[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ludwig-Maximilians - University of Munich\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":582},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,45,77,106,139,162,196,227,255,279,313,343,372,390,416,440,461,488,512,537,558],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639056","personalized-pharmaco-lifestyle-interventions-for-severe-mental-illnesses-lifetrain-100639056",false,"NCT07586150","Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)","Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies","LIFETRAIN","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Able and willing to provide written informed consent\n* Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.\n* Female participants of childbearing potential must agree to use an effective method of contraception\n* Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks\n* Reduced functioning at screening defined as SF-36 score less than or equal to 40\n* If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day\n* Stable somatic condition for at least 4 weeks\n* For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg\u002Fm² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg\u002Fm²\n* For optional adaptive neurostimulation: MADRS score at least 19\n* Expected ability to comply with study procedures in the investigator's judgment\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Current or past neurological disorder or structural brain pathology that may affect study procedures\n* Known intolerance or hypersensitivity to semaglutide\n* Pregnancy or lactation\n* Serious suicidal risk\n* Substance dependence within the last 3 months\n* BMI less than 18.5 kg\u002Fm²\n* eGFR less than 30 mL\u002Fmin\u002F1.73 m²\n* Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes\n* Pancreatitis, history of pancreatitis, or pancreatic cancer\n* Multiple endocrine neoplasia type 2 or personal\u002Ffamily history of medullary thyroid cancer\n* Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis\n* Need for acute surgery\n* Other medical condition that may affect study procedures or participant safety\n* For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment","ALL","18 Years","65 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.",[28,29,30,31],"Severe Mental Illness","Depression \u002F Major Depressive Disorder","Bipolar Disorder (BD)","Schizophrenia","NOT_YET_RECRUITING","2026-05-07",{"date":35,"type":36},"2026-05-14","ACTUAL",{"date":38,"type":22},"2028-10",{"date":40,"type":22},"2030-12",{"name":42,"class":43},"Ludwig-Maximilians - University of Munich","OTHER",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100636459","holep-thulep---comparing-lasers-for-bph-surgery-100636459","NCT07565961","HoLEP-ThuLEP - Comparing Lasers for BPH Surgery","Prospective Randomized Comparative Study Evaluating Functional and Perioperative Outcomes After Thulium Laser Enucleation of the Prostate (ThuLEP) Versus Holmium Laser Enucleation of the Prostate (HoLEP)","HOT","Inclusion Criteria:\n\n* Male, age ≥ 18 years\n* Clinically relevant benign prostatic syndrome (BPS) with an established indication for surgical treatment\n* International Prostate Symptom Score (IPSS) ≥ 8\n* Prostate volume \\> 40 ml\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Proven or suspected prostate cancer\n* Previous surgery of the prostate or urethra\n* Neurogenic bladder dysfunction\n* Anticoagulation therapy that cannot be paused perioperatively","MALE",{"count":55,"type":22},150,[25],"Benign prostatic hyperplasia (BPH) is a very common condition in older men. As the prostate enlarges, it can press on the urethra and make urination difficult. Typical symptoms include a weak urinary stream, frequent urination, getting up at night to urinate, and a feeling that the bladder is not fully empty. When medication is no longer sufficient, surgical removal of the inner part of the prostate (\"enucleation\") is the recommended treatment.\n\nTwo modern laser techniques are used for this operation. Holmium Laser Enucleation of the Prostate (HoLEP) is currently considered the reference standard, with very good long-term results and a low rate of re-operations. Thulium Laser Enucleation of the Prostate (ThuLEP) using a pulsed thulium laser is a newer alternative. Because the laser energy is delivered in short pulses, ThuLEP may allow more precise tissue cutting and better control of bleeding during surgery.\n\nSo far, only limited high-quality randomized data directly compare the two techniques, particularly for patient-reported outcomes such as urinary symptoms, continence, and erectile function.\n\nPurpose of the study The HoT-Trial investigates whether ThuLEP is as effective as HoLEP for men who need surgery for an enlarged prostate, and whether there are differences in recovery, complication rates, urinary symptoms, continence, and erectile function after surgery.\n\nResearch question Does ThuLEP lead to a similar improvement in lower urinary tract symptoms (LUTS) as HoLEP 12 months after surgery, measured by the change in the International Prostate Symptom Score (IPSS)?\n\nHow the study works A total of 150 men aged 18 years or older with clinically relevant BPH, an IPSS of 8 or higher, a prostate volume above 40 ml, and an indication for surgery will take part. Each participant will be randomly assigned (1:1) to either ThuLEP or HoLEP. Participants are blinded to the assigned technique (single-blind design). Both procedures are established, guideline-recommended treatments; taking part in the study does not add any risks beyond standard care.\n\nBefore surgery, participants complete standardized questionnaires (IPSS, ICIQ-SF, IIEF) and undergo uroflowmetry and residual urine measurement. Surgery is performed according to randomization. Participants are then followed up in the urology outpatient clinic at discharge and at 3, 6, and 12 months after surgery. The same measurements and questionnaires are repeated at each visit.\n\nPrimary outcome Change in IPSS from baseline to 12 months after surgery.