This study investigates how sex hormones affect kidney function in people undergoing gender-affirming hormone therapy (GAHT). We know men have a faster progression of kidney disease. Earlier studies suggest that the female sex hormone estradiol may have a protective effect on kidney function while the male sex hormone testosterone may have the opposite effect. But the reasons why this happens remain unclear. By studying participants undergoing (GAHT) we gain insight into the mechanisms by which testosterone and estradiol influence the kidneys. People undergoing GAHT provide a unique chance to study how sex hormones interact with the kidneys. The results may help us to understand why men and women exhibit differences in kidney disease development. This study will include 30 men and 30 women, aged 18 to 40, who start GAHT. Participants will have three study visits, two of which will happen during their scheduled healthcare appointments. During the first visit, a screening will take place to check if patients can take part in the study. At study visits before and after one year of therapy, kidney function is measured, kidney MRI is performed, urine is collected and a small sample of fat tissue. Taking part in the study does not delay the start of GAHT.",[125,126,127],"Kidney Disease","Kidney Injury","Transgender Individuals",[129,130,131,132,133],"Transgender individuals","Kidney disease","Kidney injury","Gender affirming hormone treatment","Sex hormones","2026-04-17",{"date":136,"type":44},"2026-04-21",{"date":138,"type":22},"2026-09",{"date":140,"type":22},"2028-09",{"name":50,"class":51},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":180,"locationsCount":181},"100629134","deep-relaxation-using-virtual-reality-intervention-before-surgery-for-healthcare-professionals-working-in-the-operating-room-100629134","NCT07470697","Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating Room","DEEP_VR","Inclusion Criteria:\n\n* Volunteering and consented healthcare professionals ( ≥ 18 years) working in the operating room\n* Circulatory-, scrub-, and anesthesia nurses, anesthesiologists, surgical specialists, residents, medical students, or persons in training for the above mentioned.\n\nExclusion Criteria:\n\n* history of epilepsy.\n* claustrophobia or nyctophobia.\n* experienced VR scenery via a headset including headphones a trigger for headache, migraine, dizziness, drowsiness, nausea or other physical or mental discomfort.\n* vestibular nystagmus, otosclerosis, ear infections,\n* impaired hearing or deafness of either ear.\n* glaucoma, active eye infections or damage to orbital, cornea or lens.\n* diagnosed with chronic insomnia .\n* latex allergy as VR goggles may contain latex in the lens surround.\n* arrythmia, bradycardia or tachycardia, or those using cardiac medication against dysrhythmias.\n* All medication that may potentially induce dysrhythmias or of influence on blood pressure levels.\n* not able to wear a VR headset and\u002For noise canceling headphones for any other reason as indicated by themselves.",true,{"count":151,"type":22},80,[25],"The goal of this clinical trials is to primary learn if deep relaxation using Virtual Reality (VR) compared to a low stimulus environment can lower perceived and measured stress in healthcare professionals working in the operating room.\n\nWe aim to determine:\n\n* whether the use of a low-stimulus environment significantly lowers the stress response in OR health care workers just before entering the OR;\n* whether the use of a responsive VR system environment significantly lowers the stress response in OR health care workers just before entering the OR;\n* Whether the use of a responsive VR environment is both an effective and cost-effective solution compared to the low-stimulus environment, in terms of significantly mitigating stress in OR team members as measured by their biometrics, just before they enter the OR to do their job.\n\nHypothesis\n\n* The use of a 10-minute real-time adaptive VR intervention or a low-stimulus environment intervention administered at least 15 minutes before entering the operating room (OR), significantly reduces stress in OR staff, as measured by a within-person reduction in heart rate of at least 10 beats per minute (BPM) over the 10-minute intervention period\n* The reduction in heart rate over a 10-minute intervention period is significantly greater for the real-time adaptive VR intervention compared to the low-stimulus environment intervention, with an expected mean difference (delta) of 5 BPM, indicating superior stress-reducing effects of the VR intervention.\n* The use of a real-time adaptive VR intervention and the use of a low stimulus environment intervention of 10 minutes at least 15 minutes before entering the OR significantly reduces perceived stress for OR staff, as measured by Numeric Rating Scale (NRS) stress scores within person.",[155,156,157],"Stress","Stress and Burnout","Stress Biomarkers",[159,160,155,161,162,163,164,165,166,167,168,169,170,171,172,173],"VR","Virtual Reality","Non-invasice biomarkers","Heart rate variabillity","Heart rate","Burnout","Resilience","hospital","operating room","healthcare professionals","doctor","operating room nurse","anesthesia nurse","surgeon","low stimulus environment","2026-03-12",{"date":176,"type":44},"2026-03-13",{"date":178,"type":22},"2026-06-01",{"date":46,"type":22},{"name":50,"class":51},2,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":181},"100548081","cue2walk-cost-effectiveness-of-automated-freezing-detection-and-provision-of-external-cues-in-comparison-to-usual-care-in-people-with-parkinsons-disease-100548081","NCT06416345","Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to UK Brain bank criteria\n* Daily Freezing of Gait\n* Hoehn-Yahr stage 2-4\n* Stable medication regime and\u002For DBS settings as determined by the treating neurologist\n* Ability to walk 5 minutes while unassisted by another person\n\nExclusion Criteria:\n\n* Participation in another clinical study\n* Use of a personal cueing device at home\n* Previous use of the Cue2Walk medical device\n* Presence of co-morbidities that would hamper participation\n* Cognitive impairment preventing understanding of therapeutic instructions (Montreal Cognitive Assessment (MoCA) Score \\\u003C16)",{"count":189,"type":22},84,[25],"The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated.",[193],"Parkinson Disease",[195,196,197,198],"Parkinson's Disease","Freezing of Gait","(Smart) Cueing","Costeffectiveness",{"date":200,"type":44},"2026-03-16",{"date":202,"type":44},"2025-08-22",{"date":204,"type":22},"2027-12-01",{"name":50,"class":51},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":229},"100464764","phase-3-tms-for-exposure-therapy-resistant-ocd-100464764","NCT05331937","TMS for Exposure Therapy Resistant OCD","Transcranial Magnetic Stimulation (TMS) for Patients With Exposure Therapy-resistant Obsessive-compulsive Disorder (OCD): TETRO - a Multicenter Randomized Controlled Trial","TETRO","Inclusion Criteria:\n\n* OCD as current primary diagnosis\n* Age 18 and older\n* Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 16 or higher.\n* Insufficient response to state-of-the art exposure therapy with response prevention (ERP) and\u002For drop-out from ERP due to extreme anxiety\u002Favoidance\n* The following comorbid disorders are allowed (as long as OCD is the current primary diagnosis): depression, other anxiety disorders, ADHD, tic\u002FTourette's disorder, eating disorders, personality disorders, autism spectrum disorder (when this does not dominate the clinical profile, i.e. is not main diagnosis).