[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hannover Medical School\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":479},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,52,78,101,122,145,171,200,228,252,281,305,334,361,380,411,431,453],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100639500","i-scoop-vs-c-mac-d-blade-videolaryngoscope-for-airway-management-under-spontaneous-breathing-and-analgosedation-100639500",false,"NCT07624162","I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation","Practicability of Airway Management With the Videolaryngoscopes I-scoop and C-Mac D-Blade Under Spontaneous Breathing and Analgosedation - A Prospective, Randomized, Monocentric Trial","OWN BREATH 2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled surgical procedure or intervention under general anesthesia\n* Capacity to give informed consent (free and independent decision-making capacity)\n* Willingness to provide written informed consent after comprehensive verbal and written information about study aims, procedures, and risks\n\nExclusion Criteria:\n\n* Lack of, or withdrawal of, written informed consent\n* Lack of capacity to consent or legal guardianship for health-related decisions\n* Insufficient German language skills for qualified verbal and written informed consent (exclusion to protect patients, since legally valid and substantively meaningful consent is not possible without secured language comprehension)\n* Pregnancy or breastfeeding\n* Current opioid therapy or chronic opioid therapy discontinued less than 1 month before the procedure\n* Known drug or alcohol dependence\n* Known hypersensitivity or allergy to lidocaine or its excipients (glycerol, propyl-4-hydroxybenzoate, methyl-4-hydroxybenzoate)\n* Severe psychiatric disorder impairing capacity to consent or to cooperate\n* Indication for nasal intubation\n* Non-pain-related limitation of mouth opening to less than 16 mm\n* Severe comorbidities with particular risk in the context of the study intervention (e.g., unstable cardiac or pulmonary disease, uncontrolled epilepsy)\n* Participation in another clinical study within the previous 30 days that could influence the present study question","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical trial is to investigate whether the videolaryngoscope i-scoop makes airway management under spontaneous breathing and analgosedation more clinically practicable than the established standard device, the C-Mac D-Blade videolaryngoscope, in adults undergoing surgery under general anesthesia.\n\nThe main questions it aims to answer are:\n\n• Is good clinical practicability - defined as a successful, easy, and complication-free intubation under spontaneous breathing - more frequently achieved with the i-scoop than with the C-Mac D-Blade?\n\nResearchers will compare the standardized airway management procedure under spontaneous breathing using either the i-scoop or the C-Mac D-Blade.\n\nParticipants will:\n\n* continue breathing on their own during the procedure\n* be randomly assigned (1:1) to one of the two videolaryngoscopes\n* receive standardized analgosedation and topical lidocaine anesthesia of the upper airway before the breathing tube is placed\n* be asked about discomfort and recall of the procedure after surgery (in the recovery room, on postoperative day 1, and at 7 days post-intubation) by a blinded interviewer",[27],"Airway Management",[29,30,31,32,33,34,35,36,37,38],"Videolaryngoscope","i-scoop","C-Mac D-Blade","Spontaneous breathing","Conscious sedation","Analgosedation","Topical airway anesthesia","Bladeless laryngoscope","Anatomy-guided intubation","Clinical practicability","RECRUITING","2026-06-20",{"date":42,"type":43},"2026-06-25","ACTUAL",{"date":45,"type":43},"2026-06-18",{"date":47,"type":21},"2028-04-30",{"name":49,"class":50},"Hannover Medical School","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":51},"100636623","paro-agitation-study-100636623","NCT07568093","PARO-agitation-study","Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study","Patient inclusion criteria:\n\n* ≥18 years of age\n* Elective visceral surgery\n* german-speaking\n* Patient is capable of giving informed consent\n\nPatient exclusion criteria:\n\n* Known dementia\n* Known immunodeficiency\n* Anacusia\n* Acute damage to the central nervous system\n* A preoperative systemic infection\n* Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE))\n* Postoperative systemic infection\n* Drug dependence\n* Known chronic pain syndrome",{"count":60,"type":21},300,[24],"Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device \"PARO\" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of \"PARO\" in patients undergoing elective visceral surgery and to analyze the occurence of agitation.