\n\nSecondary outcomes Maximum urinary flow rate (Qmax) and post-void residual urine; continence (ICIQ-SF) and erectile function (IIEF); operative time, laser time, blood loss, transfusion rate; catheter indwelling time and length of hospital stay; peri- and postoperative complications graded by the Clavien-Dindo classification; and the rate of re-intervention or re-catheterization within 12 months.\n\nSetting and timeline The study is conducted as a single-center trial at the Department of Urology, Ludwig-Maximilians-University Munich, Germany. Recruitment runs for approximately two years, with up to 12 months of follow-up per participant. The total study period is planned from April 2026 to April 2029.\n\nBy directly comparing the two laser enucleation techniques in a randomized setting, the HoT-Trial aims to help patients and physicians choose the most suitable surgical treatment for benign prostatic hyperplasia.",[59],"BPH (Benign Prostatic Hyperplasia)",[61,62,63,64,65,66,67],"BPH","BPS","Enculeation","Prostate","Laser","HOLEP","THULEP","RECRUITING","2026-05-02",{"date":33,"type":36},{"date":72,"type":22},"2026-06-01",{"date":74,"type":22},"2027-12-31",{"name":42,"class":43},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":76},"100578035","preoperative-physical-activity-before-radical-cystectomy-and-the-impact-on-morbidity-100578035","NCT06806059","Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity","Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy","PRACTICE","Inclusion Criteria:\n\n* Urothelial cell cancer of the bladder\n* Treatment with radical cystectomy\n\nExclusion Criteria:\n\n* Need for walking aid\n* Depression\n* cardiovascular, neuromuscular or orthopaedic deficites \u002F disorders\n* Time to surgery \\\u003C 3 Weeks",{"count":86,"type":22},146,[25],"Bladder cancer (BC) is the 6th most common tumor in Europe, with over 540,000 new cases globally each year. While 75% of cases are non-muscle-invasive and treated bladder-preservingly, muscle-invasive, non-metastatic BC requires radical cystectomy (RC), often with neoadjuvant chemotherapy. RC has one of the highest complication rates in urology, and rehabilitation focuses on mitigating functional impairments, restoring physical and mental capacity, and enabling a swift return to daily life.\n\nThe ERAS (Enhanced Recovery After Surgery) protocol has shown benefits in reducing hospital stays without increasing complications in RC. Prehabilitation studies in cancer patients have demonstrated improvements in strength and fitness, though without significant reductions in complications or mortality.\n\nThis prospective randomized study, conducted over three years at the University of Munich, will evaluate the effect of preoperative physical activity on perioperative morbidity (primary endpoint). Secondary endpoints include quality of life, hospital stay, mortality, and postoperative physical activity. The intervention group will target 8,000-10,000 daily steps for four weeks preoperatively, monitored via pedometers. Follow-ups will assess physical activity and quality of life at specific intervals pre- and post-surgery.",[90],"Urothelial Carcinoma Bladder",[92,93,94,95,96,97],"physical activity","preoperative","cystectomy","activity tracker","physical fitness","complication","2026-04-22",{"date":100,"type":36},"2026-04-27",{"date":102,"type":36},"2024-11-29",{"date":104,"type":22},"2027-11-29",{"name":42,"class":43},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":76},"100631767","dementia-friendly-apothecaries-as-a-resource-for-mental-heath-in-the-elderly-100631767","NCT07504965","Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly","Demenz-freundliche Apotheken Als Ressource für Psychische Gesundheit im Alter","DARE","Inclusion Criteria\n\n1. Age: Participants must be 60 years or older at the time of consent.\n2. Language Proficiency: Sufficient knowledge of the German language to understand instructions and participate in the study.\n3. Cognitive Status: Presence of self-reported, relative-reported, or pharmacist-identified cognitive impairments (e.g., memory problems or mild cognitive changes).\n4. Consent: Ability to provide informed consent voluntarily.\n\nExclusion Criteria\n\n1. Severe Sensory Impairments: Participants unable to see or hear well enough to complete the digital assessments or questionnaires.\n2. Previous Dementia Diagnosis: Individuals with a prior formal diagnosis of dementia, whether with or without underlying pathology.\n3. Severe Cognitive or Physical Impairments: Any condition that would prevent meaningful participation in the digital tests or structured screening process.\n\nThese criteria aim to ensure that the study includes participants at risk of early cognitive decline while excluding those for whom the interventions or assessments would not be feasible or relevant.",true,"60 Years","90 Years",{"count":118,"type":22},1020,"OBSERVATIONAL","The DARE study (Dementia-Friendly Apothecaries as a Resource for Mental Health in the Elderly) is a multicenter, prospective cohort study aiming to identify individuals with cognitive impairments early in pharmacies and enhance their access to support services. Partner pharmacies are equipped with memory test stations, and pharmaceutical staff are trained to guide participants. The digital memory test evaluates cognitive, psychosocial, and health factors, displaying results in a traffic light graphic. Participants with concerning results are referred to specialists or support services.