[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Leiden University Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":739},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,73,0,25,[9,46,85,105,134,162,190,218,264,287,314,337,360,383,408,437,458,482,509,530,549,582,614,681,718],{"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":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639200","results-of-nerve-surgery-to-treat-postamputation-pain-100639200",false,"NCT07605754","Results of Nerve Surgery to Treat PostAmputation Pain","Results of Nerve Surgery to Treat PostAmputation Pain (TreatPAP): a Prospective Study","TreatPAP","Inclusion Criteria:\n\n* Age older than or equal to 18 years\n* Intractable postamputation pain\n\nExclusion Criteria:\n\n* Cognitive impairment or delirium at the time of inclusion\n* Having received previous radiotherapy on the affected limb\n* Patients who are unable to comprehend the informed consent form or the questionnaires used in the current study\n* Unfit for general anesthesia","ALL","18 Years",{"count":21,"type":22},98,"ESTIMATED","OBSERVATIONAL","Rationale: Postamputation pain (PAP) is frequently seen after amputations and is a severe lifelong disabling condition affecting quality of life (QoL). Different nerve surgical techniques are available to treat PAP if non-surgical treatment options are not sufficient. Multiple techniques have been described for treatment of symptomatic neuromas with varying results. Techniques described include traction neurectomy with\u002Fwithout implantation, nerve grafting, nerve capping, regenerative peripheral nerve interface, and targeted muscle reinnervation (TMR). In the Leiden University Medical Center (LUMC), the most common techniques to treat painful neuromas include TMR and fascicular split (FS). TMR involves coaptating the transected mixed nerve to functional motor nerves, showing promising results in recent studies. FS is a technique closely related to neurectomy with implantation in a functional muscle. The difference is that with FS, the nerve is split into fascicles before implantation to allow for better distribution of nerve fibers. These techniques have not yet been compared. In this study, the investigators will compare both these techniques in a prospective setting for the treatment of PAP. The hypothesis is, that after 12 months, pain will be diminished and QoL will be increased in all patients versus the pre-operative status. There will be little to no difference in outcome between the surgical techniques used.\n\nObjective: To evaluate limb pain in patients with intractable postamputation pain (residual limb pain and phantom limb pain) one year after nerve embedding surgery following the standardized workup of the LUMC.\n\nStudy design: Prospective study Study population: Patients 18 years of age or older, with a history of more than 6 months of intractable postamputation neuropathic limb pain, with no history of previous surgical intervention for pain treatment, referred to the Leiden Nerve Center.\n\nMain study parameters\u002Fendpoints: The mean difference in pain scores for phantom limb pain and residual limb pain one year postoperatively. An average pain score from the past 7 days is used for PLP and RLP individually, on the 11-point (0-10) numerical rating scale (NRS). Additionally, the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior and Interference Questionnaire Short Forms (7a and 8a, respectively) are used one year postoperatively.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both techniques are currently used in the Leiden University Medical Center (LUMC) and considered standard of care. The decision to perform either technique is solely dependent on the personal preference of the treating nerve surgeon. The results of this trial will improve the understanding of the treatment effect of both surgical techniques with a minimal patient burden. Participation requires patients to complete 3-4 non-invasive questionnaires about pain, quality of life, depression and anxiety, and mobility over a period of 2 years. The pre-operative (if applicable) and 12-month postoperative questionnaire will each take approximately 15 minutes to complete. The other two questionnaires at 18 and 24 months postoperative will take approximately 3-4 minutes to complete. Additionally, participants will fill out a daily questionnaire consisting of one to three questions about pain for 7 consecutive days at 12 months.",[26],"Amputation Neuroma",[28,29,30,31,32],"Neuroma","Amputation","pain","Targeted Muscle Reinnervation","Nerve embedding","RECRUITING","2026-05-18",{"date":36,"type":37},"2026-05-26","ACTUAL",{"date":39,"type":37},"2025-08-14",{"date":41,"type":22},"2029-08-20",{"name":43,"class":44},"Leiden University Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100458902","phase-2-refining-adjuvant-treatment-in-endometrial-cancer-based-on-molecular-features-100458902","NCT05255653","Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features","Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial","RAINBO","Participants of the four RAINBO trials should be eligible according to the inclusion and exclusion criteria of both the overarching RAINBO trials program and the clinical trial that they are assigned to based on the molecular profile.\n\nInclusion Criteria of the overarching RAINBO program:\n\n* Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma and mixed endometrial carcinomas of the aforementioned histotypes.\n* Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020)\n* Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery\n* No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)\n* WHO performance status 0, 1 or 2\n* Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery\n* Patients must be accessible for treatment and follow-up\n* Written informed consent for participation in one of the RAINBO trials, permission for the contribution of a tissue block for translation research and permission for the use and sharing of data for the overarching research project according to the local Ethics Committee requirements.\n\nExclusion Criteria overarching RAINBO program:\n\n* History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years\n* Prior pelvic radiation\n\nThe p53abn-RED trial\n\nInclusion criteria:\n\n* p53 abnormal EC\n* Histologically confirmed stage I (with invasion) II or III EC\n* WHO Performance score 0-1\n* Body weight \\> 30 kg\n* Adequate systemic organ function:\n\n  * Creatinine clearance (\\> 40 cc\u002Fmin): Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n  * Adequate bone marrow function : hemoglobin \\>9.0 g\u002Fdl, Absolute neutrophil count (ANC) ≥1.0 x 109\u002Fl, platelet count ≥75 x 109\u002Fl.\n  * Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician, AND ALT (SGPT) and\u002For AST (SGOT) ≤2.5 x ULN\n\nExclusion criteria:\n\n* Pathogenic POLE mutation(s)\n* Mismatch repair deficiency\n* Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of the IP\n* History of allogenic organ transplantation\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n* Any previous treatment with a PARP inhibitor, including olaparib\n* History of active primary immunodeficiency\n* History or evidence of hemorrhagic disorders within 6 months prior to randomization\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia history or with features suggestive of MDS\u002FAML\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)\n* Active infection, including: tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1\u002F2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.\n\nThe MMRd-GREEN trial\n\nInclusion criteria:\n\n* Mismatch repair deficient EC\n* Histologically confirmed (FIGO 2009) stage IB\u002FII EC with myometrial or cervical stroma involvement and lympovascular space invasion (LVSI) OR Stage III EC OR Stage IVA with limited pelvic peritoneal involvement\n* WHO Performance score 0-1\n* Body weight \\> 30 kg\n* Adequate systemic organ function:\n\n  * Creatinine clearance (\\> 40 cc\u002Fmin): Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n  * Adequate bone marrow function : hemoglobin \\>9.0 g\u002Fdl, Absolute neutrophil count (ANC) ≥1.0 x 109\u002Fl, platelet count ≥75 x 109\u002Fl.\n  * Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN). \\\u003C\\\u003CThis will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\\>\\> AND ALT (SGPT) and\u002For AST (SGOT) ≤2.5 x ULN\n\nExclusion criteria:\n\n* Pathogenic POLE mutation(s)\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational medicinal product (IMP)\n* History of allogenic organ transplantation\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Any previous treatment with a PD(L)1 inhibitor, including durvalumab.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IMP.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with the exceptions of:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).\n  * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent.\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* History of active primary immunodeficiency\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome. The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1\u002F2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.\n\nThe NSMP-ORANGE trial\n\nInclusion criteria:\n\n* NSMP EC\n* Histologically confirmed stage II EC with substantial LVSI or stage III EC\n* ER positive EC\n* WHO performance status 0-1\n\nExclusion criteria:\n\n* Pathogenic POLE mutation(s)\n* Mismatch repair deficiency\n* p53 abnormality\n\nThe POLEmut-BLUE trial\n\nInclusion criteria:\n\n* Pathogenic POLE mutation(s)\n* For the main cohort, patients must have one of the following combinations of FIGO stage, grade, and LVSI:\n\n  * stage IA (not confined to polyp), grade 3, pN0, with or without LVSI\n  * stage IB, grade 1 or 2, pNx\u002FN0, with or without LVSI\n  * stage IB, grade 3, pN0, without substantial LVSI\n  * stage II (microscopic), grade 1 or 2, pN0, without substantial LVSI\n* For the exploratory cohort, patients must have one of the following combinations of FIGO stage, grade, and LVSI:\n\n  * stage IA (not confined to polyp), grade 3 - Stage III not included in main cohort\n  * Multiple molecular classifiers stage IA (not confined to polyp), grade 3 - Stage III\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.