\n\nA decrease in the incidence of postoperative agitation is to be expected in a cohort of patients undergoing visceral surgery who use PARO compared to a group of patients undergoing visceral surgery who do not use PARO.\n\nTo monitor the occurrence of postoperative agitation, a standardized screening will be conducted twice daily for three days using the Richmond Agitation-Sedation Scale (RASS). To assess postoperative pain, anxiety and delirium, the Numerical Pain Scale (NRS), the State-Trait-Anxiety-Inventory (STAI) and a delirium screening tool (3D-CAM\u002FCAM-ICU) are used by a trained study team. The occurrence of other neuropsychiatric symptoms and postoperative surgical complications will also be assessed.\n\nAdditionally, the interaction between PARO and the patients is analyzed regarding movements, reactions to haptic and auditory stimuli, and the frequency of interaction. Our approach involves quantitatively monitoring these metrics to collect sensor data from the robot and video recordings of the patients to identify facial expression and posture patterns. The use and acceptance of the robot on clinical wards by various professional groups are evaluated. The focus is particularly on nursing staff, who have the most interactions with patients. The project is complemented by a hygiene study examining how successfully the hygiene protocol is integrated into clinical routines and what challenges the use of PARO poses in an intensive care unit. The aim is also to examine the workflow and time-related aspects of its usage. The study will be submitted as a clinical trial of the medical device within its intended use, without any additional invasive or burdensome procedures, in accordance with the provisions of Section 15 of the Medical Practitioners Act (MBO).",[64,65,66,67],"Agitation","POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Anxiety After Surgery","Postoperative Pain",[69],"Agitation, postoperative Delirium, Anxiety","2026-04-28",{"date":72,"type":43},"2026-05-05",{"date":74,"type":43},"2025-12-15",{"date":76,"type":21},"2027-05",{"name":49,"class":50},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100592181","phase-2-t-cell-therapy-in-patients-with-pml-100592181","NCT06990087","T-cell Therapy in Patients With PML","CurePML - Allogeneic HPyV-2-specific T-cell Therapy in Patients With Progressive Multifocal Leukoencephalopathy","Inclusion Criteria:\n\n* Adults\\* aged ≥ 18 years with PML (diagnosed ≤ 60 days before screening) associated with one or more of the following risk factors: lymphoproliferative diseases, immunosuppressive therapy, or lymphopenia\n* Signed written informed consent from subject and\u002For legal representative\n* HPyV-2 detection in CSF by PCR analysis or in brain biopsy\n\nExclusion Criteria:\n\n* PML caused by HIV\n* PML caused by natalizumab\n* PML occurring within five 5 years after hematopoietic stem-cell transplantation or CAR T cell therapy, or resulting from chronic lymphocytic leukemia (CLL)\n* Patients who are unable to follow the study protocol, either on their own or with the support of a reliable representative, will be excluded\n* Pregnancy or breastfeeding\n* Currently receiving chemotherapy\n* Present (within 2 weeks before screening visit) and continuous treatment with immune checkpoint inhibition therapy\n* Severe infections other than PML (e.g. sepsis, pneumonia)\n* Hypersensitivity to any of the components of the medications used\n* Inability to undergo MRI examination (e.g. implanted incompatible medical devices, claustrophobia)\n* Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)",{"count":86,"type":21},23,[88],"PHASE2","There is no approved standard treatment für progressive multifocal leukoencephalopathy (PML). The sponsor of the study is developing a new treatment. For this reason, the investigational medicinal product (IMP) called 'human allogenic HPyV-2-specific T cells' is to be tested in this study. The sponsor wants to find out whether the IMP is safe, influences the neurological status and improves the quality of the life of patients . It is to be investigated whether the IMP can be used