\n\nThe study's primary goals are to establish pharmacies as dementia screening hubs, improve care for affected individuals, promote interdisciplinary collaboration, and lay the groundwork for legal and billing frameworks. An optional subproject validates the screening through neurological evaluations.",[122,123],"Mild Cognitive Impairment","Mild Dementia",[125,126,127,128,129,130],"Dementia-friendly pharmacies","Cognitive impairment","Early detection","Accessible healthcare","Digital cognitive assessments","Prevention of dementia","2026-03-26",{"date":133,"type":36},"2026-04-01",{"date":135,"type":36},"2025-07-01",{"date":137,"type":22},"2027-07-31",{"name":42,"class":43},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":76},"100618790","pairing-subjective-patient-rating-and-dbs-programming-100618790","NCT07336199","Pairing Subjective Patient Rating and DBS Programming","Pairing Subjective Patient Rating and Local Field Potentials for DBS Programming","PERCEPT-DBS","Inclusion Criteria:\n\nAge between 35 and 80 years\n\nClinically confirmed idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria\n\nStatus post bilateral deep brain stimulation of the subthalamic nucleus (STN-DBS)\n\nImplanted DBS system suitable for electrophysiological recordings (prospective cohort: sensing-enabled IPG)\n\nAbility to understand study procedures and communicate reliably with the investigator\n\nWritten informed consent provided\n\nExclusion Criteria:\n\nAny condition impairing the ability to provide informed consent or comply with study procedures\n\nPresence of exclusion criteria for Parkinson's disease according to MDS criteria\n\nManifest dementia according to ICD-10 criteria\n\nSevere neurological, psychiatric, or medical conditions interfering with study participation or assessments","35 Years","80 Years",{"count":150,"type":22},25,"This multicenter, prospective and retrospective diagnostic study investigates personalized programming strategies for deep brain stimulation (DBS) in patients with Parkinson's disease. DBS of the subthalamic nucleus (STN) is an established therapy for advanced Parkinson's disease; however, optimization of stimulation parameters remains time-consuming and resource-intensive due to the growing complexity of electrode designs and programming options.\n\nThe PERCEPT-DBS study aims to improve DBS programming by combining subjective patient-reported outcomes with objective electrophysiological biomarkers. Specifically, the study examines the relationship between patients' subjective assessment of stimulation efficacy, measured using a visual analogue scale (VAS), and local field potentials (LFPs), with a focus on beta-band activity recorded from implanted DBS electrodes. These data are integrated with structural and functional neuroimaging to identify individualized stimulation \"sweet spots\" within the STN.\n\nA total of 24 patients with idiopathic Parkinson's disease treated with bilateral STN-DBS will be recruited across several German DBS centers. Participants undergo standardized clinical assessments, VAS-based blinded monopolar reviews, and LFP recordings using sensing-enabled implantable pulse generators. In addition, imaging-based analyses are performed to relate electrophysiological and subjective measures to anatomical and connectomic features.\n\nThe primary objective is to determine whether electrophysiological markers correlate with subjective patient ratings and whether their overlap defines personalized optimal stimulation targets. By integrating patient perception with neurophysiological and imaging data, this study seeks to advance individualized DBS programming strategies and contribute to the development of more efficient, patient-centered, and potentially adaptive DBS therapies.",[153],"Parkinson's Disease (PD)","2026-01-12",{"date":156,"type":36},"2026-01-14",{"date":158,"type":36},"2024-12-02",{"date":160,"type":22},"2026-10-01",{"name":42,"class":43},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":76},"100605194","assessment-of-daily-stressors-in-children-with-depressive-symptoms-for-the-development-of-a-gamified-emotion-regulation-app-100605194","NCT07159347","Assessment of Daily Stressors in Children With Depressive Symptoms for the Development of a Gamified Emotion Regulation App","Assessment of Stressors in Children With Depressive Symptoms for the Development of an App to Strengthen Emotional Competences Using Serious Games and Gamification.","SG4ChildD","Inclusion Criteria (Children):\n\n* increased depressive symptoms indicated by either (1) self report assessed with Beck Depression Inventory for Youth 2 (Beck et al., 2019; T-score \\> 60) , or (2) parental report assessed with DISYPS-III - external rating scale for depressive disorders (FBB-DES; Döpfner et al., 2017; applying gender- and age-normed Stanine scores ≥ 7).\n\nExclusion Criteria (Children):\n\n* Insufficient German language skills\n* Acute suicidality\n* Schizophrenic disorder\n* Severe developmental disorder\n* Mental and behavioral disorders due to psychotropic substances\n\nInclusion Criteria (Parents):\n\nParent of a child meeting the above inclusion criteria","8 Years","12 Years",{"count":173,"type":22},15,"Digital interventions, such as serious games, are becoming increasingly important in the context of prevention and treatment approaches of mental disorders. A project (SG4ChildD) funded by the Federal Ministry of Research, Technology and Space (BMFTR) aims to develop a gamified app to promote emotion regulation in children aged 8 to 12 with increased depressive symptoms or a manifest diagnosis of depression. The app intends to train emotion regulation skills through playful and everyday-relevant scenarios. To ensure that the app meets the needs of the target group, a participatory needs assessment will be conducted that involves both children and their parents. Based on interviews with children and focus groups with parents and complemented by questionnaires, it will be assessed which everyday stressors children experience, how they cope with them, and what kind of support they and their parents find helpful.",[176,177,178],"Depressive Disorder","Depression in Children","Depressive Symptoms",[180,181,182,183,184,185,186,187],"depression","daily hassles","qualitative interviews","focus groups","serious gaming","gamification","participatory needs assessment","emotion regulation