[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical University Innsbruck\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":689},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,42,78,100,127,153,181,213,243,271,300,321,353,384,410,439,466,487,508,537,565,587,617,639,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645013","hemox-transfusion-trial-100645013",false,"NCT07677150","HemOx Transfusion Trial","Efficacy of Hemoglobin Oxygen Transport in Patients Receiving Intraoperative Cell Salvage vs. Packed Red Blood Cell Units - a Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n1. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.\n2. Female and male subjects ≥ 18 years of age at time of consent.\n3. Patient undergoes elective surgery according to Surgery List in Protocol Appendix and blood transfusion is likely to happen at the discretion of the investigator.\n\n   Inclusion criterion 4 only refers to WOCBP\n4. Negative urine pregnancy test, not breastfeeding\n\nExclusion Criteria:\n\n1. Known hemoglobinopathy\n2. Indication for irradiation of blood products\n3. preoperative Anemia (Hb \\\u003C11 mg\u002Fdl for women and Hb \\\u003C12 mg\u002Fdl for men)\n4. Contraindication for intraoperative cell salvage (septic surgery, tumor surgery)\n5. Contraindication for transesophageal Doppler ultrasound (craniofacial dysplasia or fracture, history of esophageal perforation or rupture, esophageal stricture, esophageal varices)",true,"ALL","18 Years",{"count":21,"type":22},418,"ESTIMATED","INTERVENTIONAL",[25],"NA","The proposed project, entitled \"HemOx Transfusion Study\", investigates the functionality of red blood cells (erythrocytes) in the context of oxygen transport in the blood. Erythrocytes contain haemoglobin, a protein responsible for oxygen transport in the bloodstream. Haemoglobin can bind up to four oxygen molecules. This haemoglobin-oxygen binding is particular and efficient, allowing oxygen to be taken up easily in the lungs and released just as readily in oxygen-consuming tissues. In this way, large amounts of oxygen can be transported rapidly and efficiently despite its low solubility in blood. If a patient suffers significant blood loss, for example during surgery, the amount of oxygen-transporting haemoglobin molecules may become so low that a transfusion (administration) of packed red blood cells from a blood donor becomes necessary. In major surgical procedures, which are more frequently associated with blood transfusions, special devices are used to process blood lost from the surgical site and reinfuse it into the same patient. During the storage of packed red blood cells, storage-related damage to the erythrocytes occurs, affecting their shape and functionality. In particular, the haemoglobin-oxygen binding is impaired; the binding affinity increases markedly during storage as a result of metabolic changes within the erythrocytes. This study therefore aims to investigate whether these storage-related changes in packed red blood cells, compared with processed autologous blood from the patient, normalise again after administration in the body, and over what period of time. The rejuvenation of haemoglobin-oxygen binding functionality and oxygen transport capacity of transfused blood is critical for the patient. Understanding the dynamics of this process is intended to inform clinicians about the efficiency of their interventions and to stimulate further research. The intraoperative processing of autologous blood will be examined and analysed in comparison with the administration of packed red blood cells. In this way, the clinical value of processed autologous blood will be evaluated in comparison with packed red blood cells. In the longer term, the processing and\u002For optimisation of packed red blood cells prior to administration could improve patient care.",[28],"Bleeding as Surgical Complication (Treatment)","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":22},"2026-10",{"date":37,"type":22},"2028-09",{"name":39,"class":40},"Medical University Innsbruck","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":41},"100600716","socio-cognitive-and-biological-responses-to-maltreatment-100600716","NCT07101107","Socio-cognitive and Biological Responses to Maltreatment","Socio-cognitive and Biological Responses to Childhood Maltreatment in Individuals With Bipolar Disorder and Control Subjects","Inclusion Criteria for individuals diagnosed with bipolar disorder (BD):\n\n* diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features;\n* Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20;\n* age between 18 and 65 years; and\n* able to provide written informed consent for magnetic resonance imaging (MRI) and study participation.\n\nExclusion Criteria for individuals diagnosed with BD:\n\n* a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD);\n* a current episode of illness with psychotic features (296.54);\n* a recent history of central nervous system (CNS) trauma or significant CNS trauma;\n* physical illness that might interfere with the participant's cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol derivates;\n* cardiovascular impairment with life-threatening issues;\n* electroconvulsive therapy in the last 12 months;\n* current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen;\n* IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest\" version B (MWT-B);\n* MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or\n* other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires).\n\nInclusion Criteria for healthy volunteers:\n\n* absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance;\n* age between 18 and 65 years according to clinical group; and\n* ability to give written informed consent for MRI and study participation.\n\nExclusion Criteria for healthy volunteers:\n\n* first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;\n* a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD.\n* physical illness that might interfere with the participants' cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol-derivates;\n* cardiovascular impairments with life-threatening issues;\n* current substance abuse;\n* IQ≤70;\n* MRI contraindications; or\n* other ethical considerations.","65 Years",{"count":51,"type":22},160,"OBSERVATIONAL","The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness.\n\nThe aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.",[55,56],"Bipolar 1 Disorder","Control Subjects",[58,59,60,61,62,63,64,65,66,67,68,69,70],"childhood maltreatment","Social Cognition","empathy","Bipolar Disorder","Biomolecules","Magnetic Resonance Imaging","Theory Of Mind","telomere length","mitochondria","benevolent childhood experiences","trauma","positive childhood experiences","inflammatory markers","2026-06-24",{"date":30,"type":33},{"date":74,"type":22},"2026-07-01",{"date":76,"type":22},"2030-02-28",{"name":39,"class":40},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":41},"100614819","smartphone-based-digital-screening-for-aortic-valve-stenosis-100614819","NCT07284550","Smartphone Based Digital Screening for Aortic Valve Stenosis","SMART-VALVE","The following inclusion and exclusion criteria will be used for training, validation and test sets:\n\nInclusion criteria for group I (moderate to severe AS):\n\n* Moderate to severe AS defined as AVA ≤ 1.5cm² in echocardiographic assessment\n* No other significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nInclusion criteria for group II:\n\n* No significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nExclusion criteria (applicable for all groups):\n\n• Informed consent form not signed.",{"count":86,"type":22},500,"Heart valve diseases are among the most serious cardiovascular conditions in older age. One of the most common forms is aortic valve stenosis, a narrowing of the valve opening between the left ventricle and the main artery. As the valve becomes tighter, the heart must work harder and harder to pump blood through the body. This process often develops slowly over many years and initially causes no clear symptoms. As a result, the condition is frequently detected only in advanced stages, when warning signs such as shortness of breath, chest pain, or dizziness appear. Without treatment, aortic valve stenosis can become life-threatening. If detected early, however, very effective treatment options are available today.