to treat the disease and whether it could have an advantage over the standard therapy in terms of survival rate.",[91],"Progressive Multifocal Leucoencephalopathy (PML)","2026-02-10",{"date":94,"type":43},"2026-02-12",{"date":96,"type":43},"2026-02-06",{"date":98,"type":21},"2027-11",{"name":49,"class":50},6,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":51},"100557981","phase-1-intracochlear-application-of-vsf101-for-the-reduction-of-cochlear-implant-surgery-related-trauma-100557981","NCT06545175","Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma","Extracellular Vesicle-enriched Secretome Fraction (VSF1.01) for the Reduction of Cochlear Implant Surgery Related Trauma (ESCRT). An Open-label Monocentric Phase I\u002FIIa Clinical Trial to Investigate the Safety of Intracochlear Application of VSF1.01 Enriched With hUC-MSC-EVs in Patients Receiving Cochlear Implantation.","ESCRT","Inclusion Criteria:\n\n* Men, women, inter\u002Fdiverse aged ≥ 18 years\n\n  * Women without childbearing potential defined as follows:\n\n    * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or\n    * hysterectomy or uterine agenesis or\n    * ≥ 50 years and in postmenopausal state \\> 1 year or\n  * Women of childbearing potential:\n\n    * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or\n    * who have sexual relationships with female partners only and\u002For with sterile male partners or\n    * who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.\n* Signed written informed consent from subjects capable of understanding all information and to give full informed consent\n* Functional deaf patients (profound hearing loss with or without non-functional residual hearing in the low frequencies i.e. 125 Hz: 45 dB - 95 dB; 250 Hz: 50 dB - 105 dB; 500 Hz: 55 dB - 110 dB; 750 Hz and higher: 65 dB or below) that are candidates for cochlear implantation\n\nExclusion Criteria:\n\n* Patients with prior ear surgery\n* Patients with inner ear malformations\n* Patients with acute or chronic otitis media\n* Patients with keloid disorder\n* Comorbidities concerning the central nervous system\n* Malignancies of any type\n* Kidney disease with elevated blood values: creatinine \\>1.5x above upper limit of normal (ULN), eGFR or creatinine clearance 59 mL\u002Fmin\u002F1.73 m2 (grade ≥2, CTCAE v5.0)\n* Liver disease with elevated blood values: bilirubin \\>1.5x ULN, AST\u002FALT \\>3.0x ULN, ALP and y-GT \\>2.5x ULN, LDH \\>ULN, international normalized ratio (INR) \\>1.5-2.5x baseline if on anticoagulation, albumin \\\u003C3 g\u002FdL (grade ≥2, CTCAE v5.0)\n* Suspected or verified pregnancy or breastfeeding\n* Hypersensitivity to any of the components of the medications used (such as Ringer's Lactate (excipient); any residuals from cell culture or raw materials used for pharmaceutical upstream and downstream processing to generate VSF1.01 (i.e. alpha-Modified Eagle Medium (αMEM), Dulbecco's MEM (DMEM), pooled human platelet lysate (pHPL), human serum albumin (HSA), Dipeptiven, phosphate buffered saline (PBS), animal origin free recombinant enzyme (TrypLETM Select))\n* Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)",{"count":110,"type":21},11,[112,88],"PHASE1","The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation.\n\nThe main questions it aims to answer are:\n\nPrimary objective:\n\nSafety of intracochlear application of VSF1.01 in patients receiving cochlear implantation\n\nSecondary objectives:\n\nEffectiveness on\n\n1. neural responses of auditory nerve\n2. speech understanding\n3. hearing thresholds\n4. electrode impedances\n\nDuring cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array.\n\nCochlear implantation is conducted according to the clinical standard at the investigational site.",[115],"Hearing Loss",{"date":94,"type":43},{"date":118,"type":43},"2024-11-18",{"date":120,"type":21},"2026-06",{"name":49,"class":50},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":51},"100622470","exercise-training-in-patients-with-myeloproliferative-neoplasms-100622470","NCT07384039","Exercise Training in Patients With Myeloproliferative Neoplasms","Effects of Individually Tailored Exercise on Quality of Life and Physical Performance in Patients With Myeloproliferative Neoplasms-a Randomized Controlled Study","MPN-Exercise","Inclusion Criteria:\n\n* age ≥ 18 years\n* diagnosis of myeloproliferative neoplasia according to WHO\u002FICC 2022.