[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital Heidelberg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":641},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,48,74,98,119,138,168,189,228,250,276,297,317,341,363,383,403,432,462,489,514,535,563,590,611],{"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":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100581477","heidelberg-registry-for-hip-and-knee-joint-implants-and-revisions-100581477",false,"NCT06850818","Heidelberg Registry for Hip and Knee Joint Implants and Revisions","Endoprosthesis Registry Heidelberg (EPR-HD): Registry for the Analysis of Patients Following Primary Implantation or Revision Surgery of Artificial Joints in Hip and Knee Joint Pathologies","EPR-HD","Inclusion Criteria:\n\n* All patients undergoing hip or knee arthroplasty at our institution\n* All patients undergoing revision surgery following hip oder knee arthroplasty\n\nExclusion Criteria:\n\n* Lack of prospective consent for study participation\n* Lack of capacity to provide informed consent\n* Minor status (underage)","ALL","18 Years",{"count":21,"type":22},10000,"ESTIMATED","20 Years","OBSERVATIONAL","The Endoprosthesis Registry Heidelberg (EPR-HD) is a clinical registry designed to systematically collect and analyze data from patients undergoing primary implantation or revision surgery of artificial hip and knee joints. The main objective of the registry is to evaluate long-term outcomes, complication rates, implant survival, and functional results associated with joint replacement procedures in patients with various hip and knee joint pathologies.\n\nBy gathering comprehensive clinical data, EPR-HD aims to improve the understanding of patient outcomes after endoprosthetic procedures, identify potential factors influencing implant success, and support evidence-based improvements in surgical techniques and patient care. The registry includes adult patients treated at Heidelberg University Hospital, with data collected at multiple time points during routine clinical follow-up. This registry will contribute to the optimization of joint replacement strategies and promote high-quality patient care.",[27,28],"Osteoarthritis","Arthroplasty",[30,28,31,27,32,33,34],"Endoprostheses","Joint Replacement","Registry","Knee","Hip","RECRUITING","2026-06-10",{"date":38,"type":39},"2026-06-11","ACTUAL",{"date":41,"type":39},"2007-01-01",{"date":43,"type":22},"2035-12",{"name":45,"class":46},"University Hospital Heidelberg","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100642393","the-role-of-gender-in-borderline-personality-disorder-100642393","NCT07639957","The Role of Gender in Borderline Personality Disorder","What Role Does Gender Play in Relationship and Self Experiences of Individuals With Borderline Personality Disorder?","BPD-G","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Individuals of all genders (target: n=5 with female gender identity, n=5 with nonbinary\u002Ftrans\\*\u002Fgender-non-conforming (TGNC) gender identity, n=5 with male gender identity) between the ages of 18 and 65 at the time of consent\n3. Individuals with a BPD diagnosis made within the last 2 years (ICD-10: F60.3; DSM-5: 301.83, ICD-11: Borderline qualifier)\n4. Understanding of the study procedure, ability and willingness to participate\n5. The participant is able to read and understand the informed consent form and can provide a written, personally signed, and dated informed consent form.\n\nExclusion Criteria:\n\n1. Acute suicidal ideation or acute psychotic symptoms reported by the patient or suspected\n2. Insufficient language skills (i.e., knowledge of German or English)","65 Years",{"count":58,"type":22},15,"This study is a mixed-methods, single-arm cross-sectional study comprising 1) a qualitative, exploratory, critical-constructivist content analysis examining the significance of gender in relationship experiences and self-perception among individuals with borderline personality disorder and various gender identities, and 2) a pilot study on the use of the Single-Category Implicit Association Test (SC-IATs, adapted from von Hippel et al., 2018) as preparation for a larger-scale experimental psychological study using the SC-IAT to assess implicit gender- and BPD-related thought processes in people with borderline personality disorder and various gender identities.\n\n15 individuals with BPD and different gender identities will be assessed. The research questions are:\n\n1. What gender-related relationship- and self-experiences can be identified in people with BPD? How do experiences relate to observer-coded and self-reported mentalization ability, as well as self-reported symptoms, experiences of stigmatization, and quality of life?\n2. Is there preliminary evidence that Single-Category Implicit Association Tests (SC-IATs) are suitable and reliable instruments for measuring implicit gender- and BPD-related thought processes in people with BPD?",[61],"Borderline Personality Disorder (BPD)",[63,64,65,66],"Borderline Personality Disorder","Gender","Grounded Theory","Implicit Association Test","2026-06-07",{"date":36,"type":39},{"date":70,"type":22},"2026-05-29",{"date":72,"type":22},"2027-03-31",{"name":45,"class":46},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100420249","glioblastoma-radiotherapy-using-imrt-or-proton-beams-100420249","NCT04752280","Glioblastoma Radiotherapy Using IMRT or Proton Beams","GRIPS","Inclusion Criteria:\n\n* histologically confirmed gliomblastoma WHO IV (operated or after biopsy)\n* Indication for radiotherapy \u002F radiochemotherapy\n* Informed consent\n* KI ≥ 60% or ECOG 0\u002F1\n* Age ≥ 18 years\n* Sufficient effective contraception\n\nExclusion Criteria:\n\n* Patient is not able to consent\n* Previous radiotherapy in the brain or skull base\n* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)\n* Contraindication to MRI imaging\n* Simultaneous participation in another clinical trial that could influence the outcome of this study or other study",{"count":82,"type":22},326,"INTERVENTIONAL",[85],"NA","Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.",[88],"Glioblastoma","2026-05-21",{"date":91,"type":39},"2026-05-27",{"date":93,"type":39},"2021-04-19",{"date":95,"type":22},"2033-01-19",{"name":45,"class":46},3,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":83,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":47},"100479618","mode-of-sedation-during-endovascular-treatment-of-vertebrobasilar-stroke-100479618","NCT05525325","Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke","MOONRISE","Inclusion Criteria:\n\n1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment\n2. Age 18 years or older, either sex\n3. National Institutes of Health Stroke Scale (NIHSS) ≥ 4\n4. Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA)\n5. Informed consent by the patient him-\u002Fherself or his\u002Fher legal representative obtainable within 72 h of treatment (deferred consenting procedure)\n\nExclusion Criteria:\n\n1. Intracerebral hemorrhage\n2. Coma on admission (Glasgow Coma Scale ≤ 8)\n3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary\n4. Intubated state before randomization\n5. Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)",{"count":106,"type":22},128,[85],"Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia",[110],"Stroke Thrombectomy","2026-04-29",{"date":113,"type":39},"2026-04-30",{"date":115,"type":39},"2022-10-01",{"date":117,"type":22},"2029-01",{"name":45,"class":46},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":47},"100409584","registry-study-of-proton-radiotherapy-in-lymphoma-100409584","NCT04613388","Registry Study of Proton Radiotherapy in Lymphoma","Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas","Inclusion Criteria:\n\nHistologically confirmed lymphoma according to WHO\n\n* Patient consent\n* Patient age ≥18 years.\n* Presence of the need for mediastinal radiotherapy and the presumed benefit of mediastinal radiotherapy using protons in comparison to photon radiation (e.g. improved heart, lungs, and breast protection compared to photon radiation).\n* Ability of the patient to give consent\n\nExclusion Criteria:\n\nAge \\\u003C18 years\n\n* Non-consent of the patient to the disclosure of his data\n* Cancellation of the patient's participation in the study",{"count":127,"type":22},200,"The aim is to record and document a mediastinal PT and the corresponding follow-up data (effectiveness and side effects). General recommendations for planning and feasibility are made within the framework of this study.",[130],"Mediastinal Lymphoma","2026-04-28",{"date":111,"type":39},{"date":134,"type":39},"2018-08-01",{"date":136,"type":22},"2031-08-01",{"name":45,"class":46},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":83,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100512001","phase-2-cyclosporine-in-takotsubo-syndrome-100512001","NCT05946772","Cyclosporine In Takotsubo Syndrome","Cyclosporine In Takotsubo Syndrome (CIT) Trial","CIT","Key inclusion criteria:\n\n* Patients aged over 18\n* Enrollment and first IMP administration within 24 hours after cardiac catheterization\n* Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography\n* InterTAK prognostic score- or a GEIST Score ≥ 9 -\n* Written informed consent\n\nKey exclusion Criteria:\n\n* Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)\n* Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion)\n* History of hypersensitivity to cyclosporine\n* History of hypersensitivity to egg, peanut or soybean proteins\n* History of chronic renal insufficiency (either creatinin clearance \\\u003C30 ml\u002Fmin\u002F1.73m² or current medical care for severe renal insufficiency)\n* History of liver insufficiency\n* Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure \\>180mmHg and\u002For diastolic blood pressure \\>110mmHg)\n* Current medication with any compound containing Hypericum perforatum (St. John's worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine \\>5mg within 24h intake\\\u003C48h before IMP administration)\n* Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception\n* Any disorder associated with immunological dysfunction ≤6 months prior to presentation (autoimmune disease, known positive serology for HIV or hepatitis)\n* Immunosuppressive, chemotherapeutical, or antibody treatment\n* Participation in other clinical trials except for non interventional trials",{"count":147,"type":22},204,[149],"PHASE2","The goal of this clinical trial is to investigate the impact of repetitive acute Cyclosporine A (CsA) bolus therapy in patients suffering from TTS with an elevated risk of impaired outcome. The main question it aims to answer is whether CsA reduces myocardial injury (primary outcome). Participants will receive CsA or placebo at baseline and every 12h in the first 24h after study inclusion. Researchers will compare CsA and the placebo group to see if a) myocardial injury is reduced, and b) ejection fraction is improved compared to baseline, as well as several other secondary endpoints over a one year follow-up.",[152],"Takotsubo Cardiomyopathy",[154,155,156,157,158],"Takotsubo syndrome","Troponin","Cyclosporine","Inflammation","Acute heart failure","2026-04-27",{"date":161,"type":39},"2026-05-01",{"date":163,"type":39},"2025-02-01",{"date":165,"type":22},"2028-02",{"name":45,"class":46},24,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":83,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":47},"100435142","neoadjuvant-irradiation-of-extremity-soft-tissue-sarcoma-with-ions-100435142","NCT04946357","Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions","EXTREM ION","Inclusion Criteria:\n\n* Histologically confirmed soft-tissue sarcoma of the extremities with an indication for perioperative radiation treatment\n* Resectable or marginally resectable\n* Karnofsky index of ≥ 70%\n* Age ≥ 18 years\n* Carried out patient education and written consent\n* Patient is capable to give informed consent\n\nExclusion Criteria:\n\n* Stage IV (distant metastases)\n* Lymph node metastasis\n* Metal implants that influence treatment planning with ions\n* Previous radiotherapy in the treatment area\n* Desmoid tumors\n* Simultaneous participation in another clinical trial that could influence the results of the study.\n* Active medical implants for which no ion beam irradiation permit exists at the time of treatment (e.g., cardiac pacemaker, defibrillator)",{"count":176,"type":22},42,[85],"This randomized prospective open-label phase 2 trial testes the safety and feasibility of a hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate of wound healing disorders from beginning of radiotherapy to maximum 120 days after the planned tumor resection or discontinuation of treatment due to any reason. The treatment is of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most patients and thus enhance quality of life. The treatment regimen furthermore promises a reduced rate of late side effects and significant optimization of the current treatment standards. A phase II trial is mandatory not only for obtaining the safety and feasibility data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully completed based on previous experiences in trials for seldom tumor entities.",[180],"Soft Tissue Sarcoma","2026-03-31",{"date":183,"type":39},"2026-04-06",{"date":185,"type":39},"2021-06-21",{"date":187,"type":22},"2029-07-01",{"name":45,"class":46},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":83,"phases":200,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":47},"100625264","ambulatory-stroke-unit-treatment-for-elderly-patients-100625264","NCT07420374","Ambulatory Stroke Unit Treatment for Elderly Patients","Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)","ARTIFICE","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.