\n* Patient is able (i.e., sufficiently fluent) and willing to complete the QOL and\u002For health utility questionnaires in either English, French or a validated language. The baseline assessment must be completed within the required timelines, prior to enrolment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.\n* Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating center. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial.\n* In accordance with CCTG policy, protocol treatment is to begin within 10 weeks of hysterectomy\u002Fbilateral salpingo-oophorectomy.\n\nExclusion criteria:\n\n* Prior chemotherapy for EC\n* Isolated tumor cells identified in lymph node(s) for main study cohort (patient can be included in exploratory cohort)","FEMALE",{"count":56,"type":22},1615,"INTERVENTIONAL",[59,60],"PHASE2","PHASE3","The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer:\n\n* p53 abnormal endometrial cancer patients to the p53abn-RED trial\n* mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial\n* no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial\n* POLE mutant endometrial cancer patients to the POLEmut-BLUE trial",[63],"Endometrial Cancer",[63,65,66,67,68,69,70,71,72,73,74,75],"Molecular risk factors","Olaparib","Durvalumab","Progestagens","Chemoradiation","Radiotherapy","Observation","p53","MMRd","NSMP","POLE","2026-05-12",{"date":78,"type":37},"2026-05-15",{"date":80,"type":37},"2021-11-11",{"date":82,"type":22},"2031-01-01",{"name":43,"class":44},14,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100635860","spectator-perfusion-monitoring-before-during-and-after-lower-extremity-revascularization-with-laser-speckle-contrast-imaging-100635860","NCT07558174","SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging","SPECTATOR","Inclusion Criteria:\n\n* Scheduled for lower-extremity revascularization\n* Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements\n\nExclusion Criteria:\n\nAny condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives",{"count":93,"type":22},30,"This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.",[96],"Vascular Disease，Peripheral","2026-05-04",{"date":99,"type":37},"2026-05-08",{"date":101,"type":22},"2026-05",{"date":103,"type":22},"2028-06",{"name":43,"class":44},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":57,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":45},"100634451","phase-2-belimumab-to-mobilise-memory-b-cells-from-secondary-lymhoid-organs-to-improve-memory-b-cell-hla-specificity-profiling-to-support-delisting-for-transplant-access-in-highly-sensitized-100634451","NCT07539857","Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized","BE-MOBILYZED","To be eligible for participation in this study, a subject must meet all of the following criteria:\n\nAdults aged ≥18 and ≤75 years Candidate for kidney transplantation\n\nHighly sensitized, as determined by either:\n\n* 2% probability of being matched with a donor organ within the Eurotransplant Kidney Allocation System (ETKAS), or\n* 0.5% probability of being matched with a donor organ within the Eurotransplant Acceptable Mismatch (AM) program, if eligible for inclusion in this program Provision of written informed consent for participation in this study Willingness and ability to comply with the study protocol\n\nFemale subjects are eligible if they meet one of the following criteria:\n\nNot pregnant or breastfeeding, as confirmed by a negative pregnancy test at screening Of non-childbearing potential (i.e., status post hysterectomy, postmenopausal, bilateral oophorectomy, documented bilateral tubal ligation, or other permanent sterilization procedure) Of childbearing potential and willing to use effective contraception and agree not to become pregnant during the study\n\nA potential subject who meets any of the following criteria will be excluded from participation:\n\nActive pregnancy, as confirmed by a positive urine β-hCG test or a positive serum β-hCG test, adjusted for end-stage renal disease (ESRD) Significant hypogammaglobulinemia (IgG \\\u003C4.0 g\u002FL) or IgA deficiency (IgA \\\u003C0.1 g\u002FL) Receipt of any vaccination within 3 months prior to screening Enrollment in another clinical trial investigating an investigational drug or device at the time of belimumab treatment and delisting; participation in a desensitization trial after assessment of the primary outcome is permitted\n\nPrevious administration of any of the following agents within 365 days prior to screening:\n\nBAFF inhibitors (e.g., belimumab, tabalumab) Monoclonal antibodies targeting CD20 (e.g., rituximab) Monoclonal antibodies targeting CD52 (e.g., alemtuzumab) Lymphocyte-depleting agents (e.g., rATG, ATGAM) IL-6 inhibitors or IL-6\u002FIL-6R modulators (e.g., tocilizumab, clazakizumab) Proteasome inhibitors (e.g., bortezomib) Previous administration of high-dose corticosteroids (\\>50 mg prednisolone or equivalent per day) within 90 days prior to screening\n\nActive infection at screening, defined as any of the following:\n\nHospitalization for treatment within 30 days prior to screening Current use of parenteral (intravenous or intramuscular) antimicrobial therapy (including antibacterial, antiviral, antifungal, or antiparasitic agents) Current serologic evidence of viral hepatitis, defined as positivity for HBsAg or HBcAb, or a positive hepatitis C antibody test without antiviral treatment Uncontrolled HIV infection, defined as CD4 count \\\u003C250 cells\u002Fmm³ and\u002For detectable viremia History of a primary immunodeficiency, including complement deficiencies Neutrophil count \\\u003C1.5 × 10⁹\u002FL Current indication for blood product transfusion at screening, or a high likelihood of requiring transfusion during the treatment phase, in the opinion of the investigator Significant history of infections that, in the opinion of the investigator, would make participation unsuitable History of anaphylactic or severe allergic reaction to parenteral administration of human or murine proteins or monoclonal antibodies Active malignancy or a history of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix with no evidence of metastatic disease for at least 3 years Evidence of psychiatric illness that, in the opinion of the investigator, would make participation unsuitable Any other abnormal laboratory value or intercurrent medical condition that, in the opinion of the investigator, would make participation unsuitable Known mental incapacity or language barriers precluding adequate understanding of the informed consent process and study procedures",true,{"count":7,"type":22},[59],"The goal of this clinical trial is to determine whether belimumab can improve detection of circulating HLA-specific memory B cells to support safer and more effective donor organ allocation in highly sensitized kidney transplant candidates.\n\nThe main questions it aims to answer are:\n\nDoes treatment with belimumab change the antigen specificity profile of circulating HLA-specific memory B cells compared to pre-treatment measurements?\n\nDoes a delisting strategy that incorporates mobilized memory B cells improve the probability of donor organ allocation and reduce time to transplantation?\n\nParticipants will:\n\nReceive a short course of belimumab treatment\n\nProvide blood samples before and during treatment to assess memory B-cell profiles\n\nUndergo evaluation for potential adjustment of unacceptable HLA specificities (delisting) based on test results\n\nBe followed for donor organ allocation and transplantation outcomes",[117],"Kidney Transplant Rejection",[119,120,121,122,123,124],"HLA","Memory B cell","Belimumab","Highly sensitized","Delisting","Kidney transplantation","NOT_YET_RECRUITING","2026-04-13",{"date":128,"type":37},"2026-04-20",{"date":130,"type":22},"2026-04-01",{"date":132,"type":22},"2030-01-01",{"name":43,"class":44},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100616972","occurrence-of-abdominal-aortic-aneurysms-in-patients-with-aneurysmal-subarachnoid-hemorrhage-100616972","NCT07312565","Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage","The Occurrence of Abdominal Aortic Aneurysms in Patients With Ruptured Intracranial Aneurysms","TRACE-aSAH","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n* Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)\n* Inclusion at least one year after aSAH\n* Written informed consent\n\nBy being a study subject of the SPARTA trial, the following criteria are applicable:\n\n* Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)\n* IA related SAH as confirmed with radiological imaging\n* Age 18 years or older at presentation\n* Written informed consent for the SPARTA-trial\n\nExclusion Criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Patient is not a study subject of the SPARTA trial\n* Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome",{"count":143,"type":22},233,"Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described. Screening for aortic aneurysms (AA) in patients with intracranial aneurysms (IA) or aneurysmal subarachnoid haemorrhage (aSAH) could be cost-effective and of significant importance to decrease morbidity and mortality. The available literature on the association between the two types of aneurysms is sparse and in general of poor methodological quality. This protocol presents a study to more adequately evaluate the association between IA and AA.\n\nObjective: To investigate the occurrence of abdominal aortic aneurysms (AAA) in patients who experienced aSAH.