[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment-outcome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment-outcome":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,58,106,132,163,194,220,246,274,295,330,363,394,416,456,483,516,550,577],{"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":36,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100640612","flumazenil-for-benzodiazepine-reversal-in-electroconvulsive-therapy-100640612",false,"NCT07619092","Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy","Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial","FLEET","Inclusion criteria:\n\n* Current depressive episode (unipolar or bipolar), corresponding to ICD-10 codes F31.3-5, F32 or F33.\n* Admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark\n* Referred to ECT by the regular psychiatrist and has given consent to ECT\n* Currently receiving treatment with a benzodiazepine and\u002For zopiclone, at a minimum daily dose equivalent to 0.5 mg lorazepam.\n\nExclusion criteria:\n\n* Involuntary treatment with ECT\n* Known gross abnormalities in brain structure deemed likely to influence cognitive functioning\n* Pregnancy or breast-feeding\n* Inability to read or understand Danish\n* Acute organic brain disease (e.g., delirium) influencing the ability to give informed consent\n* Any pre-existing condition associated with an increased risk of prolonged or uncontrollable seizures, including but not limited to epilepsy or alcohol- or benzodiazepine withdrawal states\n* Conditions associated with reduced metabolism of flumazenil (e.g., liver failure)","ALL","18 Years",{"count":20,"type":21},145,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to investigate whether administering flumazenil to reverse the effects of benzodiazepines and\u002For zopiclone during electroconvulsive therapy (ECT) can help reduce cognitive side effects without diminishing treatment effectiveness in hospitalized patients with depression.\n\nThe investigators hypothesize that blockade of the GABA receptor with flumazenil will reduce cognitive side effects through improved seizures and a reduced need for electrical charge escalation during the ECT series. Cognitive side effects will be measured by the total score on the Screening for Cognitive Impairment in Psychiatry (SCIP) (primary outcome) at follow-up after completion of the ECT series. Furthermore, it is expected that the flumazenil strategy will reduce pre-treatment anxiety and improve patient satisfaction (secondary outcomes). In addition, flumazenil strategy is hypothesized to have beneficial effects on subjective cognitive complaints, autobiographical memory, and executive functioning (secondary outcomes). Finally, the flumazenil strategy is expected to be associated with more favorable structural and functional changes in executive functioning and memory-related brain networks after completion of the ECT series, which may, in turn, be linked to better overall cognition and autobiographical memory (secondary outcome measures). For exploratory purposes, the study will also examine longitudinal changes in depressive symptoms and cognitive outcomes from baseline to follow-up (tertiary outcomes).\n\nInvestigators will compare two different pre-ECT benzodiazepine management strategies:\n\n1. Flumazenil strategy (experimental): continued benzodiazepine and\u002For zopiclone use up until the time of the ECT session, followed by administration of flumazenil immediately prior to ECT\n2. Benzodiazepine withholding strategy (treatment as usual):\n\ndiscontinuation of benzodiazepines and\u002For zopiclone prior to the ECT in accordance with standard clinical practice",[27,28,29,30,31,32,33,34,35],"Depression - Major Depressive Disorder","Bipolar Disorder (BD)","Functional Magnetic Resonance Imaging (fMRI)","Cognition","Autobiographical Memory","Electroconvulsive Therapy","ECT","Treatment Outcome","Inpatients",[37,38,39,40,41,42,35,43,44,34,30],"flumazenil","benzodiazepine reversal","electroconvulsive therapy","randomized controlled trial","functional magnetic resonance imaging","Autobiographical Memory Test (AMT)","Major Depressive Disorder","Bipolar Disorder","RECRUITING","2026-05-27",{"date":48,"type":49},"2026-06-01","ACTUAL",{"date":51,"type":49},"2026-01-15",{"date":53,"type":21},"2028-08",{"name":55,"class":56},"Anders Jørgensen","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":83,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100634665","early-phase-1-chloramphenicol-tetracycline-zinc-oxide-and-eugenol-paste-ctz-paste-for-emergency-dental-treatment-in-public-health-settings-a-randomized-trial-100634665","NCT07542639","Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial","Clinical and Radiographic Efficacy of Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) in the Context of Emergency Dental Treatments in Brazilian Public Health: Randomized Clinical Trial","CTZ- emergency","Inclusion Criteria:\n\n* Pediatric patients presenting with:\n* Irreversible pulpitis in primary molars;\n* Pulp necrosis, with or without abscess, in primary molars.