\n\nExclusion Criteria:\n\n* current participation in another intervention study\n* the presence of any diseases or functional impairments that, in the opinion of the examining physician, exclude participation in a physical training intervention.",{"count":131,"type":21},80,[24],"The investigators will investigate the response of an individualized exercise training program on quality of life, cardiorespiratory fitness and disease-specific markers in patients with myeloproliferative neoplasms (MPN). To this end, the investigators will randomly assign patients with MPN to a training group and a waiting control group.\n\nThe training group will undergo an individually tailored exercise training program for three months, while the control group will maintain their usual lifestyle for three months and then has the opportunity to undergo the three-month intervention program. At the beginning and at the end of the three-month intervention phase, the investigators will evaluate physical performance, daily physical activity, muscular strength, and self-reported outcomes and compare them between the training and the control group, in order to assess potential benefits of the exercise training program.",[135],"Myeloproliferative Neoplasms (MPN)","NOT_YET_RECRUITING","2026-02-03",{"date":139,"type":43},"2026-02-05",{"date":141,"type":21},"2026-02-04",{"date":143,"type":21},"2027-02-28",{"name":49,"class":50},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":51},"100620025","outreach-medical-care-for-housebound-patients-with-post-covid-19-syndrome-or-mecfs-of-any-cause-access-100620025","NCT07352254","OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME\u002FCFS of Any Cause (ACCESS)","OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME\u002FCFS of Any Cause","ACCESS","Inclusion Criteria:\n\n* ME\u002FCFS according to the Canadian Consensus Criteria\n* Bell Score ≤ 30\n* Duration of the postexertional malaise (PEM) \\> 14 hours\n* Age \\> 18 years and \\\u003C 70\n\nExclusion Criteria:\n\n\\- Pre-existing conditions or comorbidities that have (or could have) led to a restriction of mobility or mental capacity, such as various diseases of the central nervous system.","69 Years",{"count":155,"type":21},100,[24],"The significance of the Post-COVID Syndrome (PCS) has been widely acknowledged. Various efforts are made to find out about the pathomechanisms behind PCS and to establish therapies. One sub-group of PCS-patients, however, is generally excluded from any studies, and that are those who are unable to visit outpatient clinics or hospitals for diagnostic work up or participation in clinical trials, as they are unable to leave their home and to seek medical support on their own physical and mental capabilities. They are housebound, mostly or totally bedridden. Similar cases are known from myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS) of any cause and are graded as moderate to very severe ME\u002FCFS according to the Canadian Consensus criteria. The patients are usually seen by their family doctor and have no access to medical specialists.\n\nThe planned project aims to find out about the prevalence of this most severe manifestation of PCS, the clinical characteristics, the prevalence of mimics, risk factors and impact of the disease on the patients' life and their family\u002Fcaregivers. Individual care and treatment plans will be developed and the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden will be evaluated in a randomized controlled trial. The project will be performed in close cooperation between patients, caregivers, the patient's family doctor and a board of experts from internal medicine, neurology, psychosomatic medicine and general medicine at Hannover Medical School.\n\nWe expect an improvement of the patients' and caregivers wellbeing with intensified medical care. We are aware, however, that intensification of the patient-doctor interaction carries the risk to exacerbate the patients' symptoms. The results of our study will show how current models of care for PCS and ME\u002FCFS patients should be modified to fit to the individual patient's aims and capacities.",[159],"ME\u002FCFS",[159,161,162],"housebound","house call","2026-01-18",{"date":165,"type":43},"2026-01-21",{"date":167,"type":21},"2026-01",{"date":169,"type":21},"2028-12",{"name":49,"class":50},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":179,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":51},"100553970","promoting-sustainable-and-active-mobility-among-employees-and-students-100553970","NCT06493006","Promoting