skills","2025-09-03",{"date":190,"type":36},"2025-09-08",{"date":192,"type":36},"2025-09-02",{"date":194,"type":22},"2026-12",{"name":42,"class":43},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":206,"conditions":207,"keywords":216,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":76},"100525407","precision-medicine-in-stroke-evolution-of-plasma-brain-derived-tau-in-acute-stroke-100525407","NCT06121336","PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke","PRecisiOn Medicine In StrokE Study on the Evolution of Plasma Brain-Derived Tau in 100 Patients With Acute Ischemic Stroke","PROMISE-BD-100","Inclusion Criteria:\n\n* clinical diagnosis of acute ischemic stroke\n* presentation within 9 hours of symptom onset\n* large- or medium-vessel occlusion (i.e. an occlusion of the ICA, MCA \\[segments M1-M4\\], ACA \\[segments A1-A3\\], basilar artery, or PCA \\[segments P1 to P3\\]) confirmed by CT or MRI angiography\n* at least 18 years of age\n* written informed consent\n\nExclusion Criteria:\n\n* CT or MRI showing intracranial hemorrhage upon admission\n* A history of ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage, subdural hematoma, epidural hematoma, CNS tumor, meningitis, or encephalitis within the last three months\n* severe renal dysfunction (eGFR \\\u003C 30ml\u002Fmin\u002F1.73m2)\n* dementia\n* pre-stroke disability defined as a premorbid modified Rankin Scale score \\> 1",{"count":205,"type":22},100,"The investigators recently identified Brain-derived tau (BD-tau) as a sensitive blood-based biomarker for brain injury in acute ischemic stroke: in patients with acute ischemic stroke, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome. While informing on the relation of BD-tau with imaging-based metrics of brain injury, this cross-sectional study was restricted to BD-tau assessments upon admission and at day 2 and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. Here, the investigators aim to assess plasma BD-tau every hour from admission to 48 hours after onset to evaluate the hypothesis that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset.",[208,209,210,211,212,213,214,215],"Stroke","Stroke, Acute","Stroke, Ischemic","Cerebrovascular Disorders","Brain Diseases","Central Nervous System Diseases","Brain Ischemia","Nervous System Diseases",[208,217,218,219],"Brain injury","Biomarker","Pathophysiology",{"date":221,"type":36},"2025-09-04",{"date":223,"type":36},"2023-03-01",{"date":225,"type":22},"2026-09-30",{"name":42,"class":43},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":76},"100443803","amyloid--clearance-mechanisms-in-alzheimers-disease-100443803","NCT05059158","Amyloid-β Clearance Mechanisms in Alzheimer's Disease","Amyloid-β Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease","AmyClearAD","Inclusion Criteria:\n\n* Diagnosis of amnestic MCI or AD dementia or clinical normal\n* Able to provide written informed consent\n* Unchanged pharmacotherapy within 4 days prior to the study specific assessments\n* Fluent in German\n\nExclusion Criteria:\n\n* Unable to give informed consent or has a legal guardian\n* Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder\n* Clinically relevant depression\n* Acute suicidality\n* Current alcohol, drug or medication abuse\n* History of severe traumatic brain injury within 3 months prior to inclusion\n* Structural lesions of the basal ganglia or brain stem\n* Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus\n* Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension\n* Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication\n* Renal failure \\> stage 3 (GFR \\\u003C 30 mL\u002Fmin)\n* Pregnancy\n* Unresolved malignancies within two years prior to inclusion\n* Severe current infections or other chronic or systemic disorders\n* Other circumstances which preclude participation based on the investigator's judgement","50 Years","85 Years",{"count":238,"type":22},60,"The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.",[241],"Alzheimer's Disease (AD)",[243,122,244,245,246,247],"Alzheimer's Disease","Sleep","Actigraphy","Blood-brain-barrier","Amyloid-β Clearance Mechanisms",{"date":249,"type":36},"2025-07-04",{"date":251,"type":36},"2021-06-01",{"date":253,"type":22},"2025-10",{"name":42,"class":43},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":114,"sex":17,"minAge":235,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":76},"100570800","german-validation-study-of-the-subjective-cognitive-decline-questionnaire-scd-q-100570800","NCT06711952","German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q)","German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q) and Its Potential Use in Large Cohorts","Inclusion Criteria:\n\n* Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum\n* Provision of signed, written and dated informed consent\n* Capacity to give informed consent\n\nExclusion Criteria:\n\n* dementia in a very advance stage\n* Illiteracy",{"count":263,"type":22},300,[25],"The SCD-Q (Subjective Cognitive Decline-Questionnaire) is an established instrument to quantify self-perceived cognitive decline. Both self- and informant-rated versions of the SCD-Q are available. However, the SCD-Q has not been validated in the German language yet. Hence, the investigators aim to validate the self-reported SCD-Q in a clinical sample in Germany.",[267,268],"Alzheimer Disease","Subjective Cognitive Decline",[243,268,270],"German Validation","2025-05-22",{"date":273,"type":36},"2025-05-29",{"date":275,"type":36},"2023-02-01",{"date":277,"type":22},"2025-08-31",{"name":42,"class":43},{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":298,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100504026","patient-centred-deprescribing-of-psychotropic-sedative-and-anticholinergic-medication-in-elderly-patients-with-polypharmacy-100504026","NCT05842928","Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy","Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial","PARTNER","Inclusion Criteria:\n\n* Aged 65 years or older\n* Patient is capable of giving consent\n* GP contact in the quarter prior to inclusion\n* Current use of ≥ 5 drugs, including ≥ 1 PSA-PIM (hypnotics, opioids, gabapentinoids, antipsychotics, antidepressants, anticholinergic urospasmolytics) with a treatment duration of ≥ 6 months\n* Willingness