\n* Primary molars with sufficient remaining tooth structure to allow endodontic treatment.\n* Primary teeth in which the permanent successor tooth germ presents developmental stages compatible with Nolla stages 1 to 7, defined as:\n\nStage 1: Presence of bony crypt with no evidence of calcification; Stage 2: Initial calcification, with appearance of radiopaque points in the crown region; Stage 3: Approximately one-third of crown formation; Stage 4: Approximately two-thirds of crown formation; Stage 5: Crown almost complete, without full calcification; Stage 6: Crown completely formed, without initiation of root formation; Stage 7: Initial root formation.\n\n* Clinical and radiographic conditions indicating feasibility of tooth maintenance through endodontic treatment, including:\n* Permanent successor in developmental stages prior to Nolla Stage 8;\n* Preservation of the bony crypt.\n\nExclusion Criteria:\n\n* Pediatric patients presenting with:\n* Reversible pulpitis;\n* Indication for endodontic treatment in permanent teeth.\n* History of allergy or hypersensitivity to any components of the obturation materials (e.g., CTZ paste or zinc oxide-eugenol).\n* Clinical conditions that prevent adequate management in an outpatient setting.\n* Primary teeth in which the permanent successor:\n* Is in advanced developmental stages (Nolla Stage 8 or higher), and\u002For\n* Presents disruption of the bony crypt, contraindicating endodontic treatment.\n* Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.","2 Years","11 Years",{"count":69,"type":21},110,[71],"EARLY_PHASE1","The treatment of pulpal diseases in primary teeth represents a significant challenge in public health, particularly in emergency dental care settings, where factors such as limited clinical time, low child cooperation, and structural constraints directly impact treatment effectiveness. In these contexts, conventional pulpectomy using zinc oxide-eugenol (ZOE), although effective, may present operational limitations that restrict its large-scale applicability in public health systems.\n\nIn this scenario, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has emerged as a simplified alternative. Among the available options, CTZ paste shows potential for single-visit application, reducing clinical time and technical complexity.\n\nThis study aims to evaluate the clinical and radiographic non-inferiority of CTZ paste compared to conventional pulpectomy with ZOE in primary molars with pulp necrosis, with or without abscess or fistula, treated in emergency dental care settings.\n\nThis is a randomized, pragmatic, controlled, non-inferiority clinical trial conducted at a single center, with clinical and radiographic follow-up at 3, 6, and 12 months. Participants will be allocated into two groups: (1) NIET with CTZ paste and (2) conventional pulpectomy with ZOE.\n\nPrimary outcomes include pain resolution and absence of clinical signs of infection. Secondary outcomes include radiographic success, clinical time, child behavior (Frankl Scale), need for retreatment, and oral health-related quality of life.\n\nThe findings are expected to provide robust evidence regarding the effectiveness of CTZ paste under real-world clinical conditions, contributing to the development of more accessible and effective protocols within public health systems, with the potential to expand access to conservative treatment and reduce early tooth extractions in pediatric dentistry.",[74,75,76,77,78,79,80,34,81,82],"Pulp Disease, Dental","Pulp Necrosis","Pulp Therapy in Primary Molars","Primary Teeth","Pulpectomy","Endodontics","Dental Care for Children","Quality of Life","Health Services Accessibility",[84,85,86,87,88,89,90,91,92,93,94,95],"pulpectomy","pulpotomy","CTZ paste","NIET","Non-instrumental endodontic treatment","LSTR","Lesion sterilization and tissue repair","Endodontic infection","dental abscess","Fistula","Emergency dental treatment","Public health dentistry","NOT_YET_RECRUITING","2026-05-07",{"date":99,"type":49},"2026-05-12",{"date":101,"type":21},"2026-06-08",{"date":103,"type":21},"2028-02-28",{"name":105,"class":56},"University of Sao Paulo",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":57},"100285237","99tc-mdp-treatment-for-knee-osteoarthritis-100285237","NCT02993029","99Tc-MDP Treatment for Knee Osteoarthritis","99Tc-MDP Versus Celecoxib Treatment in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n1. Participants with painful osteoarthritis;\n2. The standard uptake value (SUV) of OA related knee greater than 10 on 18F- sodium fluoride bone scan;\n3. Participants voluntarily participate in the trial, and signed the informed consent.