[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heinrich-Heine University, Duesseldorf\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":705},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,53,90,116,155,183,207,238,260,289,314,346,377,408,438,472,499,525,546,567,594,614,639,659,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100054003","minimally-invasive-icg-guided-retroperitoneal-sentinel-lymph-node-dissection-in-the-primary-staging-of-testicular-cancer-versus-standard-of-care-100054003",false,"NCT07699640","Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care","RAISN 2: Prospective Randomized Trial of Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care","RAISN 2","Inclusion Criteria:\n\n* Male participants aged 18 years or older.\n* Clinically suspected testicular germ cell tumor based on physical examination and scrotal ultrasonography, with or without elevated serum tumor markers (AFP and\u002For β-hCG).\n* No radiological evidence of metastatic disease on preoperative contrast-enhanced computed tomography (CT) of the chest and abdomen (clinical stage I).\n* Eligible for radical inguinal orchiectomy.\n* Able to understand the study procedures and provide written informed consent.\n* Willing and able to comply with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment, except surgery for cryptorchidism during childhood.\n* Previous malignancy requiring abdominal surgery, chemotherapy, or radiotherapy that could interfere with study participation.\n\nPrevious radiotherapy involving the retroperitoneum.\n\n* Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide.\n* Severe medical condition that precludes surgery or study participation.\n* Psychiatric disorder or other condition preventing compliance with study procedures.\n* Inability to understand the German language sufficiently to provide informed consent and complete study assessments.\n* Individuals under legal guardianship or otherwise unable to provide legally valid informed consent.","MALE","18 Years",{"count":21,"type":22},171,"ESTIMATED","INTERVENTIONAL",[25],"NA","Testicular cancer is highly curable, but approximately 20-30% of patients with clinical stage I disease harbor occult retroperitoneal lymph node metastases that are not detected by conventional imaging. Current risk-adapted management may lead to overtreatment in some patients while failing to identify others who are at increased risk of relapse.\n\nThe RAISN 2 study evaluates whether minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection can improve primary staging and risk stratification in patients with clinical stage I testicular cancer. Participants will be randomized in a 5:1 ratio to undergo either orchiectomy combined with ICG-guided sentinel lymph node dissection or standard orchiectomy followed by guideline-based surveillance.\n\nAll participants will undergo structured follow-up according to current clinical guidelines. The primary objective is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node approach. Secondary objectives include assessment of overall survival, relapse patterns, perioperative morbidity, quality of life, psychological outcomes, and the feasibility and safety of the procedure.\n\nThis multicenter study aims to determine whether sentinel lymph node-guided staging provides more accurate risk stratification while avoiding unnecessary treatment and maintaining oncological safety.",[28,29],"Testicular Cancer","Testicular Germ Cell Tumor",[28,29,31,32,33,34,35,36,37,38,39],"Stage I Testicular Cancer","Sentinel Lymph Node Biopsy","Sentinel Lymph Node Mapping","Indocyanine Green","ICG","Retroperitoneal Lymph Nodes","Minimally Invasive Surgery","Robot-Assisted Surgery","Active Surveillance","NOT_YET_RECRUITING","2026-07-08",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":22},"2027-01",{"date":48,"type":22},"2031-01",{"name":50,"class":51},"Heinrich-Heine University, Duesseldorf","OTHER",10,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100504659","mechanisms-of-disease-progression-in-aortic-stenosis---the-modas-study-100504659","NCT05851209","Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study","Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis","Inclusion Criteria:\n\n* The patient has an acquired (tricuspid) moderate aortic valve stenosis, which is the reason for regular outpatient cardiological care.\n* The subject has been informed verbally and in writing about the study and has given written consent to participate in this study.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* The subject has contraindications for the performance of a magnetic resonance imaging or computed tomography (e.g., severe arrhythmias , contrast agent intolerance, a pacemaker, or severe renal insufficiency or severe renal insufficiency or claustrophobia).\n* Presence of only mild or already high-grade acquired tricuspid Aortic valve stenosis\n* Patient with bicuspid aortic valve\n* Inability to follow the instructions of study personnel\n* Lack of written informed consent","ALL",{"count":62,"type":22},938,"OBSERVATIONAL","Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.",[66,67,68,69,70,71],"Aortic Stenosis","Imaging","Pathogenesis","Disease Progression","Aortic Valve Calcification","Genetics",[73,74,75,76,77,78,79],"severe aortic stenosis","disease progression","pathogenesis of degenerative aortic stenosis","early detection","Cardiovascular magnet resonance","Transthoracal echocardiography","computertomography","RECRUITING","2026-06-26",{"date":83,"type":44},"2026-06-30",{"date":85,"type":44},"2023-07-01",{"date":87,"type":22},"2031-07",{"name":50,"class":51},3,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100494188","lupus-best---treat-to-target-in-systemic-lupus-erythematosus-100494188","NCT05714930","LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus","LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial","Lupus-Best","Inclusion Criteria:\n\n* Patients with SLE according to validated classification criteria\n* Age at least 18 years\n* Not in a stage of remission due to\n\n  1. Clinical SLEDAI \\> 0 AND\u002FOR\n  2. GC dosage above 5 mg prednisone equivalent per day AND\u002FOR\n  3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3\n* Fluent German language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Participation in other interventional trial(s)\n* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason. Examples could be:\n\n  * Life-threatening SLE manifestations that require intensive care treatment\n  * Active life-threatening diseases other than SLE\n  * Active malignancies\n  * Acute and chronic infections that do not allow the intensification of immunosuppressive treatment",{"count":99,"type":22},606,[25],"Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.",[103],"Systemic Lupus Erythematosus",[105,106],"Treat-to-target","shared decision making","2026-06-16",{"date":109,"type":44},"2026-06-17",{"date":111,"type":44},"2023-12-12",{"date":113,"type":22},"2030-03-31",{"name":50,"class":51},14,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":136,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100641124","do-immediate-digital-workflows-increase-patient-value-100641124","NCT07656597","Do Immediate Digital Workflows Increase Patient Value?","Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows","ITI PROM RCT","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Indication for single implant therapy in a posterior premolar or molar extraction site.