[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital, Bonn\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":610},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,62,93,152,184,204,224,240,276,306,335,355,374,399,426,452,477,507,525,546,568,585],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100638103","investigation-of-the-individual-fatigue-response-during-blood-flow-restriction-training-100638103",false,"NCT07611526","Investigation of the Individual Fatigue Response During Blood Flow Restriction Training","Investigation of the Individual Fatigue Response During Blood Flow Restriction Training on a Cycle Ergometer Following Orthopedic Surgical Interventions","Inclusion Criteria:\n\n* Elective TKA caused by osteoarthritis of the knee\n* Ability to perform cycling exercise\n* Participant of the Rehab center\n\nExclusion Criteria:\n\n* Open Wounds\n* Iatrogenic Vessel Changes (e.g. Bypasses, Stenting)\n* Sickle Cell Anemia","ALL","18 Years","85 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. The results are intended to contribute to an improved evaluation of load management during BFR training.",[27],"Total Knee Anthroplasty","RECRUITING","2026-06-27",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2026-06-26",{"date":36,"type":21},"2027-03-31",{"name":38,"class":39},"University Hospital, Bonn","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":40},"100615373","blood-flow-restriction-training-in-acute-geriatric-rehabilitation-100615373","NCT07291765","Blood Flow Restriction Training in Acute Geriatric Rehabilitation","Blood Flow Restriction Training in Acute Geriatric Rehabilitation: A Randomized Controlled Trial on Its Effects and Safety in Hospitalized Older Adults.","Inclusion Criteria:\n\n* Adults \\>65 years with a two week hospitalized acute rehabilitation after a fracture closed to the hip joint\n\nExclusion Criteria:\n\n* Sickle Cell Anemia\n* Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)","65 Years",{"count":50,"type":21},60,[24],"Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase the risk of disease. To increase muscle mass and strength, high-intensity resistance training with loads of 70 to 85% of the repetition maximum (1RM) is recommended. However, this type of training poses a major challenge in the rehabilitation sector, as there is also an increased risk of injury due to physical limitations in old age. According to current research, low-intensity occlusion training could therefore represent a safe and effective training alternative. The aim of this study is therefore to examine the feasibility and effects of blood flow restriction training (BFR) on general health in older adults in a rehabilitative setting.",[54],"Sarcopenia in Elderly","2026-05-11",{"date":57,"type":32},"2026-05-14",{"date":59,"type":32},"2026-01-01",{"date":36,"type":21},{"name":38,"class":39},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100578385","phase-2-immunochemotherapy-surgery-or-chemoradiation-and-durvalumab-for-stage-iiiab-nsclc-100578385","NCT06810609","Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA\u002FB NSCLC","Prospective Randomized Phase II Trial on Induction Immunochemotherapy Followed by Surgery or Definitive Chemoradiation and Consolidation Durvalumab (MEDI4736) in Resectable and Borderline Resectable Stage IIIA\u002FB NSCLC","InDuRanS","Inclusion Criteria:\n\n1\\. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\n2\\. Patient is willing and able to comply with the protocol for the duration of the study 3. Age ≥ 18 years and \\\u003C 75 years. 4. All sex and gender. 5. Female patients of childbearing potential as well as male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group (CTFG) during the course of this study and for at least 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n6\\. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.\n\n7\\. Histologically and \u002F or cytologically proven NSCLC (EGFRm-, ALK-). 8.\n\nSelected patients with NSCLC stage IIIA\u002FB:\n\n1. IIIA: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T1\u002FT2 N2.\n2. IIIB: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T3\u002FT4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical\u002Foncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)\u002F European Society of Thoracic Surgeons (ESTS) guidelines (Brunelli et al. 2009) and acceptable general clinical condition for multimodality treatment (interdisciplinary committee).\n\n   13\\. Life expectancy of \\> 12 weeks. 14. Body weight \\> 30 kg. 15.\n\n   Adequate normal organ and bone marrow function as defined below:\n\na. Hemoglobin ≥ 9.0 g\u002FdL. b. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL. c. Platelet count ≥ 100 × 109\u002FL. d. Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n\ne. Alanine aminotransferase (ALT\u002FSGPT) and aspartate aminotransferase (AST\u002FSGOT) ≤ 2.5 × institutional ULN.\n\nf. Measured creatinine clearance (CL) ≥ 60 mL\u002Fmin or calculated creatinine CL ≥ 60 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n\n16\\. Stable cardiac function (no myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV).\n\n17\\. Discussion in a multidisciplinary tumor board which supports participation in this clinical trial, indicating that both chemoradiotherapy and surgery are possible local treatments.\n\nPatients should only be randomized if all of the following inclusion criteria are fulfilled at the time of randomization:\n\n1. Given technical\u002Foncologic complete resectability (R0) at the time of randomization.\n2. Sufficient functional reserves for the planned surgery\n3. Adequate normal organ and bone marrow function as defined before\n\n   Exclusion Criteria:\n\n1\\. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+\u002F EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal involvement. 6. Patients with N3 tumors (IASLC\u002FUICC 8). 7. Invasion of the thoracic aorta (T4 - aorta) or the heart (except left atrium - T4 - heart) or the esophagus (T4 - esophagus), or invasion of spine (T4 - spine) NOTE: T4 with invasion of diaphragm are eligible. 8. Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx). 9. Metastatic disease (M1). 10. Endobronchial tumor extension to the contralateral main stem bronchus. 11. Lung or heart function not allowing the intended surgical procedure at the time of inclusion.\n\n12\\. Prior treatments including prior mediastinal irradiation. 13. Insufficient patients' compliance (e.g., symptomatic psychiatric disorder) or missing written informed consent or definitive refusal for participation.\n\n14\\. Prior randomization of treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n\n15\\.\n\nPatients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:\n\n1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n3. Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.\n\n   NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n\n   16\\. Participation in another clinical study with an investigational product during the last 12 months.\n\n   17\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n   18\\. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.\n\n   19\\. Any concurrent chemotherapy (other than study therapy), Investigational Product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n\n   20\\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.\n\n   21\\. History of allogenic organ transplantation or a stem cell transplantation. 22.\n\n   Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\na. Vitiligo or alopecia b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Celiac disease controlled by diet alone e. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 23. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n\n24\\. History of another primary malignancy except for\n\na. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 25. History of active primary immunodeficiency. 26. History of leptomeningeal carcinomatosis. 27. Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV-1 or HIV-2). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\n28\\.\n\nCurrent or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment.\n\n   31\\. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n   32\\. Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipient.\n\n   33\\. Any medical contraindication to treatment with platin-based doublet chemotherapy as listed in the applying SmPCs.\n\n   34\\. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.\n\n   Patients should not be randomized if any of the following exclusion criteria are fulfilled at the time of randomization:\n\n   1\\. Complete remission after induction immunochemotherapy. 2.\n\n   Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous immunochemotherapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\na. Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n\nb. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician (exception: alopecia).\n\n3\\. Allergy or hypersensitivity to durvalumab or concurrent chemotherapy drugs or any excipient appearing for the first time during previous immunochemotherapy.","74 Years",{"count":72,"type":21},176,[74],"PHASE2","The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA\u002FB compared to existing treatment methods.",[77],"Lung Cancer Non-Small Cell Cancer (NSCLC)",[68,79,80,81,82,83],"Non-Small Cell Lung Cancer","Chemoradiation","Resectable NSCLC","Durvalumab","Induction Immunochemotherapy","2026-01-25",{"date":86,"type":32},"2026-01-27",{"date":88,"type":32},"2025-04-20",{"date":90,"type":21},"2030-09-30",{"name":38,"class":39},5,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":16,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":40},"100617877","slowing-cognitive-decline-in-alpha-synucleinopathies-by-enhancing-physical-activity-100617877","NCT07324330","Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity","ALPHA-FIT","Inclusion Criteria:\n\niRBD:\n\n* Age: 50-80 years\n* Polysomnographically confirmed diagnosis of iRBD\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nHealthy controls:\n\n* Age: 50-80 years\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nExclusion Criteria:\n\niRBD:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n\nHealthy controls:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n* clinically diagnosed iRBD",true,"50 Years","80 Years",{"count":104,"type":21},130,[24],"α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.\n\nThe aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.\n\nEighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the \"Deutsches Zentrum für Neurodegenerative Erkrankungen\" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.",[108,109,110,111,112,113,114,115,116,117],"Parkinson Disease","Prodromal Stage","Neurodegenerative Diseases","Basal Ganglia Diseases","Central Nervous System Diseases","Synucleinopathies","Nervous System Diseases","Cerebral Disorder","Brain Diseases","Parkinsonian Disorders",[119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","biomarker","cognitive decline","executive function","MRI","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","PD","Parkinson","Lewy-body","MSA","multiple system atrophy","dementia","2026-01-14",{"date":146,"type":32},"2026-01-16",{"date":148,"type":32},"2025-12-04",{"date":150,"type":21},"2029-12-01",{"name":38,"class":39},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":40},"100615975","analysis-of-pharmacological-aspects-regarding-infection-free-survival-after-surgical-treatment-of-a-periprosthetic-hip-infection-a-microdialysis-study-100615975","NCT07299591","Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection: a Microdialysis Study","Analysis of Immunological and Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection During Hospitalization: a Microdialysis Study","PJI_H_MD","Inclusion Criteria:\n\n* clinical indication for two-stage revision of hip PJI\n* approval for surgery by the orthopedic and anesthesiologic department\n* being over 18 years of age\n* written, informed consent after detailed patient information about the study protocol and possible study dependent risks\n\nExclusion Criteria:\n\n* \\- known allergies to antibiotics gentamicin and vancomycin used within the spacer",{"count":161,"type":21},30,"OBSERVATIONAL","This study aims to use the technique of microdialysis to analyse the intraarticular space of the hip joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing cement spacer over the entire period of the first hospitalization (usually 14 days) to closely monitor pharmacological and immunological aspects. In detail, antibiotic concentrations in the joint cavity and systemic circulation will be assessed according to reinfection rates, infection-free survival and fucntional outcome over a 12-month folluw-up period.",[165],"Periprosthetic Hip Infection",[167,168,169,170,171,172,173,174,175],"two-stage sxchange","infection","PJI","infection free survival","treatment monitoring","patient reported outcome measures","microdialysis","bone cement","spacer treatment","2025-12-09",{"date":178,"type":32},"2025-12-23",{"date":180,"type":32},"2025-11-15",{"date":182,"type":21},"2027-11-01",{"name":38,"class":39},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":203,"locationsCount":40},"100615973","analysis-of-pharmacological-aspects-regarding-infection-free-survival-after-surgical-treatment-of-a-periprosthetic-knee-infection-a-microdialysis-study-100615973","NCT07299565","Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Knee Infection: a Microdialysis Study","Analysis of Immunological and Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Knee Infection During Hospitalization: a Microdialysis Study","PJI_K_MD","Inclusion Criteria:\n\n* clinical indication for two-stage revision of knee PJI\n* approval for surgery by the orthopedic and anesthesiologic department\n* being over 18 years of age\n* written, informed consent after detailed patient information about the study protocol and possible study dependent risks\n\nExclusion Criteria:\n\n* known allergies to antibiotics gentamicin and vancomycin used within the spacer",{"count":161,"type":21},"This study aims to use the technique of microdialysis to analyse the intraarticular space of the knee joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing cement spacer over the entire period of the first hospitalization (usually 14 days) to closely monitor pharmacological and immunological aspects. In detail, antibiotic concentrations in the joint cavity and systemic circulation will be assessed according to reinfection rates, infection-free survival and fucntional outcome over a 12-month folluw-up period.",[195],"Periprosthetic Knee Infection",[197,168,169,173,170,171,198,199,174],"two-stage exchange","muscle mass","patient reported outcom measures",{"date":178,"type":32},{"date":180,"type":32},{"date":182,"type":21},{"name":38,"class":39},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":40},"100596259","impact-of-rehabilitation-therapy-using-strength-and-blood-flow-restriction-training-on-muscular-fitness-and-regeneration-after-elective-hip-replacement-100596259","NCT07043127","Impact of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Hip Replacement","Clinical Randomized Trial of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Hip Replacement","Inclusion Criteria:\n\n* Ability for Rehabilitation\n* Total Hip Arthroplasty Surgery during the last 4 Weeks\n\nExclusion Criteria:\n\n* Sickle Cell Anemia\n* Iatrogenic changes in the vessels of the lower Extremity (e.g. Stents)\n* Open Wounds or Infections of the lower Extremity",{"count":161,"type":21},[24],"In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. Strength and BFR training in medical training therapy complements daily exercise therapy in order to ensure implementation in the guideline-based rehabilitation process. . The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 following the RTS hip and knee TEP basis KTL 2020.",[215],"Total Hip Arthroplasty (THA)","2025-12-05",{"date":218,"type":32},"2025-12-08",{"date":220,"type":32},"2025-01-01",{"date":222,"type":21},"2026-12-31",{"name":38,"class":39},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":40},"100596293","clinical-randomized-trial-of-the-effect-of-rehabilitation-therapy-using-strength-and-blood-flow-restriction-training-on-muscular-fitness-and-regeneration-after-anterior-cruciate-ligament-reconstruction-100596293","NCT07043569","Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction","Inclusion Criteria:\n\n* ACL reconstruction\n* Ability to take part in an outpatient rehabilitation\n\nExclusion Criteria:\n\n* Sickle Cell anemia\n* iatrogenic changes in the vessels of the lower limbs (stents, bypasses)\n* inflammation of the lower extremities",{"count":161,"type":21},[24],"With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.",[234],"ACL - Anterior Cruciate Ligament Rupture",{"date":218,"type":32},{"date":237,"type":32},"2025-06-20",{"date":222,"type":21},{"name":38,"class":39},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":100,"sex":248,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":40},"100525814","brain-and-voice-signatures-in-teachers-100525814","NCT06126627","Brain and Voice Signatures in Teachers","Neurobiological and Psychobiological Signatures of Vocal Effort in Early Career Teachers","BRAVO1","Inclusion Criteria:\n\nTeachers (max. 10 years full-time) or student teachers in good health between 21 and 39 years with symptoms of vocal fatigue.