\\*)\n* Symptom onset ≤ 7 days before enrollment\n* No or non-disabling newly occurring neurological deficit allowing safe ambulatory management\n* Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative\n\nExclusion Criteria:\n\n* Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)\n* Fluctuating stroke symptoms within the previous 48 hours\n* Acute febrile infection or isolation-requiring infectious disease\n* Clinically relevant dysphagia with high aspiration risk\n* Critical medical or nursing findings requiring mandatory multi-day inpatient treatment\n* Palliative care situation with limitation of acute diagnostic or therapeutic measures\n* Previous participation in the ambulatory stroke unit care model\n* No statutory health insurance coverage in Germany\n* Insufficient German language proficiency to understand study procedures and assessments","60 Years",{"count":199,"type":22},400,[85],"ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits.\n\nEligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design).\n\nSecondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.",[203,204,205],"Ischemic Stroke","Transient Ischemic Attack (TIA)","Retinal Ischemia",[207,208,209,210,211,212,213,214,215,216,217,218,219,220,221],"Ambulatory Stroke Unit","Stroke Unit Care","Minor Stroke","Transient Ischemic Attack","Geriatric Stroke","Non-Inferiority Trial","Health Services Research","Care Delivery Model","Integrated Stroke Care","Post-Stroke Outcome","Modified Rankin Scale","Quality of Life","Cost-Effectiveness","Stroke Recurrence","Delirium","2026-03-25",{"date":181,"type":39},{"date":222,"type":39},{"date":226,"type":22},"2028-12",{"name":45,"class":46},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":83,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100376780","carbon-ion-re-radiotherapy-in-patients-with-recurrent-or-progressive-locally-advanced-head-and-neck-cancer-100376780","NCT04185974","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy","CARE","Inclusion Criteria:\n\n* Locally recurrent \u002F progressive head-and-neck cancer after initial radiation therapy\n* Microscopic or macroscopic tumor after salvage surgery\n* Indication for re-irradiation\n* Completed wound healing after surgical intervention\n* Karnofsky-Performance-Score ≥ 60\n* Age ≥ 18 years\n* Written informed consent (must be available before enrolment in the trial)\n* Ability of subject to understand character and individual consequences of the trial\n* For women with childbearing potential, (and men) adequate contraception\n* Submission of previous radiotherapy records\n\nExclusion Criteria:\n\n* Re-irradiation of malignancy in the larynx\n* Diagnosed plasmocytoma, sarcoma or chordoma\n* Previous re-irradiation in-field\n* Time interval \\\u003C 6 months after initial radiotherapy\n* Distant metastases (except pulmonary metastases)\n* Patients who have not recovered from acute toxicities of prior therapies\n* Refusal of the patients to take part in the study\n* Pregnant or lactating women\n* Known carcinoma \\\u003C5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy\n* Participation in another clinical study or observation period of competing trials, respectively",{"count":237,"type":22},72,[85],"After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.\n\nIn the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity\u002F safety, local progression-free survival, overall survival and quality-of-life.",[241],"Locally Advanced Head-and-Neck Cancer","2026-03-21",{"date":222,"type":39},{"date":245,"type":39},"2020-08-25",{"date":247,"type":22},"2031-01-30",{"name":45,"class":46},2,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":258,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":83,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":47},"100589454","partial-breast-re-irradiation-for-breast-cancer-100589454","NCT06954623","Partial Breast Re-irradiation for Breast Cancer","Partial Breast Re-irradiation for Breast Cancer Recurrences After Repeat Breast-conserving Surgery With Proton Beam Therapy","BREAST","Inclusion Criteria:\n\n* histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast\n* indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, …)\n* tumor size \\\u003C 3 cm\n* clinically node-negative (cN0)\n* negative resection margin (R0)\n* time interval: start of re-RT to prior RT ≥ 12 months\n* ECOG Performance status ≤ 2\n* ability of subject to understand character and individual consequences of the clinical trial\n* written informed consent\n* ≥18 years of age\n\nExclusion Criteria:\n\n* distant metastases\n\n  * concomitant chemotherapy (concomitant endocrine hormonal therapy is allowed; sequential chemotherapy is allowed)\n  * patients who have not recovered from acute toxicities of prior therapies\n  * known carcinoma \\\u003C 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy\n  * pregnant or lactating women\n  * participation in another competing clinical study or observation period of competing trials\n  * history of active connective tissue disorder (i.e. systemic lupus erythematosus, scleroderma, dermatomyositis, xeroderma pigmentosum, …)\n  * medical implants, which are at the time of reirradiation not eligible for particle therapy at Heidelberg Ion Beam Therapy Center","FEMALE",{"count":260,"type":22},20,[85],"Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-specific mortality. However, nodal-negative women have a 10-year risk for local recurrences after RT in up to 15.6%. The management of ipsilateral breast cancer recurrence depends on the extent of tumor disease and staging results at the time of recurrence and mastectomy is currently the standard of care for previously irradiated patients. The application of particle therapy using proton beam therapy (PBT) represents an innovative radiotherapeutic technique for breast cancer patients. This trial will be conducted as a prospective single-arm phase II study in 20 patients with histologically proven invasive breast cancer recurrences with negative margins after repeat BCS and with an indication for local re-irradiation. Required time interval will be 1 year after previous RT to the ipsilateral breast. Patients will receive partial breast re-RT with proton beam therapy in 15 once daily fractions up to a total dose of 40.05 GyRBE. The primary endpoint is defined as the cumulative overall occurrence of acute \u002F subacute skin toxicity grade ≥3 within 6 months after the start of re-RT.",[264],"Breast Cancers",[266,267],"re-irratdiation","proton beam","2026-03-06",{"date":270,"type":39},"2026-03-10",{"date":272,"type":39},"2025-08-28",{"date":274,"type":22},"2029-10-01",{"name":45,"class":46},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":83,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":47},"100547449","phase-2-predicting-esophageal-cancer-borders-using-pet-imaging-100547449","NCT06408116","Predicting Esophageal Cancer Borders Using PET-Imaging","Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS","PEGASUS","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation\n* Planned surgical treatment