\n* Good oral hygiene with FMPS ≤20%.\n* Controlled periodontitis according to protocol definition.\n* At least one natural tooth adjacent to the implant site and presence of an antagonist tooth.\n* Ability to comply with study procedures and provide written informed consent.\n* Adequate bone volume for immediate or delayed placement.\n* Extraction site suitable for centrally positioned, prosthetically driven implant placement using straight prosthetic components.\n* Ability to achieve 3-4 mm circumferential implant engagement in native bone along the planned implant axis while maintaining safety distance from vital structures.\n* For molar sites, septal bone classified as Smith \\& Tarnow Type A or Type B, including cases requiring closed sinus floor elevation.\n* Post-extraction socket presenting as a contained or partially contained defect with at least three relatively intact socket walls and no individual socket wall vertical defect \\>5 mm.\n* No facial soft-tissue dehiscence or mucogingival defect associated with buccal bone dehiscence.\n\nExclusion Criteria:\n\n* • Known or suspected poor compliance, alcohol abuse, or substance abuse.\n\n  * Systemic or local contraindications to implant surgery.\n  * History of head\u002Fneck radiotherapy or recent malignancy within 5 years.\n  * Use of medications affecting bone metabolism.\n  * Bisphosphonate use within the past 5 years.\n  * Uncontrolled periodontal disease.\n  * Heavy smoking (\\>10 cigarettes\u002Fday).\n  * Pregnancy or lactation.\n  * Teeth with periapical lesions \\>5 mm in greatest diameter, or sockets demonstrating a large cortical perforation \\>5 mm in greatest dimension on CBCT.",{"count":125,"type":22},50,[25],"This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation. Participants will be randomized 1:1 to immediate implant placement at the time of tooth extraction or to delayed implant placement after approximately 16 weeks of healing following extraction and ridge preservation as indicated. The primary endpoint is oral health-related quality of life assessed longitudinally using the OHIP-14 questionnaire and analyzed as the model-based mean score averaged across the active treatment phase from baseline through definitive crown delivery. Secondary outcomes include workflow-related patient experience, chairside time, number of visits, postoperative pain, buccal contour changes based on intraoral scan-derived volumetric analysis, radiographic marginal bone level changes, implant survival, clinical peri-implant parameters, technical complications, esthetic outcomes, accuracy of guided implant placement, and clinician-reported workflow outcomes.",[129,130,131,132,133,134,135],"Dental Implant","Implant Therapy","Immediate Dental Implant Placement","Delayed Implant","Guided Surgery Accuracy","Patient-Reported Outcomes (PRO)","Single Tooth Dental Implant",[129,137,138,139,140,141,142,143,144,145],"immediate implant placement","delayed implant placement","digital workflow","guided surgery","patient-reported outcomes","OHIP-14","posterior implant rehabilitation","chairside time","volumetric analysis","2026-06-15",{"date":148,"type":44},"2026-06-18",{"date":150,"type":22},"2026-08-03",{"date":152,"type":22},"2028-10-31",{"name":50,"class":51},2,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":154},"100614000","subcutaneous-immunoglobulin-therapy-effectiveness-monitoring-in-cidp-patients-using-smart-devices-100614000","NCT07273903","Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices","STEPS","Inclusion Criteria:\n\n* Diagnosed typical or possible typical CIDP according to the 2021 EAN\u002FPNS criteria\n* Age ≥18 years\n* Ability to use a smartwatch as decided by the investigator\n* switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase\n* on investigator-confirmed stable IVIG therapy pre-switch\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Inability to operate smartwatch or smartphone device\n* current pregnancy and breastfeeding status\n* CIDP variants according to the 2021 EAN\u002FPNS criteria",{"count":163,"type":22},35,"Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).\n\nThe S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.\n\nStudy Goals:\n\nThe main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).\n\nSecondary goals include:\n\nAssessing how smartwatch data relate to patients' quality of life and sleep patterns.\n\nComparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.\n\nEvaluating how well patients can use the smartwatch over the long term during home treatment.\n\nAn additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.\n\nStudy Design:\n\nThis is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.\n\nParticipants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.\n\nDuration:\n\nRecruitment will last about 6 months, and each participant will be followed for 12 months.\n\nWhy This Matters:\n\nBy combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.",[166],"CIDP - Chronic Inflammatory Demyelinating Polyneuropathy",[168,169,170,171,172,173,174],"CIDP","IVIG","SCIG","wearable","steps","sleep","DHT","2026-06-09",{"date":177,"type":44},"2026-06-10",{"date":179,"type":44},"2026-01-15",{"date":181,"type":22},"2028-01",{"name":50,"class":51},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100540215","german-registry-of-alzheimers-disease-treated-with-transcranial-pulse-stimulation-100540215","NCT06313944","German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation","German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)","GE-R-A-TPS","Inclusion Criteria:\n\ni. Age = 18 to 85 ii. N\\>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii. MRI scan, in vivo evidence from CSF and\u002For PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration \\[AT(N)\\], which can be detected on imaging and in biofluids. If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.\n\niv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist\n\nExclusion Criteria:\n\ni. Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii. Blood coagulation disorders or oral anticoagulation iii. Epilepsy iv. Medical conditions leading to non-compliance with the protocol","85 Years",{"count":193,"type":22},100,"This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.",[196],"Alzheimer Disease",[196,198],"Transcranial Pulse Wave Stimulation (TPS)","2026-06-08",{"date":177,"type":44},{"date":202,"type":44},"2025-08-06",{"date":204,"type":22},"2026-10-01",{"name":50,"class":51},6,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":215,"conditions":216,"keywords":223,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100639681","screening-characterization-and-longitudinal-follow-up-of-patients-with-cardiac-amyloidosis-100639681","NCT07577466","Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis","Inclusion Criteria:\n\n* Age \\> 18 years\n* Male and female patients undergoing clinically indicated diagnostic work-up for amyloidosis or with a previously confirmed diagnosis of cardiac amyloidosis prior to initiation of therapy\n* Presence of left ventricular wall thickness \\> 12 mm on transthoracic echocardiography and at least one \"red flag\" suggestive of cardiac amyloidosis (according to ESC 2021 criteria) or an otherwise clinically established suspicion of amyloidosis\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Contraindications to cardiac MRI (e.g., metallic foreign bodies, older-generation pacemakers, severe obesity, claustrophobia)\n* Lack of written informed consent for study participation\n* Inability to comply with the study procedures",{"count":214,"type":22},200,"Cardiac amyloidosis is a progressive disorder caused by extracellular deposition of amyloid fibrils in the heart, leading to heart failure and impaired cardiac function. Early diagnosis and targeted therapies are essential to improve patient outcomes. This prospective, single-center study aims to longitudinally follow patients with suspected cardiac amyloidosis to characterize disease progression and assess treatment effects. Participants will undergo cardiac magnetic resonance imaging (resting and exercise stress MRI), magnetic resonance spectroscopy, cardiopulmonary exercise testing (spiroergometry) and blood testing at baseline and at 6, 12, and 24 months",[217,218,219,220,221,222],"Amyloidosis Cardiac","Heart Failure","Cardiac MRI","Spectroscopic Analysis","Diagnosis","Phenotyping",[219,224,225,226,227,69,228,229],"Exercise MRI","Magnetic Resonace Spectroscopy","Spirometry","Cardiopulmonary Exercise Testing","Treatment Monitoring","Longitudinal Study","2026-05-04",{"date":232,"type":44},"2026-05-11",{"date":146,"type":22},{"date":235,"type":22},"2029-12-31",{"name":50,"class":51},1,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":60,"minAge":246,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":237},"100636362","a-study-testing-whether-low-dose-radiation-could-help-the-immune-system-and-possibly-improve-early-onset-alzheimers-disease-100636362","NCT07564700","A Study Testing Whether Low-Dose Radiation Could Help the Immune System and Possibly Improve Early-Onset Alzheimer's Disease.","A Randomized Clinical Feasibility Trial Investigating Low-Dose Radiotherapy as an Immunomodulatory Therapeutic Modality for Early-Onset Alzheimer's Disease: A Pilot Investigation","HOPE","Inclusion Criteria:\n\nAlzheimer's diagnosis according to ICD-10 Ability to understand the clinical study and provide informed consent Early-onset disease Age older than 50 years Stable treatment with anti-dementia medication for at least 3 months\n\nExclusion Criteria:\n\n* Prodromal Alzheimer's disease Mild cognitive impairment (MCI) Severe psychiatric disorders that could interfere with participation in the study Unstable or recently changed medication therapy Other neurodegenerative diseases or severe neurological disorders Uncontrolled chronic diseases that could increase the risk of complications Previous therapeutic brain irradiation Evidence of vascular cognitive impairment on MRI (Fazekas score \\>1 and Wahlund score ≥10\u002F30) Oncological disease (except skin cancer), active or in remission for less than 5 years Evidence of substance abuse (alcohol and\u002For other drugs) with dependence within the last 12 months (DSM-IV criteria) Active or recent (within 3 months) cerebral infection or hemorrhage Immunocompromised status History of seizures Dermatological scalp disease Women who are pregnant, breastfeeding, or planning to become pregnant during the study period Patient has a history of cancer (except non-melanoma skin cancer) Patient is taking antiepileptic medication Patient and legally authorized representative are unable to provide informed consent Patient with a history of focal neurological deficits (except vibratory peripheral neuropathy)","50 Years",{"count":125,"type":22},[25],"The goal of this randomized clinical trial is to investigate whether low-dose whole-brain radiotherapy has a potential immunomodulatory effect that may influence disease progression in patients with early-stage Alzheimer's disease (ICD-10 diagnosed).\n\nThe main question(s) it aims to answer are:\n\nDoes low-dose radiotherapy have an effect on cognitive function and disease progression in early Alzheimer's disease? Is the intervention safe and feasible in this patient population under clinical trial conditions?\n\nIf there is a comparison group: Researchers will compare patients receiving low-dose whole-brain radiotherapy to a control group receiving a sham or non-active treatment, to assess potential differences in cognitive outcomes and disease-related parameters over time.\n\nParticipants will:\n\nUndergo baseline diagnostic assessments including neuropsychological testing, MRI, EEG, and laboratory tests Be randomly assigned to one of two study groups Receive either low-dose whole-brain radiotherapy (6 sessions over 3 weeks) or a control condition Attend follow-up visits at 6 weeks, 3 months, and 6 months including repeated cognitive testing and clinical assessments",[251,252],"Alzheimer Disease (AD)","Early Onset Alzheimer Disease","2026-04-27",{"date":230,"type":44},{"date":256,"type":22},"2026-05-15",{"date":258,"type":22},"2028-05-31",{"name":50,"class":51},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":237},"100635687","relieve-metab-study-100635687","NCT07555925","RELIEVE METAB Study","Interatrial Shunt Device (IASD) Treatment in Symptomatic Heart Failure With Reduced Left Ventricular Ejection Fraction (HFrEF) Alleviates Elevated Myocardial Left Ventricular Pressures, Improves Myocardial Mitochondrial Function and Promotes Regional and Global Myocardial Recovery","Inclusion Criteria:\n\n1. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40%\n2. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU.\n3. Symptoms: NYHA Class III\n4. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT)\n5. Biomarkers: NTproBNP ≥ 1,200 pg\u002Fml\n6. Age 18 years or older\n7. Subject has signed informed consent form and is willing and able to attend all follow-up visits and is physically capable of performing all tests.\n\nExclusion Criteria:\n\n1. Hemodynamics: Resting SBP \\\u003C 90 or \\> 160 mmHg\n2. Severe PH (PASP \\>70 mmHg, PVR \\> 4 Wood Units)\n3. Anatomy\u002FStructure:\n\n   * intracardiac thrombus\n   * Severe RV dysfunction (TAPSE \\\u003C12 mm or RVFAC ≤25%)\n   * LVEDD \\> 8 cm\n   * Significant ASD or PFO\n4. Valvular Disease:\n\n   * Severe, untreated mitral stenosis or aortic stenosis or regurgitation\n   * Mitral repair device \\\u003C3 months prior to enrollment\n5. Recent Events:\n\n   * ACS, PCI, Cardiac Surgery (\\\u003C 3 months prior to enrollment)\n   * CAD requiring revascularization\n   * Stroke, TIA, PE, Thrombosis (\\\u003C 6 months prior to enrollment)\n6. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI\n7. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint\n8. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits\n9. Any non-cardiac condition with life expectancy \\\u003C1 years (e.g., cirrhosis, cancer not in remission, etc.)\n10. Subject belongs to a vulnerable population",{"count":268,"type":22},15,[25],"This prospective, single-center post-market-follow-up study aims to fill knowledge gaps by combining advanced cardiac MRI\u002FMRS with systemic mitochondrial assays and exercise testing to characterize the energetic and functional impact of IASD therapy in HFrEF patients.",[272],"Heart Failure With Reduced Ejection Fraction (HFrEF)",[274,275,276,277,278,279,280],"Interatrial Shunt Device (IASD)","Ventura Shunt","Myocardial Energetics","Mitchondrial Function","MRI","CMR","MRS","2026-04-22",{"date":283,"type":44},"2026-04-29",{"date":285,"type":22},"2026-06-01",{"date":287,"type":22},"2027-07-01",{"name":50,"class":51},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":237},"100630719","liquid-biopsy-in-paraneoplastic-neurological-syndromes-100630719","NCT07491328","Liquid Biopsy in Paraneoplastic Neurological Syndromes","Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies","LiB-PNS","Inclusion Criteria:\n\n* Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or\n* Patients with peripheral tumors without PNS\n\nExclusion Criteria:\n\n* Age below 18 years at the time of inclusion.\n* Any mental condition impairing the capacity to provide informed consent.\n* Presence of contraindications to DLA.",{"count":298,"type":22},60,"The main objective of the study is to assess whether circulating tumor cells (CTCs) can be detected in the peripheral blood of patients with paraneoplastic neurological syndromes (PNS) by diagnostic leukapheresis (DLA) combined with the CELLSEARCH® System during clinical routine workup. If CTCs can be identified, a detailed molecular genetic analysis will be performed to characterize mutations in oncogenes and tumor suppressor genes. In addition, the study aims to analyze cell-free DNA (cfDNA) in serum of patients.\n\nIndividuals with PNS and high- or intermediate-risk or GAD65-antibodies with a detectable tumor (PNS+T), PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor (PNS w\u002Fo T), and matched tumor patients without PNS (T w\u002Fo PNS) will be included in the study.",[301],"Paraneoplastic Neurological Syndromes",[303,304,305],"Circulating tumor cells (CTCs)","Circulating tumor DNA (ctDNA)","Diagnostic leukapheresis (DLA)","2026-03-18",{"date":308,"type":44},"2026-03-24",{"date":310,"type":44},"2023-05-20",{"date":312,"type":22},"2030-12-30",{"name":50,"class":51},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":321,"sex":60,"minAge":19,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":325,"conditions":326,"keywords":333,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":154},"100625773","cognitive-performance-sleep-disturbances-and-fatigue-in-multiple-sclerosis-100625773","NCT07426991","Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis","The Effects of Sleep Disturbances on Fatigue and Cognition in Multiple Sclerosis","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 79 years (all groups)\n* Adequate (corrected) hearing and vision to complete neuropsychological testing (all groups)\n* Sufficient proficiency in German to participate in assessments (all groups)\n* Capacity to provide informed consent and understanding of study procedures (all groups)\n* Diagnosis of MS according to the 2017 revised McDonald criteria (MS group)\n* Indication for sleep medicine evaluation due to at least mild fatigue, operationalized as ≥ 43 points on the Fatigue Scale for Motor and Cognitive Functions (FSMC) (MS group)\n* Indication for sleep medicine evaluation (control group)\n\nExclusion Criteria:\n\n* Lack of signed informed consent or inability to provide consent (all groups)\n* Age \\\u003C 18 years or \\> 79 years (all groups)\n* Presence of another neurological disorder in addition to MS, with the exception of migraine (all groups)\n* Use of medications that influence polysomnographic parameters (e.g., benzodiazepines) (all groups)\n* Uncorrected hearing or vision impairment and\u002For insufficient German language proficiency likely to impact neuropsychological test results (all groups)",true,"79 Years",{"count":324,"type":22},837,"Fatigue is a prevalent symptom in patients with multiple sclerosis (MS) and is associated with considerable impairment in quality of life as well as loss of occupational capacity. Sleep disturbances are regarded as a critical factor in the development of fatigue and are frequently observed in individuals with MS. However, they often remain underrecognized, undiagnosed, and consequently untreated.\n\nPolysomnography, the gold standard for assessing sleep architecture and quality, has rarely been applied in the investigation of sleep disorders in MS. Accordingly, uncertainties remain regarding the prevalence and extent to which sleep disturbances contribute to fatigue in this population. Moreover, emerging evidence suggests an association between sleep disorders and cognitive dysfunction in MS. Yet, it is unclear whether cognitive impairment arises from the sleep disorder itself, from the resulting fatigue, or from other independent factors.\n\nPharmacological treatments for MS-related fatigue remain limited, given heterogeneous and frequently non-replicable effects. Non-pharmacological interventions such as physical activity, cognitive behavioral therapy, and psychoeducation have shown promise but yield variable outcomes. The development of novel and effective therapeutic strategies requires a more comprehensive understanding of the etiology of fatigue. To date, the role of sleep disturbances and their relationship to cognitive performance in MS have not been adequately investigated.\n\nThe objective of this project is to determine the prevalence and characteristics of sleep disorders in MS patients with fatigue using polysomnography and to examine their relationship with cognitive impairment. In addition, the study will compare sleep quality parameters and the prevalence of sleep disorders across different MS subtypes (relapsing-remitting, primary progressive, and secondary progressive). Furthermore, within a sub-study, it will be investigated whether the type of immunotherapy has an influence on the aforementioned aspects.\n\nFinally, the project seeks to integrate artificial intelligence (AI) into polysomnography analysis to streamline data evaluation and facilitate the future assessment of therapeutic interventions.