to select a regular pharmacy for the study period\n* Consent to data exchange between GP and community pharmacy\n\nExclusion Criteria:\n\n* Terminal illness (life expectancy \\\u003C 6 months)\n* Current treatment of pain associated with cancer\n* Other serious physical illness or mental distress (e.g. bereavement) that makes participation in the study impossible (according to the GP's assessment)\n* Psychiatric illness or addiction that makes participation in the study impossible (according to the GP's assessment)\n* Unable to meet the requirements of the study (participation in telephone or written questionnaires, visits to the GP practice or community pharmacy, alone or with the help of caregivers for physical infirmity)\n* Current participation in research projects on medication safety or geriatric medicine",{"count":288,"type":22},352,[25],"The PARTNER study is a multicentre, two-arm, pragmatic cluster-randomised trial evaluating the impact of a focused and patient-centred cooperation between general practitioners (GPs) and community pharmacists (PARTNER intervention) on reductions in the use of psychotropic, sedative and anticholinergic potentially inappropriate medication (PSA-PIM) compared to a control intervention. The PARTNER intervention comprises (1) education for health care professionals, (2) an interprofessional workshop and case conference, (3) a pharmacy visit with brown bag\u002Fmedication review and patient empowerment, (4) GP practice visit with shared decision making. The control intervention only comprises a pharmacy visit with brown bag review.",[292,293,294,295,296,297],"Deprescriptions","Antidepressive Agents","Antipsychotic Agents","Analgesics, Opioid","Hypnotics and Sedatives","Cholinergic Antagonists",[299,300,301,302,303],"Polypharmacy","General Practice","Primary Health Care","Pharmacies","Medication Safety","2025-04-30",{"date":306,"type":36},"2025-05-04",{"date":308,"type":36},"2023-03-25",{"date":310,"type":22},"2026-10",{"name":42,"class":43},3,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":76},"100573655","plaque-imaging-in-routine-care-to-detect-intraplaque-hemorrhage-100573655","NCT06749106","Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage","PARADE","Inclusion Criteria:\n\n* Patients with acute ischemic stroke\n* Availability of non-contrast carotid MRI scans obtained through routine diagnostic work-up\n\nExclusion Criteria:\n\n* Infarct in the posterior circulation or bilateral ischemic infarcts\n* Time between symptom onset and non-contrast carotid MRI \\> 10 days\n* Prior stenting of a carotid artery or carotid endarterectomy\n* Age \\\u003C 18 years\n* Life expectancy \\\u003C 1 year\n* Inability to provide written informed consent\n\nThis eligibility criteria apply for the prospective part of the PARADE study.",{"count":263,"type":22},"The aim of this study is to investigate the association between intraplaque hemorrhage (IPH) detected by non-contrast magnetic resonance imaging (MRI) of the carotid artery in routine clinical practice and ipsilateral acute ischemic events. The investigators' overarching aim is to determine whether this sequence aids the diagnostic work-up of stroke patients.\n\nFor this purpose, the investigators set up a prospective single-center longitudinal observational study with one year follow-up. In addition, this study will analyze retrospectively obtained data collected through clinical routine.",[323],"Acute Ischemic Stroke",[325,326,327,328,329,330,331,332,333,334],"plaque imaging","plaque vulnerability","cryptogenic stroke","routine care","stroke etiology","recurrent stroke","intraplaque hemorrhage","IPH","acute ischemic stroke","AIS","2025-01-21",{"date":337,"type":36},"2025-01-24",{"date":339,"type":36},"2025-01-16",{"date":341,"type":22},"2029-12-31",{"name":42,"class":43},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":114,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":76},"100567476","evaluation-of-the-naturalistic-user-experience-of-the-website-ich-bin-alles-schule-i-am-everything-school-100567476","NCT06668688","Evaluation of the Naturalistic User Experience of the Website \"ich Bin Alles @Schule\" (i Am Everything @school)","Evaluation of the Naturalistic User Experience of the Website \"ich Bin Alles @Schule\" (i Am Everything @school) - an Information Platform for Educational Professionals on Depression and Mental Health in Childhood and Adolescence","Inclusion Criteria:\n\n* 40 seconds Website-use\n\nExclusion Criteria:\n\n\\-",{"count":205,"type":22},"The aim of this study is to investigate the naturalistic user experience and acceptance of the German website \"ich bin alles @Schule\". This website for educational professionals offers information on depression and mental health of pupils. Another aim of this study is to determine whether the desired target groups of the website can be reached.",[353,176,177,354],"Depression","Depression in Adolescence",[180,356,357,358,359,360,361,362,363],"prevention","web-based","adolescents","mental health","school","user experience","acceptance","teachers","2024-10-30",{"date":366,"type":36},"2024-10-31",{"date":368,"type":36},"2024-07-05",{"date":370,"type":22},"2025-07",{"name":42,"class":43},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":114,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":76},"100567477","evaluation-of-the-naturalistic-user-experience-of-the-website-ich-bin-alles-100567477","NCT06668701","Evaluation of the Naturalistic User Experience of the Website \"ich Bin Alles\"","Evaluation of the Naturalistic User Experience of the Website \"ich Bin Alles\" - an Information Platform for Children and Adolescents with and Without Depression and Their Relatives","Inclusion Criteria:\n\n* 40 seconds website-use\n\nExclusion Criteria:\n\n* no exclusion criteria",{"count":263,"type":22},"Using a multi-method approach, the aim of this study is to investigate the naturalistic user experience and acceptance of the German website \"ich bin alles\". This website offers evidence-based information about the