Sustainable and Active Mobility Among Employees and Students","Impact of Physically Active Versus Passive Way to Work on Physical and Mental Aspects of Health in Members at Hannover Universities: an Observational Study","DiNaMo-active","Inclusion Criteria:\n\n* living within 50km around the workplace\n\nExclusion Criteria:\n\n* current participation in another interventional study",true,"75 Years",{"count":182,"type":21},500,"OBSERVATIONAL","The aim of the study is to assess health data (heart rate variability, blood pressure, blood glucose, particulate matter pollution) and travel characteristics (length, duration and type of commute) on the way to and from work from members of the universities in Hannover (Germany).",[186],"Mobility on the Way to Work and Health-related Outcomes",[188,189,190,191],"commuting to work","active mobility","heart rate variability","sustainable universities","2025-11-19",{"date":194,"type":43},"2025-11-24",{"date":196,"type":43},"2024-08-01",{"date":198,"type":21},"2026-06-30",{"name":49,"class":50},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":208,"targetDuration":210,"studyType":183,"phases":4,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":51},"100424007","tips-in-patients-with-decompensated-liver-cirrhosis-100424007","NCT04801290","TIPS in Patients With Decompensated Liver Cirrhosis","Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis","Inclusion Criteria:\n\n* Liver cirrhosis\n* Indication for TIPS insertion\n* Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School\n* Informed consent\n\nExclusion Criteria:\n\n* Pregnancy or Lactation\n* Age \\\u003C18 years\n* Lack of Informed consent\n* Symptomatic anemia with Hb \\\u003C7g\u002Fdl","99 Years",{"count":209,"type":21},250,"12 Months","This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).",[213],"Decompensated Liver Cirrhosis",[215,216,217,218,219],"Portal hypertension","TIPS","Refractory ascites","Variceal bleeding","Liver cirrhosis","2025-09-10",{"date":222,"type":43},"2025-09-16",{"date":224,"type":43},"2019-08-29",{"date":226,"type":21},"2027-12",{"name":49,"class":50},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":179,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":236,"targetDuration":237,"studyType":183,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":51},"100605975","health-literacy-and-self-efficacy-expectations-in-patients-with-alcohol-related-liver-cirrhosis-100605975","NCT07169526","Health Literacy and Self-efficacy Expectations in Patients With Alcohol-related Liver Cirrhosis","Gesundheitskompetenz Und Selbstwirksamkeitserwartung Bei PatientInnen Mit Alkoholbedingter Leberzirrhose","GESA","Inclusion Criteria:\n\n* age (18-99)\n* liver cirrhosis\n\nExclusion Criteria:\n\n* pregnancy\n* insufficient german",{"count":20,"type":21},"1 Month","The goal of this observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis.",[240,241,242,243],"Self-Efficacy","Health Literacy","Liver Cirrhosis","ALD - Alcoholic Liver Disease","2025-09-05",{"date":246,"type":43},"2025-09-11",{"date":248,"type":43},"2025-08-11",{"date":250,"type":21},"2026-10",{"name":49,"class":50},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":51},"100573013","intermittent-theta-burst-stimulation-to-improve-negative-symptoms-and-cognition-in-schizophrenia-100573013","NCT06740747","Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia","Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie","ITBS-NKS-2024","Inclusion Criteria:\n\n* Diagnosis of schizophrenia (ICD-10: F20.-)\n* Age: 18-65 years\n* Ability to give informed consent\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Any electronic implants\n* Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)\n* Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)\n* Claustrophobia\n* Epilepsy\n* History of traumatic brain injury within the last 3 months\n* History of stroke\n* Active central nervous system (CNS) infection\n* History of CNS infection within the last 3 months\n* Pregnancy\n* Current drug, medication, or alcohol abuse\n* Simultaneous participation in another clinical trial\n* Planned changes in psychopharmacological medication within the next 2 weeks\n* Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden","65 Years",{"count":262,"type":21},60,[24],"The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.