\n\nStudy design: This single cohort prospective study will include patients who experienced aSAH. The study participants will receive an abdominal ultrasound of the aorta to detect an AAA.\n\nStudy population: aSAH patients from a prospective cohort trial in the Netherlands.\n\nMain study parameters\u002Fendpoints: The primary outcome, which will be investigated in the here above described study population, is the number of AAA detected on abdominal ultrasound.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will not receive an intervention, but only a diagnostic imaging without radiation. The burden associated with this study are considered minimal and the risks negligible. An abdominal ultrasound is a non-invasive diagnostic method with no risks for the participant. The only possible existing burden to the participant is travel and appointment time with a risk of detecting an abdominal aortic aneurysm or other (occult) intra-abdominal pathologies. When an aneurysm, sub-aneurysm or other intra-abdominal pathology is detected, surveillance or treatment according to standard of care and guidelines will follow.",[146,147],"Aneurysm Abdominal","Cerebral Aneurysm Ruptured",[149,150,151,152,153],"abdominal aortic aneurysm","aneurysmal subarachnoid hemorrhage","ruptured intracranial aneurysm","prospective single cohort study","ultrasound","2026-04-09",{"date":156,"type":37},"2026-04-14",{"date":158,"type":22},"2026-06-01",{"date":160,"type":22},"2026-12-01",{"name":43,"class":44},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":57,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100631289","making-diabetes-care-fit-for-young-adults-living-with-type-1-diabetes-observations-reflections-and-expert-opinions-100631289","NCT07498738","Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions","Inclusion Criteria:\n\n* Young adults (age 18-30)\n* with ≥1 year since the diagnosis of type 1 diabetes\n* receiving ongoing treatment at participating diabetes clinics (Leiden university medical center (LUMC), Diabeter),\n* able to speak and read Dutch\n* able to provide informed consent for study participation\n\nExclusion Criteria:\n\n* People who do not fit the participant requirements\n* People who cannot give consent themselves (who are incapacitated)","30 Years",{"count":170,"type":22},60,[172],"NA","The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians.\n\nThe main question it aims to answer is:\n\nWhat are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool?\n\nResearchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life.\n\nParticipants will:\n\n* Take part in an observed clinical encounter with their clinician\n* Participate in a post-encounter video-stimulated interview reflecting on the consultation\n* Complete questionnaires about their experiences of the consultation",[175],"Type 1 Diabetes",[177,178,179,180],"Make Care Fit","young adults","type 1 diabetes","qualitative research","2026-03-23",{"date":183,"type":37},"2026-03-27",{"date":185,"type":22},"2026-03-13",{"date":187,"type":22},"2026-10-30",{"name":43,"class":44},2,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":45},"100351962","determining-prognostic-immune-markers-in-patients-with-ovarian-cancer-100351962","NCT03862677","Determining Prognostic Immune Markers in Patients With Ovarian Cancer","IMPrOVE","Inclusion Criteria:\n\n* Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and\u002For immunotherapy.\n* Age ≥18 years.\n* WHO performance status 0-2.\n* Accessible for treatment and follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer.\n* Any known severe infection like HIV, hepatitis A, B and C.\n* Receiving immune suppressive treatment.\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.",{"count":198,"type":22},300,"The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).",[201],"Epithelial Ovarian Cancer",[203,204,205,206,207,195,208,209],"Epithelial ovarian cancer","Fallopian tube cancer","Primary peritoneal cancer","EOC","Immunity","Prognostic","Immune markers","2026-02-12",{"date":212,"type":37},"2026-02-13",{"date":214,"type":37},"2020-08-15",{"date":216,"type":22},"2027-01-31",{"name":43,"class":44},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":228,"studyType":23,"phases":4,"briefSummary":229,"conditions":230,"keywords":239,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100587722","adult-congenital-heart-disease-international-evaluation-of-the-effectiveness-of-sglt2i-registry-100587722","NCT06932081","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry","ACHIEVE-SGLT2i","Inclusion Criteria:\n\n* Congenital heart defect.\n* Age ≥ 18 years.\n* Initiated on treatment with an SGLT2i.\n\nExclusion Criteria:\n\n\\- No consent for data collection.",{"count":227,"type":22},400,"1 Year","This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.",[231,232,233,234,235,236,237,238],"Adult Congenital Heart Disease","Congenital Heart Disease","Systemic Right Ventricle","Transposition of the Great Arteries","Congenitally Corrected Transposition of the Great Arteries","Fontan","Single Ventricle","Tetralogy of Fallot (TOF)",[240,241,242,243,244,245,246,247,248,249,250,251,252,236,253,254,255],"adult congenital heart disease","ACHD","congenital heart disease","CHD","sodium-glucose cotransporter 2 inhibitors","SGLT2i","SGLT2","heart failure","HF","transposition of the great arteries","TGA","systemic right ventricle","sRV","single ventricle","tetralogy of fallot","ToF","2026-02-11",{"date":212,"type":37},{"date":259,"type":37},"2023-01-01",{"date":261,"type":22},"2027-12-31",{"name":43,"class":44},11,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":57,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100589623","empowering-patients-to-improve-safety-in-polymedication-100589623","NCT06956820","Empowering Patients to Improve Safety in Polymedication","Empowering Patients to Improve Safety in Polymedication (EmPaSafe)","EmpaSafe","In order to be eligible to participate in this study, a subject must meet all of the following crite-ria:\n\n* Polypharmacy defined as the use of 5 or more drugs\n* Start usage of at least one index drug according to the list in table 3.\n* Subject must be ≥ 18 years old\n* Subject is able and willing to take part and be followed-up for at least 12 weeks\n* Subject is able to donate blood or saliva\n* Subject has signed informed consent\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy or lactating\n* Life expectancy estimated to be less than three months by treating clinical team\n* Unable to consent to the study\n* Unwilling to take part\n* Subject has no fixed address\n* Subject has previously been genotyped for PGx genes\n* Subject has no current general practitioner\n* Subject is, in the opinion of the Investigator, not suitable to participate in the study\n* Estimated glomerular filtration rate (MDRD) of less than 15 ml\u002Fmin per 1,73m2\n* Patients with advanced liver failure (stage Child-Pugh C)",{"count":273,"type":22},120,[172],"Rationale: In current clinical practice, polypharmacy and patient empowerment are critical yet often overlooked. Polypharmacy, the chronic use of five or more drugs, poses risks such as adverse drug reactions and decreased medication adherence, especially in elderly and multimorbid patients. Despite the interconnected nature of drug-drug and drug-gene pro inter-actions, they are considered separately. Ignoring these interactions can be hazardous, yet clinical trials to investigate them are infeasible due to fast-growing complexity, variability among patients, high costs associated with large-scale studies, and ethical and logistical chal-lenges. Consequently, there is a substantial knowledge gap in managing complex medication regimens in real-life scenarios and providing guidelines to enhance patient empowerment and drug safety. The SafePolyMed project aims to develop a patient-centred framework to define, assess and manage drug-drug, drug-gene and drug-drug-gene interactions. This framework, a web-based medication management centre, will support patients in managing their therapy-related health data, enhancing education and empowerment, and improving patient safety.\n\nObjective: To assess the impact of the developed medication management centre on patient empowerment in polypharmacy patients, thereby improving drug safety. Secondary objec-tives are to explore if the tool is able to identify patients at risk for a drug-drug-gene interaction and lower the adverse drug event rate.\n\nStudy design: The study is a proof of concept study conducted at four institutes located in Germany, Greece, Slovenia and The Netherlands. Polypharmacy patients will use the medi-cation management centre (MMC), which provides curated, patient-specific information about drug interactions and PGx. To assess patient empowerment, patients will receive ques-tionnaires during a 12 week follow-up period.\n\nStudy population: 120 subjects with polypharmacy (defined as the chronic use of 5 or more drugs) of at least 18 years of age, with a first prescription for one of 10 index drugs. The study will be performed at 4 different sites (Leiden (NL), Patras (GR), Ljubljana (SL), Aachen (DE)) to represent different clinical settings across Europe. Each site will recruit 30 patients.\n\nIntervention: The MMC that provides patient centred information on drug-drug interactions and pharmacogenetics affecting personal polytherapy. The MMC will show a selection of high quality publicly available information such as details on different types of medications, includ-ing their uses, side effects and instructions for use, in the language of the patient. This infor-mation is targeted at an individual patient's medication profile to inform patients to better un-derstand and deal with their personal health information, with regard to drug therapy. Patients in the Netherlands, Slovenia and Greece also will receive their PGx profile to further personal-ise the MMC experience.