\n\nControl participants in good health between 21 and 39 years without symptoms of vocal fatigue.\n\nExclusion Criteria:\n\n* Lefthandedness\n* Smoking (past 5 years)\n* Known changes of the vocal folds (e.g., vocal fold nodules), vocal fold paralysis, surgeries on the larynx or thryoid or current organic or neurological changes of the vocal folds or vocal function per videoendoscopy and -stroboscopy of the larynx\n* History of voice therapy\n* Hoarseness\n* Respiratory illness, allergies (respiratory, silver), reflux or asthma at time of participation\n* Hearing disorder or hearing aids\n* Psychological, neurological or endocrinological disorders\n* Psychotropic or steorid medications\n* Body mass index \\> 30\n* Indications against MRI such as metail parts in or on the body (e.g., permanent dental prostheses or braces, screws, prostheses, piercings or large tattoos\n* Nearsightedness \\> -5 diopters, if only glasses are worn\n* Claustrophobia\n* Pregnancy","FEMALE","21 Years","39 Years",{"count":252,"type":21},100,[24],"Primary muscle tension dysphonia voice disorder with symptoms of vocal strain and vocal fatigue is common and can have a significant negative impact on quality of Life. Yet, primary muscle tension dysphonia's causes are unknown precluding precise diagnostic classification. Stress and personality are thought to play a role and thus, the project aims to determine the practical and clinical effect of stress on the control of voice and speech in the brain. Participants are female early career teachers and student teachers with symptoms of vocal fatigue, as well as control participants without vocal fatigue, who perform speech tasks on two different occasions. Neural (imaging of brain), psychobiological (saliva, personality), and voice and speech (muscle activity of voice muscles on the neck with surface sensors, audio recordings) data will compare reactivity patterns of teachers who are stressresponders with those who are nonresponders as well as control participants. The central hypothesis is that voice box stress responders have heightened emotion-motor activations involving the emotional voice production pathway, which correlate with changes in voice muscle activity in the anterior neck. The results will provide fundamentally missing data in our understanding of the role of stress in vocal complaints and will yield new insights about the neural underpinnings of primary muscle tension dysphonia. The study findings will have a significant impact on how clinicians identify so-called laryngoresponders to help them prevent voice disorders.",[256,257],"Voice Disorders","Voice Fatigue",[259,260,261,262,263,264,265,266,267],"voice disorders","vocal fatigue","occupational voice disorders","stress reactivity","vocal control","laryngeal motor cortex","teachers","speech motor control","voice motor control","2025-08-20",{"date":270,"type":32},"2025-08-27",{"date":272,"type":32},"2023-08-01",{"date":274,"type":21},"2026-07-31",{"name":38,"class":39},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":100,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":40},"100596641","progression-assessment-of-pxe-associated-alterations-100596641","NCT07048106","Progression Assessment of PXE-associated Alterations","Natural History and Structural Consequences of a Diseased Bruch's Membrane in Pseudoxanthoma Elasticum (PXE)","PAPA","Inclusion Criteria for PXE cohort:\n\n* PXE based on the criteria of Plomp et al.\n* Clear ocular media\n* Ability to perform the tasks of the study protocol (i.e., holding the head still for image aquisition)\n\nExclusion Criteria:\n\n* Any confounding ocular disease not associated with PXE\n* Systemic diseases hindering the study examinations",{"count":252,"type":21},"This monocentric clinical observational study at the University Eye Hospital Bonn investigates the natural history and structural consequences of a diseased Bruch's membrane (BrM) in Pseudoxanthoma elasticum (PXE). The study includes four main objectives:\n\n1. Direct Bruch's Membrane Alterations: Longitudinal analysis of BrM reflectivity using high-resolution OCT to assess correlations with disease progression\n2. Choriocapillaris Flow Deficits: Evaluation of choriocapillaris (CC) perfusion in relation to BrM calcification, aiming to clarify whether CC deficits precede or result from BrM changes\n3. Retinal Atrophy Progression: Monitoring the development and expansion of retinal atrophic areas over two years, including correlations with specific features like reticular pseudodrusen and hyperreflective spots\n4. Genotype-Phenotype Correlation: Analysis of different ABCC6 gene mutations to identify correlations with imaging features and disease severity, potentially guiding future personalized therapeutic strategies\n\nThe study will recruit 100 PXE patients and 100 controls, with data collection over 10 years. It involves non-invasive imaging and blood sampling. No direct benefit is expected for participants, but the findings may inform future clinical trials and improve patient counseling.",[287,288,289,290],"Pseudoxanthoma Elasticum","Angioid Streaks","Peau d'Orange","Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)",[292,293,294,295,296,297],"ABCC6","Pseudoxanthoma elasticum","PXE","Angioid streaks","Peau d'orange","Grönblad-Strandberg