\n\nThe goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:\n\nDoes iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.\n\nParticipants will:\n\n* Receive 10 sessions of iTBS over the course of 2 weeks\n* Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations.\n\nThe study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.",[266],"Schizophrenia Patients",[268,269,270,271,272],"iTBS","intermittent theta-burst stimulation","negative symptoms","cognition","schizophrenia","2025-07-16",{"date":275,"type":43},"2025-07-20",{"date":277,"type":43},"2025-04-08",{"date":279,"type":21},"2026-12-31",{"name":49,"class":50},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":51},"100398441","clinical-results-and-rsa-migration-analysis-of-the-global-icon---stemless-anatomic-shoulder-100398441","NCT04468178","Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder","Inclusion Criteria:\n\n1. Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis\n2. Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.\n3. Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.\n4. Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.\n5. Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).\n\nExclusion Criteria:\n\n1. Previous operation on the rotator cuff of the affected shoulder\n2. Dysfunctional rotator cuff\n3. Infection of the affected shoulder joint or systemic infection\n4. Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure","80 Years",{"count":262,"type":21},[24],"The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).",[292],"Osteoarthritis of the Shoulder",[294,295,296],"osteoarthritis","shoulder","joint replacement","2025-03-21",{"date":299,"type":43},"2025-03-25",{"date":301,"type":43},"2021-09-17",{"date":303,"type":21},"2027-12-31",{"name":49,"class":50},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":314,"studyType":183,"phases":4,"briefSummary":315,"conditions":316,"keywords":320,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100528427","d-solve-cohorts-cohort-a-and-b-100528427","NCT06160635","D-SOLVE Cohorts (Cohort a and B)","HDV750","Inclusion Criteria:\n\n* Anti-HDV positive\n* ≥18 years old\n* Sex: m\u002Ff\u002Fd\n* Informed consent for prospective procedures\n\nExclusion Criteria:\n\n* Anti-HDV negative",{"count":313,"type":21},750,"3 Years","Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. Hepatitis D is caused by coinfection Hepatitis D is caused by co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV).\n\nThis multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined HDV-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by HDV infection.",[317,318,319],"HDV","HDV Infection","Chronic Liver Disease",[317,321,322,323,324],"Hepatitis Delta","chronic liver disease","patient cohort","biomarker","2025-03-11",{"date":327,"type":43},"2025-03-12",{"date":329,"type":43},"2023-02-22",{"date":331,"type":21},"2026-09-30",{"name":49,"class":50},4,{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100495103","efficacy-of-add-on-plasma-exchange-as-an-adjunctive-strategy-against-septic-shock-100495103","NCT05726825","Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock","Randomized, Prospective, Multicenter, Open-label, Controlled, Parallel-group Trial Investigating the Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock - 2","EXCHANGE-2","Inclusion Criteria:\n\n* New onset of septic shock (\\\u003C 24 hrs), (SEPSIS-3 definition)\n* Norepinephrine (NE) dose ≥ 0.4 μg\u002Fkg\u002Fmin ≥ 30 min OR NE ≥ 0.3 μg\u002Fkg\u002Fmin + vasopressin (any dose)\n* Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 80 years\n* Urogenital focus of infection\n* Pregnancy\n* Heparin-induced thrombocytopenia\n* Known reaction against fresh frozen plasma (FFP)",{"count":343,"type":21},274,[24],"Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.",[347],"Septic Shock",[347,349,350,351,352],"Sepsis","Multi-organ failure","Extracorporeal therapy","Plasmapheresis",{"date":354,"type":43},"2025-03-13",{"date":356,"type":43},"2025-02-19",{"date":358,"type":21},"2028-04",{"name":49,"class":50},25,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":370,"studyType":183,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":51},"100443184","a-non-interventional-registry-for-patients-with-hepatitis-b-virus-infection-100443184","NCT05051098","A Non-interventional Registry for Patients with Hepatitis B Virus Infection","The European HBV Registry: a Joint Initiative of TherVacB and DZIF","Inclusion