\n* Commitment to actively undergo intensive exposure therapy (both supervised during ERP sessions, as well as unsupervised at home)\n* Unmedicated (for at least 8 weeks) or stable dosage of psychotropic medication (for at least 8 weeks), involving serotonergic antidepressants (SSRI, SNRI, clomipramine). Other psychotropic medication that is allowed (provided dosage is stably established for at least 8 weeks): methylphenidate, mood stabilizers, antipsychotic drugs\n* Ability to participate in frequent treatment sessions (4 days\u002Fweek, for 5 (or 6, or 7) weeks) at one of the 5 sites nearest to their home and\u002For work\n* Ability to participate in pre-treatment MRI session (for neuronavigation) at one of the 3 academic sites nearest to their home and\u002For work\n* Capacity for providing informed consent\n\nExclusion Criteria:\n\n* OCD patients with hoarding as main symptom dimension\n* The following comorbid disorders (current diagnosis) are not allowed: psychotic disorders, bipolar disorder, autism spectrum disorder (when this dominates the clinical profile, i.e. is diagnosed as main disorder), substance use disorder\n* Active suicidal thoughts and intent to act on it\n* Chronic use of benzodiazepines is not allowed\n* Cochlear implant\n* (History of) epilepsy\n* Pregnancy\n* Extreme claustrophobia or metallic objects in or on the body, preventing from participation in MRI session\n* Space-occupying lesion on MRI\n* Previous rTMS treatment (for blinding reasons)",{"count":215,"type":22},250,[217],"PHASE3","TETRO is a multi-center placebo-controlled double-blind randomized controlled trial with an intervention phase of 5-7 weeks and a follow-up phase of 12 months in 250 adult (18 years and older) OCD patients who show no\u002Finsufficient response to ERP, aiming to establish the cost-effectiveness of low frequency (1 Hz) rTMS to the pre-SMA (compared to sham rTMS to the pre-SMA) as adjuvant treatment to exposure with response prevention (ERP). The treatment consists of 4 times\u002Fweek rTMS combined with ERP for at least 5 weeks (20 sessions), with optional extension phase of 1 or 2 weeks (maximum of 28 sessions in total).",[220,221],"1 Hz Real rTMS to the Pre-SMA","1 Hz Sham rTMS to the Pre-SMA","2026-03-01",{"date":224,"type":44},"2026-03-04",{"date":226,"type":44},"2022-05-16",{"date":204,"type":22},{"name":50,"class":51},8,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100545642","phase-1-neoadjuvant-triple-therapy-for-borderline-resectable-pancreatic-cancer-preopanc-5-100545642","NCT06384560","Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)","Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib\u002FII Trial of the Dutch Pancreatic Cancer Group","PREOPANC-5","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)\n* Male or female participants who are at least 18 years of age on the day of signing informed consent\n* Primary resectable or borderline resectable disease (DPCG criteria)\n* ECOG performance status 0 or 1\n* Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy\n* Leucocytes (WBC) ≥ 3.0 X 10\\*9\u002Fl, Platelets ≥ 100X 10\\*9 \u002Fl, Hemoglobin ≥ 6 mmol\u002Fl, Renal function: E-GFR \\> 50 ml\u002Fmin, Bilirubin \\\u003C 50 µmol\u002Fl or planned for biliary drainage\n* A male participant must agree to use a contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least one of the following conditions applies: Not a:\n\nwoman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 18 weeks after the last dose of study treatment Written informed consent\n\nExclusion criteria\n\n* Metastatic or locally advanced (i.e. unresectable) pancreatic cancer.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\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 intervention\n* Complete dihydropyrimidine dehydrogenase deficiency. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. 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 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 re placement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Serious concomitant systemic disorders that would compromise the safety of the patient or their ability to complete the study, at the discretion of the investigator.\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 participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\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* A WOCBP who has a positive urine pregnancy test within 72 hours prior to start of treatment (see Appendix 6). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\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 or father children within the projected duration of the study, starting with the screening visit until 18 weeks after the last dose of trial treatment.\n* Has contra-indications for MRI (only for Amsterdam UMC and RAKU)\n* Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants.\n* Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal.\n* Patients with severe claustrophobia not able to tolerate an MRI scan",{"count":239,"type":22},66,[64,65],"Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.",[243,244,245],"Localized Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma","Resectable Pancreatic Adenocarcinoma",[247,248,249,250,251,252,253,254,255,256,257],"neoadjuvant treatment","checkpoint inhibition","chemotherapy","stereotactic radiotherapy","surgical resection","progression free survival","resectable pancreatic cancer","localized pancreatic cancer","borderline resectable pancreatic cancer","FOLFIRINOX","pembrolizumab","2026-02-10",{"date":260,"type":44},"2026-02-13",{"date":262,"type":44},"2024-09-23",{"date":264,"type":22},"2028-03",{"name":50,"class":51},4,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":229},"100622176","use-of-mechanical-left-ventricular-unloading-in-complex-higher-risk-indicated-procedures-100622176","NCT07380217","Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures","Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures","UNLOAD-CHIP","Inclusion Criteria:\n\n* Age ≥18 years AND\n* Multidisciplinary heart team consensus for high risk PCI +\u002F- MCS AND\n* Hemodynamically stable (SCAI A-B) AND\n* LVEF \\\u003C30% OR LVEF \\\u003C35% with moderate MR OR LVEF \\\u003C40% with severe MR AND\n* Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native).\n\nExclusion Criteria:\n\n* Contraindications for Pulsecath IVAC2L:\n\n  1. severe aortic regurgitation\n  2. known presence of an LV thrombus (contrast echo\u002FMRI)\n  3. Mechanical aorta valve prosthesis\n  4. severe aortic valve stenosis\n  5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device\n* Cardiogenic shock defined as either SCAI CSWG stage C-E\n* Patient is intubated and mechanically ventilated\n* Stroke \\\u003C3 months\n* Major bleeding event \\\u003C3 months\n* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy\n* Pregnancy, or suspected thereof.\n* BMI \\> 35\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and\u002For to comply with study procedures.\n* Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention).",{"count":276,"type":22},98,[25],"If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual.\n\nDuring the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs.\n\nTo help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it.