\n\nMain study parameters\u002Fendpoints: The primary outcome is the sense of empowerment and health literacy for participants before and after use of the MMC. Secondary outcomes include an evaluation of the drug-drug-gene interactions and adverse drug events in the study popula-tions compared to matched historical controls.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness: Patients are exposed to the regular treatment. In addition, patients will receive questionnaires at baseline, two, and twelve weeks regarding the use and experience of the medication management centre, and a close-out interview at week twelve. In addition, 10ml of blood will be collected during a venipuncture for pharmacogenetic analyses.\n\nBenefits include having access to the medication management centre for the duration of the study. Additionally, patients will receive their PGx profile. This can be used to individualize drug treatment, based on the Dutch Pharmacogenetics Working Group (DPWG) guidelines.\n\nOverall, minimal risks are expected for subjects as they will receive normal clinical care. In-formation from the MMC will be a curation of existing publicly available data. Any information regarding DDIs and DGIs will be supplemented with a disclaimer that the patient should not adjust their treatment without talking to a healthcare provider.",[277],"Polypharmacy","2025-12-22",{"date":280,"type":37},"2025-12-30",{"date":282,"type":37},"2025-07-27",{"date":284,"type":22},"2026-08",{"name":43,"class":44},4,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":295,"targetDuration":296,"studyType":23,"phases":4,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":45},"100601367","surface-electrical-myography-oxygen-consumption-effort-and-weaning-in-the-mechanically-ventilated-patient-in-the-intensive-care-unit-100601367","NCT07109570","Surface Electrical Myography, Oxygen Consumption, Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit","Surface Electrical Myography, Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU): SERA-Effort Study","SERA-Effort","Inclusion Criteria:\n\n* 18 years of age or older\n* Esophageal catheter in situ (standard of care)\n* Eligible for an SBT in the near future according to the LUMC SBT protocol currently valid\n\nExclusion Criteria:\n\n* Severe cardiac failure NYHA class IV without mechanical support (LVAD or Impella)\n* COPD Gold IV\n* Pregnancy\n* Patients with ECMO",{"count":170,"type":22},"2 Days","The goal of this observational study is to measure effort using esophageal pressure measurements, oxygen consumption and diaphragm activity in mechanically ventilated Intensive Care Unit patients during a Spontaneous Breathing Trial. The main question aims to answer whether the sEMG signal derived from the SERA device, effort parameters and oxygen consumption have an association with weaning failure.\n\nParticipants will be measured while performing a spontaneous breathing trial.",[299,300,301,302,303,304,305],"Critical Illness","Intensive Care Units (ICUs)","Weaning Failure","Mechanical Ventilation","Spontaneous Breathing Trial","Diaphragm Electrical Activity","Oxygen Consumption","2025-11-20",{"date":308,"type":37},"2025-11-26",{"date":310,"type":37},"2025-07-08",{"date":312,"type":22},"2029-06",{"name":43,"class":44},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":57,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100589120","phase-2-efficacy-safety-and-tolerability-of-low-sodium-oxybate-for-nocturnal-cluster-headache-attacks-100589120","NCT06950281","Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks","Low Sodium Oxybate Use for Nocturnal Cluster Headache: Safety, Efficacy and Tolerability of JZP-258 (XYWAV) - a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Bi-center Study.","SUNCET","Inclusion criteria\n\nAge ≥18 and ≤75 at the time of consent.\n\nDiagnosed with chronic cluster headache according to the International Classification of Headache Disorders (ICHD-III) criteria.\n\nFree of other cluster headache prophylactic medication OR on stable dose for at least 4 weeks.\n\nNot having received a GON (Greater Occipital Nerve) injection or oral prednisone in the previous 3 months.\n\nAt least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset during the night between 22:00 and 08:00), not exclusively appearing during a single night, but spread across multiple nights.\n\nExclusion criteria\n\nSuspected of having another trigeminal autonomic cephalalgia (TAC).\n\nOther headaches if the patient cannot reliably distinguish them from cluster headache attacks.\n\nWeight at inclusion of \\\u003C50kg or \\>120kg.\n\nSignificant active or unstable psychiatric disease in the opinion of the investigator.\n\nSignificant pulmonary or neuromuscular diseases in the opinion of the investigator.\n\nA history of or current indication of substance abuse or substance use disorder.\n\nUnwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm.\n\nStimulator devices which could influence sleep or cluster headache symptoms, such as an occipital nerve stimulator (ONS), when settings have not been stable for at least three months prior to screening.\n\nParticipation in a clinical trial of an investigation drug or device in the past 30 days.\n\nWomen who are pregnant\u002Fbreastfeeding. Woman of childbearing age need to agree to sufficient contraception during the trial.\n\nContraindications for using LXB:\n\n* Sleep apnoea syndrome or increased apnoea index (AI \\> 15\u002Fh).\n* High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5).\n* Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator.\n* Porphyria.\n* Succinic semialdehyde dehydrogenase (SSADH-)deficiency.\n* Use of opiates, barbiturates, valproic acid, phenytoin, ethosuximide, tricyclic antidepressants, topiramate, LXB (except for the intervention dose) or sedatives including benzodiazepines during the study. If benzodiazepines are used prior to inclusion, they must be discontinued at least one week before the baseline phase.","75 Years",{"count":324,"type":22},52,[59],"The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.\n\nIt is an 16 week, randomized, double-blind, placebo- controlled, bi-center trial.\n\nLXB will be administered as a twice nightly regimen. All subjects will undergo an 6 week Treatment Titration and Optimization Phase.\n\nThe main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.",[328],"Chronic Cluster Headache","2025-11-19",{"date":331,"type":37},"2025-11-24",{"date":333,"type":22},"2026-01",{"date":335,"type":22},"2028-05",{"name":43,"class":44},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":57,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":189},"100464211","phase-3-repeated-gon-injections-in-cch-100464211","NCT05324748","Repeated GON Injections in CCH","Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache","REGON","Inclusion Criteria:\n\n* Age ≥18 and ≤ 70 years\n* Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)\n* Ictal pain must be always at the same side\n* ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period\n* On a stable regimen of cluster headache prophylactics for \\>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period\n\nExclusion Criteria:\n\n* Contra-indication against, or current use of, corticosteroids\n* Occipital nerve stimulation (ONS)\n* Use of anticoagulation medication or a known bleeding disorder\n* Inability to use an electronic diary to monitor individual attacks and other items\n* Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache\n* Current use of prophylactic medication for other headaches\n* Pregnancy","70 Years",{"count":347,"type":22},50,[60],"Background:\n\n\\- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.\n\nObjectives:\n\n\\- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.\n\nEligibility:\n\n\\- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.\n\nDesign:\n\n\\- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.",[351],"Cluster Headache",[353],"GON-injection",{"date":331,"type":37},{"date":356,"type":37},"2022-11-07",{"date":358,"type":22},"2026-06",{"name":43,"class":44},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":57,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":45},"100557990","microsampling-for-therapeutic-drug-monitoring-of-oral-oncolytics-in-oncology-patients-100557990","NCT06545292","Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients","Microsampling to Facilitate Drug Monitoring of Oncolytics","MSTDM","Inclusion Criteria:\n\n* Willing and able to provide informed consent;\n* 18 years of age or older;\n* Using one or more of the following drugs: Cabozantinib, Pazopanib, Sunitinib, Lenvatinib, Imatinib, Abiraterone, Enzalutamide, Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab or Enfortumab vedotin\n\nExclusion Criteria:\n\n* Not able to sample themselves using a finger prick","90 Years",{"count":370,"type":22},360,[172],"The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin. The secondary objective is to test the feasibility of home monitoring (microsampling TDM) of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin in oncology patients.",[374],"Drug Monitoring","2025-11-18",{"date":377,"type":37},"2025-11-21",{"date":379,"type":37},"2025-10-06",{"date":381,"type":22},"2028-07-01",{"name":43,"class":44},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":57,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":407,"locationsCount":45},"100605471","icu-recover-box-20-smart-technology-for-home-monitoring-of-icu-patients-100605471","NCT07162948","ICU-Recover Box 2.0, Smart Technology for Home Monitoring of ICU Patients","The ICU-Recover Box: Using Smart Technology for Monitoring Health Status After ICU Admission Pilot Study 2.0","Inclusion Criteria:\n\n* Patient has been admitted to the ICU of the LUMC for \\> 24 hours.\n* Patient has received mechanical ventilation.\n* Patient masters the English or Dutch language.\n* Patient is able to use smart technology at home. (i.e. Wi-Fi available, sufficient comprehension of smart technology).\n* Patient can be contacted and informed about the ICU-Recover box on one of the clinical wards of the LUMC.