Criteria:\n\n* Hepatitis B Virus Infection\n\nTherVacB sub-cohort:\n\n* confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion\n* HBeAg status documented for at least 6 months\n\nExclusion Criteria:\n\nTherVacB sub-cohort:\n\n* age \\>70 years\n* co-infection with HIV, HCV (RNA positive),\n* clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)\n* significant comorbidities (e.g. malignancies)\n* immunosuppressive treatment (\\> 40 mg Cortisol- equivalent)\n* liver cirrhosis (judged clinically or based on ultrasound\u002Ftransient elastography)\n* History of hepatocellular carcinoma",{"count":369,"type":21},3000,"5 Years","In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.\n\nExtensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.\n\nFurthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).",[373],"Hepatitis B Virus Infection",{"date":354,"type":43},{"date":376,"type":43},"2021-05-06",{"date":378,"type":21},"2025-12",{"name":49,"class":50},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":388,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100553723","german-funded-laparoscopic-approach-to-cervical-cancer-100553723","NCT06489795","German-funded Laparoscopic Approach to Cervical Cancer","A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical\u002FSimple Hysterectomy Versus Abdominal Radical\u002FSimple Hysterectomy in Patients With Early-stage Cervical Cancer","G-LACC","Inclusion Criteria:\n\n1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix\n2. Patients with FIGO stage IA2, IB1, or IB2 disease (\\\u003C4 cm)\n3. Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification)\n\n   OR\n\n   Simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \\\u003C 2cm, \\\u003C 10 mm depth of stromal invasion (LEEP\u002Fcone). Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5mm vaginal cuff is required to ensure negative margins.\n4. Performance status of ECOG 0-1\n5. Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery\n6. Patients who have signed an approved Informed Consent\n7. Patients with a prior malignancy only if \\> 5 years previous with no evidence of disease\n8. Females, aged 18 years or older\n\nExclusion Criteria:\n\n1. Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix\n2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination\n3. FIGO stage IB3 - IV\n4. Patients with a history of pelvic or abdominal radiotherapy\n5. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \\> 2 cm, or histologically positive lymph nodes\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position\n8. Patient compliance and geographic proximity that do not allow adequate follow-up\n9. Women who are pregnant\n10. Patients with contraindications to surgery\n11. Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity)","FEMALE",{"count":390,"type":21},756,[24],"The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.\n\nThe main goal of this clinical trial is to evaluate the non-inferiority of minimally invasive radical hysterectomy in contrast to abdominal radical hysterectomy in patients with early-stage cervical cancer. In the case of SHAPE criteria, surgery may also be performed as minimally invasive or abdominal simple hysterectomy. The primary criterion for assessment is disease-free survival (DFS). As secondary outcomes, overall survival (OS), disease recurrence, quality of life, intra-\u002Fpostoperative complications, and serious adverse events are recorded for assessment.",[394],"Cervical Cancer",[396,397,398,399,400,401],"cervical cancer FIGO stage IA2","cervical cancer FIGO stage IB1","cervical cancer FIGO stage IB2","laparoscopic or robot-assisted radical\u002Fsimple hysterectomy","abdominal radical\u002Fsimple hysterectomy","simple hysterectomy in the case of SHAPE criteria","2025-01-31",{"date":404,"type":43},"2025-02-03",{"date":406,"type":43},"2024-07-17",{"date":408,"type":21},"2034-01",{"name":49,"class":50},14,{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":51},"100569838","the-seamless-patientfrom-preoperative-preparation-to-postoperative-rehabilitation-100569838","NCT06699446","The \"Seamless\" Patient:From Preoperative Preparation to Postoperative Rehabilitation","The \"Seamless\" Patient: From Preoperative Preparation to Postoperative Rehabilitation","Inclusion Criteria:\n\n* Patient is capable of giving consent;\n* planned, elective cardiac surgery (coronary bypass surgery and heart valve surgery incl. combination surgery). The planned surgery can be performed with or without a heart-lung machine.