\n\nThis study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.",[280,281],"High-risk PCI","Coronary Artery Disease Risk High",[280,283,284,285,286,287],"CHIP","Mechanical Circulatory Support","Pulsecath iVAC2L","Pulsecath","iVAC2L","2026-01-26",{"date":290,"type":44},"2026-02-02",{"date":292,"type":44},"2024-01-25",{"date":294,"type":22},"2027-03-01",{"name":50,"class":51},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":304,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},"100565339","power2walk-the-impact-of-functional-power-training-on-participation-and-activity-in-children-with-cerebral-palsy-100565339","NCT06640894","Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy.","Power2Walk: The Impact of Functional Power Training on Participation and Activity in Children With Cerebral Palsy - A Randomized Controlled Trial","Power2Walk","Inclusion Criteria:\n\n* Children with cerebral palsy or a related non-progressive disorder between the ages of 4 to 12.\n* Gross Motor Function Classification System (GMFCS) level I - III.\n* Parents and\u002For children have a treatment question related to participation of the child.\n\nExclusion Criteria:\n\n* Participants that suffer from a progressive neurological disorder.\n* Treatment with botulinum toxin and\u002For serial casting in lower extremities planned during the study period.\n* Treatment with botulinum toxin in the twelve weeks prior to participation in the study.\n* Treatment with serial casting in the three weeks prior to participation in the study.\n* Children that underwent a selective dorsal rhizotomy twelve months prior to participation in the study.\n* Children that underwent orthopedic surgery on their lower extremities in the 12 months before participation in the study.\n* Children that have received MegaPower training in the last 4 months before participation in the study.\n* Children for whom walking is not their preferred method of locomotion (yet).","4 Years","12 Years",{"count":239,"type":22},[25],"Rationale: Children with cerebral palsy (CP) experience limitations in walking ability due to functional motor impairments caused by neurodevelopmental damage during fetal or early child development. Due to these motor impairments, children with CP struggle to keep up with typically developing peers when participating in physical and\u002For social activities. Consequently, the development of these children may be hampered. Recently, functional power training (FPT) emerged as a potentially successful supplementary treatment method to improve participation in children with CP. It is understood that FPT is more effective than progressive resistance training in improving walking ability and endurance, and thereby better supports participation in ambulatory children with CP. Nevertheless, high-level scientific evidence underpinning the efficacy of FPT on these parameters in ambulant children with CP is still lacking. The investigators hypothesize that FPT effectively helps accomplish patient-tailored participation and activity goals in ambulant children with CP.\n\nObjective: This study aims to investigate whether twelve weeks of FPT (MegaPower training) effectively accomplish patient-tailored participation and activity goals in ambulant children with CP, when compared to their usual care. Additionally, the goal is to investigate i) whether MegaPower training improves walking ability, aerobic endurance, and anaerobic capacity; ii) what factors best identify which ambulant children with CP benefit most from twelve weeks of MegaPower training; iii) to what extend the MegaPower training was implemented as intended in the participating study centers?, and iv) whether the effects of the MegaPower training are maintained after 12 and 24 weeks of follow-up.\n\nStudy design: A single-blind randomized controlled parallel trial with a 24 week follow-up. During the follow-up, the control group will also receive MegaPower training.\n\nStudy population: Ambulant children with cerebral palsy or a related non-progressive disorder between the ages of 4 - 12.\n\nIntervention: One group will receive twelve weeks of FPT (MegaPower training), whilst the other group will receive twelve weeks of usual care (control group).\n\nMain study parameters\u002Fendpoints: Accomplishment of patient-tailored participation and activity goals, measured through Goal Attainment Scaling.",[310],"Cerebral Palsy, Spastic",[312],"Cerebral palsy","2025-12-19",{"date":315,"type":44},"2025-12-29",{"date":317,"type":44},"2024-07-19",{"date":319,"type":22},"2027-08-31",{"name":50,"class":51},10,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":337,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":52},"100614331","brain-stimulation-in-long-covid-100614331","NCT07278206","Brain Stimulation in Long COVID","Mitigating Cognitive Problems and Fatigue With Brain Stimulation in Long COVID","MALIBU","Inclusion Criteria:\n\n* Meet the World Health Organization (WHO) definition of long COVID.\n* Aged 18 years or older.\n* Severe fatigue, defined as a score ≥35 on the Checklist Individual Strength (CIS) fatigue subscale.\n* Significant cognitive complaints, defined as a score ≥18 on the CIS concentration subscale.\n* Commitment to actively undergo rTMS\n* Ability to attend the study site regularly for treatment sessions.\n* Capacity to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior rTMS treatment or current intensive\u002Fexperimental treatment for long COVID.\n* History of epilepsy or first-degree family history of epilepsy.\n* Recent initiation or dosage change of psychotropic medication (less than six weeks for psychotropic medication including antidepressants and antipsychotic drugs, less than two weeks for benzodiazepines). Medication doses must remain stable during the study.\n* Other active concurrent pharmacological treatments for post-covid symptoms\n* Contraindications to MRI scanning (e.g., non-removable metallic implants, severe claustrophobia).\n* Presence of a cochlear implant.\n* Neurological disorders such as multiple sclerosis or other neurodegenerative conditions.\n* Pregnancy.\n* Known brain lesions or ischaemic scars influencing seizure threshold.\n* Severe uncontrolled migraines.\n* Severe cardiovascular disease\n* Raised intracranial pressure.\n* High alcohol consumption (males\u002Ffemales: 21\u002F14 units per week) or use of epileptogenic drugs.\n* Severe sleep deprivation at the time of treatment.",{"count":239,"type":22},[25],"Cognitive problems and severe fatigue are two frequently occurring symptoms in long COVID, also known as Post-Covid Condition or Post-Acute Sequelae of COVID-19 (PASC), and their causes are currently unknown. Previous studies have shown reduced blood flow and increased inflammation in the brains of people with PASC. These brain processes are related to fatigue and cognitive problems. In other conditions, these disrupted brain processes have been treated safely and successfully with non-invasive brain stimulation. This may offer an effective treatment for people with PASC.\n\nThe main goal of this clinical trial is to see whether non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can reduce fatigue in adults with PASC who also have trouble concentrating. rTMS uses short magnetic pulses on the scalp to gently stimulate a small brain area.\n\nIn this study, 66 adults with PASC will be included, recruited through the Post-COVID Network Netherlands. Participants will be randomly assigned to receive either active rTMS or sham (placebo) rTMS. Sham rTMS feels and looks similar to the active treatment, but it does not generate effective magnetic pulses. The brain area that will be targeted is personalized using a brain scan (MRI) during a planning task. All participants will receive 24 rTMS sessions over six weeks (four per week).