symptoms, causes, course, treatment, and prevention of youth depression. Another aim of this study is to determine whether the desired target groups of the website can be reached.",[176,353,177,354],[180,356,357,358,383,361,362],"depression literacy",{"date":366,"type":36},{"date":386,"type":36},"2024-06-20",{"date":388,"type":22},"2025-06",{"name":42,"class":43},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":76},"100451068","infectious-complications-after-cystectomy-a-prospective-observational-study-100451068","NCT05153694","Infectious Complications After Cystectomy: A Prospective Observational Study","Inclusion Criteria:\n\n* Disease which requires removal of the urinary bladder\n\nExclusion Criteria:\n\n* Patient does not want to participate",{"count":397,"type":22},200,"Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.",[400,401,402,403,404,405,406,407],"Bladder Cancer","Infections","Infection, Bacterial","Infection, Hospital","Infection Wound","Urinary Tract Infections","Urinary Bladder Diseases","Urinary Tract Disease","2024-09-13",{"date":410,"type":36},"2024-09-19",{"date":412,"type":36},"2021-12-01",{"date":414,"type":22},"2025-12-31",{"name":42,"class":43},{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100379750","phase-2-atezolizumabbevacizumab-followed-by-on-demand-tace-or-initial-synchronous-treatment-with-tace-and-atezolizumabbevacizumab-100379750","NCT04224636","Atezolizumab\u002FBevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab\u002FBevacizumab","A Randomized, 2-arm Non-comparative Phase II Study on the Efficacy of Atezolizumab and Roche Bevacizumab (Atezo\u002FBev) Followed by On-demand Selective TACE (sdTACE) Upon Detection of Disease Progression or of Initial Synchronous Treatment With TACE and Atezo\u002FBev on 24-months Survival Rate in the Treatment of Unresectable Hepatocellular Carcinoma Patients","DEMAND","Key Inclusion Criteria\n\n1. Patient's signed informed consent\n2. Age ≥18 years at time of signing Informed Consent Form\n3. Ability to comply with the study protocol, according to investigator's judgement\n4. Life expectancy of at least 12 weeks\n5. HCC with histologically confirmed diagnosis\n6. Disease that is not amenable to curative surgical and\u002For local ablation but eligible for TACE\n7. ECOG Performance Status of 0 or 1\n8. Child-Pugh class A or B7\n9. Adequate hematologic and end-organ function\n10. Negative HIV test at screening\n\nKey Exclusion Criteria\n\n1. Diffuse HCC or presence of vascular invasion or extrahepatic spread or more than 7 lesions or at least one lesion \\>= 7 cm\n2. Clinically relevant ascites\n3. Uncontrolled pleural effusion or pericardial effusion\n4. History or presence of hepatic encephalopathy\n5. Co-infection of HBV and HCV\n6. Patients on a liver transplantation list.\n7. Prior systemic therapy for HCC\n8. Prior treatment with TACE or selective internal radiation treatment (SIRT)\n9. Any condition representing a contraindication to TACE\n10. Major gastrointestinal bleeding within 4 weeks prior to randomization, untreated or incompletely treated varices with bleeding or high-risk for bleeding.\n11. Active or history of autoimmune disease or immune deficiency\n12. Prior allogeneic stem cell or solid organ transplantation\n13. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n14. Active tuberculosis\n15. Severe infection requiring antibiotics within 4 weeks prior to randomization\n16. Significant cardiovascular disease\n17. History of congenital long QT syndrome or corrected QT interval \\>500 ms at screening ECG\n18. Inadequately controlled arterial hypertension or prior history of hypertensive crisis or hypertensive encephalopathy\n19. Significant vascular disease including aortic aneurysm requiring surgical repair or peripheral arterial thrombosis with 6 months prior to randomization\n20. History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.\n21. History or clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure\n22. History of intra-abdominal inflammatory process within 6 months prior to randomization, including but not limited to peptic ulcer disease, diverticulitis, or colitis\n23. Evidence of bleeding diathesis or significant coagulopathy\n24. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n25. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at enrollment.\n26. Severe, non healing or dehisced wound, active ulcer, or untreated bone fracture\n27. History of malignancy other than HCC, with the exception of patients who have been disease-free for at least five years before enrollment or patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer\n28. Current or recent (within 10 days of randomization) use of acetylsalicyclic acid or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol\n29. Current or recent (within 10 days prior to randomization) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose.\n30. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.\n31. Treatment with a live, attenuated vaccine within 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab\n32. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and antiPD-L1 therapeutic antibodies\n33. Hypersensitivity to atezolizumab or bevacizumab or any of the excipients, known hypersensitivity to Chinese hamster ovary cell products, known hypersensitivity to human or humanized antibodies\n34. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization\n35. Treatment with systemic immunosuppressive medication within 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n    Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible.\n\n    Inhaled corticosteroids for chronic obstructive pulmonary disease or bronchial asthma, supplemental mineralocorticosteroids or low-dose corticosteroids for adrenalcortical insufficiency are allowed.\n36. Major surgical procedure other than for diagnosis, open biopsy, or significant traumatic injury within 28 days prior to randomization, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to randomization or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure\n37. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of bevacizumab\n38. Pregnant or breastfeeding females\n39. Participation in a clinical trial or experimental drug treatment within 28 days prior to inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n40. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n41. Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator",{"count":425,"type":22},106,[427],"PHASE2","Aim of the study is to evaluate the efficacy of up-front atezolizumab\u002F bevacizumab (Atezo\u002FBev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo\u002FBev in the treatment of unresectable HCC patients.",[430],"Hepatocellular Carcinoma Non-resectable","2024-06-12",{"date":433,"type":36},"2024-06-14",{"date":435,"type":36},"2020-06-10",{"date":437,"type":22},"2025-03-01",{"name":42,"class":43},7,{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100160664","prospective-cohort-with-incident-stroke-100160664","NCT01364168","Prospective Cohort With Incident Stroke","PROSCIS","Inclusion Criteria:\n\n* Age ≥18 years\n* Language: German\n* First ever acute ischemic stroke that occurred with stroke onset in the last 7 days\n* Written informed consent by patient prior to study participation\n* Willingness to participate in follow-up\n\nExclusion Criteria:\n\n* Prior stroke (definition according to WHO criteria)\n* Patients presenting brain tumour or brain metastasis\n* Participation in an intervention- \u002F AMG-study",{"count":448,"type":22},850,"The primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. For this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 3, 12, 24 and 36 months.",[451],"Ischemic Stroke","2024-03-18",{"date":454,"type":36},"2024-03-19",{"date":456,"type":36},"2011-02",{"date":458,"type":22},"2027-12",{"name":42,"class":43},2,{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":76},"100365125","phase-2-optimal-anti-egfr-treatment-of-mcrc-patients-with-low-frequency-ras-mutation-100365125","NCT04034173","Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation","FIRE-5 -Study: Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation","Inclusion Criteria:\n\n* Histologically confirmed, UICC stage IV metastatic adenocarcinoma of the colon or rectum\n* Primarily non-resectable metastases or surgical resection refused by the patient\n* RAS mutation determined by the local pathology\n* Age ≥18\n* ECOG performance status 0-2\n* Patients suitable for chemotherapy administration\n* Patient's written declaration of consent obtained\n* Estimated life expectancy \\> 3 months\n* Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria\n* Primary tumor tissue available and patient consents to storage and molecular and genetic profiling of tumor material. Molecular profiling of blood samples is optionally performed.\n* Adequate bone marrow function:\n\n  * Leukocytes ≥ 3.0 x 109\u002FL with neutrophils ≥ 1.5 x 109\u002FL\n  * Thrombocytes ≥ 100 x 109\u002FL\n  * Haemoglobin ≥ 5.6 mmol\u002FL (equivalent to 9 g\u002FdL)\n* Adequate hepatic function:\n\n  * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)\n* Adequate renal function:\n\n  ▫ Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL\u002Fmin\n* No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumor load, symptoms) may have received one application of FOLFIRI prior to study treatment.\n\nExclusion Criteria:\n\n* Previous chemotherapy for metastatic disease with the exception of one cycle of FOLFIRI (e.g. while waiting for the result of RAS mutation frequency).\n* Patients planned to be treated with FOLFOX or another oxaliplatin-based regimen as first-line treatment\n* Primarily resectable metastases and the patient agrees to resection\n* Grade III or IV heart failure (NYHA classification)\n* Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study\n* Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study\n* Participation in an investigational clinical study or experimental drug treatment within 30 days prior to study inclusion or within a period of 5 half-lives of the substances administered in the investigational clinical study or during an experimental drug treatment prior to inclusion in the study, depending on which period is longest\n* Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, panitumumab, irinotecan, and chemically related substances and\u002For hypersensitivity to any of the excipients of any of the aforementioned substances including known hypersensitivity reactions to monoclonal antibodies NCI CTCAE Grade ≥ 3.\n* Known hypersensitivity to Chinese hamster ovary cell (CHO) - cellular products or other recombinant human or humanised monoclonal antibodies\n* History of uncontrolled bronchial asthma\n* Patients with interstitial pneumonitis or pulmonary fibrosis\n* Patients with known brain metastasis\n* History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea\n* Symptomatic peritoneal carcinomatosis\n* Severe, non-healing wounds, ulcers or bone fractures\n* Patients with acute or chronic infection requiring systemic therapy\n* Known history of positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Active or chronic Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive; serologic tests required in patients who receive study treatment).\n* Known DPD deficiency (specific screening not required)\n* Known glucuronidation deficiency (Gilbert's syndrome);(specific screening not required\n* Treatment with sorivudine or brivudine within 28 days before study enrollment or requirement for concomitant antiviral treatment with sorivudine or brivudine\n* History of a second primary malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.\n* Known previous or ongoing alcohol or drug abuse\n* Pregnant or breast-feeding patients\n* Any other severe concomitant disease or disorder which, in the investigator's opinion, could influence the patient's ability to participate in the study or influence his\u002Fher safety during the study or interfere with interpretation of study results\n* Both, absent and restricted legal capacity",{"count":469,"type":22},120,[427],"The present hypothesis is that anti-EGFR agents are active in tumors with low-level RAS mutation when the majority of tumor cells is still sensitive. While response rate may be high and may reflect sensitivity to anti-EGFR agents, PFS is anticipated to be shorter than in RAS wild-type patients due to the faster development of resistance when sensitive cells are eradicated and when the RAS-mutant anti-EGFR resistant clones become predominant.