\n\nExclusion Criteria:\n\n1. Knee joint replacement;\n2. Inflammatory arthritis or joint infection of knee;\n3. Nervous joint disease;\n4. Fracture of joint;\n5. Gout arthritis of the knee;\n6. Traumatic arthritis.","40 Years",{"count":115,"type":21},40,[24],"Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has received growing attention in the society because of the increase of old age population, disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.",[34],[120,121,122],"99Tc-MDP","osteoarthritis","celecoxib","2026-04-22",{"date":125,"type":49},"2026-04-28",{"date":127,"type":49},"2017-09-01",{"date":129,"type":21},"2027-12-30",{"name":131,"class":56},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":57},"100629258","home-based-acute-care-for-older-persons-initiated-by-the-emergency-medical-and-ambulance-services---a-retrospective-observation-of-effects-on-healthcare-utilisation-and-mortality-100629258","NCT07472335","Home-based Acute Care for Older Persons Initiated by the Emergency Medical and Ambulance Services - a Retrospective Observation of Effects on Healthcare Utilisation and Mortality","Inclusion Criteria:\n\n* Contact with the emergency number (112), followed by either a telephone assessment by the Emergency Medical Dispatch Centre or an in-home assessment by an ambulance nurse\n* Home-based acute care a weekday between 8 AM - 4 PM\n* Emergency-department care weeknight 4 PM - 8 AM or weekends\n* Registered residence in one of the municipalities of Gothenburg, Mölndal, Partille, or Härryda\n\nExclusion Criteria:\n\n* Immediate conditions requiring hospital care\n* Care at the emergency department or by a mobile primary care team occurring more than 24 hours after assessment by the Emergency Medical Dispatch Centre or ambulance services\n* Individuals who have already been assessed by a physician and\u002For have a written referral to the emergency department","75 Years",{"count":140,"type":21},5000,"OBSERVATIONAL","This observational study aims to examine outcomes of home-based acute care delivered by a mobile healthcare team in persons aged 75 years and older following an episode of acute illness.\n\nThe study will assess whether home-based acute care initiated by the emergency medical dispatch centre or ambulance services is non-inferior to emergency department care with regard to care needs and mortality.",[144,145,146,147,148,149,150,151,152,34],"Aged","Home Care, Hospital-Based","Home Care Services","Emergency Medical Dispatch Centre","Emergency Medical Services","Ambulances","Emergency Service, Hospital","Acute Disease","Mortality","2026-03-10",{"date":155,"type":49},"2026-03-16",{"date":157,"type":21},"2026-04-01",{"date":159,"type":21},"2027-12-31",{"name":161,"class":162},"Vastra Gotaland Region","OTHER_GOV",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":57},"100402865","liver-disease-and-other-systemic-diseases-100402865","NCT04525833","Liver Disease and Other Systemic Diseases","The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation","Inclusion Criteria:\n\n* Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation\n\nExclusion Criteria:\n\n* Age younger than 18 or older than 99 years",true,"99 Years",{"count":173,"type":21},15000,"Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.",[176,177,178,179,180,181,182,183,184,34],"Liver Diseases","Humans","Progression","Carcinogenesis","Fatty Liver Disease","Hepatitis C","Hepatitis B","Hepatocellular Carcinoma","Liver Cirrhoses","2025-09-16",{"date":187,"type":49},"2025-09-19",{"date":189,"type":49},"2020-01-01",{"date":191,"type":21},"2026-12-31",{"name":193,"class":56},"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":57},"100504038","the-stereo-dbs-study-7-tesla-mri-brain-network-analysis-for-deep-brain-stimulation-100504038","NCT05843084","The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation","STEREO-DBS","1.2 Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age \\> 18 years;\n* Idiopathic PD who underwent STN DBS\n\n1.3 Exclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Legally incompetent adults;\n* No written informed consent.",{"count":202,"type":21},500,"Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized.\n\nObjective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III).\n\nSecondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden.\n\nStudy design: The study will be a single center prospective observational study.\n\nStudy population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database.\n\nMain study parameters\u002Fendpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.",[205,206,207,208,209,210,34],"Parkinson Disease","Diffusion Magnetic Resonance Imaging","Brain","Subthalamic Nucleus","Deep Brain Stimulation","Human","2025-07-22",{"date":213,"type":49},"2025-07-25",{"date":215,"type":49},"2022-04-11",{"date":217,"type":21},"2033-04-11",{"name":219,"class":56},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":57},"100597161","assessment-of-the-quality-of-life-of-patients-visiting-the-emergency-department-of-the-saint-brieuc-hospital-following-an-ankle-sprain-100597161","NCT07054892","Assessment of the Quality of Life of Patients Visiting the Emergency Department of the Saint-Brieuc Hospital Following an Ankle Sprain","EntoQuaVie - Assessment of the Quality of Life of Patients Visiting the Emergency Department of the Saint-Brieuc Hospital Following an Ankle Sprain: A Follow-up-based