Syndrome","2025-06-24",{"date":300,"type":32},"2025-07-02",{"date":302,"type":32},"2024-09-01",{"date":304,"type":21},"2027-10",{"name":38,"class":39},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":318,"conditions":319,"keywords":322,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":40},"100594583","phase-3-anterior-temporal-lobectomy-in-temporal-glioblastoma-100594583","NCT07021339","Anterior Temporal Lobectomy in Temporal Glioblastoma","Randomized, Controlled Trial of Anterior Temporal Lobectomy Versus Gross Total Resection in Newly-diagnosed Temporal Glioblastoma (ATLAS\u002FNOA-29)","ATLAS\u002FNOA-29","* Suspected glioblastoma with contrast-enhancement in preoperative MRI\n* Diffuse high-grade glioma in frozen section procedure, newly-diagnosed\n* Tumor localization (in gadolinium-enhanced MRI): solely temporal, non-dominant side (right hemisphere in right-handed patients, or left-handed patients after testing for dominance): within 6.5 cm from the temporal pole; dominant side (left hemisphere in right-handed patients, all left-handed patients unless additional testing for dominance performed): within 4.0 cm from the temporal pole, as determined dorsally along the Sylvian fissure.\n* Macroscopic complete resection (no remaining contrast-enhancing tumoral lesion on early postoperative MRI) is achievable (decision of the treating neurosurgeon)\n* In case further T1-contrast-enhancing and\u002For T2\u002FFLAIR lesions are detected beyond the resection margins (6.5 cm on the non-dominant side and 4.0 cm on the dominant side), these lesions are not attributed to the tumor (except perifocal edema) but to other conditions according to the local treating neurosurgeon\n* ≥ 18 and \\\u003C 75 years of age\n* KPS ≥ 70%\n* Estimated life expectancy of at least 6 months\n* Written informed consent\n* Cognitive state to understand the rationale and necessity of the study therapy and procedures\n* Patient compliance and geographic proximity that allow adequate follow-up\n* For patients with childbearing potential: negative serum pregnancy test (beta-HCG) at baseline visit, patient's commitment to use an approved contraceptive method during the trial and for 3 months after (Pearl index \\\u003C 1%)\n* Adequate organ function at baseline visit that does not preclude alkylating chemotherapy and neurosurgical procedures (all criteria required):\n\n  * Adequate bone marrow reserve: white blood cell (WBC) count ≥ 3.000\u002Fµl; granulocyte count \\> 1.500\u002Fµl; platelets ≥ 100.000\u002Fµl; haemoglobin ≥ 10 g\u002Fdl\n  * Adequate liver function: bilirubin \\\u003C 1.5 times above upper limit of normal range (ULN); alanine transaminase (ALT\u002FSGPT) and aspartate transaminase (AST\u002FALAT) \\\u003C 3 times ULN\n  * Adequate renal function: creatinine \\\u003C 1.5 times ULN\n* Adequate blood clotting: Partial Thromboplastin Time (PTT) not exceeding the upper limit of normal range and International Normalized Ratio (INR) \\\u003C1.5; in case of intake of anticoagulant medication or platelet function inhibitors, the coagulation analysis must show no detectable effect in specific blood tests (as described below) at the time of surgery, and discontinuation of the anticoagulant medication must be justifiable for at least 1 week postoperatively\n\n  * Direct acting oral anticoagulants (e.g., rivaroxaban, apixaban, edoxaban, dabigatran): anti-Factor Xa (aFXa)-activity within the normal range (rivaroxaban, apixaban, edoxaban), TT\u002FTCT (thrombin clotting time) or ecarin clotting time (ECT) not exceeding the upper limit of normal range (Dabigatran) or verification of subtherapeutic drug levels (apixaban, edoxaban, rivaroxaban, dabigatran)\n  * Vitamin K antagonists (coumarins): INR \\\u003C 1.5\n  * Unfractionated heparin (UFH) and argatroban: activated Partial Thromboplastin Time (aPTT) not exceeding the upper limit of normal range\n  * Fractionated heparin\u002Flow-molecular-weight heparin (e.g., dalteparin, enoxaparin), heparinoid (e.g., fondaparinux, danaparoid): aFXa-activity within the normal range\n  * Antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor): platelet function analyzer (PFA) test not exceeding the upper limit of normal range (aspirin), whole blood aggregometry not below lower limits of normal range (clopidogrel, prasugrel, ticagrelor)\n\nFor details see study protocol.",{"count":315,"type":21},178,[317],"PHASE3","The ATLAS\u002FNOA-29 trial is a prospective, multicenter, phase III randomized controlled study evaluating whether anterior temporal lobectomy (ATL), a standardized resection technique adapted from epilepsy surgery, improves clinical outcomes in patients with newly diagnosed glioblastoma of the anterior temporal lobe compared to conventional gross-total resection (GTR). The rationale is based on the concept of glioblastoma as a diffusely connected tumor network, with infiltrative spread extending beyond MRI-detectable tumor margins. ATL offers a reproducible supramarginal resection approach within anatomical boundaries that are routinely respected in epilepsy surgery.