\n\nThe study will be conducted as a non-invasive, non-interventional, longitudinal observational trial including MS patients with fatigue and a control group of patients with subjective sleep complaints but without MS. Recruitment will take place over 36 months at two centers: the Department of Neurology at the University Hospital Düsseldorf and the Maria Hilf Clinics in Mönchengladbach. Additional recruitment will be supported by community-based neurologists in the Mönchengladbach region to broaden the study cohort and ensure representativeness of the study population.\n\nApproximately 382 MS patients are expected to be enrolled. The number of control participants will be determined by the proportion of MS patients presenting with sleep disorders and will be recruited consecutively from the neurological sleep laboratory of the Maria Hilf Clinics. For AI training, retrospective polysomnography data from the past five years (N ≥ 10,000 patients) at the Maria Hilf Clinics will be utilized.\n\nThe study protocol includes overnight polysomnography to assess sleep quality, along with comprehensive clinical evaluation, neuropsychological testing, and validated questionnaires addressing fatigue, subjective sleep quality, daytime sleepiness, depression, and anxiety.\n\nBased on manually scored polysomnography, AI models will be trained to identify key parameters of sleep quality. The findings of this study will advance the understanding of the role of sleep disturbances in MS-related fatigue and will facilitate the integration of AI into sleep research, thereby streamlining the evaluation of future therapeutic approaches.",[327,328,329,330,331,332],"Multiple Sclerosis","Remitting-Relapsing Multiple Sclerosis","Primary Progressive Multiple Sclerosis","Secondary Progress Multiple Sclerosis","Fatigue Syndrome, Chronic","Sleep Disorders",[334,335,336,337],"MS","Sleep","Fatigue","Cognition","2026-03-05",{"date":340,"type":44},"2026-03-06",{"date":342,"type":44},"2024-11-01",{"date":344,"type":22},"2028-12",{"name":50,"class":51},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":60,"minAge":352,"maxAge":191,"enrollmentInfo":353,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":355,"conditions":356,"keywords":361,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":237},"100512919","mitochondrial-substrate-utilization-in-the-diabetic-human-heart-100512919","NCT05958706","Mitochondrial Substrate Utilization in the Diabetic Human Heart","Inclusion Criteria:\n\n* Age ≥ 20 and ≤ 85 years\n* Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus.\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute infectious diseases within the last 2 weeks before the examination\n* Autoimmune diseases or acute immunocompromising diseases (leukocytes \\\u003C 5000\u002Fμl)\n* Pregnancy\n* Use of alcohol or drugs (addiction), psychiatric diseases\n* Suspected or manifest AIDS (HIV); hepatitis B or C.\n* Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure\n* Malignant cancer\n* Lack of capacity to give informed consent or lack of consent to participate in the study\n* For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.","20 Years",{"count":354,"type":22},500,"Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control\u002FT2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.",[218,357,358,359,360],"Type2diabetes","Insulin Resistance","Mitochondrial Diseases","Diabetic Cardiomyopathies",[362,363,364,365,366,367,368],"mitochondrial function","respirometry","heart failure","type 2 diabetes mellitus","insulin resistance","mitochondrial disease","diabetic cardiomyopathy","2026-02-17",{"date":371,"type":44},"2026-02-19",{"date":373,"type":44},"2021-12-01",{"date":375,"type":22},"2035-06",{"name":50,"class":51},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":321,"sex":385,"minAge":386,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":390,"conditions":391,"keywords":396,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":154},"100623239","impact-of-new-hormone-replacement-therapy-after-menopause-on-heart-health-in-women-100623239","NCT07394049","Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women","Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)","CATCH-Menopaus","Inclusion Criteria:\n\n* Age 45-75 years\n* Score 2 \\> 5%\n* Or existing coronary heart disease\n* Or cAVK\n* Or PAD\n\nExclusion Criteria:\n\n* Age \\\u003C45 years \u002F \\> 75 years\n* Existing cancer\n* Language barrier, inability to provide informed consent\n* GFR \\\u003C30 ml\u002Fmin or dialysis\n* Child C cirrhosis of the liver\n* Known genetic cardiomyopathies","FEMALE","45 Years","75 Years",{"count":389,"type":22},2725,"This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women.\"",[392,393,394,395],"Hormone Replacement Therapy","Cardiovascular Diseases","Hormone Replacement Therapy, Post-Menopausal","Menopause",[397,398,399],"hormone replacement therapy","cardiovascular disease","menopause","2026-02-06",{"date":402,"type":44},"2026-02-10",{"date":404,"type":22},"2026-03-01",{"date":406,"type":22},"2035-03",{"name":50,"class":51},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":60,"minAge":415,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":418,"conditions":419,"keywords":423,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":437,"locationsCount":237},"100622581","chronic-and-acute-cardiovascular-diseases-in-elderly-intensive-care-patients-100622581","NCT07385482","Chronic and Acute Cardiovascular Diseases in Elderly Intensive Care Patients","Impact of Chronic and Acute Cardiovascular Diseases in Older Intensive Care Patients: A Prospective Multicenter Observational Study - VIP4","Inclusion Criteria:\n\n* 80 years or older\n* Admission to the intensive care unit\n* Signed informed consent or absence of discernible indications suggesting the presumed intention of the patient not to participate in the study.\n\nExclusion Criteria:\n\n* \\\u003C 80 years\n* Absence of informed consent\n* Discernible indications suggesting the presumed intention of the patient not to participate in the study.","80 Years",{"count":417,"type":22},4000,"Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.",[420,421,422],"Chronic Cardiovascular Disease","Acute Cardiovascular Disease","Frailty",[424,425,398,426,427,428,429,430],"older intensive care patients","intensive care unit","frailty","multimorbidity","mortality","functional outcome","health-related quality of life","2026-02-03",{"date":433,"type":44},"2026-02-05",{"date":404,"type":22},{"date":436,"type":22},"2027-03-01",{"name":50,"class":51},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":459,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":237},"100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657","NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months",{"count":214,"type":22},[25],"The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[450,451,452,453,454,455,456,457,458],"Diabetic Foot","Diabetes Mellitus","Peripheral Arterial Disease","Diabetic Neuropathies","Diabetic Retinopathy","Anemia","Ulcer Foot","Ulcer Ischemic","Diabetic