\n\nUp to now, the disease has been reliably diagnosed mainly through echocardiography. Yet this method is complex, costly, and requires specialized medical staff. A simple, affordable, and broadly accessible screening option does not yet exist.\n\nThe interdisciplinary clinical research project explores whether conventional smartphones could fill this gap. Almost all modern devices are equipped with sensors such as microphones, accelerometers, and gyroscopes. These can capture both heart sounds and subtle vibrations of the chest. The research team is investigating whether reliable diagnostic information for the diagnosis of aortic valve stenosis can be extracted from such recordings. To achieve this, the signals are processed with newly developed methods and analyzed using artificial intelligence.\n\nFor the study, several hundred patients with and without valve disease will be examined. The smartphone results will be compared with established diagnostic standards, particularly echocardiography, to test accuracy and reliability.\n\nIf successful, the approach could enable a straightforward, digital heart check at home using nothing more than a conventional smartphone. Such a tool would provide an accessible, low-cost, and widely available method for early detection, helping more people receive timely and potentially life-saving treatment.",[89,90],"Aortic Valve Stenosis","Artifical Intelligence","RECRUITING","2026-05-27",{"date":94,"type":33},"2026-05-28",{"date":96,"type":33},"2026-01-12",{"date":98,"type":22},"2029-11",{"name":39,"class":40},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":41},"100638039","clonal-hematopoiesis-of-indeterminate-potential-and-infarct-severity-in-st-elevation-myocardial-infarction-100638039","NCT07615023","Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction","CHIP in STEMI","Inclusion Criteria:\n\n* Diagnosis of first acute ST-elevation myocardial infarction according to current European Society of Cardiology guidelines\n* Symptoms consistent with ST-elevation myocardial infarction lasting more than 30 minutes and less than 12 hours before primary percutaneous coronary intervention\n* Treatment with primary percutaneous coronary intervention\n* Age 18 to 75 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention\n* Persistent hemodynamic instability, Killip class greater than 2 including cardiogenic shock, or resuscitated cardiac arrest not allowing cardiac magnetic resonance imaging\n* Known active or prior malignancy, including hematologic malignancies or myelodysplastic syndromes\n* Prior oncologic treatment with chemotherapy, radiotherapy, or radioisotopes\n* Abnormal baseline complete blood count with clinically significant cytopenia, defined as leukocytes less than 3.0 x 10\\^9\u002FL, platelets less than 100 x 10\\^9\u002FL, or hemoglobin less than 10 g\u002FdL\n* Chronic viral infection associated with systemic inflammation\n* Active autoimmune disease or chronic systemic inflammatory disorder\n* Chronic kidney disease with creatinine clearance less than 30 mL\u002Fmin\u002F1.73 m2\n* Contraindication to cardiac magnetic resonance imaging\n* Pre-ST-elevation myocardial infarction life expectancy of less than 1 year\n* Participation in an interventional trial\n* Limited possibility to attend follow-up examinations, for example residence abroad\n* Pregnancy","75 Years",{"count":109,"type":22},350,"Clonal Hematopoiesis of Indeterminate Potential (CHIP) refers to the age-related expansion of hematopoietic stem cell clones carrying somatic mutations in leukemia-associated driver genes (e.g., DNMT3A, TET2, ASXL1) in the absence of a hematological malignancy. CHIP has been identified as an independent cardiovascular risk factor associated with increased rates of myocardial infarction, stroke, and cardiovascular mortality, likely mediated through enhanced inflammatory signaling in mutant macrophages and monocytes.\n\nST-elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate reperfusion by primary percutaneous coronary intervention (PCI). Despite successful reperfusion, adverse cardiac remodeling and heart failure may occur depending on myocardial injury severity, microvascular obstruction (MVO), and intramyocardial hemorrhage (IMH) - phenomena substantially driven by ischemia-reperfusion injury and the inflammatory response.\n\nThe CHIP in STEMI study is a prospective, observational, single-center cohort study at the Medical University of Innsbruck investigating whether CHIP - detected by targeted next-generation sequencing - is associated with greater infarct severity and worse cardiac outcomes in STEMI patients undergoing primary PCI. The primary endpoint is the presence of MVO and\u002For IMH on cardiac MRI (CMR) at 5±2 days post-PCI. Secondary endpoints include infarct size, left and right ventricular function, major adverse cardiovascular events (MACE), and immune cell transcriptome profiling by single-cell RNA sequencing.\n\n350 patients (18-75 years, minimum 90 female) will be enrolled over 36 months and followed for 4 years (2026-2030).",[112,113],"ST-elevation Myocardial Infarction (STEMI)","Clonal Hematopoiesis of Indeterminate Potential (CHIP)",[115,116,117,118],"CHIP","STEMI","cardiac MRI","microvascular obstruction","2026-05-22",{"date":121,"type":33},"2026-05-29",{"date":123,"type":22},"2026-06-20",{"date":125,"type":22},"2030-06-20",{"name":39,"class":40},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100624368","monoaxial-vs-polyaxial-percutaneous-hybrid-stabilization-100624368","NCT07408726","Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization","Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization for Thoracolumbar Fractures in Elderly Patients: A Randomized, Single-Blind Pilot Study","Inclusion Criteria:\n\nPatient-related criteria:\n\n1. Age ≥ 60 years (male and female patients)\n2. Ability to understand nature, risks, and benefits of study participation and to provide written informed consent.\n3. Psychosocially, mentally, and physically capable of complying with all study requirements, including scheduled follow-up visits, completion of forms, and participation in all procedures as defined by the protocol.\n4. Ambulatory prior to fracture, with or without the use of assistive devices\n\nFracture-related criteria:\n\n1. Acute vertebral fractures located between T11 and L4 (inclusive)\n2. Fractures deemed suitable for bisegmental hybrid stabilization based on clinical and radiological assessment - primarily OF type 3 and type 4 fractures according to DGOU classification; type 2 and 5 fractures may also be included based on individual evaluation, with the final treatment decision left to the discretion of the treating surgeon.