\n\nPatients are randomized intraoperatively in a 1:1 ratio following histopathological confirmation via intraoperative frozen section procedure. The trial's primary objective is to demonstrate superiority of ATL in overall survival (OS), while confirming non-inferiority in health-related quality of life (QoL), measured by the global health status scale of the European Organisation for Research and Treatment of Cancer (EORTC) - Quality of Life Questionnaire Core 30 (QLQ-C30). Secondary outcomes include progression-free survival (PFS), seizure control, neurocognitive functioning, and longitudinal assessments of selected EORTC QLQ-C30 and BN20 domains. A total of 178 patients will be enrolled over three years, with a minimum follow-up of three years. An interim safety analysis after inclusion of 57 patients will assess functional outcome differences using the modified Rankin Scale (mRS) at 6 months postoperatively. The study is powered (\\>80%) to detect a survival benefit assuming a median OS increase from 17 to 27.5 months. If proven superior to GTR, ATL could emerge as the preferred surgical strategy for isolated temporal lobe glioblastoma, offering robust evidence in favor of extending supramarginal resection principles to the broader context of glioblastoma care.",[320,321],"Newly-diagnosed Glioblastoma","Temporal Lobe",[312,323,324,325,326],"ATLAS","NOA-29","Anterior temporal lobectomy","gross total resection","2025-06-07",{"date":329,"type":32},"2025-06-13",{"date":331,"type":32},"2024-11-28",{"date":333,"type":21},"2031-02-28",{"name":38,"class":39},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":40},"100588918","impact-of-different-perioperative-tourniquets-on-blood-loss-and-surgeon-satisfaction-in-total-knee-arthroplasty-100588918","NCT06947655","Impact of Different Perioperative Tourniquets on Blood Loss and Surgeon Satisfaction in Total Knee Arthroplasty","Impact of Two Different Perioperative Tourniquets on Blood Loss, Surgical Field and Surgeon Satisfaction During Total Knee Arthroplasty","Inclusion Criteria:\n\n* Inidication for a Total Knee Arthroplasty\n* Approval for Surgery by the Department of Anesthesia\n\nExclusion Criteria:\n\n* Open Wounds of the lower extremities\n* Acute or chronic infections of the lower extremities",{"count":343,"type":21},50,[24],"The present study investigates the impact of two different perioperative tourniquets with different closing features on operative blood los, surgical field quality and surgeon satisfaction.",[347],"Total Knee Arthroplasty",{"date":349,"type":32},"2025-04-27",{"date":351,"type":32},"2024-10-01",{"date":353,"type":21},"2025-12-31",{"name":38,"class":39},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":100,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":373,"locationsCount":40},"100458200","acute-effects-of-physical-exercise-in-patients-with-borderline-personality-disorder-100458200","NCT05246527","Acute Effects of Physical Exercise in Patients with Borderline Personality Disorder","Inclusion Criteria:\n\n* estimated verbal intelligence quotient \\>80 (MWT-B; Lehrl 2005)\n* patients: diagnosis of borderline personality disorder according to DSM-5\n\nExclusion Criteria:\n\n* neurological disorders\n* health conditions interfering with exercise safety, e.g. coronary heart disease\n* visual impairments that may interfere with performance of the cognitive tasks\n* endocrine disorders, e.g. hyperthyreosis or diabetes mellitus;\n* following psychiatric disorders: psychosis or affective disorders with psychotic symptoms, schizophrenia, substance abuse or dependence, autism spectrum disorders, anorexia nervosa;\n* healthy controls: BPD, intake of psychotropic drugs",{"count":362,"type":21},120,[24],"The aim of the proposed project is to investigate the effects of a single session of physical exercise on stress regulation, cognitive and emotional functioning, and associated neurophysiological processes (saliva and blood samples) in patients with borderline personality disorder. A further aim is to identify the optimal exercise intensity (moderate vs. high intensity). The investigatiors expect that acute exercise will lead to positive effects on behavioral and biomarker level.",[366],"Borderline Personality Disorder","2024-12-06",{"date":369,"type":32},"2024-12-11",{"date":371,"type":32},"2022-02-08",{"date":353,"type":21},{"name":38,"class":39},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":382,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},"100561820","ai-pod-clinical-validation-study-for-obese-patients-100561820","NCT06595134","AI-POD Clinical Validation Study for Obese Patients","AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study","AI-POD","Inclusion Criteria:\n\n* Age greater than or equal to 45 years at the time of signing informed consent\n* BMI greater than or equal to 30 kg\u002Fm2\n* Patients with suspected CVD (\\>15% pretest probability \\[ESC guidelines\\]), referred for cardiac CT examinations (consisting of coronary calcium scoring and coronary CT angiography)\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,\n* Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.\n* Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion\n* Presently classified NYHA IV heart failure\n* Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of inclusion\n* Having uncontrolled hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 100 mmHg) as measured at inclusion\n* Having severe renal impairment measured as an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 at inclusion\n* Alanine aminotransferase (ALT) or alkaline phosphatase (APT) level \\\u003C 3.0 x the upper limit of normal (ULN)for the reference range\n* Total bilirubin level \\>1.5 x the ULN for the reference range\n* History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years\n* Previous organ transplantation or awaiting an organ transplant\n* Pregnancy or breastfeeding","45 Years",{"count":384,"type":21},1200,"The study is aimed at patients who suffer from severe obesity and receive a computerised tomography (CT) scan of the heart. A total of 1200 patients across Europe are to take part in the study. It is a multi-centre, controlled, open, randomised study. As part of the study, a citizen app will be installed on a smartphone for randomly selected study participants. A fitness tracker will also be issued so that certain parameters, such