Evaluation Considering the Severity Grade of the Ankle Sprain","EntoQuaVie","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ankle trauma\n* Initial consultation at the emergency department of Saint-Brieuc\n\nExclusion Criteria:\n\n* Surgical treatment following the trauma\n* Fracture resulting from the trauma\n* Ligament or bone injury to either lower limb (knee, hip, ankle) occurring within 6 months prior to the trauma\n* Injury to another joint during the trauma with functional impairment\n* Adult under legal protection (guardianship, trusteeship, or judicial protection) or deprived of liberty\n* Pregnant woman",{"count":229,"type":21},176,"Lateral ankle sprains account for nearly 6,500 emergency department visits per day in France. They are clinically classified into three grades, which can be assessed approximately 3-5 days after an acute sprain. However, this classification remains somewhat approximate, with only mild and severe sprains being reliably identified.\n\nWhen it comes to immobilization, if weight-bearing is possible, treatment options include an elastic ankle brace for mild sprains, taping, or a semi-rigid orthosis known as a \"stabilizing\" brace. It is worth noting that, according to Rodineau and Besch, the preferred form of immobilization is the semi-rigid orthosis. In cases of severe sprains where weight-bearing is not possible, rigid immobilization may be used.\n\nTo date, few thesis-level studies have focused on trauma care and the outpatient follow-up of ankle sprains. Two studies from the early 2010s assessed general practice management of trauma using questionnaires-one in Seine-Maritime and another in Bouches-du-Rhône. The latter study found that 96.7% of surveyed physicians reported managing all types of sprains. In the Seine-Maritime study, half of the physicians systematically followed up on ankle sprains, while the other half only did so if the patient's condition worsened. It was also found that nearly 47% of physicians referred their patients directly to emergency departments. This pathway was more frequently chosen by urban practitioners or those without specific training in trauma care.\n\nExcept in certain predefined cases depending on the hospital, there is currently no systematic follow-up for ankle sprains in emergency departments. Most patients are redirected toward follow-up in outpatient care.\n\nThe objective of this research project is to assess the recovery of baseline quality of life in participants who consulted the emergency department of Saint-Brieuc for an ankle sprain, three months after the injury. The evaluation will take into account the type of follow-up care (physician, physiotherapist) as well as the severity of the sprain.",[232,34],"Ankle Injuries",[234,235,236],"ankle injuries","emergency department","patient follow-up","2025-07-10",{"date":239,"type":49},"2025-07-11",{"date":241,"type":49},"2025-04-01",{"date":243,"type":21},"2025-10-01",{"name":245,"class":56},"Centre Hospitalier de Saint-Brieuc",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":57},"100574800","safety-and-efficacy-of-connecting-the-residual-ear-to-the-cartilage-scaffold-in-first--vs-second-stage-surgery-100574800","NCT06763991","Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery","Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery : a Protocl of a Randomized Controlled Trial in Non-expanded Auricular Reconstruction for Concha-type Microtia","Inclusion Criteria:\n\nAll consecutive patients between 6 and 30 years with a congenital concha-microtia8, admitted to our hospital are potentially eligible, and enrollment in the study will be based on the following criteria.\n\n1. Patients were fully informed about the purpose, modalities and risks associated with this study, signed an informed consent form and were willing to be followed up.\n2. Contrast-enhanced computed tomography (CT) scan shows he or she has 3.Patients can tolerate general anesthesia without severe chronic organic or mental illness.\n\nExclusion Criteria:\n\n1. Patients combined with other ear diseases such as ear fistula, titis media, etc.\n2. Patients receive other unrelated ear surgeries during the study\n3. Skin in the surgical area with infection, ulceration, and scarring.","6 Years","30 Years",{"count":256,"type":21},78,[24],"Eligible patients will be admitted from the outpatient clinic to complete the relevant examinations after admission（Preoperative routine examination and chest CT）. The baseline parameters will be registered when admitted to hospital, including case number, diagnosis, sex, age, height, weight, and underlying medical conditions. Patients have at least 12 hours to consider participation in the study and will be given the opportunity to ask questions about the study. Written informed consent will be obtained by the surgical resident or the surgeon after admission to the hospital.