\n\nExclusion Criteria:\n\nPatient-related criteria:\n\n1. Body mass index (BMI) \\> 35\n2. Permanent or progressive neurologic deficits (including upper motor neuron disease and myelopathy)\n3. Rheumatoid arthritis or known disorders of bone metabolism (excluding osteopenia\u002Fosteoporosis, Vitamin D deficiency)\n4. History of radiation therapy to the spine\n5. History of alcohol or drug abuse within the last 2 years prior to randomization\n6. Current therapy with high-dose systemic corticosteroids (e.g., \\>10 mg\u002Fday prednisone equivalent for more than 3 months)\n7. Ongoing or planned treatment with cytotoxic chemotherapy (excluding biologicals, immunotherapy, or targeted agents) at the time of enrollment\n8. Known allergy to any component of the spinal instrumentation\n9. Participation in other clinical investigations (drug or device) that may interfere with the outcomes of this study\n\nFracture-related criteria:\n\n1. Vertebral fractures associated with neurological deficits\n2. Fracture age \\> 4 weeks at the time of enrollment\n3. Pathological fractures due to spinal infection or metastatic bone disease\n4. Planned major spinal surgery within 12 months of enrollment\n5. Severe spinal deformities or fusion at the index or adjacent segments\n6. Previous spinal surgery involving the index or adjacent vertebrae, with the exception of minor non-instrumented procedures, such as simple sequestrectomies or decompressions","60 Years",{"count":136,"type":22},44,[25],"Vertebral body fractures in older adults mostly affect the thoracolumbar junction and are challenging to treat due to osteoporosis and other comorbidities. Treatment options range from conservative approaches to minimally invasive procedures like vertebroplasty or balloon kyphoplasty, as well as surgical techniques such as posterior or combined stabilization. A common method for more severe fractures (from OF3 onwards) is percutaneous bisegmental hybrid stabilization using cement-augmented pedicle screws and balloon kyphoplasty. Polyaxial screws are easier to implant but offer less biomechanical stability. In contrast, monoaxial screws provide greater stiffness, allowing better correction of kyphosis and restoration of vertebral body height. The study compares radiological and clinical outcomes in patients aged 60 and older with thoracolumbar fractures (T11-L4) between monoaxial and polyaxial hybrid stabilization. The primary goal is to evaluate and compare the degree of kyphosis correction six months after surgery.",[140,141],"Thoracolumbar","Fractures in the Elderly",[143,144],"Thoracolumbar fractures","Percutaneous hybrid stabilization","2026-04-03",{"date":147,"type":33},"2026-04-09",{"date":149,"type":22},"2026-05-01",{"date":151,"type":22},"2028-11-01",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100573287","fast-discharge-after-acute-myocardial-infarction-discharge-mi-100573287","NCT06744322","Fast Discharge After Acute Myocardial Infarction Discharge MI","Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial","DISCHARGE-MI","Inclusion Criteria:\n\n* Uncomplicated acute myocardial infarction (NSTEMI and STEMI) diagnosed according to the 2023 acute coronary syndrome guidelines of the ESC\n* Age ≥ 18 years at time of consent\n* Invasive management strategy and in case of PCI successful intervention of the culprit lesion defined by post-interventional TIMI 3 flow\n* Ability to understand and willingness to sign and date written informed consent\n\nExclusion Criteria:\n\n* Myocardial infarction complicated by cardiac arrest (out-of-hospital cardiac arrest\u002Fin-hospital cardiac arrest)\n* PCI-related complications (coronary perforation, side branch closure, inability to deliver stent\u002Fballoon, aortic dissection, allergic reaction grade ≥2, stroke\u002Fthromboembolism, access site complications including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage and arterial dissection\u002Focclusion or emboli)\n* Malignant arrhythmias including sustained ventricular arrhythmias and persistent bradycardia (\\\u003C 50 beats per minute due to sinus node or atrioventricular conduction system abnormalities, second- \u002Fthird-degree atrioventricular block) after PCI\n* Ongoing hemodynamic instability (systolic blood pressure \\\u003C90 mmHg, elevated lactate concentrations, need for inotropes or vasopressors)\n* Ongoing respiratory instability defined by Killip class \\>I (rales, pulmonary edema)\n* Ongoing quantitative disorders of consciousness (somnolence, sopor, coma)\n* Acute kidney injury defined by Kidney Disease Improving Global Outcomes (KDIGO) stages 2 and 3\n* Pregnancy\n* Untreated critical non-culprit lesions requiring revascularization during index hospitalization not allowing fast discharge\n* Immobility\u002Flimited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team",{"count":162,"type":22},2070,[25],"To evaluate the hypothesis that a fast discharge strategy (discharge at 24 \\[± 12\\] hours) following invasive management for acute myocardial infarction is non-inferior to standard of care (\\>36 hours) with respect to the risk of major adverse cardiovascular events (MACE) during follow-up.",[166],"Acute Myocardial Infarction (AMI)",[168,116,169,170,171],"Myocardial Infarction","NSTEMI","Discharge","Randomized","2026-03-11",{"date":174,"type":33},"2026-03-16",{"date":176,"type":33},"2024-12-01",{"date":178,"type":22},"2029-12-31",{"name":39,"class":40},8,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":41},"100629120","fiber-optic-navigation-during-tips-creation-a-prospective-pilot-study-100629120","NCT07470515","Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study","Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters","FLIGHT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Pregnancy or breastfeeding\n* Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)\n* Participation in another clinical study that may interfere with the results of this study",{"count":190,"type":22},30,[25],"Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts.\n\nThis prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure.\n\nApproximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications.\n\nThe results may help to improve procedural efficiency and radiation safety during TIPS interventions.",[194,195,196,197],"Liver Cirrhosis","Refractory Ascites","Variceal Bleeding","Portal Hypertension",[199,197,200,201,202,203,204],"TIPS","Interventional Radiology","Fiber-Optic Navigation","Image-Guided Intervention","Endovascular Navigation","Radiation Reduction","2026-03-10",{"date":207,"type":33},"2026-03-13",{"date":209,"type":22},"2027-01",{"date":211,"type":22},"2028-12",{"name":39,"class":40},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":221,"minAge":222,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":41},"100612369","the-effect-of-gender-affirmative-measures-on-breast-perception-in-trans-men-100612369","NCT07252687","The Effect of Gender-affirmative Measures on Breast Perception in Trans Men","The Effect of Gender-affirmative Measures on Breast Perception in Trans Men (TRANSBREAST) - a Prospective Cohort Study","TRANSBREAST","Inclusion Criteria:\n\n* AFAB (Assigned Female At Birth)\n* before starting GAHT\n* before mastectomy\n\nExclusion Criteria:\n\n* Ongoing GAHT\n* Mastectomy already performed\n* Lack of capacity to give consent\n* Insufficient knowledge of German","FEMALE","16 Years",{"count":224,"type":22},100,"Breast dysphoria in transmasculine or genderdiverse individuals is a distinct psychological burden associated with depression, anxiety and suicidality. The aim is to systematically investigate the effect of GAHT (gender-affirming hormone therapy) and mastectomy on this form of dysphoria.\n\nThe primary objective of this study is to analyse and investigate the psychological and physical effects of breast development on trans men or genderdiverse individuals.\n\nA secondary objective is to determine the extent to which the stress affects the well-being of trans men depending on the coping strategies used (binding vs. taping).",[227,228],"Transgender","Gender Dysphoria in Adolescents and Adults",[230,231,232,233,234],"transgender","breastdysphoria","trans male","non binary","genderdiverse","2026-03-04",{"date":237,"type":33},"2026-03-06",{"date":239,"type":33},"2025-11-30",{"date":241,"type":22},"2030-11",{"name":39,"class":40},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":41},"100626999","crystallization-of-la-and-adjuvant-mixtures-in-cerebrospinal-fluid-100626999","NCT07442929","Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid","Crystallization of Local Anesthetic and Adjuvant Mixtures in Cerebrospinal Fluid as a Model for Interstitial Space - a Semiquantitative in Vitro Trial","Inclusion Criteria:\n\n* Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",{"count":251,"type":22},10,"Different mixtures of local anesthetics or local anesthetics with adjuvants that are known to precipitate in vitro are tested in human cerebrospinal fluid (CSF). CSF is gained from patients with normal pressure hydrocephalus scheduled for elective lumbar puncture. Patients signed an ICF for leftover samples.