as heart rate and daily number of steps, can be recorded.",[387],"Acute Cardiovascular Disease",[389],"Obesity, Heart CT, Artificial Intelligence","2024-09-10",{"date":392,"type":32},"2024-09-19",{"date":394,"type":32},"2024-07-01",{"date":396,"type":21},"2028-07",{"name":38,"class":39},6,{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":40},"100545575","placebo-optimization-of-the-presurgical-long-term-video-eeg-monitoring-100545575","NCT06383689","Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring","Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)","OPERA","Inclusion Criteria:\n\n* eligibility for presurgical epilepsy diagnostics\n\nExclusion Criteria:\n\n* inclusion criterion implies all exclusion criteria for this procedure\n* legal guardian\n* lack of consent or lack of capability to provide informed consent",{"count":408,"type":21},90,[24],"The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure (\"seizure pill\") versus (2) the subjective well-being (\"comfort pill\") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo.",[412],"Symptomatic Epilepsy",[414,415,416,417,418],"epilepsy","emotional well-being","placebo","video-EEG long-term monitoring","presurgical epilepsy diagnostics","2024-06-07",{"date":421,"type":32},"2024-06-10",{"date":423,"type":32},"2024-05-13",{"date":222,"type":21},{"name":38,"class":39},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":434,"minAge":17,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":437,"conditions":438,"keywords":443,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":449,"leadSponsor":451,"locationsCount":40},"100543157","prevalence-of-synovitis-in-patients-with-haemophilia-a-100543157","NCT06352216","Prevalence of Synovitis in Patients With Haemophilia A","Prevalence of Synovitis in Adult Patients With Haemophilia A in Germany and Austria","SynoPrev","Inclusion Criteria:\n\n* Participants (≥ 18 years old) suffering from moderate or severe haemophilia A, also with inhibitor or joint replacement\n* Complete documentation of hemophilia severity, treatment history (past 12 months), and bleeding events (past 12 months), inhibitor status (at time of enrollment and in past medical history)\n* Submitted written consent to participate in the study\n\nExclusion Criteria:\n\n* Patients suffering from other bleeding disorders conflicting with the research question\n* Patients in clinical studies with investigational drugs","MALE",{"count":436,"type":21},300,"The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A.",[439,440,441,442],"Haemophilia A","Synovitis","Hemophilia Arthropathy","Sonography",[440,439,444],"Prevalence","2024-04-15",{"date":447,"type":32},"2024-04-16",{"date":445,"type":32},{"date":450,"type":21},"2027-03",{"name":38,"class":39},{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":461,"conditions":462,"keywords":468,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":40},"100406890","predicting-acute-on-chronic-liver-failure-after-surgical-intervention-in-chronic-liver-disease-100406890","NCT04578301","Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease","PERSEVERE","Inclusion Criteria:\n\n* Male or female adult (≥18 years) patient\n* With or without liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and radiological signs)\n* Or Non-cirrhotic portal hypertension\n* Non-pregnant, non-lactating females\n* Ability to understand the patient information and to personally sign and date the informed consent to participate in the study\n* The patient is co-operative and available for the entire study\n* Provided written informed consent\n* Indication for surgical intervention\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Patients undergoing surgery as form of palliative cancer therapy\n* Presence or history of severe extra-hepatic diseases\n* HIV-positive patients\n* Previous liver or other transplantation\n* Patients with acute or subacute liver failure without underlying cirrhosis\n* Patients who decline to participate\n* Physician´s denial (e.g. the investigator considers that the patient will not follow the protocol scheduled)",{"count":460,"type":21},200,"Prospective, observational study to define precipitants and predictors of development of Acute-on-Chronic Liver Failure (ACLF) after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients. As well as identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.",[463,464,465,466,467],"Liver Cirrhosis","Portal Hypertension","Surgery","Acute-On-Chronic Liver Failure","Non-Cirrhotic Portal Hypertension",[469,466,463,464,465,467],"ACLF","2022-05-17",{"date":472,"type":32},"2022-05-18",{"date":474,"type":32},"2020-09-22",{"date":222,"type":21},{"name":38,"class":39},{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":40},"100396803","non-invasive-evaluation-of-the-predictive-value-of-ceus-and-swe-in-aclf-renal-failure-and-hepatorenal-syndrome-100396803","NCT04446858","Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome","Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome","NECTAR","Inclusion Criteria:\n\n* All patients with portal hypertension and kidney failure\n\nExclusion Criteria:\n\n* no consent, no kidney failure, no portal hypertension","100 Years",{"count":487,"type":21},1000,"Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.",[490],"Kidney Failure, Acute",[492,493,494,495,496,497,498,499,500],"transjugular intrahepatic portosystemic shunt (TIPS)","non-invasive assessments","circulating biomarkers","Transthoracic echocardiography (TTE) with Speckle-tracking","Elastography","Contrast-enhanced ultrasound","Computer tomography scan (CT-scan)","Magnetic resonance imaging (MRI)","Urine