Polyneuropathy",[460,461,462,463,464],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty",{"date":466,"type":44},"2026-02-04",{"date":468,"type":44},"2024-02-01",{"date":470,"type":22},"2028-11-01",{"name":50,"class":51},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":237},"100621607","metabolic-deterioration-in-htx-determines-outcomes-100621607","NCT07372820","METABolic Deterioration in HTX Determines Outcomes","METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation","METAB-HTX","Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Planned or already conducted heart transplantation\n* Informed consent\n\nExclusion Criteria:\n\n* Absence of informed consent",{"count":481,"type":22},270,"METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients.",[484],"Heart Transplantation",[486,487,488,489,364,490],"cardiac metabolism","Systemic Metabolism","cardiac function","heart transplant","Type 2 diabetes","2026-01-20",{"date":493,"type":44},"2026-01-28",{"date":495,"type":44},"2025-07-24",{"date":497,"type":22},"2032-02-01",{"name":50,"class":51},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":237},"100327134","systemic-organ-communication-in-stemi-100327134","NCT03539133","Systemic Organ Communication in STEMI","SYSTEMI","Inclusion Criteria:\n\n* Patients suffering from STEMI\n\nExclusion Criteria:\n\n* \\\u003C 18 years",{"count":507,"type":22},1000,"Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.\n\nWithin the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.",[510],"ST-segment Elevation Myocardial Infarction (STEMI)",[512,513,514,515,516,517],"STEMI","infarction","coronary artery disease","comorbidities","diabetes","anemia",{"date":519,"type":44},"2026-01-22",{"date":521,"type":44},"2017-10-18",{"date":523,"type":22},"2030-06",{"name":50,"class":51},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":237},"100615964","biological-determinants-and-neural-compensation-of-dysphagia-in-parkinsons-disease-100615964","NCT07299448","Biological Determinants and Neural Compensation of Dysphagia in Parkinson's Disease","Biological Determinants and Neural Compensatory Mechanisms of Oropharyngeal Dysphagia in Parkinson's Disease","Inclusion Criteria:\n\n.- Patients with idiopathic Parkinson's disease diagnosed according to the MDS diagnostic criteria\n\n* Participation possible in all disease stages, regardless of the presence or absence of subjective or objective oropharyngeal dysphagia\n* Cognitive ability sufficient to comply with the study paradigm\n* Daily oral intake of food and fluids (exclusion of patients with exclusive tube feeding)\n\nExclusion Criteria:\n\n* Presence of other conditions associated with oropharyngeal dysphagia, such as stroke, head and neck cancer, neuroinflammatory diseases, neuromuscular disorders, or other brain injuries\n* Presence of electronic stimulation devices (e.g., pacemaker, deep brain stimulation) or other contraindications for MRI imaging\n* Diagnosis of asthma or COPD (due to performance of the cough reflex test in \"Block 1: Assessment of OD and pharyngeal hyposensitivity\")",{"count":193,"type":22},"Parkinson's disease (PD) is the second most common neurodegenerative disorder and frequently leads to oropharyngeal dysphagia, a swallowing disorder that strongly affects patient health and quality of life. Dysphagia in PD is associated with aspiration pneumonia, malnutrition, and impaired medication intake, which together represent one of the leading causes of morbidity and premature mortality in these patients. Despite its clinical relevance, the underlying biological mechanisms of dysphagia in PD are not fully understood, and current treatment strategies are limited.\n\nThe purpose of this study is to investigate the clinical, biological, and neural determinants of oropharyngeal dysphagia in patients with PD, and to explore compensatory mechanisms of the brain that may counteract swallowing difficulties. We hypothesize that dysphagia in PD is linked not only to disease severity and progression but also to specific biological markers and neural plasticity in the swallowing network.\n\nThis is a prospective, cross-sectional observational study including 100 patients with PD. Swallowing function will be systematically assessed using flexible endoscopic evaluation of swallowing (FEES), a gold standard method for detecting penetration and aspiration. Additional clinical data will be collected, including motor and non-motor symptoms, disease severity, and quality of life measures. Biological assessments will include blood-based biomarkers related to inflammation and neurodegeneration. Furthermore, functional magnetic resonance imaging (fMRI) will be used to examine cortical and subcortical activity patterns associated with swallowing and to identify potential compensatory activation in dysphagic and non-dysphagic patients.\n\nBy integrating clinical, biological, and imaging approaches, this study aims to provide a comprehensive characterization of dysphagia in PD. The findings are expected to improve the understanding of disease mechanisms and to identify predictors of dysphagia onset and severity. Ultimately, this knowledge may help to guide the development of targeted therapeutic strategies, reduce the risk of severe complications, and improve quality of life for patients with Parkinson's disease.",[535,536],"Parkinsons Disease (PD)","Oropharyngeal Dysphagia",[538],"Dysphagia, Swallowing Disorder, Parkinson's Disease, Swallowing Compensation, Neuroimaging Biomarkers, Functional MRI, Proteomics","2025-12-09",{"date":541,"type":44},"2025-12-23",{"date":543,"type":44},"2025-09-01",{"date":181,"type":22},{"name":50,"class":51},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":321,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":89},"100612521","gel--medication-dysphagia-100612521","NCT07254663","GEL & MEDication Dysphagia","Influence of Swallow Gel and Semi-solid Consistency on Medication Dysphagia: A Multicenter Observational Study","GELMED","Inclusion Criteria:\n\nPatients:\n\nAdults with a dysphagia-associated disease (neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; in other centers also ENT-related diseases), for whom FEES is clinically indicated.\n\nCapable of providing informed consent and cognitively able to follow the study protocol.\n\nHealthy Controls Adults without any dysphagia-associated disease (no neurovascular, neurodegenerative, neuroinflammatory, or neuromuscular disorders; no ENT-related diseases with structural abnormalities of the oropharynx or esophagus).\n\nCapable of providing informed consent and cognitively able to follow the study protocol.