\n\nCSF will be assessed for pH values at different timepoints (t0-t3; 0 to 60 minutes).\n\nIn a second step six commonly used mixtures of LA with LA or LAs with adjuvants will be mixed using the following mixture ratios: ropivacaine 0.75% + lidocaine 2% (ratio 1:1), ropivacaine 0,75% + mepivacaine 2% (ratio 1:1), ropivacaine 0.75% + chloroprocaine 2% (ratio 1:1), lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:0.1), ropivacaine 0.75% + lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:1:0.1) and ropivacaine 0.75% + dexamethasone (1.5:1). The used mixture ratios are inspired by commonly mixtures described in the current literature and have been proven to precipitate in vitro. For every mixture, a Grade of Crystallisation will be determined at baseline without CSF and then at t0 (immediately) to t3 (60 minutes) every 15 minutes.",[254],"Hydrocephalus",[256,257,258,259,260,261,262],"local anesthetics;","local anesthetic mixtures","cerebrospinal fluid","in vitro","crystallization","pH","adjuvants","2026-02-26",{"date":265,"type":33},"2026-03-02",{"date":267,"type":33},"2025-09-01",{"date":269,"type":22},"2026-09-01",{"name":39,"class":40},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":221,"minAge":19,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":288,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100626362","comparison-of-mastectomy-expander-trial-100626362","NCT07434648","Comparison of Mastectomy Expander Trial","Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial","COMMET","Inclusion Criteria:\n\n* Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n* Female subjects aged ≥ 18 years at time of consent\n* INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND \u002F OR positive genetic counseling for high-risk family history of breast cancer\n* RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction\n* Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.\n* Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan\n* Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding\n\nExclusion Criteria:\n\n* Subject with implanted device that may be affected by magnetic fields (pacemaker)\n* Known presence of HIV, viral hepatitis (patient-reported)\n* Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy\n* The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.",{"count":280,"type":22},80,[25],"Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the \"approved\" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy\u002Fexpander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.\n\nRequested answers:\n\n* how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment,\n* how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants,\n* how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material,\n* which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).",[284,285,286,287],"Mastectomy and Breast Reconstruction","Tissue Expander Based Breast Reconstruction","Adjuvant Radiotherapy","Long Term Outcome",[289,290,291],"breast reconstruction","implant capsular fibrosis","tissue expander comparison","2026-02-20",{"date":294,"type":33},"2026-02-25",{"date":296,"type":22},"2026-03-01",{"date":298,"type":22},"2031-12-31",{"name":39,"class":40},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":310,"studyType":52,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":41},"100449072","pacemaker-based-long-term-monitoring-of-sleep-apnea-100449072","NCT05127720","Pacemaker-based Long-term Monitoring of Sleep Apnea","Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring","ACaSA","Inclusion Criteria:\n\n* implanted Microport TEO SR\u002FDR or BOREA SR\u002FDR or ALIZEA SR\u002FDR pacemaker device\n* signed informed consent\n\nExclusion Criteria:\n\n* any contraindication to perform a cardiac CT examination\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* allergy against CT contrast medium\n* hyperthyreoism\n* inability of the patient to understand the study purpose and plan\n* inability of the patient to perform baseline examinations\n* pregnancy or breast-feeding; women with childbearing potential\n* estimated life expectancy below one year",{"count":309,"type":22},1000,"20 Years","This is a prospective, non-interventional cohort study. It tests the hypothesis that\n\n* Pacemaker-derived monitoring of sleep-related breathing disorders and\u002For daily physical activity predicts clinical outcome.\n* Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients.\n* Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and\u002For device-detected sleep apnea.\n* Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and\u002For device-detected sleep apnea.\n* Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes.\n* Burden \u002F variation of device-detected sleep apnea and\u002For device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.",[313],"Bradycardia",{"date":315,"type":33},"2026-02-24",{"date":317,"type":33},"2021-11-30",{"date":319,"type":22},"2041-12-31",{"name":39,"class":40},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":41},"100623057","telemedically-assisted-optimization-for-heart-failure-patients-before-cardiac-surgery-to-improve-perioperative-outcome-100623057","NCT07391683","Telemedically Assisted Optimization for Heart Failure Patients Before Cardiac Surgery to Improve Perioperative Outcome","Prospective, Randomized Open Label Trial of Telemedically Assisted Optimization for Heart Failure Patients Before Cardiac Surgery to Improve Perioperative Outcome","PREPARE-HF","Inclusion Criteria:\n\n* Indication for elective cardiac surgery in the Heart team\n* NTproBNP ≥ 1500 ng\u002FL\n* ≥ 18 years willing to participate in trial\n* Written informed consent\n\nExclusion Criteria:\n\n* Neuropsychiatric disorders \u002F illnesses (e.g. drug addiction, alcohol abuse) that do not allow adherent participation in the study\n* No sufficient ability to measure and transfer data or existing support in the social environment\n* no sufficient ability to communicate (language skills, eyesight, hearing)\n* Pregnancy\n* Chronic kidney disease requiring dialysis\n* Planed procedure: heart transplantation (HTX), implant of left ventricular mechanical assist devices (L-VAD)",{"count":330,"type":22},162,[25],"Patients with heart failure undergoing cardiac surgery face a significantly increased perioperative risk, yet no standardized strategy exists to mitigate this risk effectively. Current preoperative management relies on optimization of medical therapy without a structured prehabilitation approach. Given the strong association between eleveated preoperative N-terminal pro-B-type natriuretic peptide levels and postoperative outcomes, patients at increased risk could be identified using this biomarker. Telemedical disease management programs have demonstrated efficacy in outpatient heart failure care, but their role in preoperative optimization remains underexplored. This study aims to assess whether a structured, multidisciplinary, telemedicine-assisted prehabilitation program can reduce perioperative complications, and improve surgical outcomes.",[334],"Patients With Heart Failure Undergoing Cardiac Surgery",[336,337,338,339,340,341,342,343,344],"cardiac surgery","heart failure","Telemedically Assisted optimization program","prehab","Cardiac Surgical