\n* Patient is discharged from a ward within the LUMC to home or an extra-hospital facility.\n\nExclusion Criteria:\n\n* Patient is \\\u003C 18 years old.\n* Patient is pregnant.\n* Patient breastfeeds during the course of the study.\n* Patient is discharged for palliative care.\n* Patient is considered an incapacitated adult.\n* Patient is unwilling to sign the informed consent form.\n* Patient is discharged to another hospital.",{"count":347,"type":22},[172],"Smart technology could improve quality of care in patients who have been admitted to the ICU and have been discharged from ICU and hospital, by early diagnosis of complications and early (ambulatory) treatment.\n\nWith the ICU-Recover Box and its smart technology the investigators see new opportunities to improve patient health and to recognize early if escalation of medical care is needed.\n\nThe primary objective of the pilot study is to assess the feasibility of the use of smart technology by persons that have been discharged from the ICU in the twelve months following ICU discharge.",[394],"ICU Acquired Weakness",[396,397,398,399,400],"smart technology","post-ICU recovery","post intensive care syndrome","health care utilization","health related quality of life","2025-09-23",{"date":403,"type":37},"2025-09-29",{"date":405,"type":37},"2025-07-01",{"date":160,"type":22},{"name":43,"class":44},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":416,"targetDuration":4,"studyType":57,"phases":418,"briefSummary":419,"conditions":420,"keywords":425,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100571360","prevention-of-postamputation-pain-with-targeted-muscle-reinnervation-100571360","NCT06719245","Prevention of PostAmputation Pain With Targeted Muscle Reinnervation","Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial, Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Amputations of the Lower Extremities","PreventPAP","Inclusion criteria\n\n* Patients aged between 18 and 75 years old.\n* Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease.\n\nExclusion criteria\n\n* Insensate limbs at the level of amputation.\n* Complex Regional Pain Syndrome.\n* Existing neuroma or prior neuroma surgery in the affected limb.\n* Undergoing radiotherapy on the affected limb.\n* Cognitive impairment, or delirium at the time of consent.\n* Patients who are unfit for general anesthesia.\n* No nerve surgeon trained in the TMR procedure is available",{"count":417,"type":22},203,[172],"The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received Targeted Muscle Reinnervation (TMR).\n\nPatients between 18 and 75 years old, scheduled for an LEA (transfemoral to transtibial) as a primary or secondary sequela of vascular disease, are randomized into standard neurectomy or TMR. TMR is a frequently studied surgical technique and prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve.\n\nThe investigators hypothesize that TMR during amputation surgery will significant improve PostAmputation Pain (PAP), quality of life, participation in family life and society, and reduction of health-related costs. Participants will be asked to complete multiple online questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).",[421,422,423,424],"Amputation, Surgical","Phantom Limb Pain","Neuroma Amputation","Surgery",[426,29,427,28],"TMR","Phantom pain","2025-09-15",{"date":430,"type":37},"2025-09-19",{"date":432,"type":37},"2024-12-31",{"date":434,"type":22},"2028-01-01",{"name":43,"class":44},7,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":45},"100576739","outcomes-in-moderate-mixed-aortic-valve-disease-100576739","NCT06789211","Outcomes in Moderate Mixed Aortic Valve Disease","Impact of Symptoms and Left Ventricular Systolic Function in Patients With Moderate Mixed Aortic Valve Disease","Inclusion Criteria:\n\n1. Patients with concomitant moderate AS and moderate AR\n2. Patients with isolated severe AS\n3. Patients with isolated severe AR\n\nExclusion Criteria:\n\n1. Previous aortic valve surgery\n2. Concomitant left valvular heart disease more than mild grade\n3. Acute AR\n4. Bad echocardiographic image quality",{"count":445,"type":22},1900,"Mixed aortic valve disease (MAVD) is defined as the combination of aortic valve stenosis (AS) and regurgitation (AR) and is relatively frequent, with a reported prevalence up to 20-30% of patients with aortic valve disease. Mortality of patients with moderate MAVD (coexistence of both moderate AS and moderate AR) is largely unknown, and therefore there are currently no guidelines-based indications for surgical or transcatheter intervention for these patients, which is considered only when one of the two lesions (AS or AR) becomes severe. Of note, indication for valve intervention in patients with isolated moderate AS is currently under investigation in several randomized clinical trials but only in the presence of relevant symptoms and signs of left ventricular (LV) dysfunction. One initial single-center study including 250 patients with moderate MAVD has evaluated outcomes in this specific subgroup and showed that patients with asymptomatic moderate MAVD and preserved left ventricular ejection fraction (LVEF) had similar adverse event rates (progression to New York Heart Association (NYHA) class III-IV, aortic valve intervention or cardiac death) to patients with isolated asymptomatic severe AS with preserved LVEF. However, the results were primarily driven by the progression of the NYHA Class and aortic valve replacement, and larger multi-center studies are advocated to confirm these findings, which may therefore identify a (new) group of high risk patients who should in principle benefit from an aortic valve intervention as much as patients with isolated severe AS. In addition, prognostic factors (including clinical and echocardiographic characteristics) for risk-stratification of patients with moderate MAVD have not been identified, which may help to refine the indication for valve intervention and optimize patient management.",[448],"Mixed Aortic Valve Disease",[450,451],"valvular heart disease","mixed aortic valve disease","2025-09-09",{"date":428,"type":37},{"date":455,"type":37},"2024-06-06",{"date":160,"type":22},{"name":43,"class":44},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":481,"locationsCount":45},"100529886","prospective-cohort-study-on-thermal-ablation-of-malignant-liver-tumors-100529886","NCT06179602","Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors","Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)","A-IMAGIO","Inclusion Criteria:\n\n* 18 years or above\n* Candidate for percutaneous thermal liver ablation as discussed in a multidisciplinary tumorboard (MDT)\n* Informed consent\n\nExclusion Criteria:\n\n* Patients lacking capacity to give informed consent.","110 Years",{"count":468,"type":22},1500,"The endpoint of this study is to develop and validate algorithms, using artificial intelligence and machine learning, to optimize patient selection, treatment planning, treatment evaluation and outcome prediction in patients undergoing thermal ablation of a malignant liver tumor. The long-term objective is to establish thermal ablation as the treatment of choice for the vast majority of patients with a primary or secondary liver tumor by development of an accessible workflow that can be widely implemented in different centers performing thermal ablation. Over a time span of at least four years, data will be collected prospectively, encompassing patient information, tumor characteristics, and treatment details. Additionally, pre-, intra-, and post-procedural imaging will be systematically gathered.",[471,472,473,474],"Liver Cancer","Liver Metastases","Liver Metastasis Colon Cancer","Hepatocellular Carcinoma","2025-09-03",{"date":477,"type":37},"2025-09-10",{"date":479,"type":37},"2024-01-01",{"date":434,"type":22},{"name":43,"class":44},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":492,"conditions":493,"keywords":496,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":189},"100573223","capturing-key-mg-symptoms-using-smartphone-recordings-100573223","NCT06743490","Capturing Key MG-symptoms Using Smartphone Recordings.","Capturing Key Symptoms Using Smartphone Recordings in Patients With Myasthenia Gravis (CAPTURE-MG)","CAPTURE - MG","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to understand the requirements of the study and provide written informed consent.\n\nInclusion Criteria for MG participants only:\n\n1. A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category \"definite\" or \"probable\" MG).\n2. MGFA Clinical Classification of disease severity I-IV.\n3. Subjects have at least one of the symptoms of interest (namely dysarthria, dysphonia, proximal arm fatigue and\u002For ptosis).\n\nInclusion Criteria for non-MG participants only\n\n1. Subjects are not diagnosed with and have no clinical suspicion of MG.\n2. Subjects do not have a medical history of any of the symptoms of interest (namely dysarthria, dysphonia, proximal arm fatigue and\u002For ptosis).\n\nExclusion Criteria:\n\n1. Not willing to be audio-recorded for the study assessments.\n2. Not willing to be video-recorded for the study assessments.\n3. Subjects currently taking part in a clinical trial of an Investigational Medicinal Product.\n4. Subjects who have used an immediate release pyridostigmine-based medication in the 12 hours prior to their participation and participants on prolonged release pyridostigmine.\n5. Subjects have cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to complete study procedures\u002F\n\nExclusion Criteria for MG participants only:\n\n1. Subjects with an upper-limb amputation or who are non-verbal.\n2. Subjects with a diagnosed neurological disease resulting in muscle weakness, other than MG.