\n\nFatigue will be measured within two weeks before and two weeks after treatment to determine whether active rTMS works better than sham. We will also look at cognition, brain connectivity and blood flow, signs of (neuro)inflammation, daily activity using an activity watch, and questionnaires about quality of life, mood, and sleep. Follow-up on cognition and questionnaires will take place 3 and 6 months after the end of the treatment.",[334,335,336],"Long COVID","PASC Post Acute Sequelae of COVID 19","Post COVID-19 Condition (PCC)",[338,339,340,341,342,343,344],"TMS","PASC","long COVID","PCC","neuroimaging","non-invasive brain stimulation","transcranial magnetic stimulation","2025-12-18",{"date":313,"type":44},{"date":348,"type":44},"2025-11-17",{"date":350,"type":22},"2029-05-12",{"name":50,"class":51},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":360,"minAge":361,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":368,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":52},"100565338","phase-2-preoperative-partial-breast-reirradiation-and-repeat-breast-conserving-surgery-in-patients-with-recurrent-breast-cancer-the-repeat-trial-100565338","NCT06640881","Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial","Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial - a Study Protocol","REPEAT","Inclusion Criteria:\n\n* Female ≥ 50 years with an ipsilateral invasive recurrent breast cancer event after previous breast-conserving surgery and postoperative whole breast irradiation\n* World Health Organization performance status 0-2\n* Tumor size ≤ 2 cm and unifocal on MRI\n* Tumor histology as assessed on biopsy:\n\nBloom-Richardson grade 1 or 2 Non-lobular invasive histological type carcinoma Estrogen receptor positive HER2 receptor negative No lymphovascular invasion\n\n* No extensive DCIS (outside tumor size of 2 cm) on mammography or tumor biopsy, including non-mass enhancement on MRI\n* Clinical node negative on 18-F FDG PET-CT, ultrasound and MRI\n* No distant metastasis\n* No or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy\n* Adequate understanding of the Dutch language\n\nExclusion Criteria:\n\n* Ipsilateral invasive breast cancer event less than two years after first breast-conserving therapy for breast cancer\n* Other malignancy within 5 years before ipsilateral breast recurrence diagnosis. For carcinoma in situ no specific time span to ipsilateral breast recurrence diagnosis is required for inclusion\n* Known breast cancer mutation gene carrier\n* Collagen synthesis disease (e.g. osteogenesis imperfect, Ehlers-Danlos syndrome, systemic sclerosis)\n* Previous ipsilateral mastectomy\n* Invasive lobular carcinoma, DCIS without invasive cancer\n* MRI absolute contraindications\n* Indication for treatment with neoadjuvant chemotherapy\n* Legal incapacity","FEMALE","50 Years",{"count":7,"type":22},[65],"Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumor, and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.\n\nThe REPEAT trial is a multicenter, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥ 50 years, have a unifocal non-lobular invasive breast cancer ≤ 2 cm, Bloom-Richardson grade 1 or 2, estrogen receptor-positive, HER2-negative and clinically negative axillary lymph nodes. The study plans to enroll 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 weeks post-PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome, and biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 5 years after PBI.\n\nThis trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE. This treatment approach is expected to minimize the irradiated volume, reduce toxicity, and improve cosmetic outcomes compared to postoperative PBI after second BCS. Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment.",[366,367],"Recurrent Breast Carcinoma","Ipsilateral Recurrence",[369,370,371,372,373],"single-dose preoperative radiotherapy","pathologic response","radiologic response","cosmetic outcome","partial breast irradiation","2025-09-30",{"date":376,"type":44},"2025-10-01",{"date":378,"type":44},"2025-01-01",{"date":380,"type":22},"2026-12",{"name":50,"class":51},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":52},"100550854","postoperative-re-irradiation-with-and-without-hyperthermia-toxicity-quality-of-life-and-survival-in-patients-with-locoregional-recurrent-breast-cancer-100550854","NCT06452485","Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer","RT-HYPE","Inclusion Criteria:\n\n* WHO performance scale ≤2\n* \\>=18 years\n* Patients with a LRR breast cancer after postoperative irradiation of the primary breast cancer. LRR is defined as a local and\u002For regional recurrence, including patients with a second primary ipsilateral breast cancer.\n* Patients treated with salvage mastectomy with high-risk\\* tumor characteristics or local excision with an indication for postoperative re-irradiation.\n* Previously treated with whole or partial breast irradiation.\n* (Neo)adjuvant systemic therapy (NST) is allowed.\n* Use of (FES\u002FFDG-)PET-CT in staging of nodal and disseminated disease.\n* Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary\u002Fsupraclavicular region (up to a maximal number of five) is allowed.\n* Adequate communication and understanding skills of the Dutch language.\n\nExclusion Criteria:\n\n* Diagnosed with primary breast sarcoma\n* Have a low-risk LRR after previous breast-conserving surgery\u002Ftherapy",{"count":390,"type":22},500,"In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.",[393,394,395,396],"Locoregional Recurrence","Breast Cancer","Re-irradiation","Hyperthermia",{"date":398,"type":44},"2025-10-06",{"date":400,"type":44},"2024-01-01",{"date":402,"type":22},"2027-05",{"name":50,"class":51},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":417,"conditions":418,"keywords":422,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":52},"100566695","phase-4-right-ventricular-compensation-with-sotatercept-a-prospective-single-arm-open-label-phase-4-study-to-evaluate-the-effects-of-sotatercept-on-right-ventricular-function-in-pulmonary-arterial-hypertension-recompense-100566695","NCT06658522","Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)","RECOMPENSE: Right vEntricular COMPENsation With SotatercEpt: a Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension","RECOMPENSE","Inclusion Criteria:\n\n1. Adult patients between 18-70 years of age\n2. Able to provide signed informed consent\n3. WHO FC II to IV\n4. NTproBNP \\> 300 ng\u002FL\n5. PAH etiology belonging to one of the following groups (Nice classification):\n\n   * Idiopathic PAH\n   * Heritable PAH\n6. Hemodynamic diagnosis of PAH confirmed by RHC during screening showing:\n\n   * mPAP \\> 20 mmHg\n   * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg\n   * PVR ≥ 4WU (320 dyn.sec.cm-5)\n7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period\n8. All patients are on stable background therapy at least 3 months prior to RHC during the screening period\n9. Women of childbearing potential must have a negative pregnancy test at screening and agree to use reliable methods of contraception\n10. Males must agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study. Males should refrain from donating blood or sperm for the duration for the study and for 16 weeks after last dose of sotatercept\n\nExclusion Criteria:\n\n1. Any contraindication to treatment with sotatercept\n2. Body weight \\< 40 kg\n3. Body mass index (BMI) \\> 35kg\u002Fm2\n4. Pregnancy, breastfeeding, or intention to become pregnant during the study\n5. Recently started (\\< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program\n6. Known concomitant life-threatening disease with a life expectancy \\< 12 months\n7. Any condition likely to affect protocol or treatment compliance\n8. Hospitalization for PAH within 3 months prior to informed consent signature\n9. Left atrial volume per body surface area ≥ 43mL\u002Fm2 by echocardiography or CMR\n10. Valvular disease grade 2 or higher\n11. History of pulmonary embolism or deep vein thrombosis\n12. Documented moderate to severe chronic obstructive pulmonary disease\n13. Documented moderate to severe restrictive lung disease\n14. Historical evidence of significant coronary artery disease\n15. Diabetes mellitus\n16. Active cancer\n17. Systolic blood pressure \\< 90 mmHg\n18. Need for dialysis\n19. Responders to acute vasoreactivity testing based on medical history\n20. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation)\n21. Claustrophobia\n22. Permanent cardiac pacemaker, automatic internal cardioverter\n23. Metallic implant (e.g. defibrillator, neurostimulator, hearing aid, infusion device)\n24. Atrial fibrillation, multiple premature ventricular or atrial contractions , or any other condition that would interfere with proper cardiac gating during CMR.\n25. History of major bleeding\n26. Hemoglobin above ULN for age and gender","70 Years",{"count":414,"type":22},20,[416],"PHASE4","Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA). This elevated pressure ultimately leads to fulminant right heart failure. Current therapeutic options are limited and are centred around vasodilatory medications such as phosphodiesterase-5 inhibitors and prostacyclin. While these medications allow for the widening of blood vessels that are narrowed due to remodelling, they have no effect on the remodelling itself.\n\nSotatercept is a novel medication which targets the BMPR2\u002FTGF-β pathway and restore a pro- and anti- proliferative balance to ultimately counteract vascular remodelling. Recent phase 2 and 3 trials showed that treatment with sotatercept led to lower resistance and pressure in the pulmonary vasculature and improved exercise tolerance. However, these results were not coupled with an increase in cardiac output, a change that is seen with other PAH-medications with a primarily vasodilatory effect. These results suggest that cardiac work is reduced and cardiac efficiency is improved in patients being treated with sotatercept, in contrast with conventional PAH therapies. This is a potentially beneficial effect that may result in improved disease control in the long-term. Our study aims to explore the effect of sotatercept on cardiac work and function. We hypothesize that the effects of sotatercept are more beneficial for cardiac function than that of traditional PAH medications.\n\nAll participants included in the trial will undergo a screening visit in which it will be checked that all inclusion criteria and no exclusion criteria are met. The screening visit involves a physical exam, blood draw, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast to assess fibrosis.\n\nUpon inclusion, all participants will receive a subcutaneous injection of sotatercept starting at a dose of 0.3 mg\u002Fkg. Participants will return to the hospital every three weeks for a blood draw, physical examination and an adverse event review. If the laboratory values (specifically haemoglobin and platelet counts) stay stable after the first dose, the dosage will be escalated to 0.7 mg\u002Fkg. The dose will not be escalated beyond 0.7 mg\u002Fkg.\n\nAfter 24 weeks of receiving sotatercept, there will be an end of treatment visit including a physical exam, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast material.",[419,420,421],"Pulmonary Arterial Hypertension PAH","Pulmonary Arterial Hypertension WHO Group I","Pulmonary Arterial Hypertension",[423,424,425,426],"Pulmonary arterial hypertension","PAH","Right Ventricle","Sotatercept","2025-09-16",{"date":429,"type":44},"2025-09-22",{"date":431,"type":44},"2025-05-14",{"date":433,"type":22},"2026-05-01",{"name":50,"class":51},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":149,"sex":18,"minAge":305,"maxAge":19,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":452,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":266},"100530006","yopa---a-youth-centred-participatory-action-100530006","NCT06181162","YoPA - A Youth-centred Participatory Action","YoPA - A Youth-centred Participatory Action Approach Towards Co-created Implementation of Socially and Physically Activating Environmental Interventions in Africa and Europe.","YoPA","Inclusion Criteria:\n\n* aged 12 to 18 years\n* living in a disadvantaged area in Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), or Soweto (South Africa)\n* active informed consent by the adolescents and at least one parent\u002Fcaregiver where applicable for the participation of the adolescent\n\nExclusion Criteria:\n\n* none",{"count":444,"type":22},1000,[25],"Background\n\nA vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations.\n\nMethods\n\nIn diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner.\n\nDiscussion\n\nYoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.",[448,449,450,451],"Physical Activity","Health Promotion","Sleep","Screen Use",[453,449,454,455,456,457,458],"Participatory Action Research","Systems Approach","Adolescents","24-hour movement behaviour","Physical activity","Urban health","2025-09-11",{"date":461,"type":44},"2025-09-17",{"date":463,"type":44},"2023-11-01",{"date":465,"type":22},"2026-12-31",{"name":50,"class":51},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":149,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":491,"locationsCount":181},"100604912","evaluating-healthcare-professionals-satisfaction-and-stress-mitigation-using-virtual-reality-intervention-in-surgical-ward-100604912","NCT07155681","Evaluating Healthcare Professionals' Satisfaction and Stress Mitigation Using Virtual Reality Intervention in Surgical Ward","Evaluating Healthcare Professionals' Satisfaction and Stress Mitigation Using Virtual Reality Intervention in Surgical Ward: a Multination Feasibility Study","Inclusion Criteria:\n\n* Volunteering healthcare professionals (≥18 years old) working in direct patient care, such as nurses, residents, physician assistants, and surgeons, on the surgical ward.\n\nExclusion Criteria:\n\n* Diagnosed with epilepsy\n* Experienced VR as a trigger for their migraines\n* Severe dizziness, nausea or physical disabilities will be excluded.\n* Diagnosed with arrythmias, bradycardia or tachycardia\n* Not able to wear the VR headset due to physical or psychological conditions",{"count":475,"type":22},75,[25],"The goal of this feasibility study is to learn whether a VR intervention is feasible, acceptable, and satisfactory for healthcare workers in surgical wards to help mitigate stress. Secondary objectives include assessing its potential contribution to stress reduction, user comfort, and practical integration into daily workflows.\n\nParticipants will take part in a single 10-minute VR intervention session.",[155,479],"Stress (Psychology)",[159,160,155,165,481,482,483,166,484],"Healthcare professionals","healthcare workers","nurses","surgical ward","2025-08-26",{"date":487,"type":44},"2025-09-04",{"date":489,"type":22},"2025-11-01",{"date":178,"type":22},{"name":50,"class":51},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":181},"100568948","phase-2-metformin-as-a-metabolic-intervention-in-oesophageal-adenocarcinomas-to-improve-response-to-neoadjuvant-chemoradiotherapy-100568948","NCT06687876","Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy","Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy.","MEMENTO","Inclusion Criteria:\n\n* Surgical resectable (\\\u003CT4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to undergo neoadjuvant chemoradiotherapy.\n* Adult patients (age ≥ 18 years).\n* ECOG performance status 0 or 1 (cf. Appendix A).