Procedures","Perioperative Care","Preoperative Exercise","Remote Patient Monitoring","Telemedicine","2026-02-17",{"date":347,"type":33},"2026-02-18",{"date":349,"type":33},"2026-02-16",{"date":351,"type":22},"2034-01-01",{"name":39,"class":40},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":360,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":369,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":41},"100625205","migrafit-evaluating-a-group-therapy-program-combining-physical-activity-progressive-muscle-relaxation-and-psychoeducation-for-adolescents-with-migraine-100625205","NCT07419607","MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine","MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine - Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)\n* Age: 13-17 years\n* Place of residence within a 35-kilometer radius of the study site, except for children who live outside of this radius but commute close to the study site daily due to school or work attendance\n\nExclusion Criteria:\n\n* Intake of continuous prophylactic medication for migraine\n* Any change in migraine medication within the past 4 weeks\n* Psychiatric or somatic comorbidities which could interfere with participation in a weekly group therapy that includes physical activity","13 Years","17 Years",{"count":190,"type":22},[25],"Background: Migraine is a headache disorder highly prevalent in children and adolescents. It significantly affects academic performance and quality of life. A conservative approach to pharmacological prophylaxis for pediatric patients persists in clinical practice, as potential risks must be carefully weighed against the benefits for each individual patient. Non-pharmacological interventions, including physical activity, progressive muscle relaxation (PMR) and psychoeducation have shown promising effects individually but demand a high level of patient motivation. This study protocol creates the foundation to evaluate a novel group therapy program combining high-intensity interval training (HIIT), PMR, and psychoeducation tailored for children and adolescents with migraine.\n\nMethods: This single-centre, open-label, randomized controlled trial will enrol 80 participants aged 13 to 17 years and diagnosed with migraine according to ICHD-3 criteria. Participants are randomized 1:1 into an intervention and control group. The intervention group will receive a 18-week, once-weekly 65-minute group therapy (comprising HIIT and PMR) plus two sessions of psychoeducation. The control group receives no intervention. Primary outcomes are changes in migraine frequency, duration, intensity and acute medication use, assessed through standardized headache diaries before and after the intervention. Secondary outcomes include changes in migraine-related disability (PedMIDAS questionnaire), exploratory analysis of physical activity patterns in a subgroup and a patient-centered evaluation of the intervention's feasibility and perceived effectiveness.\n\nDiscussion: This trial will provide evidence on the effectiveness and feasibility of a structured, time-efficient, multimodal group therapy intervention for pediatric migraine. By combining physical and psychological strategies within a supportive group setting, the program aims to overcome key limitations of adherence and offer a non-pharmacological treatment alternative. If successful, the intervention is intended to be incorporated into routine outpatient care for pediatric migraine at the Medical University of Innsbruck.",[366,367,368],"Migraine","Headache Disorders","Pediatric Migraine",[366,370,371,372,373,374,375,376],"children","adolescents","physical activity","high intensity interval training","progressive muscle relaxation","psychoeducation","randomized controlled trial","2026-02-11",{"date":379,"type":33},"2026-02-19",{"date":296,"type":22},{"date":382,"type":22},"2027-06-30",{"name":39,"class":40},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":41},"100623280","preoperative-optimization-before-total-hip-or-knee-replacement-surgery-100623280","NCT07394582","Preoperative Optimization Before Total Hip or Knee Replacement Surgery","Preoperative Optimization Before Total Hip or Knee Replacement Surgery - a Controlled, Randomized, Single-blind Study","PrOpE","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status classification ≥ 3\n* Age between 18 and 99 years\n* All sexes\n* Elective total hip or knee replacement with a waiting period of ≥ 8 weeks between surgical indication and surgery\n* Ability to understand the nature, content, and procedures of the study and to provide written informed consent\n* Written informed consent obtained prior to any study-related procedure\n\nExclusion Criteria:\n\n* Pregnancy or active breastfeeding\n* Severe trauma or major blood loss within 14 days prior to enrollment\n* Participation in another pharmacological or interventional clinical study\n* Contraindications to physical training\n* Pre-existing diagnosis of moderate to severe dementia","99 Years",{"count":394,"type":22},180,[25],"Preoperative Optimisation prior to Hip and Knee Arthroplasty (PrOpE) Many patients scheduled for planned hip or knee replacement surgery have health conditions that may affect recovery, such as reduced physical fitness, nutritional problems, multiple medications, or increased stress and anxiety. These factors can increase the risk of complications and delay recovery after surgery.\n\nThe PrOpE study examines whether a structured preparation programme before surgery, known as preoperative optimization or prehabilitation, can be safely implemented and may support recovery after hip or knee replacement.\n\nAim of the study The main aim is to assess the feasibility of a comprehensive preoperative optimisation programme and to explore its potential effects on recovery and health outcomes. The results will help improve future care for patients undergoing major orthopaedic surgery.\n\nWho can participate? Adult patients scheduled for elective total hip or knee replacement surgery who are classified as ASA \\>2, aged between 18 and 99 years old and without a severe cognitive impairment. Participation is voluntary.\n\nStudy design\n\nA total of 180 participants will be included and randomly assigned to one of two groups:\n\n• Standard Care Group: Participants receive usual medical care before and after surgery.\n\n• Intervention Group:\n\nIn addition to standard care, participants receive an individualised preparation programme over several weeks before surgery. This programme may include:\n\n* Personalised physical exercise\n* Nutritional assessment and advice\n* Support for stress, pain, and mental well-being\n* Review of regular medications Some elements may be delivered at home or via telemedicine, depending on individual needs.\n\nWhat information is collected? The study evaluates recovery after surgery, including complications, length of hospital stay, physical function, quality of life, and use of health care services. Questionnaires, physical tests, and blood samples are used to better understand health status before and after surgery.