\n\nRandomization will be done by relevant member . After inclusion, patients will be allocated to one of the two study groups (First-stage Connection or Second-stage Connection) using an online randomization program. The perioperative care will be the same for all included patients.Surgery will be performed by experienced surgeons, with non-expanded ear reconstruction using autologous rib cartilage. The surgery normally comprises two stages. After each surgery, details and duration of the surgery will be documented. For each stage of surgery, patients are scheduled for visits about 3-6 months. In addition, after the total surgery, patients are to fill out 'Glasgow Benefit Inventory' and 'Patient and Observer Scar Assessment Scale'.",[260,261,262,263,34,264],"Microtia","Outcome Assessment","RCT","Surgery Related Complications Rate","Reconstruction","2025-05-15",{"date":267,"type":49},"2025-05-16",{"date":269,"type":21},"2025-06-01",{"date":271,"type":21},"2027-02-20",{"name":273,"class":56},"Sichuan Provincial People's Hospital",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":57},"100590340","a-real-world-study-of-sacituzumab-govitecan-100590340","NCT06966141","A Real World Study of Sacituzumab Govitecan","A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients","Inclusion Criteria:\n\n1. Male or female aged 18 or above;\n2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;\n3. Unresectable or metastatic triple-negative breast cancer confirmed by tumor histology or cytology, and having received at least two systemic treatments previously (at least one of which was for metastatic disease); Or HR+\u002FHER2- (IHC 0, 1+ or IHC 2+\u002FISH-) unresectable or metastatic breast cancer confirmed by tumor histology or cytology, with previous endocrine therapy and ≥2 lines of systemic therapy (for metastatic disease);\n4. Receive gosatetuzumab treatment in the advanced stage;\n5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;\n6. All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;\n3. Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.\n4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;\n5. Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;\n6. Patients allergic to gosatetuzumab;\n7. Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;\n8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.",{"count":282,"type":21},100,"Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients",[285,34],"Breast Cancer Metastatic","2025-05-02",{"date":288,"type":49},"2025-05-11",{"date":290,"type":49},"2024-08-12",{"date":292,"type":21},"2027-08-01",{"name":294,"class":56},"Fudan University",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":314,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":328,"locationsCount":4},"100588663","reduction-of-complications-associated-with-picc-management-100588663","NCT06944327","Reduction of Complications Associated With PICC Management","Reduction of Complications Associated With PICC Management. Randomization in Care.","PICC managemen","Inclusion Criteria:\n\n* be over 18 years of age\n* accept participation in the study\n* independent patient in the care and management of activities of daily living\n\nExclusion Criteria:\n\n* patient over 18 years of age\n* patient with functional or cognitive limitation\n* patient with mild, moderate or high level of dependence\n* patient does not accept to perform the study\n* patient with device withdrawal prior to 14 days of duration",{"count":304,"type":21},460,[24],"The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation.\n\nA high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up.\n\nObjective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).",[34,308,309,310,311,312,313],"Vascular Access","Vascular Access Device","Vascular Access Complication","Care Delivery","Nurse","Nurse Based Care Management",[315,316,317,318,319,320,321,322],"vascular","vascular access","catheter","central catheter","nurse","vascular access device","management","complication","2025-04-23",{"date":325,"type":49},"2025-04-25",{"date":243,"type":21},{"date":159,"type":21},{"name":329,"class":56},"Fundacion Miguel Servet",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":339,"conditions":340,"keywords":345,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100504719","study-on-prognosis-of-acutely-ruptured-intracranial-aneurysms-100504719","NCT05851989","Study on Prognosis of Acutely Ruptured Intracranial Aneurysms","SPARTA","Inclusion Criteria:\n\n* Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan)\n* Intracranial aneurysm proven within 6 months to be the cause of subarachnoid haemorrhage\n* Age 18 years or over at presentation.\n* Written informed consent\n\nExclusion Criteria:\n\n* Subarachnoid haemorrhage deemed most likely of 'perimesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)\n* Subarachnoid haemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)\n* Diagnosis of intracerebral arteriovenous malformations or dural arteriovenous fistula.\n* No diagnosis of intracranial aneurysm at 6 months after onset of symptoms.\n* Not mastering the Dutch language",{"count":338,"type":21},880,"The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored.\n\nFurthermore, cost effectiveness and radiological prognostic factors will be examined.",[341,342,343,344,34],"Aneurysmal Subarachnoid Hemorrhage","Endovascular Procedures","Craniotomy","Patient Outcome Assessment",[346,347,348,349,350,351,352],"Aneurysmal subarachnoid hemorrhage","Clipping","Neurosurgery","Coiling","Endovascular treatment","Outcome","Modified Rankin Scale","2025-03-22",{"date":355,"type":49},"2025-03-25",{"date":357,"type":49},"2021-07-14",{"date":359,"type":21},"2034-07-14",{"name":361,"class":56},"Haaglanden Medical Centre",6,{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":371,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":381,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":4},"100583138","the-effect-of-psychosocial-skills-focused-group-psychoeducation-in-schizophrenia-patients-100583138","NCT06872424","The Effect of Psychosocial Skills Focused Group Psychoeducation in Schizophrenia Patients","The Effect of Psychosocial Skills Focused Group Psychoeducation on Functional Improvement, Treatment Compliance and Mental Well-Being in Schizophrenia Patients: a Randomised Controlled Study","Schizophrenia","Inclusion Criteria:\n\n1. Having a diagnosis of schizophrenia according to DSM-5 diagnostic criteria\n2. To have continuity in the Community Mental Health Center\n3. Being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor,\n4. To be mentally capable of understanding the questions posed\n5. To have the cognitive competence to understand the training provided\n6. Not having any visual or auditory disability\n7. Graduating from at least primary school\n\nExclusion Criteria:\n\n1. Refusing to participate in the study\n2. Being under 18 years of age\n3. Being illiterate in Turkish\n4. Having Mental Retardation","18 Weeks",{"count":373,"type":21},34,[24],"The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.",[377,378,379,34,380],"Schizophrenia Patients","Psychoeducation","Functional Status","Mental Development",[369,378,382,383,384],"Functional recovery","Treatment adherence","Mental well-being","2025-03-10",{"date":387,"type":49},"2025-03-12",{"date":389,"type":21},"2025-04-15",{"date":391,"type":21},"2025-08-15",{"name":393,"class":56},"Gazi University",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":57},"100582508","plasma-sphingolipid-metabolites-and-radiotherapy-efficacy-in-hepatocellular-carcinoma-100582508","NCT06864221","Plasma Sphingolipid Metabolites and Radiotherapy Efficacy in Hepatocellular Carcinoma","Correlation Between Plasma Sphingolipid Metabolites and the Efficacy of Radiotherapy in Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Patients voluntarily signed the informed consent form.\n* Aged between 18 and 80 years.\n* Clinically diagnosed with primary liver cancer according to the latest treatment guidelines.\n* Determined by the treating physician to require radiotherapy.\n* Expected survival time of more than 3 months.\n\nExclusion Criteria:\n\n* Patients who discontinued radiotherapy or did not complete the planned treatment.\n* Presence of malignancies from other origins.\n* Severe metabolic diseases such as uncontrolled diabetes, significant obesity, or fatty liver disease.\n* Uncontrolled comorbidities, such as severe cardiovascular or pulmonary diseases, that may affect treatment or study outcomes.","80 Years",{"count":403,"type":21},260,"Plasma contains a variety of metabolites, among which sphingolipids, including ceramide, sphingosine, and sphingosine-1-phosphate, serve as important intracellular second messengers and are involved in various cellular signaling pathways, such as apoptosis. We hypothesize that plasma sphingolipid levels may be associated with the efficacy of radiotherapy for liver cancer. This study will utilize LC-MS\u002FMS technology for qualitative and quantitative analysis of plasma sphingolipids in liver cancer patients undergoing radiotherapy. Clinical data related to patient prognosis will also be collected to investigate the correlation between plasma sphingolipid levels and the therapeutic efficacy of liver cancer radiotherapy. The aim is to establish the clinical diagnostic significance of plasma sphingolipid levels in predicting the efficacy of liver cancer radiotherapy, providing new insights to enhance the effectiveness of radiotherapy in liver cancer treatment.",[183,406,34,407,408],"Radiotherapy","Biomarkers","Sphingolipids","2025-03-09",{"date":387,"type":49},{"date":412,"type":49},"2024-09-01",{"date":48,"type":21},{"name":415,"class":56},"Nanfang Hospital, Southern Medical University",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":424,"enrollmentInfo":425,"targetDuration":427,"studyType":141,"phases":4,"briefSummary":428,"conditions":429,"keywords":434,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":57},"100486629","precision-medicine-in-the-depression-treatment-100486629","NCT05616559","Precision Medicine in the Depression Treatment","The BrainDrugs-Depression Study: A Prospective Precision Psychiatry Cohort Study in the Treatment of Depression","BDD","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).