\n\nExclusion Criteria for non-MG participants only:\n\n1\\. Limitation of upper limb mobility or speech impairment of any cause.",{"count":491,"type":22},225,"This study will make use of a cross-sectional design of MG patients and non-MG participants to quantitatively assess key MG symptoms, and to explore the applicability of machine learning algorithms to their measurement.",[494,495],"Myasthenia Gravis","Fatigue",[494,495,497,498,499,500,501,502],"Digital features","Machine Learning Algorithms","Dysarthria","Dysphonia","Proximal arm fatigue","Ptosis","2025-09-02",{"date":452,"type":37},{"date":506,"type":37},"2025-03-18",{"date":130,"type":22},{"name":43,"class":44},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":57,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":45},"100566780","interventions-against-fatigue-in-patients-with-myasthenia-gravis-100566780","NCT06659627","Interventions Against Fatigue in Patients With Myasthenia Gravis","Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis","FIT to ACT-MG","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category \"definite\" or \"probable\" MG).\n3. The diagnosis of MG was made at least a year ago and the MG is stable, as determined by the treating neurologist.\n4. Patients who use the following medication: prednisone, intravenous immunoglobulin (IVIg), complement inhibitor (e.g. Eculizumab), neonatal Fc receptor (FcRn) inhibitor (e.g. Efgartigimod) have been on a stable dosing regimen for at least one month.\n5. MGFA Clinical Classification of disease severity I-IV.\n6. Clinically relevant fatigue (a score ≥ 27 on the CIS-fatigue).\n7. Ability to walk and exercise.\n8. Ability to understand the requirements of the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.\n2. The patient is unable to use the activity tracker and digital infrastructure provided.\n3. Co-morbidity interfering with AET or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator.\n4. Co-morbidity interfering with CBT, a clinical diagnosis of depression or a score ≥12 on the Hospital Anxiety and Depression Scale (HADS) depression subscale, as assessed by the investigator.\n5. Use of beta blockers.\n6. The patient is already engaged in strenuous exercise more than twice a week.\n7. The patient is already undergoing cognitive behavioural therapy.\n8. Pregnancy or intention to become pregnant during the study.\n\nExclusion Criterion for muscle MRI 1. Inability to undergo MRI.\n\n\\- In case of uncertainty about the MRI-contraindications, the MR-safety commission of the Radiology department will decide whether this subject can be included in the study or not.",{"count":170,"type":22},[172],"A prospective assessor-blinded randomized clinical trial investigating the effect of aerobic exercise therapy or cognitive behavioural therapy on fatigue in patients with myasthenia gravis.",[494,495],[494,495,522,523],"Aerobic Exercise Therapy","Cognitive Behavioural Therapy",{"date":452,"type":37},{"date":526,"type":37},"2024-12-04",{"date":528,"type":22},"2026-12",{"name":43,"class":44},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":45},"100519129","tino-t-cells-in-the-nose-of-older-adults-100519129","NCT06039527","TINO: T Cells in the Nose of Older Adults","TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals","TINO","Inclusion Criteria:\n\n•Adults able and willing to provide informed consent.\n\nSpecific inclusion criteria per group:\n\n* Young adults aged 18-30 years old\n* Healthy elderly aged \\>65 years old\n* Frail elderly \\>65 years old\n* Clinical Frailty score healthy elderly 1-3\n* Clinical Frailty score frail elderly \\>3\n* Self-reported respiratory tract infection in previous year healthy elderly 0-1\n* Self-reported respiratory tract infection in previous year frail elderly 0-1 or \\>1\n\nExclusion Criteria:\n\n* Incompetence to provide informed consent prior or during study\n* Current smoker or \\>40 pack year history\n* History of severe nose bleedings\n* Diagnosed with asthma, COPD or chronic rhinosinusitis\n* Use of inhalation corticosteroids or antibiotics in the past 6 weeks\n* Current use of anti-coagulants (to prevent nosebleeds). Platelet inhibitors like acetylsalicylzuur (Ascal) are allowed.\n* Respiratory tract infection or common cold in the past 2 weeks\n* Immunocompromised individuals (with primary immune deficiency or secondary immune deficiency)\n* Life expectancy \\\u003C28 days in the opinion of study physician\n* Vaccination in the 2 months prior to study start. A potential subject that is only excluded from participation based on a recent vaccination will be asked to re-participate 2 months post vaccination.",{"count":539,"type":22},170,"Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. How alterations in the mucosal immune system with advanced age predispose to infections remains unclear as access to relevant tissue samples is limited. With minimally-invasive nasal sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype, underlying mechanisms, key molecules and consequences of this have not yet been investigated.\n\nObjective:\n\nElucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the differences of T cells in young and older adults and associate this loss with susceptibility to infections.\n\nStudy design: Prospective cohort study\n\nStudy population: Participants will be recruited from 3 groups:\n\n* healthy young adults (18-30 years, n=50)\n* vital older adults (\\>65 years, n=60)\n* frail elderly (\\>65 years, n=60). This group includes individuals without a history of recurrent respiratory infections or with \\>2 self-reported episodes of respiratory infection in the past year.\n\nMain study parameters\u002Fendpoints: Frequency of nasal CD8+ T cells in young adults and frail older adults.\n\nSecondary study parameters\u002Fendpoints:\n\n* Phenotype (subsets, activation status), functionality, transcriptomic state, clonality and frequency of nasal and blood T cell populations\n* Stability of T cells and other immune parameters, as described for main study parameter, during a second sample after 3 months.\n* Analysis of other immune populations as for main study parameter\n* Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations\n* Respiratory tract microbiota profiles and presence of asymptomatic viral infections and their association with T cells and other immune parameters\n* Chronological and biological age, sex, and other immunologically relevant parameters with T cell populations and other immune parameters\n* Alteration of T cell phenotype, during and following respiratory tract infections. Levels of antigen-specific T cells and other immune parameters in nose and blood post infection.",[542,543],"Respiratory Tract Infections","Aging",{"date":452,"type":37},{"date":546,"type":37},"2021-01-24",{"date":101,"type":22},{"name":43,"class":44},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":57,"phases":559,"briefSummary":561,"conditions":562,"keywords":567,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":581},"100560808","phase-4-individual-targeted-thrombosis-prophylaxis-versus-the-standard-one-size-fits-all-approach-in-patients-undergoing-total-hip-or-total-knee-replacement-100560808","NCT06581965","inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT","The DISTINCT Trial: inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT: a National, Multicenter, Randomized, Multi-arm, Open-label Trial.","DISTINCT","Inclusion Criteria:\n\n* Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Primary arthroplasty for fractures\n* Revision surgery\n* Hemiarthroplasty\n* Pregnancy\n* Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)\n* A contraindication for either study drug\n* Insufficient knowledge of the Dutch language\n* Insufficient mental or physical ability to fulfil trial requirements\n* Active malignancy (i.e. cancer diagnosis within six months before surgery (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before surgery)\n* Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician",{"count":558,"type":22},10078,[560],"PHASE4","After hip or knee replacement all patients receive a standardized treatment with blood thinners, this medication is called thrombosis prophylaxis. However, despite this standard treatment some individuals still develop venous thrombosis (VTE), while others experience bleeding. This indicates that not all patients have the same VTE risk following surgery. Individualizing the amount of thrombosis prophylaxis following surgery might lead to less thrombotic and bleeding events. In this study the investigators individualize the treatment with thrombosis prophylaxis based on the medical history of a patient.\n\nThe main questions this study aims to answer are:\n\nCan thrombosis prophylaxis be shortened in patients with a low VTE risk to decrease the risk of bleeding without increasing the risk of VTE? Does an increase in the dose and duration of thrombosis prophylaxis in patients with a high VTE risk reduce the risk of VTE without inducing an unacceptable risk of bleeds?\n\nResearchers will compare both the shortened treatment in low VTE risk patients and the intensified and extended treatment in high VTE risk patients with the standard treatment to assess the risk of VTE and bleeding in comparison to the standard treatment.\n\nParticipants will receive 4 questionnaires to evaluate whether they have experienced a VTE or bleed. For this study no additional hospital visits are necessary.",[563,564,565,566],"Venous Thromboembolism","Venous Thromboses","Pulmonary Embolism","Deep Vein Thrombosis",[568,569,570,571,572,573],"Venous thromboembolism","Prophylaxis","Individualized Medicine","Total hip arthroplasty","Total knee arthroplasty","Randomized controlled trial","2025-08-26",{"date":475,"type":37},{"date":577,"type":37},"2024-11-11",{"date":579,"type":22},"2031-02-01",{"name":43,"class":44},10,{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":57,"phases":592,"briefSummary":593,"conditions":594,"keywords":599,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":581},"100594378","phase-2-18ff-fapi-petct-and-laparoscopy-in-staging-advanced-gastric-cancer-100594378","NCT07018661","[18F]F-FAPI PET\u002FCT and Laparoscopy in Staging Advanced Gastric Cancer","[18F]F-FAPI PET\u002FCT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study","PLASTIC-3","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy;\n* Age greater than or equal to 18 years;\n* Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making;\n* Patients must have given written informed consent;\n* Patients who have recently participated in an interventional study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period).