biomarker",{"date":472,"type":32},{"date":503,"type":32},"2021-01-01",{"date":505,"type":21},"2030-07-01",{"name":38,"class":39},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":40},"100343020","non-invasive-characterization-of-focal-liver-lesions-in-liver-cirrhosis-100343020","NCT03746210","Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis","NICETIES","Inclusion Criteria:\n\n* all patients with focal liver lesions and liver cirrhosis\n\nExclusion Criteria:\n\n* no consent\n* under 18 years","99 Years",{"count":460,"type":21},"This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.",[518],"Liver Cirrhoses",{"date":472,"type":32},{"date":521,"type":32},"2016-01-01",{"date":523,"type":21},"2027-12-31",{"name":38,"class":39},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":40},"100449428","immunophenotyping-in-patients-with-osteoporosis-100449428","NCT05132348","Immunophenotyping in Patients With Osteoporosis","Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis","IPO","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) diagnosed with osteoporosis.\n* Written informed consent from the patient\n\nExclusion Criteria:\n\n* Patients without diagnosed osteoporosis\n* Patients without written informed consent\n* Patients \\\u003C 18 years old\n* Patients with secondary osteoporosis",{"count":534,"type":21},250,"In addition to a medical history and clinical examination, the diagnosis of osteoporosis includes the measurement of bone surface density by means of dual X-ray absorptiometry (DXA). In addition, blood tests are performed for certain parameters, such as vitamin D, calcium, phosphate and C-reactive protein. In order to optimize osteoporosis diagnostics, the development of further specific methods is required. The modulation of the immune system seems promising in this respect, since osteoporosis is based on an inflammatory reaction. Various regulatory markers of the innate and acquired immune system, which seem to be relevant in the development of the disease, have already been detected in osteoporosis patients. This study may help to gain new insights into disease-associated immunoregulatory markers that could revolutionize both the diagnosis and therapy of osteoporosis in the long term. By means of a simple blood test, patients could be diagnosed early and without additional radiation exposure, and effective therapy options could be developed.",[537],"Immunophenotyping Blood Samples of Patients With Osteoporosis","2021-11-11",{"date":540,"type":32},"2021-11-24",{"date":542,"type":32},"2021-10-10",{"date":544,"type":21},"2026-10-19",{"name":38,"class":39},{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":485,"enrollmentInfo":554,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":40},"100392707","non-invasive-evaluation-program-for-tips-and-follow-up-network-2-neptun2-100392707","NCT04393519","Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)","Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2","NEPTUN2","Inclusion Criteria:\n\n* Insertion of TIPS according to guidelines\n\nExclusion Criteria:\n\n* Contraindication for TIPS",{"count":487,"type":21},"Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.",[464],[492,493,495,498,499,558,559,496],"Circulating biomarkers","Electroencephalography (EEG)","2021-10-04",{"date":562,"type":32},"2021-10-05",{"date":564,"type":32},"2020-05-12",{"date":566,"type":21},"2030-12-31",{"name":38,"class":39},{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":485,"enrollmentInfo":575,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":584,"locationsCount":40},"100340842","vascular-liver-disease-evaluation-follow-up-and-non-invasive-diagnostics-program-100340842","NCT03717792","Vascular Liver Disease Evaluation, Follow Up and Non-Invasive Diagnostics Program","VALID","Inclusion Criteria:\n\n* all patients with vascular liver disease\n\nExclusion Criteria:\n\n* patients without vascular liver disease",{"count":576,"type":21},500,"Background Vascular liver disorders (VALDI) are rare diseases, for which knowledge on risk factors, appropriate methods of diagnosis, effect of therapy and prognosis still need to be improved.\n\nAim of the study This project aims to study risk factors, methods of detection, therapy and prognosis in order to elaborate and disseminate updated recommendations for the optimal management of patients with VALDI.\n\nDesign of the study Data on patients will be collected from baseline (the date of diagnosis) up to 3 years. During this period, data on clinical condition, laboratory results, diagnostic tests, interventions and outcome will be collected anonymously using standardised review of medical charts by one special trained investigator. Only patients with VALDI are eligible to participate.",[579],"Vascular Disorder of Liver",{"date":562,"type":32},{"date":582,"type":32},"2010-01-01",{"date":523,"type":21},{"name":38,"class":39},{"id":586,"slug":587,"hasResults":11,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":593,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100330589","skeletal-muscle-parameters-of-liver-cirrhosis-in-non-invasive-imaging-and-outcome-100330589","NCT03584204","Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome","Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis","SLIM","Inclusion Criteria:\n\n* liver cirrhosis of any etiology\n* CT scan available\n\nExclusion Criteria:\n\n* HCC or any malignant disease",{"count":594,"type":21},400,"The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.",[463],[598,599,600,601,602,469],"sarcopenia","cirrhosis","transjugular intrahepatic portosystemic shunt","TIPS","acute-on-chronic liver failure",{"date":562,"type":32},{"date":605,"type":32},"2018-01-01",{"date":607,"type":21},"2026-08-31",{"name":38,"class":39},3,""]