\n* Adequate hematological, renal and hepatic functions defined as:\n\n  * Absolute Neutrophil Count ≥ 1.5 x 10\\^9\u002FL\n  * Platelets ≥ 100 x 10\\^9\u002FL\n  * Hemoglobin ≥ 5.6 mmol\n  * Total bilirubin ≤ 1.5 x upper normal limit\n  * Creatinine clearance (Cockroft) \\> 30 ml\u002Fmin\n* Patients must be willing to undergo two endoscopies for investigational purposes.\n* Written, voluntary informed consent.\n* Patients must be accessible to follow up and management in the treatment center.\n\nExclusion Criteria:\n\n* Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.\n* Patients prescribed metformin or another anti-diabetic drug for any reason.\n* Patients allergic or intolerant to metformin.\n* Excessive alcohol consumption.\n* Use of OCT1\u002FOCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib).\n* Use of OCT1\u002FOCT2 inducers (e.g. rifampicine).\n* Use of immunosuppressive medication (corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, cyclophosphamide).\n* Previous systemic therapy or radiotherapy on the oesophagus.\n* Severe renal impairment (CLcr ≤ 30 ml\u002Fmin).\n* Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of oesophageal cancer.\n* Previous systemic therapy for other forms of cancer within the last six months.\n* Patients with prior allogeneic stem cell or solid organ transplantation\n* Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.\n* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.\n* Pulmonary fibrosis, active, non-infectious pneumonitis and\u002For severely impaired lung function precluding major surgery and\u002For radiation.\n* Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.\n* Dementia or altered mental status that would prohibit the understanding and giving of informed consent.",{"count":501,"type":22},14,[65],"The primary objective of this study is to investigate whether two weeks of metformin treatment can activate the tumour microenvironment in patients with stage II and III oesophageal adenocarcinomas.",[505,506],"Oesophageal Adenocarcinoma","Tumor Microenvironment",[508,509,510,511,512,513],"metabolic intervention","adenocarcinoma","oesophageal cancer","metformin","tumor microenvironment","neoadjuvant chemoradiotherapy","2025-07-09",{"date":516,"type":44},"2025-07-10",{"date":518,"type":44},"2025-03-09",{"date":520,"type":22},"2030-12",{"name":50,"class":51},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":532,"conditions":533,"keywords":538,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":52},"100597275","adaptive-anastomosis-for-anterior-resection-in-sigmoid-and-proximal-rectal-cancer-or-premalignant-lesions-100597275","NCT07056374","Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions","Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesion: a Multicentre Non-randomised Clinical Effectiveness Trial )ADAPT","ADAPT","Inclusion Criteria:\n\n* Biopsy proven cancer of the sigmoid colon or proximal rectum (cT1-4aN0-2M0) that require AR as the procedure of choice or premalignant lesions not amenable to endoscopic resection, that require AR as the procedure of choice.\n* Suitable for curative AR\n* Suitable for elective laparoscopic or robotic surgery\n* Cognitive ability to take part in the study, to understand the information the patient receives about participating in the study, to provide informed consent and to agree to complete the questionnaires.\n\nExclusion Criteria:\n\n* Pre-existing health conditions requiring emergency surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.\n* Cancer with distant metastases (TNM Stage IV).\n* Intestinal or anal stenosis or other obstructions distal to the planned anastomosis.\n* Prior pelvic radiation including neoadjuvant chemoradiotherapy.\n* Contraindications to general anaesthesia.\n* Need for defunctioning ileostomy (intention to treat).\n* Patients who have a contra-indication for or are unable to receive preoperative bowel preparation or at least two enemas prior to surgery.\n* Immunocompromised patients e.g. taking steroids or receiving immunotherapy.\n* Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection (e.g. diverticulitis) which may impair the use of C-REX RectoAid Cath",{"count":531,"type":22},165,"Background: Anastomotic leakage (AL) after colorectal surgery remains a significant challenge, associated with increased morbidity, mortality, poor oncological outcomes, and reduced quality of life. Despite surgical advances, AL rates for colorectal procedures continue to range from 3% to 25%, especially in distal anastomoses.\n\nThe commonly used cross-stapled circular anastomosis for anterior resections (AR) activates a foreign body response delaying gastrointestinal wound healing and potentially increasing the risk of AL. Additionally, crossed stapler lines further increase the risk of AL. An adaptive anastomosis technique eliminates permanent foreign body material, thereby reducing negative effects on wound healing and avoiding cross-stapling potentially lowering the incidence of AL. These areas have shown to have a lower burst pressure compared to a single stapled anastomosis.\n\nAn adaptive anastomotic technique eliminates cross-stapling and permanent foreign body material in the anastomosis reducing the negative effects on wound healing potentially lowering the incidence of AL.\n\nDesign: This is a prospective, international, non-randomized, multicentre study.\n\nEndpoints: The Primary objective of this trial is to assess the incidence of AL within 30 days after surgery. Secondary objectives are to assess anastomotic integrity at 90 days and 1 year, intraoperative efficacy and efficiency of the C-REX device, time to evacuation of the anastomotic ring, mode of evacuation and related patient experience, postoperative morbidity and readmissions, C-reactive protein (CRP) profile in the early postoperative period, functional outcomes, cost-effectiveness and surgical quality.\n\nPopulation: A total of 165 patients (age ≥ 18 years) with histologically proven cT1-4aN0-2M0 cancer of the sigmoid colon or proximal rectum, or premalignant lesions not amenable to endoscopic resection, that require elective AR will be enrolled throughout 10 European colorectal centers.\n\nStudy procedures: The anastomosis will be created using the C-REX RectoAid Cath. The healing period will be approximately 10 days. The anastomotic ring detaches via necrosis and is evacuated with the feces. Patients will be asked to fill out questionnaires regarding Low Anterior Resection Syndrome (LARS) and use of healthcare and these will be gathered preoperatively, 90 days postoperative and 1 year after surgery. At 12 months a CT-scan and colonoscopy will be performed.",[534,535,536,537],"Rectal Cancer","Sigmoid Cancer","Premalignant Lesion","Colorectal Cancer",[539,540,541,33,542,543],"Anterior Resection","Adaptive anastomosis","Compression anastomosis","Sigmoid resection","Partial Mesorectal Excision","2025-07-08",{"date":514,"type":44},{"date":547,"type":44},"2025-03-25",{"date":549,"type":22},"2027-09-01",{"name":50,"class":51},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":4},"100563118","superimposition-of-intra-oral-scans-in-mad-therapy-for-osa-100563118","NCT06612008","Superimposition of Intra-oral Scans in MAD Therapy for OSA","Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea","SIMT-OSA","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Patients with a diagnosis of OSA\n* Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour\n* Patients initially treated with MAD\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients without a diagnosis of mild to moderate OSA\n* Patients undergoing other treatments for OSA\n* Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)\n* Patients diagnosed with central sleep apnea\n* Patients undergoing orthodontic treatment (e.g. braces)\n* Pregnant patients\n* Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),\n* Patients undergoing cancer treatment with chemotherapy or radiation\n* Patients with a history of maxillofacial surgery\n* Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth\n* Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids",{"count":215,"type":22},"Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients.\n\nGoals:\n\n1. To track dental and jaw changes in OSA patients using 3D scans.\n2. To assess the impact of MAD on quality of life and cognitive function.\n\nStudy Details:\n\nThe aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging.\n\nOutcome:\n\nThe study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.",[562],"Obstructive Sleep Apnea",[562,564,565,566],"Obstructive Sleep Apnea Syndrome","Oral Appliance Therapy","Mandibular Advancement Device","2025-07-04",{"date":516,"type":44},{"date":570,"type":22},"2025-07",{"date":75,"type":22},{"name":50,"class":51},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":181},"100591640","phase-4-dietary-sodium-intake-effects-on-ertugliflozin-induced-changes-in-gfr-renal-oxygenation-and-systemic-hemodynamics-the-design-study-a-randomized-placebo-controlled-cross-over-study-with-ertugliflozin-in-people-with-type-2-diabetes-100591640","NCT06983054","DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes","DESIGN","Inclusion Criteria:\n\nAdults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria\n\n* HbA1c 6.5-10%\n* Age 18 - 85 years of age\n* Overweight or obese with BMI: \\>25 kg\u002Fm2\n* We will make every effort to enrol participants of all races\u002Fethnicities.\"\n* Both sexes (females must be post-menopausal; no menses \\>1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as \\>31 U\u002FL)\n* Ability to provide signed and dated, written informed consent prior to any study procedures\n* Estimated GFR 60-90 ml\u002Fmin\u002F1.73m2 by CKD-EPI matching the eGFR range of most participants in VERTIS-CV\n* Sodium intake at baseline \\\u003C 200 mmol\u002Fday\n* UACR \\\u003C 30 mg\u002Fmmol\n* All participants need to be on a stable dose of diabetes medication, including Metformin, SU, DPP4-inhibitors, or insulin.\n* Participants suffering from hypertension need to be on a stable dose of RAS inhibitors. In case RAS inhibition is not tolerated, the participant should to be on a stable dose of other antihypertensive treatment.\n\nExclusion Criteria:\n\n* History of unstable or rapidly progressing renal disease NL80772.029.22 \u002F DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version 5.0dd22-02-2024 14 of 45\n\n  * Estimated GFR \\\u003C60 mL\u002Fmin\u002F1.73m2 or eGFR \\> 90 mL\u002Fmin\u002F1.73m2 determined by CKD-EPI\n  * UACR \\> 30 mg\u002Fmmol\n  * Current\u002Fchronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics Participants should be on a stable dose of antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.\n  * Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e.\n\nsports injury, headache or back ache). However, no such drug can be taken within a timeframe of 2 weeks prior to renal testing\n\n* History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and\u002For hospitalization) within 1 month prior to the Screening visit.\n* Current urinary tract infection and active nephritis\n* Recent (\\\u003C6 months) history of cardiovascular disease, including:\n\n  * Acute coronary syndrome\n  * Chronic heart failure (New York Heart Association grade II-IV)\n  * Stroke or transient ischemic neurologic disorder\n* Severe hepatic insufficiency and\u002For significant abnormal liver function defined as aspartate aminotransferase (AST) \\>3x upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>3x ULN\n* Active malignancy. History of malignancy is allowed unless the participant still has active treatment other than hormonal therapy.• History of or actual severe mental disease\n* Substance abuse (alcohol: defined as \\>4 units\u002Fday)\n* Allergy to any of the agents used in the study\n* Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study\n* Inability to understand the study protocol or give informed consent","85 Years",{"count":582,"type":22},34,[416],"SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake. Therefore, carefully designed mechanistic trials are needed to better understand the interplay between ertugliflozin and salt intake and to potentially modify salt intake to maximize treatment response. In addition, the study could contribute to hypotheses concerning the effects of SGLT2 inhibitors in combination with other drugs that affect sodium homeostasis and could help to explain the differences in kidney outcomes observed in (outcome) trials, which include different ethnicities with potential differences in dietary habits.",[586],"Type 2 Diabetes","2025-05-13",{"date":589,"type":44},"2025-05-21",{"date":591,"type":44},"2023-07-25",{"date":593,"type":22},"2025-12",{"name":50,"class":51},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":613,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":52},"100587060","phase-2-neoadjuvant-gemcitabine-and-cisplatin-in-combination-with-perioperative-pembrolizumab-versus-upfront-surgery-for-patients-with-primary-resectable-and-borderline-resectable-perihilar-and-distal-cholangiocarcinoma-100587060","NCT06923475","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma (NEODISCO): A Multicentre Phase 2B\u002F3 Randomized Controlled Trial","NEODISCO","Inclusion Criteria:\n\n* Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications.\n* Successful drainage, in case of clinical significant bile duct obstruction.\n* MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection.\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n\nExclusion Criteria:\n\n* Upfront \"clearly\" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and\u002For insufficient FLR for potential radical resection. Insufficient FLR is defined as \\\u003C30% residual volume or a function \\\u003C2.7 min\u002Fm2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration\u002Fresection, are considered ineligible for NEODISCO.\n* Upfront clearly unresectable dCCA (following DPCG criteria).\n* Patients with proven N2 lymph nodes (according to the AJCC 8th edition).\n* PCCA eligible for liver transplantation.\n* Intrahepatic cholangiocarcinoma with hilar involvement.\n* Cancer suspicious for ampullary carcinoma (for instance involvement of papilla during endoscopy).\n* Local recurrence following prior resection of eCCA (patients who develop local recurrence during the study are however not excluded).\n* Patients with underlying liver diseases: PSC, untreated hepatitis, cirrhosis child-Pugh B, C.\n* Previous malignancy unless no evidence of disease, or diagnosed more than 3 years before diagnosis of eCCA, or with a life expectancy of more than 5 years from date of inclusion.\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 (eg, CTLA-4, OX-40, CD137).",{"count":604,"type":22},150,[65,217],"Extrahepatic cholangiocarcinoma (eCCA) is a rare and aggressive cancer with poor prognosis. ECCA can be further subcategorised in perihilar and distal cholangiocarcinoma (pCCA and dCCA). Surgical resection is the only potential cure, but only one-third of patients are eligible. Even among those deemed resectable, a significant portion (≈30%) experience disease progression before surgery, while another 30% are found unresectable during exploration. High recurrence rates and postoperative complications further limit survival, with 5-year overall survival ranging from 13% (R1 resection) to 40% (R0 resection). Given the long preoperative work-up period and lack of treatment during this phase, a neoadjuvant approach may improve outcomes by increasing R0 resections, reducing recurrence, and optimizing patient selection.