of esophageal carcinoma\n* Possible staging advantage through FAPI PET\u002FCT diagnostics\n* Patient information and written consent\n\n  -\\> KI 60% or ECOG 0\u002F1 (at least: self-sufficiency)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Previous radiation therapy in the tumor region\n* Previous tumor disease with \\\u003C 5 years of remission\n* Surgical therapy is not functionally or technically possible\n* Distant metastasis\n* Patient is not capable of giving consent\n* Concurrent participation in another clinical trial that could affect the results of this trial or the other trial\n* Illnesses that do not allow the person concerned to assess the nature and scope as well as possible consequences of the clinical study\n* pregnant or breastfeeding women\n* Signs that the person taking part is unlikely to comply with the therapy (e.g. unwillingness to cooperate)",{"count":285,"type":22},30,[149],"The study examines the diagnostic precision of endosonography, mpMRI and PET\u002FCT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery.",[289,290],"Esophagus Cancer, Stage I","Esophagus Cancer, Stage II",{"date":270,"type":39},{"date":293,"type":39},"2024-03-01",{"date":295,"type":22},"2028-04",{"name":45,"class":46},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":83,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":47},"100524146","plasma-extracellular-vesicles-in-meningioma-patients-100524146","NCT06104930","Plasma Extracellular Vesicles in Meningioma Patients","Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy","MOLI","Inclusion Criteria:\n\n* confirmed meningioma (histologically or MRI\u002FDOTATOC-PET CT)\n* macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)\n* indication for radiotherapy\n* completed wound healing after surgical intervention)\n* Alter ≥ 18 Jahre\n* Karnofsky Performance Score ≥ 60%\n* written informed consent\n* ability of subject to understand character and individual consequences of the trial\n* adequate contraception for women of childbearing potential\n\nExclusion Criteria:\n\n* previous or known tumor diseases \\\u003C 5 years ago\n* previous (cerebral) radiotherapy\n* simultaneous chemo\u002Fimmunotherapy\n* evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)\n* the refusal of patients to participate in the study\n* participation in another clinical study or observation period in a competing trial",{"count":306,"type":22},60,[85],"While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.",[310],"Meningioma",{"date":270,"type":39},{"date":313,"type":39},"2023-11-01",{"date":315,"type":22},"2028-02-01",{"name":45,"class":46},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":83,"phases":326,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":47},"100468350","the-cyberchallenge-trial-how-much-is-too-much---what-is-the-role-of-cyberknife-radiosurgery-in-patients-with-multiple-brain-metastases-100468350","NCT05378633","The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?","CyberChallenge","Inclusion Criteria:\n\n* histologically confirmed malignant illness\n* 4-15 suspect intracranial lesions, taking into consideration all available MRI series\n* age ≥ 18 years of age\n* For women with childbearing potential, (and men) adequate contraception.\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent (must be available before enrolment in the trial)\n\nExclusion Criteria:\n\n* Refusal of the patients to take part in the study\n* Inability to tolerate irradiation consistent with the protocol\n* Small-cell lung cancer (SCLC) or lymphoma as primary malignant illness\n* \\>15 suspect intracranial lesions, taking into consideration all available MRI series\n* leptomeningeal disease\n* Previous radiotherapy of the brain\n* Patients who have not yet recovered from acute high-grade toxicities of prior therapies\n* Pregnant or lactating women\n* Participation in another competing clinical study or observation period of competing trials, respectively\n* MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)",{"count":325,"type":22},190,[85],"Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.\n\nTherapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (\\>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.",[329,330],"Brain Metastases","Nsclc",[332,333,334],"Metastases","Cyberknife","Lung Cancer",{"date":270,"type":39},{"date":337,"type":39},"2022-02-24",{"date":339,"type":22},"2028-02-24",{"name":45,"class":46},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":83,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":47},"100441388","phase-2-magnetic-resonance-guided-adaptive-stereotactic-body-radiotherapy-for-hepatic-metastases-100441388","NCT05027711","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -","MAESTRO","Inclusion Criteria:\n\n* confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma)\n* 1-3 hepatic metastases confirmed by pre-therapeutic MRI\n* indication for SBRT of 1-3 hepatic metastases\n* maximum diameter each hepatic metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm)\n* age ≥ 18 years of age\n* Karnofsky Performance Score ≥ 60%\n* ability to lie still on the radiotherapy treatment couch for at least one hour\n* ability to hold one's breath for more than 25 seconds\n* for women with childbearing potential, adequate contraception\n* ability of subject to understand character and individual consequences of the clinical trial\n* written informed consent (must be available before enrolment in the trial)\n\nExclusion Criteria:\n\n* refusal of the patients to take part in the study\n* patients with primary liver cancer (eg. HCC, CCC)\n* patients after liver transplantation\n* impairment of liver function to an extent contraindicating radiotherapy (to the discretion of the treating radiation oncologist)\n* active acute hepatic\u002Fbiliary infection (e.g. hepatitis, cholangitis, cholecystitis)\n* previous radiotherapy of the hepatobiliary system, if previous and current target volumes overlap MAESTRO Study Studienprotokoll Seite 25 von 54 Version 1.0 vom 17.12.2020\n* patients who have not yet recovered from acute toxicities of prior therapies\n* claustrophobia\n* pregnant or lactating women\n* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)\n* participation in another competing clinical study or observation period of competing trials",{"count":350,"type":22},90,[149],"Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastases. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. MR-guided radiotherapy (MRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT).",[354],"Hepatic Metastasis",[356],"Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy",{"date":270,"type":39},{"date":359,"type":39},"2021-08-12",{"date":361,"type":22},"2030-01-31",{"name":45,"class":46},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":83,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":47},"100379332","neoadjuvant-irradiation-of-retroperitoneal-soft-tissue-sarcoma-with-ions-retro-ion-100379332","NCT04219202","Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion","Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie","Retro-Ion","Inclusion Criteria:\n\n* Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable\n* Karnofsky index of ≥ 70%\n* Age from 18 years\n* Completed patient information and written consent\n* ability to give consent\n\nExclusion Criteria:\n\n* Stage IV (distant metastases)\n* Lymphogenic metastasis\n* Metal implants at the level of the sarcoma, which influence the treatment planning\n* Previous radiation therapy in the treatment area\n* Desmoid tumors, peritoneal sarcomatosis, GIST\n* Simultaneous participation in another clinical study that could influence the results of the respective study\n* Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)\n* Pregnant women",{"count":372,"type":22},64,[85],"The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and \u002F or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.",[376],"Sarcoma,Soft Tissue",{"date":270,"type":39},{"date":379,"type":39},"2019-05-09",{"date":381,"type":22},"2027-05-09",{"name":45,"class":46},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":390,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":83,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":47},"100368947","prostate-cancer-patients-treated-with-alternative-radiation-oncology-strategies-100368947","NCT04083937","Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies","PAROS","Inclusion Criteria:\n\n* histology-proven prostate cancer with Gleason Score and PSA-value;\n* indication for prostate bed irradiation (adjuvant\u002F salvage) after prostatectomy;\n* Karnofsky-Index ≥ 70%\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* androgen deprivation therapy\n* lymphatic spread\n* macroscopic tumor\u002F R2\n* stage IV (M1)\n* previous irradiation","MALE",{"count":392,"type":22},897,[85],"As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an \"adjuvant\" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.\n\nThe current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.",[396],"Prostate Cancer",{"date":398,"type":39},"2026-03-09",{"date":400,"type":39},"2018-09-12",{"date":117,"type":22},{"name":45,"class":46},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":410,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":83,"phases":412,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":47},"100627036","microbiological-and-clinical-effects-of-pre--and-probiotics-in-non-surgical-periodontal-therapy-100627036","NCT07443410","Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy","PROPARO","Inclusion Criteria:\n\n* Age ≥ 18 years\n\n  * Stage III or IV periodontitis (localized or generalized)\n  * Ability to provide informed consent\n  * Written informed consent including data protection consent\n\nExclusion Criteria:\n\n* • Pregnancy or breastfeeding\n\n  * Conditions\u002Fmedications likely to substantially confound the oral microbiome or periodontal healing (e.g., uncontrolled diabetes mellitus, systemic immunosuppression, chronic steroid use)\n  * Antibiotic use within the last 3 months\n  * Use of oral pre-\u002Fprobiotic supplements within the last 3 months\n  * Recent subgingival instrumentation within the last 6 months\n  * Need for obligatory adjunctive systemic antibiotic prophylaxis\u002Ftherapy for NSPT\n  * Severe active systemic infection or other conditions judged by investigators to pose undue risk\n  * Regular use of antiseptic mouthrinses during the study period (unless medically required)\n  * Strict diets likely to substantially alter baseline microbiome trajectories (e.g., ketogenic, strict vegan) per protocol definition\n  * Chronic bowel diseases (for systemic confounding considerations)",true,{"count":306,"type":22},[85],"Periodontitis is a prevalent chronic inflammatory disease driven by a dysbiotic oral biofilm and a dysregulated host immune response. Standard non-surgical periodontal therapy (NSPT) is primarily mechanical and, in selected cases, may be accompanied by antiseptics or systemic antibiotics. Targeted modulation of the oral microbiome (\"microbiome engineering\") is currently not part of routine periodontal care due to limited high-quality evidence.\n\nPROPARO is a single-center, randomized, controlled pilot study designed to assess whether adjunctive oral supplementation with a probiotic containing Limosilactobacillus reuteri (commercial dietary supplement lozenge) alone or combined with vitamin B12 (commercial dietary supplement drops) is associated with changes in supragingival and subgingival oral microbiome composition during guideline-concordant NSPT compared with standard care alone. Participants with Stage III or IV periodontitis will be randomized 1:1:1 to: (1) NSPT\u002FSPT without supplementation (control), (2) NSPT\u002FSPT plus probiotic lozenges for 3 months, or (3) NSPT\u002FSPT plus probiotic lozenges and vitamin B12 drops for 3 months.\n\nThe primary outcome is change in oral microbiome composition and structure (supragingival and subgingival), assessed using 16S rDNA-based profiling and metagenomic sequencing approaches. Secondary outcomes include clinical periodontal parameters (e.g., probing depth, clinical attachment level, bleeding on probing), oral hygiene\u002Fgingival indices, dental status, and participant-level ecological covariates (diet quality, perceived stress, physical activity). Sampling and assessments are aligned with routine care time points from baseline through supportive periodontal therapy follow-up (up to 12 months). This pilot trial aims to generate feasibility and effect-size estimates to inform future confirmatory studies and potential translation into guideline-based periodontal care.",[415,416,417],"Periodontitis, Adult","Periodontitis (Stage 3)","Periodontitis Stage IV",[419,420,421,422,423],"Periodontitis","Non-surgical periodontal treatment","Probiotics","Prebiotics","Oral Microbiome","2026-02-24",{"date":426,"type":39},"2026-03-02",{"date":428,"type":39},"2024-10-25",{"date":430,"type":22},"2026-10",{"name":45,"class":46},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":83,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":453,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":47},"100622786","exercise-therapy-for-multiple-myeloma-patients-100622786","NCT07388147","Exercise Therapy for Multiple Myeloma Patients","Structural Measures for Multiple Myeloma Patients to Improve Rehabilitation by Exercise Therapy","SAPPHIRE-MM","Inclusion Criteria:\n\n* newly diagnosed multiple myeloma\n* Survival prognosis \\> 6 months\n* ECOG status ≤ 3\n* Age ≥18 years\n* Patients who state that they want to carry out the training program at least 2 x\u002Fweek and participate in the planned follow-up visits\n* Ability to give informed consent\n* Written consent to participate in the study\n* Sufficient knowledge of written and spoken German\n\nExclusion Criteria:\n\n* physical or mental limitation