\n\nRisks and benefits The study involves low additional risk. All measures are adapted to individual abilities and supervised by trained professionals. The main burden is the additional time required for participation. Participants in the optimisation group may benefit from improved preparation for surgery. The study also contributes to improving care for future patients.",[398,399],"Prehabilitation","Preoperative Care",[401,402],"Preoperative Optimization","orthopedic surgery","2026-02-09",{"date":377,"type":33},{"date":406,"type":22},"2026-02-05",{"date":408,"type":22},"2034-02-05",{"name":39,"class":40},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":41},"100598229","shockwave-intervention-for-enhanced-wound-healing-in-no-touch-pedicle-saphenous-vein-graft-harvesting-for-coronary-artery-bypass-grafting-100598229","NCT07068776","Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting","Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting: A Prospective, Single-Center, Single-Blind, Randomized, Sham-Controlled Study","SHIELDS-CABG","Inclusion Criteria:\n\n* Male or female patients \\> 18 years\n* Isolated CABG procedure in the need of 2 or more venous grafts\n* Elective or urgent cases\n* Median sternotomy approach\n* eGFR ≥ 15 ml\u002Fmin\n* Willing to participate in trial\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* History of venous stripping or ligation\n* Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)\n* Enrolled in other therapeutic or interventional trial\n* Hemodynamically unstable\n* Cardiogenic shock\n* Any condition that seriously increases the risk of noncompliance or loss of follow-up\n* Emergency case\n* Salvage case",{"count":419,"type":22},120,[25],"The aim of this trial is to apply shockwaves to the leg wound after saphenous vein harvesting and closure in order to reduce the occurrence of postoperative wound healing complications following coronary artery bypass grafting using venous grafts.",[423],"Coronary Arterial Disease (CAD)",[425,426,427,428,429,430],"Coronary artery bypass grafting","Saphenous vein graft (SVG)","No-touch vein harvesting","Wound healing complications","Shockwave therapy (SWT)","Cardiac surgery","2025-12-21",{"date":433,"type":33},"2025-12-23",{"date":435,"type":33},"2025-10-03",{"date":437,"type":22},"2029-01",{"name":39,"class":40},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":41},"100590277","study-on-the-detection-of-pleuropulmonary-manifestations-in-rheumatoid-arthritis-100590277","NCT06965322","Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis","Prospective Observational Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis","REASSESS","Inclusion Criteria:\n\n* Patients ≥18 years diagnosed with rheumatoid arthritis according to current ACR\u002FEULAR criteria\n* Residence in Austria\n* Signed and dated consent of the patient in accordance with ICH-GCP guidelines\n\nExclusion Criteria:\n\n* pregnancy\n* age below 18 years\n* Contraindications to study-related routine examinations (e.g., inability to draw blood due to needle phobia, no CT scan possible due to claustrophobia, pregnancy, etc.)",{"count":448,"type":22},800,"The aim of the study is to develop a standardized, risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. To assess the risk of these manifestations, a comprehensive range of functional and clinical evaluations will be performed and correlated with structural lung assessments using computed tomography (CT).",[451,452],"Rheumatic Arthritis","Interstitial Lung Disease in Patients With Rheumatoid Arthritis",[454,455,456,457],"rheumatoid arthritis","interstitial lung disease","risk prediction","RA-ILD","2025-12-01",{"date":460,"type":33},"2025-12-02",{"date":462,"type":33},"2024-11-11",{"date":464,"type":22},"2029-09-30",{"name":39,"class":40},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":41},"100413390","optimization-of-cardiac-resynchronization-therapy-by-non-invasive-imaging-of-cardiac-electrophysiology-100413390","NCT04662970","Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology","Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study","NICE CRT","Inclusion Criteria:\n\n* patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software\n* left bundle branch block before CRT implantation\n* PQ interval ≤ 250 ms before implantation\n\nExclusion Criteria:\n\n* high-grade AV block\n* any contraindication concerning a safe CMR performance including claustrophobia\n* terminal heart failure (NYHA IV) or cardiac decompensation\n* life expectancy \\\u003C 1 year\n* women with child-bearing potential, pregnancy\n* drug abusus",{"count":7,"type":22},[25],"The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology",[478],"Heart Failure","2025-09-29",{"date":481,"type":33},"2025-10-02",{"date":483,"type":33},"2020-01-01",{"date":485,"type":22},"2027-12-31",{"name":39,"class":40},{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":392,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":251},"100594601","protoporphyrin-imaging-in-multispectral-evaluation-of-resections-100594601","NCT07021573","Protoporphyrin Imaging in Multispectral Evaluation of Resections","PRIMER","Inclusion criteria:\n\n* Age Requirement: Patients must be 18 years of age or older.\n* Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.\n* MRI Findings: Patients must meet one of the following criteria:\n\n  * Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like).\n  * Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like).\n* Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.\n* 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.\n* Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center).\n* Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study.\n* Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization.\n* Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care.\n* No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy.\n\nExclusion criteria:\n\n* Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.\n* Use of all other fluorescent markers.\n* Patients with a history of porphyria or other disorders related to 5-ALA metabolism.\n* Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.\n* Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.\n* Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study.\n* Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care.\n* Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA.\n* Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants).\n* Patients unable to provide written informed consent due to cognitive, language, or other barriers.\n* Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach.\n* Pregnancy",{"count":280,"type":22},[25],"Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.",[498],"Glioma",[500],"Suspected high-grade gliomas","2025-09-08",{"date":503,"type":33},"2025-09-09",{"date":505,"type":22},"2025-09-30",{"date":149,"type":22},{"name":39,"class":40},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":523,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":41},"100601213","assessment-of-coronary-artery-disease-before-transcatheter-aortic-valve-replacement-a-randomized-multicenter-non-inferiority-trial-100601213","NCT07107568","Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial","TAVR-CT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines\n* TAVR candidate\n* Written informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock at presentation (e.g., emergency indication for TAVR)\n* Severe renal impairment with an estimated glomerular filtration rate of \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Life expectancy \\\u003C1 year due to other severe non-cardiac disease (e.g., malignancy)\n* Pregnancy",{"count":516,"type":22},700,[25],"The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.",[520,521,522],"Aortic Valve Stenosis and Insufficiency","Coronary Artery Disease(CAD)","Transcatheter Aortic Valve Replacement (TAVR)",[513,524,525,526,527,528,529],"PCD-CT","Severe Aortic Stenosis","Transcatheter Aortic Valve Replacement","TAVR","Photon-Counting Detector CT","Randomized Controlled Trial","2025-08-18",{"date":532,"type":33},"2025-08-22",{"date":534,"type":33},"2025-08-14",{"date":178,"type":22},{"name":39,"class":40},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":554,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100434641","crp-apheresis-in-stemi-100434641","NCT04939805","CRP Apheresis in STEMI","Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction","Inclusion Criteria:\n\n1. Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation\n2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)\n3. CRP elevation of ≥7 mg\u002Fl measured between 6 to 16 hours after primary PCI\n4. Eligible for primary PCI\n5. Age ≥18 years\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI.\n2. Persistent hemodynamic instability (Killip class \\>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.\n3. The patient is febrile (temperature \\>38°C) or has experienced an acute infection with fever in the last 14 days.\n4. CRP \\>15 mg\u002Fl at time of hospital admission.\n5. Chronic inflammatory disease.\n6. Known history of severe hepatic failure\n7. Chronic kidney disease with a creatinine clearance \\\u003C30ml\u002Fmin.\u002F1.73m²\n8. Contraindication to CMR.\n9. Pre-STEMI life expectancy of \\\u003C1 year\n10. Participation in another interventional trial\n11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad)\n12. Pregnancy","85 Years",{"count":546,"type":22},202,[25],"Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.\n\nObjective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.\n\nDesign: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.\n\nInnovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.",[550,551,552,553],"ST Elevation Myocardial Infarction","C-Reactive Protein","Apheresis","Myocardial Injury",[555],"Cardiac magnetic resonance imaging","2025-05-06",{"date":558,"type":33},"2025-05-09",{"date":560,"type":33},"2021-04-01",{"date":562,"type":22},"2025-08-31",{"name":39,"class":40},5,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":573,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":41},"100588048","counterpressure-maneuvers-in-postural-orthostatic-tachycardia-syndrome-100588048","NCT06936319","Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome","Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial","CPM_in_POTS","Inclusion Criteria:\n\n* POTS diagnosis\n* 18 to 80 years of age at time of consent\n* stable medication in the seven days prior to the baseline visit\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* participation in other interventional trials\n* pregnant or breastfeeding females\n* on treatment with vasoactive medications including medications for heart rate control\n* acute infections at the time of enrolment or in the two weeks before\n* acute pain\n* surgery in the last three months\n* inability or contraindication for performing hip and knee flexion, hip adduction or squatting\n* inability to stand for at least two minutes\n* Any other cardiological, internal, psychiatric or neurological condition, which may prevent engagement in the sturdy procedures in the judgement of the investigator","80 Years",{"count":5,"type":22},[25],"The present study evaluates whether performing a 14-days counter pressure maneuvers (CPM)-biofeedback training improves the symptomatic burden (primary objective) and secondarily the interference of POTS symptoms with daily activities, fatigue, and health-related quality of life of individuals with POTS compared to best clinical practice non-pharmacological measures. Secondary in-laboratory objectives are to assess the influence of CPM on the supine-to-standing heart rate (HR) and blood pressure (BP) changes as well as on the severity of orthostatic intolerance after performing CPM for two minutes compared to a baseline (intervention-free) active standing test, and to assess the safety and tolerability of CPM-biofeedback training in individuals with POTS.\n\nThis is a monocentric, proof-of-concept, 1:1 randomized, controlled trial with rater-blinded evaluation of the hemodynamic effect of CPM in 40 individuals suffering from POTS.\n\nAll study participants will receive detailed counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life and will be invited to practice them regularly (best clinical practice). Participants randomized to the interventional arm will receive a CPM-biofeedback training session in the autonomic function laboratory at the Department of Neurology of the Innsbruck Medical University to learn four different CPM under continuous HR and BP monitoring. The CPM-biofeedback training will consist of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times a minute).\n\nThe trial foresees three study visits for both the interventional and the control arm (screening and baseline on-site, as well as a telephone visit 14 days later). For the interventional trial arm, two additional visits are planned (CPM-biofeedback training session in the autonomic function laboratory and a follow-up telephone visit 7 days later).\n\nTo evaluate the baseline to day-14 change in symptom severity, the Malmö POTS Score (MAPS) total score (primary endpoint) and the MAPS single items, Vanderbilt Orthostatic Symptom Score, Orthostatic Grading Scale, Fatigue Severity Scale and Health-related Quality of Life Questionnaire (EuroQol -EQ-5D-5L ) will be administered.",[578],"Postural Orthostatic Tachycardia Syndrome (POTS)","2025-04-29",{"date":581,"type":33},"2025-05-02",{"date":583,"type":33},"2025-01-15",{"date":585,"type":22},"2025-12-31",{"name":39,"class":40},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":18,"minAge":595,"maxAge":19,"enrollmentInfo":596,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":597,"conditions":598,"keywords":601,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":251},"100589430","therapeutic-drug-monitoring-for-biological-therapy-in-pediatric-inflammatory-bowel-disease-100589430","NCT06954311","Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease","Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study","TDMpIBD","Inclusion Criteria:\n\n* Pediatric patients with an Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, and IBD-unclassified) being under 18 years of age\n* Treatment with Infliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase\n\nExclusion Criteria:\n\n\\-- Patients with primary (congenital) immunodeficiency","0 Years",{"count":419,"type":22},"Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood. In recent decades, an increasing incidence of IBD has been observed in this age group.\n\nA wide range of immunomodulatory agents, from corticosteroids to monoclonal antibodies, are now available for the treatment of IBD. These antibodies, known as biologics, target, for example, tumor necrosis factor-alpha (TNF-α; e.g., infliximab and adalimumab), integrin α4β7 (vedolizumab), or interleukin-12\u002F23 (ustekinumab). While infliximab and adalimumab are approved for pediatric use in CD and UC, vedolizumab is only approved for moderate-to-severe UC from the age of 16, and ustekinumab is not approved for pediatric use at all. Nevertheless, vedolizumab and ustekinumab are frequently used off-label in cases of treatment failure with approved therapies, as efficacy has been demonstrated in adult IBD patients, and since 2015, increasing pediatric literature has emerged on their use.\n\nTo facilitate appropriate dose adjustment in pediatric clinical practice, biologic therapies can be monitored through measurement of drug trough levels. Current pediatric guidelines already recommend incorporating therapeutic drug monitoring (TDM) of infliximab and adalimumab in the management of CD and UC. Studies on TDM for vedolizumab and ustekinumab have so far been conducted almost exclusively in adult IBD patients, where improved treatment responses have also been demonstrated.