\n\nExclusion Criteria:\n\nNo additional exclusion criteria beyond those specified in the inclusion criteria.",{"count":354,"type":22},"This research project examines the prevalence of medication-related dysphagia in patients with dysphagia-associated diseases. Its primary aim is to assess how frequently swallowing difficulties occur during medication intake and to evaluate the impact of different consistencies-such as semi-solid formulations and commercial swallowing gels-on the swallowing process. Flexible endoscopic evaluation of swallowing serves as the diagnostic gold standard to determine whether alternative administration forms can facilitate safer swallowing. The findings are intended to support the optimization of medication intake and the prevention of complications in patients with dysphagia.",[557,558],"Neurological Diseases or Conditions","Healthy Participants","2025-11-26",{"date":561,"type":44},"2025-11-28",{"date":563,"type":44},"2025-09-15",{"date":565,"type":22},"2027-09-15",{"name":50,"class":51},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":575,"studyType":63,"phases":4,"briefSummary":576,"conditions":577,"keywords":582,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":237},"100608024","electrophysiological-registry-duesseldorf-100608024","NCT07196176","Electrophysiological Registry Duesseldorf","Registry on Electrophysiological Studies (EPS) at University Hospital Düsseldorf","Inclusion Criteria:\n\n* Patients who undergo an electrophysiological study (EPS) or electrical cardioversion at University Hospital Düsseldorf since 2015 (retrospective cohort)\n* Patients scheduled to undergo an EPS or electrical cardioversion at University Hospital Düsseldorf from 2019 onward (prospective cohort) •- Written informed consent for participation in the registry (prospective part only)\n\nExclusion Criteria:\n\n* \\\u003C 18 years\n* Lack of written informed consent\n* Pregnancy",{"count":507,"type":22},"2 Years","This registry at University Hospital Düsseldorf collects retrospective and prospective (from 2019 onward) data on patients undergoing electrophysiological studies (EPS), catheter ablation, and electrical cardioversion. The primary goal is to evaluate safety, efficacy, and clinical outcomes of these standard procedures in routine care. Data will be used for quality assurance and to identify prognostic patient- and procedure-related factors.",[578,579,580,581],"Atrial Fibrillation (AF)","Atrial Flutter","Supraventricular Tachycardias","Ventricular Tachycardia (VT)",[583,584,585],"atrial fibrillation","catheter ablation","cardioversion","2025-09-26",{"date":588,"type":44},"2025-09-29",{"date":590,"type":44},"2019-06-01",{"date":592,"type":22},"2031-12-31",{"name":50,"class":51},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":385,"minAge":19,"maxAge":4,"enrollmentInfo":601,"targetDuration":603,"studyType":63,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":613,"locationsCount":237},"100570566","ai-based-pcr-assessmentprediction-in-her2-positive-bc-using-petmri-100570566","NCT06708910","AI-based pCR Assessment\u002FPrediction in HER2-Positive BC Using PET\u002FMRI","Multiparametric 18F-FDG PET\u002FMRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence","Inclusion Criteria:\n\n* Female\n* HER2-positive breast carcinoma\n* legally competent female patients aged ≥ 18 years\n* willing and able to attend scheduled examinations\n* written informed consent for study participation\n* decision to receive neoadjuvant systemic therapy \u002F exclusion of distant metastases\n\nExclusion Criteria:\n\n* previous cancer diagnosis within the last five years or second, synchronous malignancy\n* contraindication to MRI examination\n* severe renal insufficiency\n* pregnancy or lactation",{"count":602,"type":22},460,"15 Weeks","Goal of the observational study: Based on PET\u002FMRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.\n\nThe main question it aims to answer are:\n\nPrimary endpoint:\n\n1\\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n\nSecondary endpoint(s):\n\n1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET\u002FMRI (response assessment)\n2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET\u002FMRI (response assessment)\n4. Evaluation of pre-treatment (baseline) 18F-FDG PET\u002FMRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction)\n5. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction)\n6. Evaluation of 18F-FDG PET\u002FMRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction)\n\nThe guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET\u002FMRI, including dedicated 18F-FDG PET\u002FMRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard.\n\nThe study protocol involves the following examinations for all included patients:\n\n1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast\n2. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after the first two cycles of systemic therapy\n3. Thoracic 18F-FDG PET\u002FMRI including 18F-FDG PET\u002FMRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery",[606],"HER2 Positive Breast Carcinoma","2025-09-23",{"date":609,"type":44},"2025-09-24",{"date":611,"type":44},"2025-07-18",{"date":87,"type":22},{"name":50,"class":51},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":246,"maxAge":387,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":638,"locationsCount":4},"100438763","randomized-prospective-multi-center-cohort-study-for-primary-diagnosis-of-clinically-significant-prostate-cancer-with-combination-of-psadre-and-multi-parametric-magnetic-resonance-imaging-100438763","NCT04993508","Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA\u002FDRE and Multi Parametric Magnetic Resonance Imaging","PRIMA","Inclusion Criteria:\n\n* Men aged from 50 to 75 years\n* elevated PSA ≥ 3 ng\u002Fml and\u002For cancer suspicious DRE\n\nExclusion Criteria:\n\n* Men with known prostate cancer\n* men with prior prostate biopsy\n* men with non-MRI compatible devices\n* men with acute prostatitis",{"count":622,"type":22},1908,[25],"This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (\\>= 3 ng\u002Fml) and \u002For suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI\u002FUS fusion-guided biopsies (= TB with a maximum of 3 targets and 4 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with unsuspicious mpMRI will be receive follow-up according to current clinical standards. PRIMA will prospectively evaluate if stand-alone targeted MRI\u002FUS fusion-guided biopsy alone is sufficient to detect clinically significant prostate cancer (csPC with (ISUP grade group ≥ 2) and to avoid unnecessary detection of low-grade PC (ISUP 1) in biopsy-naïve men compared to a combined biopsy (systematic plus targeted) approach. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.",[626],"Prostate Cancer",[628,629,630,631,632,633],"prostate cancer","prostate cancer diagnosis","multiparametric Magnetic Resonance Imaging (mpMRI)","detection of clinically significant prostate cancer","avoidance of over diagnosis","PSA",{"date":586,"type":44},{"date":636,"type":22},"2026-04-01",{"date":113,"type":22},{"name":50,"class":51},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":60,"minAge":19,"maxAge":646,"enrollmentInfo":647,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":237},"100561132","understanding-the-durable-effect-concept-of-b-cell-modulating-therapies-100561132","NCT06586177","Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies","REBELLION-MS","Inclusion Criteria:\n\n* Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria\n* Current treatment with B cell modulating therapies or initiation\u002Ftransition to B cell modulating therapies according to the \"Summary of Product Characteristics (SmPC)\"\n* EDSS score of 0.0 to 7.0\n\nExclusion Criteria:\n\n* Previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation or bone marrow transplantation\n* Medical, psychiatric, cognitive, or other conditions that, in the opinion of the investigator, impair the patient's ability to understand the patient information and give informed consent\n* Patients receiving immunosuppressive treatment for conditions other than MS or long-term corticosteroid treatment\n* Patients with confirmed infection by the Human Immunodeficiency Virus or Hepatitis C Virus","60 Years",{"count":193,"type":22},"This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - will be collected, along with results from imaging techniques such as Optical Coherence Tomography (OCT) and Magnetic Resonance Imaging (MRI). This clinical data will be combined with immunological analyses, including multidimensional flow cytometry (mFC), bulk RNA sequencing (bulk-Seq), T and B cell receptor sequencing (TCR\u002FBCR-Seq), proteomics, and immunoglobulin analysis. This approach aims to enable a detailed characterization of changes in the immune cell repertoire and their impact on the clinical disease course.",[650],"Relapsing-remitting Multiple Sclerosis","2025-09-12",{"date":653,"type":44},"2025-09-18",{"date":655,"type":44},"2021-10-27",{"date":657,"type":22},"2028-12-31",{"name":50,"class":51},{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":667,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":237},"100526346","robot-assisted-icg-guided-sentinel-node-biopsy-in-testicular-cancer-100526346","NCT06133543","Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer","RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer","RAISN","Inclusion Criteria:\n\n* Clinically confirmed unequivocal testicular tumor by palpation and sonography with or without elevation of specific tumor markers AFP and\u002For ß-HCG.\n* Clinical exclusion of metastases in preoperative staging using contrast-enhanced CT of the thorax and abdomen.\n* The patient is of legal age.\n* The patient can communicate with the investigator without issues or limitations and can understand and sign the patient information and consent form without problems or limitations.\n\nExclusion Criteria:\n\n* Testicular tumor with uncertain dignity\n* Patients with small testicular masses (\\\u003C 1 cm)\n* Patients with prior scrotal or retroperitoneal surgery for reasons other than a germ cell tumor.\n* The patient has received different chemotherapy.\n* The patient has undergone retroperitoneal radiotherapy.\n* Exclusion criteria for the use of ICG include a history of anaphylactic reactions to ICG and iodine intolerance (ICG solution contains sodium iodide).\n* The patient is in a reduced general condition or has a life-threatening illness.\n* The patient has a psychiatric illness.","99 Years",{"count":669,"type":22},44,[25],"Robot-assisted image-guided sentinel lymph node biopsy (RAISN) in testicular cancer is a novel technique that has not been widely investigated yet. This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage (CS) I testicular cancer. Current staging strategies have a poor predictive accuracy for occult metastatic disease.\n\nSo far, feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment. The development of a robot-assisted image-guided lymph node resection technique with indocyanine green (ICG) is potentially more precise, easier to apply and widely available. With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure.",[673,674,675],"Germ Cell Tumor","Seminoma","Nonseminomatous Germ Cell Tumor","2025-09-09",{"date":563,"type":44},{"date":679,"type":44},"2023-09-06",{"date":681,"type":22},"2028-03-31",{"name":50,"class":51},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":4,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":667,"enrollmentInfo":690,"targetDuration":4,"studyType":23,"phases":691,"briefSummary":693,"conditions":694,"keywords":695,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":699,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":237},"100527205","phase-2-primetest-ii---clinical-stage-ii-ab-seminoma-treated-with-ra-rplnd-100527205","NCT06144736","PRIMETEST II - Clinical Stage II A\u002FB Seminoma Treated With RA-RPLND","PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A\u002FB Seminoma Treated With RA-RPLND","Inclusion Criteria:\n\n* Histologically confirmed pure seminomatous testicular germ cell tumor\n* Presence of iliac or retroperitoneal lymph node metastasis detected in contrast-enhanced CT or MRI, classified as local or unilaterally regional\n* Maximum extent of lymph node metastasis (LN-M) singular or multiple, with a maximum size of 5 cm in transverse CT diameter (UICC IIB)\n* Patients with an elevation in HCG after orchiectomy at the time of staging examination can be included if the directly preoperatively determined HCG does not exceed 5 IU\u002FL.\n\nPatients can be included in the following scenarios:\n\n* Initial diagnosis of a tumor in UICC stage IIA\u002FIIB\n* Recurrence of a tumor in clinical stage (CS) I under active surveillance\n* Recurrence of a CS I tumor after adjuvant therapy with carboplatin mono\n\nExclusion Criteria:\n\n* LN-M with a transverse diameter \\>5 cm in CT (UICC IIC)\n* Other metastases than LN-M (UICC III)\n* The patient received a different chemotherapy than described above\n* The patient underwent retroperitoneal radiotherapy\n* The patient is in a reduced general condition or has a life-threatening illness\n* The patient has a psychiatric illness\n* Evidence of non-seminomatous germ cell tumor components in the RPLND histology\n* Complete resection cannot be ensured due to previous surgeries\n* In the \"high risk\" group: Contraindications to cisplatin, etoposide, or bleomycin (severe liver insufficiency, severe kidney insufficiency, severe lung insufficiency, hypersensitivity, severe bone marrow depression, profound hearing impairments)",{"count":298,"type":22},[692],"PHASE2","PRIMETEST II is an interventional study involving low-volume metastatic seminoma. It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection, aiming to reduce long-term side effects and improve quality of life. By identifying factors predicting cancer recurrence, the study hopes to tailor treatments for better outcomes. The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates, presenting a promising shift in testicular cancer care for this specific patient group.",[674],[696,697,698],"seminoma","low volume metastases","clinical stage IIA\u002FB",{"date":563,"type":44},{"date":701,"type":44},"2023-08-28",{"date":703,"type":22},"2029-08-31",{"name":50,"class":51},""]