that would prevent participation in the training program or the planned follow-up visits","75 Years",{"count":442,"type":22},71,[85],"Physical exercise is an important supportive therapy for cancer patients, as it improves quality of life in general and might mitigate the side effects of drug treatment. For patients with multiple myeloma in particular, significantly less evidence on the effectiveness of exercise therapy is available due to the fact that this disease is associated with severe bone degradation which might affect bone stability. Advances in oncologic drug treatment have improved overall survival in multiple myeloma significantly. Therefore, there is an increased interest for recommendations on physical activity in this patient group. Due to uncertainties regarding safety and feasibility of exercise therapy in multiple myeloma, both patients and therapists often remain hesitant. Therefore, an orthopaedic outpatient clinic has been established at the Myeloma Center of Heidelberg University Hospital. Here, patients receive consultation on bone stability and individualized physical exercise plans. Based on the expertise gained at the orthopaedic outpatient clinic, the aim of this study is to establish and evaluate structural measures for improved rehabilitation in multiple myeloma and to integrate them into routine clinical care.",[446],"Multiple Myeloma Bone Lesions",[448,449,450,451,452],"Implementation of structural measures","Rehabilitation","Exercise therapy","Multiple Myeloma","Bone lesions","NOT_YET_RECRUITING","2026-01-30",{"date":456,"type":39},"2026-02-04",{"date":458,"type":22},"2026-03-01",{"date":460,"type":22},"2029-03-31",{"name":45,"class":46},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":83,"phases":472,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":488},"100464732","phase-3-a-clinical-study-to-improve-brain-function-and-quality-of-life-of-patients-with-newly-diagnosed-brain-tumors-gliomas-100464732","NCT05331521","A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).","Improvement of Functional Outcome for Patients With Newly Diagnosed Grade 2 or 3 Glioma With Co-deletion of 1p\u002F19q - IMPROVE CODEL: the NOA-18 Trial","ImproveCodel","Inclusion Criteria:\n\n1. Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma.\n2. Tumor carries an isocitrate dehydrogenase (IDH) mutation (determined by immunohistochemistry (IHC) and\u002For deoxyribonucleic acid (DNA) sequencing).\n3. Tumor is co-deleted for 1p\u002F19q (determined by copy number variations, fluorescence in situ hybridization (FISH), multiplex ligation-dependent probe amplification (MLPA) or other appropriate methods).\n4. Biopsy (with sufficient tissue for molecular pathology) or resection.\n5. Age: ≥18 years.\n6. Karnofsky Performance status (KPI) ≥60%.\n7. Life expectancy \\>6 months.\n8. Availability of formalin-fixed paraffin-embedded (FFPE) or fresh-frozen tissue and ethylenediamine tetraacetic acid (EDTA) blood for biomarker research.\n9. Standard magnetic resonance imaging (MRI) ≤ 72 h post-surgery according to the present national and international guidelines.\n10. Craniotomy or intracranial biopsy site must be adequately healed.\n11. ≥ 2 weeks and ≤ 3 months from surgery without any interim radio- or chemotherapy or experimental intervention.\n12. Willing and able to comply with regular neurocognitive and health-related quality of life tests\u002Fquestionnaires.\n13. Indication for postsurgical cytostatic\u002F-toxic therapy.\n14. Written Informed consent.\n15. Female patients with reproductive potential have a negative pregnancy test (serum or urine) day -6 until day 0 of screening (and 3 days prior to first IMP-intake or RT). Female patients are surgically sterile or agree to use adequate contraception during the period of therapy and 7 months after the end of study treatment, or women have been postmenopausal for at least 2 years.\n16. Male patients are willing to use contraception\n\nExclusion Criteria:\n\n1. Participation in other ongoing interventional clinical trials.\n2. Inability to undergo MRI.\n3. Abnormal (≥ Grade 2 CTCAE v5.0 laboratory values for hematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine).\n4. Clinically active tuberculosis; known HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV) infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue (e.g. rabies).\n5. Any prior anti-cancer therapy or co-administration of anti-cancer therapies other than those administered\u002Fallowed in this study. History of low-grade glioma that did not require prior treatment with chemotherapy or radiotherapy is not an exclusion criterion.\n6. Immunosuppression, not related to prior treatment for malignancy.\n7. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years.\n8. Any clinically significant concomitant disease (including hereditary fructose intolerance) or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.\n9. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and\u002For follow-up procedures; those conditions should be discussed with the patient before trial entry.\n10. Pregnancy or breastfeeding.\n11. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. (E.g.: In the discretion of the investigator patients are allowed to take part in the study even if they suffer from celiac disease: Cecenu contains very small amounts of gluten (from wheat starch). It is considered gluten-free and is tolerated by patients suffering from celiac disease. One capsule contains no more than 4 micrograms of Gluten.)\n12. QTc time prolongation \\>500 ms.\n13. Patients under restricted medication for procarbazine, lomustine, vincristine and temozolomide.\n14. Liver disease characterized by:\n\n    1. ALT or AST (≥ Grade 2 CTCAE v5.0) confirmed on two consecutive measurements OR\n    2. Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices (≥ Grade 2 CTCAE v5.0) OR\n    3. Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis.\n15. Known uncorrected coagulopathy, platelet disorder, or history of non-drug induced thrombocytopenia.\n16. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; autoimmune-related hypothyroidism (patients on a stable dose of thyroid replacement hormone are eligible for this study) and type I diabetes mellitus (patients on a stable dose of insulin regimen are eligible for this study).\n17. Vaccination with life vaccines during treatment and 4 weeks before start of treatment.\n18. Existing neuromuscular diseases, especially neural muscular atrophy with segmental demyelination (demyelinising form of Charcot-Marie-Tooth syndrome).\n19. Chronic constipation and subileus.\n20. Combination treatment with mitomycin (risk of a pronounced bronchospasm and acute shortness of breath).\n21. Hypersensitivity to dacarbazine (DTIC).\n22. Patients with hereditary galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption (Temodal contains Lactose).