\n\nThe presented research is a prospective, non-interventional observational study involving pediatric IBD patients at multiple Austrian pediatric gastroenterology centers. The study duration is five years. The aim is to include at least 40 patients receiving induction and maintenance therapy with infliximab or adalimumab, and 20 patients treated with vedolizumab or ustekinumab during both treatment phases. The primary objective is to gain a better understanding of the pharmacokinetic dynamics of these biologics and the associated treatment response in pediatric settings. Data will be collected exclusively from routine clinical assessments. No additional study-related visits or interventions are planned.",[599,600],"Ulcerative Colitis (UC)","IBD-unclassified (IBD-U)",[602,603,604,605,606,607,608],"IBD","Pediatric","Biologicals","Infliximab","Adalimumab","Vedolizumab","Ustekinumab","2025-04-24",{"date":611,"type":33},"2025-05-01",{"date":613,"type":33},"2025-02-17",{"date":615,"type":22},"2030-02-17",{"name":39,"class":40},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":392,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":41},"100466605","high-intensity-prehab-before-major-abdominal-surgery-100466605","NCT05355909","High Intensity PreHab Before Major Abdominal Surgery","Effect of a Two Week Prehabilitation Program Before Major Abdominal Surgery","Inclusion Criteria:\n\n* ASA I-III\n* BMI 18 - 35kg\u002Fm2\n* Signed informed consent\n* Elective abdominal surgery with moderate to high risk\n\nExclusion Criteria:\n\n* Pregnancy of lactation\n* Major trauma or massive haemorrhage with the last two weeks\n* Inclusion of the patient in a interventional study\n* Contraindication for preoperative fitness training or ergometry\n* Transplantation surgery",{"count":625,"type":22},60,[25],"The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE \\\u003C1%), moderate risk (MACE 1-5%) and high risk (MACE \\> 5%). In addition with patient related risk factors it can raise to values of 40%.\n\nThe preoperative aerobic fitness \\[oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \\\u003C11 mL\u002Fkg\u002Fmin\\] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.\n\nHowever some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.\n\nThe aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.",[398],[630],"ventilatory anaerobic threshold, Prehabilitation","2025-03-24",{"date":633,"type":33},"2025-03-26",{"date":635,"type":33},"2022-08-01",{"date":637,"type":22},"2026-12-31",{"name":39,"class":40},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":17,"sex":18,"minAge":647,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":650,"conditions":651,"keywords":655,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":4},"100570610","predicting-postoperative-delirium-with-heart-rate-variability-obtained-by-analgesia-nociception-index-100570610","NCT06709482","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index - A Prospective Clinical Pilot Study","DANI","Inclusion Criteria:\n\n1. \\> 50 years of age\n2. Scheduled for elective moderate to major risk traumatology or orthopedic surgery (excluding spine surgery) and anticipated duration of general anaesthesia ≥ 60 minutes.\n\nExclusion Criteria:\n\n1. Delirium before surgery.\n2. Patients with emergency surgery\n3. Contraindication to general anesthesia\n4. ASA ≥ 4.\n5. Terminal disease.\n6. h\u002Fo documented dementia, MoCA Score \\\u003C18\n7. h\u002Fo atrial fibrillation\n8. h\u002Fo Parkinson´s disease \u002F Multiple system atrophy \u002F Pure autonomic failure\n9. h\u002Fo autonomic dysfunction (neurogenic autonomic dysfunction)\n10. h\u002Fo stroke\u002Fintracerebral hemorrhage\n11. Cerebral neoplasia\n12. h\u002Fo chronic central nervous disorder (e.g. multiple sclerosis)\n13. Major Depression\n14. Language, vision, or hearing impairments that may compromise delirium or cognitive assessments.\n15. h\u002Fo malignant hyperthermia\n16. h\u002Fo structural muscle disease\n17. h\u002Fo substance abuse\n18. h\u002Fo polyneuropathy\n19. h\u002Fo psychiatric disease\n20. h\u002Fo or current substance use disorder (DSM V)","50 Years",{"count":649,"type":22},150,"The aim of this pilot study is to establish a correlation between perioperative heart rate variability (HRV) as an expression of the shift in the balance of the autonomic nervous system and the occurrence of postoperative inflammation and delirium. The main question it aims to answer is: Do patient with increased sympathetic nervous system activity develop postoperative delirium (POD) more often than patients with increased parasympathetic tone?",[652,653,654],"POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Heart Rate Variability","Biomarkers",[656,657,658],"postoperative delirium","inflammation","heart rate variability","2025-03-06",{"date":661,"type":33},"2025-03-07",{"date":663,"type":22},"2025-03-01",{"date":665,"type":22},"2026-12-01",{"name":39,"class":40},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":677,"briefSummary":679,"conditions":680,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":41},"100560836","phase-2-effect-of-alpha-1-antitrypsin-supplementation-on-alcohol-associated-hepatitis-100560836","NCT06582329","Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis","Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis - A Prospective Pilot Study","EARTH","Inclusion Criteria:\n\n1. Male or female patient ≥18 years of age at time of consent.\n2. Severe AAH (Maddrey's discriminant function score ≥ 32) at screening.\n3. No ACLF or ACLF Grade 1 at screening.\n4. Daily average intake of \\>80 g (men)\u002F\\>60 g (women) ethanol during the past 3 months (patient reported).\n5. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.\n6. Outpatient or hospitalized patient not being on the Intensive Care Unit (ICU) at screening.\n\n   Inclusion criterion 7 only applies to women of childbearing potential (WOCBP)\n7. Negative urine pregnancy test, not breastfeeding \\& agreement to use highly-effective means of contraception during the study. Allowed are sexual abstinence, vasectomized partners (˃3 months previously-vasectomy has to be confirmed by two negative semen analyses) or the consistent and correct use of an approved contraceptive method in accordance with the product label, for example: Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide; intrauterine device; prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or intramuscular (IM) route Inclusion criterion 8 only applies to male patients\n8. Male patients who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use one other approved method of highly effective contraception from the time of investigational product administration for at least 90 days after the dose of investigational product and must refrain from sperm donation from Screening through at least 90 days following the last dose of investigational product.\n9. Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.\n\nExclusion Criteria:\n\n1. Uncontrolled Diabetes Mellitus type 1 or 2 (defined by HbA1c \\> 10%).\n2. Corticosteroid use contraindicated.\n3. Viral hepatitis, autoimmune hepatitis, HIV infection, Wilson disease, hemochromatosis, toxic liver injury, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC).\n4. Participation in another interventional clinical study within 6 months prior to screening and\u002For during trial participation.\n5. Presence of any active malignancy (other than non-melanoma skin cancer) which required treatment within the past 12 months.\n6. Chronic kidney disease receiving dialysis.\n7. Do Not Attempt Resuscitation (DNAR) order in place.\n8. IgA deficiency (IgA level \\\u003C7mg\u002FdL) or known intolerance to A1AT.\n9. History of liver transplantation or currently listed for liver transplant.",{"count":676,"type":22},16,[678],"PHASE2","The trial is designed as a prospective, single center, open label, randomized controlled pilot study evaluating the effect of A1AT (Alpha 1 Antitrypsin) on inflammation in patients with severe AAH (alcohol-associated hepatitis).\n\nThe objective is to evaluate the safety and the effect of intravenous A1AT on the systemic inflammation in patients with severe AAH. The objectives also include the assessment of A1AT on clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs) and the cytokine.",[681],"Alcohol-Associated Hepatitis","2025-03-05",{"date":659,"type":33},{"date":685,"type":22},"2025-04",{"date":687,"type":22},"2026-12",{"name":39,"class":40},""]