\n* Minimally invasive procedures may also be explicitly included in the study.\n\nExclusion Criteria:\n\n* Emergency care;\n* congenital heart defects;\n* age less than 18 years;\n* patient unable to give consent;\n* patient unable to perform simple physical training;\n* high-risk surgery with a calculated Euroscore II of more than 8%.",{"count":60,"type":21},[24],"The \"seamless\" patient: from preoperative preparation to postoperative rehabilitation.\n\nThe effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated",[422],"Heart Failure","2024-11-20",{"date":425,"type":43},"2024-11-21",{"date":427,"type":43},"2023-06-28",{"date":429,"type":21},"2026-12",{"name":49,"class":50},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100501532","predicting-steroid-dependent-liver-injury-with-polyreactive-immunoglobulin-g-100501532","NCT05810480","PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G","Prospective Multicenter Study: PredIcting SterOid DepeNdEnt LivEr Injury (PIONEER) with Polyreactive Immunoglobulin G","PIONEER","Inclusion Criteria:\n\n* Diagnostic liver biopsy for the work-up of any liver disease\n* Informed consent\n* Definition of any liver disease according to current societal guidelines\n\nExclusion Criteria:\n\n* No ongoing immunosuppression at the liver biopsy or prior to the liver biopsy\n* Liver biopsies for the grading or staging of an already known liver disease (e.g. non-alcoholic fatty liver disease (NAFLD), Hepatitis B\u002FD Virus Infections (HBV\u002FHDV Infection), …)",{"count":20,"type":21},"The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https:\u002F\u002Fdoi.org\u002F10.1002\u002Fhep.32134) and children (in preparation). Quantification of these pIgG using a \"home-made\" ELISA facilitates the diagnosis of autoimmune hepatitis (AIH) as compared to non-AIH liver diseases and healthy controls. Positivity for pIgG was independent from ANA\u002FSMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA\u002FSMA\u002FSLA\u002FLKM) were negative.\n\nAdditionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia\u002Fdrug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jhepr.2022.100605).\n\nAims of the study The study aims to evaluate the diagnostic capacity of pIgG to predict AIH in comparison to other liver diseases prospectively. To avoid diagnostic inaccuracy between AIH with long-term need for an immunosuppression and drug induced liver injury with autoimmune features, which can be indistinguishable from AIH at baseline and which has a very low relapse rate after a short steroid course, a follow-up after six months is obligatory for inclusion.\n\nTherefore, the investigators will collect one serum sample from every patient (without immunosuppressive treatment) that presents to the respective hospital for evaluation of liver disease by liver biopsy within one year after initiation of the study and that provided written informed consent. Follow-up for evaluation of steroid dependency at six months after diagnosis is obligatory.",[442,443],"Autoimmune Hepatitis","Autoimmune Liver Disease","2024-10-14",{"date":446,"type":43},"2024-10-16",{"date":448,"type":43},"2023-06-06",{"date":450,"type":21},"2027-01",{"name":49,"class":50},8,{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":460,"maxAge":18,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":468,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":4},"100561421","stopping-hypertension-and-improving-childrens-lives-after-kidney-transplantation-100561421","NCT06589947","StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation","SOPHOCLES","Inclusion Criteria:\n\n* Kidney transplantation \\>12 months ago\n* Arterial hypertension\n\nExclusion Criteria:\n\n* Cardiac malformation\n* Treatment for a rejection episode within three months prior to inclusion","6 Years",{"count":462,"type":21},170,[24],"Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels \\\u003C75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients \\>12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target \\\u003C90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.",[466,467],"Arterial Hypertension","Kidney Transplant; Complications",[469,470],"Left ventricular mass","Pediatric kidney transplantation","2024-09-06",{"date":473,"type":43},"2024-09-19",{"date":475,"type":21},"2024-09-16",{"date":477,"type":21},"2029-03",{"name":49,"class":50},""]