\n\nThe characteristics of low-level RAS mutant tumors would be:\n\n* Objective response rate (ORR) high (reflecting the sensitive clone)\n* Progression-free survival (PFS) short (reflecting the more rapid outgrowth of RAS mutant clones)",[473],"Treatment Related Cancer",[475,476,477,478,479],"colorectal cancer","FIRE","low-RAS","mCRC","Panitumumab","2019-07-24",{"date":482,"type":36},"2019-07-26",{"date":484,"type":22},"2019-08-01",{"date":486,"type":22},"2026-08-01",{"name":42,"class":43},{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":496,"conditions":497,"keywords":501,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":76},"100346601","prospective-observational-trial-to-evaluate-quality-of-life-after-definitive-chemoradiation-in-patients-with-anal-cancer-lanacare-100346601","NCT03792854","Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)","LANACARE","Inclusion Criteria:\n\n* histologically proven anal cancer without distant metastases\n* indication for definitive chemoradiation therapy based on multidisciplinary evaluation\n* age \\>=18 years\n* written informed consent\n* ability to answer the standardized questionaires according to the treating physician\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* prior systemic therapy with regard to anal cancer\n* distant metastases\n* second malignancy",{"count":205,"type":22},"Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer",[498,499,500],"Anal Cancer","Quality of Life","Chemoradiation",[502,503,504],"anal cancer","quality of life","chemoradiation","2019-01-02",{"date":507,"type":36},"2019-01-03",{"date":509,"type":36},"2018-12-01",{"date":194,"type":22},{"name":42,"class":43},{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":76},"100341864","prospective-observational-trial-to-evaluate-quality-of-life-after-neoadjuvant-radiation-or-chemoradiation-followed-by-surgery-in-patients-with-rectal-cancer-100341864","NCT03731130","Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer","Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer","NEOCARE","Inclusion Criteria:\n\n* histologically proven rectal Cancer without distant metastases\n* indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation\n* age \\>=18 years\n* written informed consent\n* ability to answer the standardized questionaires according to the treating physician\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* prior systemic therapy with regard to rectal Cancer\n* distant metastasis\n* second malignancy",{"count":205,"type":22},"Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery",[523,499,524,500],"Rectal Cancer","Radiation Therapy",[526,503,527,528,504],"rectal cancer","neoadjuvant","radiation therapy","2018-11-02",{"date":531,"type":36},"2018-11-06",{"date":533,"type":36},"2018-10-05",{"date":535,"type":22},"2026-12-31",{"name":42,"class":43},{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":76},"100340458","prospective-observational-trial-to-evaluate-quality-of-life-after-neoadjuvant-or-definitive-chemoradiation-in-patients-with-esophageal-cancer-100340458","NCT03712774","Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer","ESOCARE","Inclusion Criteria:\n\n* histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)\n* indication for neoadjuvant or definitive chemoradiation using either cisplatin\u002F5-FU or carboplatin\u002Fpaclitaxel with curative intent\n* age \\>= 18 years\n* written informed consent\n* ability to answer the standardized questionaires according to the treating physician\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* Treatment with palliative intent\n* distant metastases (except supraclavicular nodes)\n* second malignancy\n* Prior systemic treatment for esophageal Cancer\n* Treatment in an interventional study",{"count":238,"type":22},"Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.",[499,500,547],"Esophageal Cancer",[503,527,549,504,550],"definitive","esophageal cancer","2018-10-18",{"date":553,"type":36},"2018-10-19",{"date":555,"type":36},"2018-10-12",{"date":535,"type":22},{"name":42,"class":43},{"id":559,"slug":560,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":566,"conditions":567,"keywords":571,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":76},"100305234","prospective-observational-trial-to-evaluate-quality-of-life-after-stereotactic-ablative-radiation-therapy-in-patients-with-hepatocellular-carcinoma-100305234","NCT03253536","Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma","LIVERCARE","Inclusion Criteria:\n\n* histologically or radiologically proven hepatocellular carcinoma\n* 1-3 lesions suitable for stereotactic radiation therapy\n* indication for SBRT according to multidisciplinary board evaluation\n* age \\>= 18 years\n* written informed consent for study participation\n* mental and verbal ability to complete standardized questionaires according to assessment by investigator (physician)\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* prior HCC specific systemic therapy\n* concurrent oncological systemic treatment\n* distant metastases\n* inadequate ability tobe compliant with the protocol or to complete standardizes questionaires\n* inability to receive contrast-enhanced planning CT\n* missing ability to give informed consent\n* legal custody",{"count":205,"type":22},"Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.",[568,499,569,570],"Hepatocellular Cancer","Stereotactic Body Radiation Therapy","Observational",[568,499,572,573],"stereotactic body radiation therapy","observational","2017-08-16",{"date":576,"type":36},"2017-08-18",{"date":578,"type":36},"2017-07-10",{"date":580,"type":22},"2027-07-10",{"name":42,"class":43},""]