\n\nExclusion Criteria:\n\n* Siewert type I-II esophagogastric junction tumor;\n* Unfit or unwilling to undergo study procedures;\n* Unfit or unwilling to undergo surgery;\n* Pregnancy at time of the \\[18F\\]AlF-FAPI-74 PET\u002FCT scan, due to the investigational PET radiation burden;\n* Incapacitated subjects without decision-making capacity;\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;\n* Illiterate patients unable to complete the resource use and quality of life questionnaires;\n* Inability to undergo PET\u002FCT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).",{"count":591,"type":22},250,[59,60],"The goal of this clinical trial is to learn if a new type of scan, FAPI-PET\u002FCT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases.\n\nThe main questions it aims to answer are:\n\n* In how many patients can FAPI-PET\u002FCT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)?\n* In how many patients does FAPI-PET\u002FCT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed?\n\nApart from the usual care gastric cancer patients receive, participants will:\n\n* Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time)\n* Complete a number of questionnaires, which will take approximately 4 hours in total",[595,596,597,598],"Locally Advanced Gastric Adenocarcinoma","STOMACH NEOPLASM","Gastric Cancer","PET-CT",[600,601,602,603,604,597,605],"FAPI","18F-FAPI-74","PET\u002FCT","Imaging biomarker","Gastrectomy","Diagnostics","2025-08-20",{"date":608,"type":37},"2025-08-27",{"date":610,"type":37},"2025-07-03",{"date":612,"type":22},"2029-01",{"name":43,"class":44},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":624,"conditions":625,"keywords":631,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":680},"100594595","skin-disease-profiling-by-an-exploratory-prospective-biomarker-study-in-dermatology-practice-skinergy-100594595","NCT07021495","SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","A Prospective, Multi-Center, Observational Biomarker Real-World Evidence Study for In-Depth Profiling of Patients With Chronic Immune-Mediated Inflammatory Skin Diseases in Daily Practice","SKINERGY","Inclusion Criteria:\n\nPatients:\n\n1. Able to understand and provide a written informed consent prior to any study procedures\n2. Male or non-pregnant female, ≥18 years of age\n3. Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day.\n4. Patient is willing and able to comply with the study protocol\n5. Female participants are willing to not get pregnant between M0 until M12, from study entry to the last study visit\n6. The patient is willing to start the prescribed treatment.\n\nDisease-specific inclusion criteria\n\nFor patients with AD:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria:\n\n6\\. Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka for at least 3 years before baseline visit.\n\n7\\. Documented recent history (last 6 months) of eligibility for (local or systemic) treatment with immunosuppressants, biologics or JAK-inhibitors.\n\n8\\. When applicable, documented recent history (last 6 months) of inadequate response to treatment with topical therapy, immunosuppressants, biologics or JAK-inhibitors.\n\n9\\. Current treatment can include moisturizers, topical treatment and\u002For systemic treatments with preferable wash-out (see exclusion criterion #9). On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment.\n\n10\\. EASI≥7 (moderate-to-severe disease) 11. At least one suitable target lesion at the discretion of the investigator 12. Intention to start treatment with cyclosporine A, dupilumab, tralokinumab, lebrikizumab or a JAK1-inhibitor (abrocitinib or upadacitinib)\n\nFor patients with CLE:\n\nParticipants must have a diagnosis of CLE, including SCLE, CDLE or LET that fulfil the following:\n\n6\\. Confirmed CLE diagnosis by clinicopathological correlation. 7. An overall CLE Disease Area and Severity Index Activity (CLASI-A) Score ≥3 without counting any diffuse alopecia or oral ulcers.\n\n8\\. Intention to start treatment with TCS, hydroxychloroquine or methotrexate (combination or mono-treatment).\n\nIf participating in the exploratory study with the skin biopsy: location of the lesion(s) selected for biopsy preferably outside the facial area (possible are e.g., neck, chest, back, limbs, scalp, ear etc.).\n\nFor patients with CSU:\n\n6\\. Diagnosis of CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for ≥3 months and symptomatic disease despite treatment with second generation H1 antihistamines (up to fourfold the approved dose).\n\n7.Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period.\n\n8\\. Intention to start (add-on to antihistamine) treatment of omalizumab, cyclosporine A or BTK inhibitor\\*. (\\*when approved and reimbursed in NL)\n\nFor patients with HS:\n\n6\\. Patient with a history of signs and symptoms consistent with moderate-to-severe HS, based on IHS4 score (Zouboulis et al., 2017), for at least 1 year prior to baseline 7. Current treatment can include topical treatment. On-study treatment is at physician and patient discretion but must include eligibility to starting systemic treatment 8. Intention to start treatment with anti-TNF or anti-IL17 (secukinumab, bimekizumab\\*) \\*when approved and reimbursed in NL.\n\nFor patients with MF:\n\n6\\. A confirmed diagnosis of CTCL MF type and stage classification via histology or clinicopathological correlation 7. For the stage IA-IIA CTCL patients: at least one patch and\u002For one plaque lesion is present 8. Intention to start treatment with topical chlormethine, topical corticosteroids or phototherapy (PUVA \u002F UV-B).\n\nFor patients with PSO:\n\n6\\. Diagnosed with chronic plaque psoriasis at least 6 months prior to study participation 7. PASI≥5 with at least one suitable target lesion at the discretion of the investigator 8. Current treatment can include moisturizers, topical treatment and\u002For systemic treatments with preferable wash-out. On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment 9. Intention to start treatment with biologics: anti-TNF, anti-IL23, anti-IL17 or anti-TYK2\n\nHealthy volunteers:\n\nAll healthy volunteers must meet all of the following inclusion criteria:\n\n1. Signed informed consent before any study-mandated procedure.\n2. Male or non-pregnant female volunteers, ≥18 years of age\n3. Subject is in stable good health as per judgement of the investigator based upon the results of medical history and assessments performed at baseline.\n4. No clinically significant skin disease as judged by the investigator.\n5. No history of hypertrophic scarring or keloid.\n6. Subject is willing to refrain from extensively washing (including bathing, swimming) the skin 12 hours before every study visit.\n7. Subject is willing and able to wash out and withhold any topical treatment (prescription and over-the-counter products) in the investigational area for 2 weeks prior to Day 1.\n8. Subject is willing to refrain from application of any topical product (e.g. ointments, cream, or washing lotions) on the skin 24 hours prior to every study visit day.\n9. Subject is willing and able to wash out any antibiotic therapy for 14 days prior to Day 1.\n10. Subject is willing and able to comply with the study protocol.\n11. Female participants are willing to not get pregnant from study entry to the last study visit\n\nExclusion Criteria:\n\nPatients:\n\n1. Have any other relevant skin infection\u002Fdisease in the treatment area other than the investigated skin disease.\n2. Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit.\n3. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator. 4. Having received treatments for the investigated skin disease within the following intervals prior to the start of the study is not a strict exclusion criterion since this is a real-world study. However, preferred intervals for washout are as follows:\n\n   * 1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors\n   * 4 weeks for phototherapy, e.g. UVB, PUVA, PDT\n   * 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors\n   * 8 weeks for radiotherapy or surgery in the treatment area\n   * 8 weeks for biologics\n   * 3 months for any systemic chemotherapeutical treatment\n\nDisease specific exclusion criteria for patients with CLE:\n\n5\\. Diagnosed with SLE\n\nDisease specific exclusion criteria for patients with CSU:\n\n5\\. Treatment with omalizumab within 8 weeks prior to Day 1 6. Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary, acquired angioedema or drug-induced (e.g., due to C1 esterase inhibitor deficiency, ACE-inhibitor induced).\n\nDisease specific exclusion criteria for patients with MF:\n\n5\\. Ongoing uncontrolled active skin infection, other than secondary impetiginized CTCL lesions as judged by the investigator\n\nDisease specific exclusion criteria for patients with PSO:\n\n5\\. Having primarily erythrodermic, pustular or guttate psoriasis; 6. Having drug-induced psoriasis;\n\nHealthy volunteers:\n\nAll healthy volunteers must meet none of the following exclusion criteria:\n\n1. History of immunological abnormality (e.g. immune suppression, severe allergy, or anaphylaxis) that may interfere with study objectives as per judgement of the investigator.\n2. History or symptoms of any uncontrolled, significant disease including (but not limited to), a neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives as per judgement of the investigator.