\n23. Patients with clinical wheat allergy.",{"count":471,"type":22},406,[473],"PHASE3","Oligodendrogliomas in the novel edition of the Central Nervous System (CNS) World Health Organization (WHO) classification are now molecularly defined by isocitrate dehydrogenase (IDH)1 or IDH2 mutations and 1p\u002F19q co-deletion. The prognosis of these molecularly defined tumors is to be determined in new series since survival data from older histology-based studies and population-based registries are confounded by the inclusion of 20-70% not molecularly matching subsets. Also, the optimal treatment is a matter of ongoing investigations. An extensive, but safe surgery is associated with improved outcome as is the addition of chemotherapy with procarbazine, CCNU (lomustine), and vincristine (PCV) to the partial brain radiotherapy (RT). However, the exact timing of postsurgical therapy especially for tumors of the WHO grade 2 and acknowledging some variability in grading as well as the choice of chemotherapy, temozolomide instead of PCV (CODEL: NCT00887146 randomizing CNS WHO grade 2 and 3 oligodendrogliomas to chemoradiation(CHRT)therapy with PCV or with temozolomide) or the need for primary radiotherapy RT are subjects of clinical studies (POLCA: NCT02444000 randomizing patients with newly diagnosed CNS WHO grade 3 oligodendrogliomas to standard CHRT with PCV or PCV alone). Given the young age of patients with CNS WHO grade 2 and 3 oligodendrogliomas and the relevant risk of neurocognitive, functional and quality-of-life impairment with the current aggressive standard of care treatment, chemoradiation with PCV, of the tumor located in the brain optimizing care is the major challenge.\n\nNOA-18\u002FIMPROVE CODEL aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG), thereby delaying radiotherapy (RT) and adding the chemoradiotherapy (CHRT) concept at progression after initial radiation-free chemotherapy, allowing for an effective salvage treatment and delaying potentially deleterious side effects. QOS represents a new concept and is defined as OS without functional and\u002For cognitive and\u002For quality of life (QOL) deterioration regardless whether tumor progression or toxicity is the main cause.",[476],"Oligodendroglioma",[478,479,480],"Radiotherapy","Chemotherapy","Temozolomide",{"date":482,"type":39},"2026-02-03",{"date":484,"type":39},"2021-04-07",{"date":486,"type":22},"2033-03-31",{"name":45,"class":46},19,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":83,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":513},"100555342","lumbar-drainage-of-intraventricular-hemorrhage-100555342","NCT06510842","Lumbar Drainage of Intraventricular Hemorrhage","Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial","DRAIN IVH","Inclusion Criteria:\n\n* ICH with IVH (with hemorrhage in the 3rd and\u002For 4rth ventricle) with the need for EVD placement due to acute hydrocephalus\n* Age ≥ 18 y\n* Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well\n\nExclusion Criteria:\n\n* Premorbid mRS score \\> 2\n* Pregnancy\n* Life expectancy \\\u003C6 months\n* Patient\u002Ffamily\u002Fcaregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures\u002Fdiscontinuation of life support measures.\n* Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.\n* Other clear contraindication for treatment with a lumbar drain",{"count":498,"type":22},354,[85],"Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.",[502,503,504],"Intraventricular Hemorrhage","Lumbar Drainage","External Ventricular Drainage","2026-01-26",{"date":507,"type":39},"2026-01-28",{"date":509,"type":39},"2025-01-16",{"date":511,"type":22},"2029-07",{"name":45,"class":46},12,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":83,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":47},"100621684","influence-of-supine-positioning-on-the-outcomes-after-descemet-membrane-endothelial-keratoplasty-dmek-100621684","NCT07373821","Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)","SUPINE","Inclusion Criteria:\n\nFuchs Endothelial Corneal Dystrophy Bullous Keratopathy\n\nExclusion Criteria:\n\nComorbidities preventing supine positioning",{"count":522,"type":22},102,[85],"The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain.\n\nThe main questions it aims to answer are:\n\n* Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day?\n* Do participants who lie on their back longer need fewer additional procedures (rebubbling)?\n* What symptoms or problems do participants experience with short vs. long back positioning?\n\nResearchers will compare two groups:\n\n* 1 day of back positioning\n* 5 days of back positioning\n\nParticipants will:\n\n* Be randomly assigned to one of the two positioning groups\n* Wear a movement sensor that records head position\n* Have their eyes checked regularly with vision tests and imaging (AS-OCT)\n* Answer questions about their vision and comfort\n* Keep a diary of any positioning-related complaints, such as back pain",[526,527],"Fuchs Endothelial Corneal Dystrophy","Descemet Membrane Endothelial Keratoplasty (DMEK)","2026-01-23",{"date":507,"type":39},{"date":531,"type":39},"2025-10-02",{"date":533,"type":22},"2027-03",{"name":45,"class":46},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":83,"phases":544,"briefSummary":545,"conditions":546,"keywords":550,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":47},"100596359","fall-risk-assessment-and-an-exercise-intervention-for-prevention-of-falls-in-multiple-myeloma-patients-100596359","NCT07044427","Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients","Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma","Myfall","Inclusion Criteria:\n\n* Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)\n* ECOG status ≤ 3\n* Age ≥18 years\n* Patients who state that they want to carry out the training program at least 3 times\u002Fweek and participate in the planned follow-up visits\n* Ability to give informed consent\n* Written consent to participate in the study\n* Sufficient written and spoken German to complete the questionnaire\n\nExclusion Criteria:\n\n* Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.",{"count":306,"type":22},[85],"Approximately one third of the population over the age of 65 falls at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be implemented.