\n\nThis multicenter, randomized phase 2B\u002F3 trial aims to assess whether neoadjuvant gemcitabine and cisplatin plus perioperative pembrolizumab improves event-free survival in patients with resectable and borderline resectable pCCA and dCCA.",[608,609,610,611,612],"Extrahepatic Cholangiocarcinoma","Perihilar Cholangiocarcinoma","Distal Cholangiocarcinoma","Resectable","Borderline Resectable",[614,609,610,611,615],"Extrahepatic cholangiocarcinoma","Borderline resectable","2025-04-03",{"date":618,"type":44},"2025-04-11",{"date":620,"type":22},"2025-05-05",{"date":622,"type":22},"2028-11-06",{"name":50,"class":51},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":643,"leadSponsor":645,"locationsCount":52},"100537802","feelfit-high-intensity-interval-training-to-improve-self-reported-physical-fitness-in-brain-tumor-patients-100537802","NCT06282562","FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients","FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients: a Randomized Controlled Trial","FeelFit","Inclusion Criteria:\n\n* reduced self-reported physical fitness;\n* minimum age of 18 years;\n* diagnosed with a primary brain tumor;\n* stable disease, i.e. no signs of radiological or clinical tumor progression;\n* no oncological treatment for at least two months prior to inclusion;\n* able to speak, read and write in Dutch.\n\nExclusion Criteria:\n\n* Karnofsky Performance Score \\\u003C 70;\n* already participated in a HIIT program \\\u003C 1 month prior;\n* contraindication of exercise.",{"count":633,"type":22},36,[25],"The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.",[637,638],"Brain Tumor, Primary","Exercise","2025-04-02",{"date":641,"type":44},"2025-04-06",{"date":400,"type":44},{"date":644,"type":22},"2026-08-15",{"name":50,"class":51},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":653,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":656,"briefSummary":657,"conditions":658,"keywords":660,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":670,"locationsCount":52},"100521360","dont-be-late-postponing-cognitive-decline-and-preventing-early-unemployment-in-people-with-multiple-sclerosis-100521360","NCT06068582","Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis","DBL","Inclusion Criteria:\n\n* Confirmed MS diagnosis according to the McDonald 2017 criteria\n* Age between 18 and 67\n* No changes in disease modifying therapy prior to inclusion (i.e., no changes in last 3 months) - this criterion only applies at inclusion to ensure participants are in a stable situation at the start of the study and for follow-up measures, changes in treatment will be registered but will not result in exclusion from the study\n* no current relapse or steroid treatment in the six weeks prior to study visits\n* presence of mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery\n* being able to participate in an exercise intervention (i.e., EDSS \\\u003C 6.0)\n* fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia)\n\nExclusion Criteria:\n\n* presence of neurological (other than MS) and psychiatric disorders\n* a current or history of drug or alcohol abuse\n* being unable to speak or read Dutch\n* currently on sick leave for a period of 6 weeks or longer\n* currently pregnant","67 Years",{"count":655,"type":22},270,[25],"The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are:\n\n* to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network\n* to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions\n* aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice\n\nParticipants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.",[659],"Multiple Sclerosis",[659,661,638,662,663,664],"Cognition","Employment","Prevention","Health-related Quality of Life","2025-03-31",{"date":616,"type":44},{"date":668,"type":44},"2023-04-16",{"date":138,"type":22},{"name":50,"class":51},{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":680,"conditions":681,"keywords":683,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":52},"100551261","assessment-of-pet-tracers-to-evaluate-t-cell-change-and-activation-in-relation-to-immunotherapy-treatment-response-in-non-small-cell-lung-cancer-100551261","NCT06457789","Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer","iRelate","Inclusion Criteria:\n\n* Histologically confirmed NSCLC\n* T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET\u002FCT\n* Planned to undergo resection after chemo-IO according to routine treatment guidelines\n* Willing and able to provide written informed consent for the trial\n* Above 18 years of age on day of signing informed consent\n* Have measurable disease based on RECIST 1.1\n* Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and\u002For exercise testing\n\nExclusion Criteria:\n\n* Patients deemed inoperable\n* Patients who have received a splenectomy\n* Patients who have received any vaccination within 14 days of enrollment\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.",{"count":582,"type":22},[25],"The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor.\n\nThis study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.",[682],"NSCLC",[682,684,685,686,687,688,689,690,691,692,693],"immunoPET","18F-AraG","AraG","89Zr-crefmirlimab","Crefmirlimab","tracers","PET tracers","[18F]F-AraG","[89Zr]Zr-Df-Crefmirlimab","IAB22M2C","2025-03-27",{"date":639,"type":44},{"date":697,"type":44},"2024-12-01",{"date":699,"type":22},"2028-07",{"name":50,"class":51},{"id":702,"slug":703,"hasResults":12,"nctId":704,"briefTitle":705,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":23,"phases":710,"briefSummary":711,"conditions":712,"keywords":714,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":52},"100493132","a-clinical-imaging-study-of-the-changes-in-18ff-arag-uptake-following-anti-pd-1-therapy-in-non-small-cell-lung-cancer-100493132","NCT05701176","A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer","SHARP","Inclusion Criteria:\n\n* Histologically confirmed NSCLC, a histological biopsy is mandatory, negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations\n* Be willing to provide either archival biopsy or fresh biopsy at screening.\n* Stage IIIB-IV patients that are planned to be treated with anti-PD-1 monotherapy\n* High PD-L-1 expression (≥50% TPS)\n* No prior systemic therapy for the treatment of cancer\n* Be willing and able to provide written informed consent for the trial.\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale\n* Be above 18 years of age on day of signing informed consent.\n\nExclusion Criteria:\n\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Untreated or symptomatic brain metastases\n* Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Active infection requiring systemic therapy.\n* A history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Active Hepatitis B or C.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of \\[18F\\]F-AraG.",{"count":709,"type":22},15,[25],"\\[18F\\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in \\[18F\\]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).",[713],"Advanced Stage Non-small Cell Lung Cancer",[715,691,716,717],"Positron Emission Tomography","T-Lymphocytes","Longitudinal Imaging",{"date":719,"type":44},"2025-03-28",{"date":721,"type":44},"2022-11-03",{"date":723,"type":22},"2028-01",{"name":50,"class":51},""]