\n3. The use of systemic antibiotic therapy for \\>2 months in the past 12 months.\n4. The use of any immunosuppressive or immunomodulatory therapy within the past 30 days prior to Day 1.\n\n6\\. Loss or donation of blood over 500mL within three months prior to baseline. Participation in an investigational drug study within 3 months prior to baseline visit or more than 4 times a year.\n\n7\\. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months prior to baseline. Alcohol consumption will be prohibited for at least 24 hours preceding each study visit.\n\n8\\. Positive urine test for drugs or history of abuse at baseline. 9. Exposure to high doses of UV radiation is not permitted within 3 weeks of the first study visit until the end of the study 10. Extreme physical activities are not permitted within 48 hours before each study visit 11. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator.",{"count":623,"type":22},840,"The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:\n\n* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO?\n* How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers?\n* Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice?\n* How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO)\n* How do biomarker levels change over time in response to treatment in these patient populations?\n* Which skin tissue biomarkers are associated with disease progression or treatment response?\n* How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes?\n* Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?\n\nResearchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.\n\nParticipants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4\u002F13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\\*; CLE: TSC, HCQ, MTX)\n\n\\*once approved and reimbursed in the Netherlands\n\nParticipants will:\n\n* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands).\n* Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional).\n* Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional).\n* Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.",[626,627,628,629,630],"Chronic Spontaneous Urticaria (CSU)","Hidradenitis Suppurativa (HS)","Psoriasis (PsO)","Atopic Dermatitis (AD)","CTCL\u002F Mycosis Fungoides",[632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671],"Urticaria","Hives","Mast cells","Autoimmune","Autoallergic","Wheals","Angioedema","Abscess","Nodules","Sweat glands","Acne inversa","Eczema","Itchy, dry skin","Mycosis Fungoides","Skin patches","Tumors","T-cells","Lupus","Skin rash","Photosensitivity","Plaques","Scaling","Erythema","Induration","Inflammatory skin diseases","Immune-mediated","Deep phenotyping","Multi-omics","Transcriptomics","Lipidomics","Metabolomics","Proteomics","Genomics","Microbiomics","Imaging mass cytometry (CyTOF)","Real-world practice","Standard care","NextGenerationImmunoDermatology","NGID","Biomarkers","2025-08-18",{"date":674,"type":37},"2025-08-19",{"date":676,"type":37},"2025-07-29",{"date":678,"type":22},"2029-12-31",{"name":43,"class":44},8,{"id":682,"slug":683,"hasResults":12,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":112,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":689,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":691,"conditions":692,"keywords":695,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":45},"100599985","an-observational-study-to-assess-objective-skin-pigmentation-variation-100599985","NCT07091604","An Observational Study to Assess Objective Skin Pigmentation Variation.","Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging","SKIN-IMAGING","Inclusion Criteria:-\n\n* Age ≥ 18 years\n* Ability to understand oral and written Dutch or English\n\nExclusion Criteria:\n\nFor study cohort #1 (Healthy volunteers):\n\n* Extensive tattoos covering \\>50% of the total body area\n* Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks\n* Use of self-tanner products in the last 3 weeks\n\nFor study cohort #2 (Patients):\n\n* Extensive tattoos covering \\>50% of the total body area\n* Extensive skin lesions covering \\>50% of the total body area\n* Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks\n* Use of self-tanner products in the last 3 weeks",{"count":690,"type":22},600,"Accurate assessment of skin pigmentation is essential in dermatology for properly diagnosing and managing a wide range of skin conditions. Traditionally, skin colour has been evaluated through visual inspection or by using classifications like the Fitzpatrick skin type. However, these methods can be subjective, culturally biased, and often are centered around lighter skin tones, which may lead to misdiagnosis or inappropriate treatment for individuals with darker skin.\n\nWith advances in technology, non-invasive imaging tools such as colorimetry and multispectral imaging now offer more precise and objective ways to measure skin pigmentation. These methods can help provide consistent and unbiased information about skin tone, benefiting both clinical care and research. Despite these technological advances, there is currently no agreed-upon standard for how to measure skin pigmentation objectively in everyday clinical practice or research settings.\n\nThis study aims to explore better, more accurate ways to measure skin pigmentation using modern, non-invasive imaging technologies. Traditional methods for assessing skin colour, like visual inspection or classifying by ethnicity, are often unreliable and biased. In this study, researchers will use tools such as colorimetry and multispectral imaging to measure skin pigmentation more objectively.\n\nThe study includes two groups of participants: healthy adults and adults with skin conditions. Researchers will measure a value called the melanin index, which reflects the amount of pigment in the skin, and compare it across different areas of the body and among people with different skin tones and conditions.\n\nThe goal is to understand how skin pigmentation varies and to see if these new technologies can help doctors more accurately diagnose and manage skin diseases for people of all skin types.",[693,694],"Skin Diseases","Healthy Skin",[696,697,698,699,700,701,702,703,704,705,706,707,708,709,710],"Skin pigmentation","Melanin index","Colorimetry","Multispectral imaging","Line-Field Confocal Optical Coherence Tomography","Skin parameters","Skin colour","Skin color","Etnicity","TEWL","Erythema index","Non-invasieve measurement","Skin Disease","Skin of Colour","Laser speckle contrast imaging",{"date":712,"type":37},"2025-08-01",{"date":714,"type":22},"2025-07-22",{"date":716,"type":22},"2027-01-22",{"name":43,"class":44},{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":723,"acronym":724,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":57,"phases":728,"briefSummary":729,"conditions":730,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":733,"lastUpdatePostDateStruct":734,"startDateStruct":735,"completionDateStruct":736,"leadSponsor":738,"locationsCount":4},"100599888","phase-3-semaglutide-in-patients-undergoing-transcatether-aortic-valve-replacement-100599888","NCT07090343","Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement","Semaglutide for Reducing Cardiovascular Events in Patients Undergoing Transcatether Aortic Valve Replacement","REVERSE-TAVR","Inclusion Criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n* Adults (≥18 years) undergoing TAVR for severe AS, and\n* BMI ≥30 kg\u002Fm2, or\n* BMI 27-30 kg\u002Fm2, AND at least one of the following:\n* Dysglycemia (prediabetes or type 2 diabetes) ≥90 days prior to the day of screening with HbA1c of ≤ 10.0% as measured at the screening visit.\n* Arterial Hypertension\n* Hypercholesterolemia\n* Obstructive sleep apnea\n* History of stroke (ischemic or hemorrhagic)\n* History of myocardial infarction\n* Symptomatic peripheral artery disease (intermittent claudication with ankle-brachial index \\\u003C0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease)\n\nExclusion Criteria:\n\n* Treatment with an GLP-1 receptor agonist within the previous 90 days.\n* Myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the previous 60 days.\n* Planned coronary, carotid or peripheral artery revascularization known on the day of screening.\n* eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m² or intermittent hemodialysis or peritoneal dialysis.\n* Presence of acute pancreatitis within the last 180 days prior to screening.\n* History or presence of chronic pancreatitis.\n* Self-reported change in body weight of \\>5 kg within 90 days before screening.\n* Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.\n* Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.\n* Known or suspected hypersensitivity to trial product(s) or related products.\n* Participation in any clinical trial of an approved or non-approved device for the treatment of aortic stenosis or obesity within 30 days before screening.\n* Receipt of any investigational medicinal product within 30 days before screening.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n* Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.\n* Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.",{"count":727,"type":22},826,[60],"This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) who meet current clinical criteria for semaglutide treatment. A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure. The primary endpoint is time to first occurrence of a composite of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic accident (TIA), and hospitalization for heart failure (HF). The study is event-driven and powered to detect a 20% relative risk reduction in primary outcome events. This trial aims to address the unmet need for medical therapies that improve outcomes in patients with severe AS following TAVR, with potential for direct clinical implementation.",[731,732],"Aortic Stenosis","Heart Failure","2025-07-24",{"date":676,"type":37},{"date":130,"type":22},{"date":737,"type":22},"2031-04-01",{"name":43,"class":44},""]