\n\nThe aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.",[451,547,548,549],"Fall Risk Factors","Strength Training Effects","Balance Training Effects",[451,551,552,553,554],"Fall risk","pertubation training","strength training","Balance","2026-01-19",{"date":557,"type":39},"2026-01-22",{"date":559,"type":39},"2024-02-02",{"date":561,"type":22},"2026-12-30",{"name":45,"class":46},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":573,"conditions":574,"keywords":578,"overallStatus":453,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":589,"locationsCount":4},"100619765","predictive-accuracy-of-machine-perfusion-for-kidney-transplant-outcomes-in-germany-100619765","NCT07348874","Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany","Predictive Accuracy of Machine Perfusion Parameters for Kidney Allograft Outcome - A National Analysis Following the Commencement of Hypothermic Machine Preservation of Extended Criteria Donor (ECD) Kidneys in Germany","PRE-MAP-Kidney","Inclusion Criteria:\n\n1. Signed informed consent\n2. Patients 18 years or older\n3. Listed for kidney transplantation (KT)\n4. Receiving ECD\\* donation after brain death kidney allografts following national organ procurement\n5. Kidney allograft being transported at continuous HMP\n6. Transplantation of recipient at a national transplant center\n\n   * Extended Criteria Donation:\n\n1\\. Donor age ≥ 60 years 2. Donor age 50 - 59 plus 2 additional attributes: I. Arterial hypertension in medical history II. Last serum creatinine \\>1.5mg\u002FdL (133mmol\u002FL) III. Cerebrovascular cause of death\n\nExclusion Criteria:\n\n1. Recipients of living donor KT\n2. Combined transplantations (liver-kidney, kidney-pancreas, etc.)\n3. Participation in another intervention-trial with interference of intervention and\u002For outcome of this study\n4. Unwilling or unable to follow the procedures outlined in the protocol\n5. Mentally or legally incapacitated\n6. Inability to understand the procedures due to language barriers",{"count":572,"type":22},300,"Kidney transplantation remains the only definitive treatment for end-stage renal disease, yet the increasing use of extended criteria donor (ECD) kidneys heightens the risk of ischemia-reperfusion injury, particularly under static cold storage (SCS). Continuous hypothermic machine perfusion (HMP) has been introduced to improve preservation quality, but robust clinical evidence regarding its predictive value for post-transplant outcomes in ECD kidneys after donation after brain death (DBD) is limited.\n\nThe PRE-MAP Kidney Study is a prospective, non-interventional, multicenter observational study conducted across all German transplant centers. The study systematically collects technical machine perfusion parameters (flow, resistance, perfusion duration) and correlates these with clinical outcomes following kidney transplantation.\n\nThe primary endpoint is 12-month kidney function (eGFR). Secondary endpoints include surgical complications, length of stay, and transplant-specific events (acute rejection, primary non-function, delayed graft function).\n\nThis national cohort aims to determine the prognostic significance of HMP parameters in marginal donor kidneys and to generate evidence supporting future recommendations for organ preservation and allocation practices.",[575,576,577],"Kidney Transplant","Renal Transplant","Organ Preservation",[579,580,581,582,577,583],"Machine Perfusion","Hypothermic Machine Perfusion","Upfront Machine Perfusion","Continuous Machine Perfusion","Marginal Allograft","2026-01-09",{"date":586,"type":39},"2026-01-16",{"date":555,"type":22},{"date":315,"type":22},{"name":45,"class":46},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":83,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":249},"100616060","functional-mri-for-monitoring-progression-and-assessing-trends-in-ild-100616060","NCT07300696","Functional MRI for Monitoring Progression and Assessing Trends in ILD","Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease","IMPACT-ILD","Inclusion Criteria:\n\n* Clinical indication for a routine HRCT because of either newly diagnosed idiopathic pulmonary fibrosis (IPF) or hypersensitivity pneumonitis (HP) or idiopathic non-specific interstitial pneumonia (iNSIP), suspected diagnosis, or follow-up\n* Capacity to consent\n* Ability to participate fully in the study (defined by the ability to lie still for the duration of imaging)\n\nExclusion Criteria:\n\n* Pregnancy and breast feeding\n* Persons under the age of 18 and persons not able to give informed consent\n* Any medical conditions that could hinder the ability to adhere to the protocol\n* Any MRI contraindication, including previous allergic reactions to Gd-based MRI contrast material and renal dysfunction (eGFR \\\u003C 30 ml min\u002F1,73 m2)",{"count":127,"type":22},[85],"The main objective of this study is to investigate the utility of functional MRI to differentiate, characterize, and monitor subgroups of ILD. This can be broken down into three specific objectives:\n\nDetermine if ILD features observed on high-resolution computed tomography (HRCT), such as ground glass opacities (GGO), are functionally different.\n\nAnalyse MRI metrics within each subgroup to determine whether these metrics distinguish different ILDs.\n\nAssess MRI metrics longitudinally to see if these parameters change with disease progression, stability, or reversibility.",[602],"Interstitial Lung Diseases (ILD)","2025-12-17",{"date":605,"type":39},"2025-12-24",{"date":607,"type":39},"2025-11-20",{"date":609,"type":22},"2027-07",{"name":45,"class":46},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":619,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":83,"phases":622,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":453,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":47},"100606928","is-mentalization-based-therapy-more-effective-than-treatment-as-usual-for-adolescents-with-dissocial-disorders-100606928","NCT07181928","Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders?","Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?","MEDAL","Inclusion Criteria:\n\n* Primary diagnosis of Oppositional defiant disorder (ODD) \u002F Conduct-dissocial disorder (CDD) (ICD-11: 6C90-6C91; ICD-10: F91.0-F91.9; DSM-5: 312.81, 313.81)\n* Aged 12 to 19 years\n* Living with their parents\n* Provide written informed consent (plus parental consent for minors)\n* At least one parent provides written informed consent and agrees to active participation in treatment and study, including randomization\n\nExclusion Criteria:\n\n* Severe acute substance dependence requiring inpatient detoxification\n* Acute psychotic symptoms or early-onset schizophrenia\n* Neurological impairments or intellectual disability (IQ \\\u003C 80)\n* Insufficient proficiency in German\n* Other clinical contraindications for outpatient psychotherapy (e.g., acute suicidality)","12 Years","19 Years",{"count":350,"type":22},[85],"The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders.\n\nMBT is an intervention that aims to improve mentalizing. Mentalizing is the ability to reflect on mental states in oneself and others that motivate behavior. TAU-plus consists of psychiatric care for the adolescent, along with additional emotion-focused skills training for the parents.\n\nParticipants will be randomized in one of two groups using one study center.",[625,626],"Conduct Disorders in Adolescence","Oppositional Defiant Disorder",[628,629,630,631,632],"Adolescence","MBT","Conduct Disorder","Externalizing behaviour disorders","Treatment-as-usual","2025-09-16",{"date":635,"type":39},"2025-09-18",{"date":637,"type":22},"2025-10-01",{"date":639,"type":22},"2028-08-31",{"name":45,"class":46},""]