\n* Referral to a treatment package for single-episode depression.\n\nExclusion Criteria:\n\n* Psychosis or psychotic symptoms\n* History of severe head trauma\n* Somatic disease associated with morphological brain changes (e.g., brain tumour)\n* Insufficient Danish language skills to complete questionnaires and cognitive testing\n\nAdditional exclusion criteria for Cohort II:\n\n* Severe somatic disease\n* Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)\n\nAdditional exclusion criteria for Cohort III:\n\n* Severe somatic disease\n* Contraindications for MRI\n* Exposure to radioactivity \\>10 mSv within the last year\n* Pregnancy or breastfeeding\n* Use of psychotropic drugs","65 Years",{"count":426,"type":21},800,"18 Months","The BrainDrugs-D study uses multimodal neuroimaging combined with self-report measures, clinical and molecular markers to identify clinically relevant predictors that can identify subtypes of major depressive disorder (MDD) and, in a naturalistic setting, predict treatment response to standard antidepressive treatment. The cohorts are followed in nationwide health registries.",[430,34,431,432,433],"Depressive Disorder, Major","Cognitive Dysfunction","Cognitive Behavioral Therapy","Antidepressive Agents",[435,436,437,438,439,440,441,442,443,444,445,446],"PET","MRI","fMRI","EEG","Prediction of treatment response","Early life stress","Selective Serotonin Reuptake Inhibitor","Psychometrics","MDD","Cold cognition","Social cognition","Anxiety","2024-10-03",{"date":449,"type":49},"2024-10-08",{"date":451,"type":49},"2021-06-15",{"date":453,"type":21},"2026-12",{"name":455,"class":56},"Rigshospitalet, Denmark",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":138,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":57},"100549980","phase-3-multicenter-clinical-trial-on-the-effectiveness-and-safety-of-instillation-of-bcg-and-alternative-bcg-protocols-for-intermediate-and-high-risk-non-muscle-invasive-bladder-cancer-100549980","NCT06441110","Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Voluntary participation in the trial with signed informed consent;\n2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);\n4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;\n5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.\n\nExclusion Criteria:\n\n1. Any of the following conditions:\n\n   Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;\n2. Concurrent urogenital system tumors or tumors in other organs;\n3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;\n4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);\n5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);\n6. Known or suspected intraoperative bladder perforation;\n7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;\n8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;\n9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;\n10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;\n11. Participation in other drug clinical trials within 3 months before enrollment;\n12. Known or suspected opioid or alcohol dependence;\n13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.",{"count":464,"type":21},76,[466],"PHASE3","Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1\u002FPD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.",[469,470,471,472,34,473],"Urinary Bladder Neoplasms","BCG Vaccine","Immunotherapy, Active","Multicenter Study","Neoplasm Recurrence, Local","2024-06-03",{"date":476,"type":49},"2024-06-04",{"date":478,"type":49},"2023-06-01",{"date":480,"type":21},"2035-06-01",{"name":482,"class":56},"Fujian Medical University Union Hospital",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":424,"enrollmentInfo":491,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":500,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":57},"100471041","weber-b-ankle-fractures-with-associated-posterior-malleolus-fracture-100471041","NCT05413707","Weber B Ankle Fractures With Associated Posterior Malleolus Fracture","Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial","PMFIX","Inclusion Criteria:\n\n* Posterior malleolar (PM) fracture, of Mason \\& Molly type 2A\u002F2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture\n* Posterior malleoli \\>=2 mm displaced (on CT in axial, sagital or coronal plane)\n* Patients informed, written consent\n* Age 18-65 years\n* For inclusion axial CT images are examined\n\n  * Measurements are performed 5 millimeters (mm) cranial to the tibia plafond\n  * Posterior malleolus fractures involving less than 40% of the fibular notch are included.\n\nExclusion Criteria:\n\n* Non-compliant patient, i.e.: dementia, alcohol- or substance abuse\n* ASA-4 patients\n* Known congenital bone decease\n* Pathological fractures\n* Immunocompromised patients\n* Tourists or patients on a short-term work\u002Fstudy permit\n* Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction\n* Poor controlled diabetes\n* Patients with known arterial insufficiency\n* Open fractures\n* Severely traumatized patients (ISS\\>16)\n* Patient declines to participate in study",{"count":492,"type":21},198,[24],"Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF.\n\nThrough a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients.\n\nMason and Molly type 2A and 2B fractures will be included in the study.",[496,497,498,499,34],"Posterior Malleolus Fractures","Ankle Fractures","Syndesmotic Injuries","Patient Reported Outcome Measure",[501,502,503,504,505,506],"Posterior malleolus fractures","Ankle factures","Weber B fractures","Syndesmotic injuries","Fixation","Randomized Controlled Trial","2024-02-27",{"date":509,"type":49},"2024-02-29",{"date":511,"type":49},"2023-03-13",{"date":513,"type":21},"2030-12-31",{"name":515,"class":56},"Haukeland University Hospital",{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":535,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100471348","efficacy-of-transcutaneous-vagus-nerve-stimulation-paired-with-tailor-made-notched-music-therapy-versus-tailor-made-notched-music-training-for-chronic-subjective-tinnitus-100471348","NCT05417711","Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus","Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients with tinnitus as the main complaint: the patients subjectively feel the sound in the ear or deep part of the head without internal or external sound stimulation, and therefore seek medical treatment\n* Chronic (≥ 6 months) and tonal tinnitus\n* Age 18-60\n* Tinnitus frequency is 125-8000 Hz\n* Hearing threshold at each frequency shall not exceed 70 dB HL\n\nExclusion Criteria:\n\n* Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular distortion and tinnitus caused by Meniere disease\n* History of head trauma, central nervous system diseases, mental diseases and drug abuse","60 Years",{"count":525,"type":21},388,[24],"This clinical study is a prospective, multicenter, randomized, controlled, double-blind clinical study. Sun Yat Sen Memorial Hospital of Sun Yat sen University was the central unit, and Nanjing First Hospital, Sun Yat Sen people's Hospital, Guanfzhou Panyu central Hospital and Zhuhai integrated traditional Chinese and Western medicine hospital were the cooperative units. In this study, 388 patients with chronic subjective tinnitus were recruited. In view of chronic subjective tinnitus, a common ear disease, the study gave the patients three months of treatment with transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy or tailor-made notched music training alone. By comparing the changes of subjective scale scores related to tinnitus before and after treatment in patients receiving two different therapies, such as THI, VAS, BAI, BDI, PSQI, to evaluate the efficacy of the two therapies, so as to judge whether transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy is better than tailor-made notched music training alone. In addition, the study will continue to follow up the patients after the treatment for one year to observe the difference in the long-term sustained efficacy of the two therapies. This clinical study will also evaluate the two therapies from the perspective of compliance and safety, and explore the factors that affect the efficacy of the two therapies.",[529,530,531,532,533,534,177,34],"Tinnitus, Subjective","Vagus Nerve Stimulation","Music Therapy","Double-Blind Method","Female","Male",[536,537,538,539,540],"Chronic subjective tinnitus","Tailor-made notched music training","Vagus nerve stimulation","Electroencephalogram","Clinical trial","2023-11-22",{"date":543,"type":49},"2023-11-27",{"date":545,"type":21},"2023-11-23",{"date":547,"type":21},"2026-09-01",{"name":549,"class":56},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":557,"minAge":558,"maxAge":138,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":567,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":57},"100464247","urinary-continence-of-female-poprc-and-oin-100464247","NCT05325216","Urinary Continence of Female POPRC and OIN","Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study","Inclusion Criteria:\n\n1. Female patients aged between 55-75.\n2. Patients those who are diagnosed with organ-confined urothelial carcinoma（\\\u003CpT3）\n3. Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.\n4. ECOG score between 0-2;\n5. Normal renal function;\n6. Patients those who volunteer to participate in this study and sign the informed consents.\n7. Patients those who are able to cooperate in the study.\n\nExclusion Criteria:\n\n1. Absence of tumour in bladder neck or urethra;\n2. Patients thsoe who are diagnosed distant metastasis before surgery.\n3. Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;\n4. Patients those who are diagnosed with other malignancies.;\n5. Patients those who had received pelvic radiotherapy or major pelvic operation.\n6. Pregnancy status;\n7. Any other conditions that the researcher considers to be excluded from this study","FEMALE","55 Years",{"count":560,"type":21},58,[24],"To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.",[469,564,565,34,566],"Woman","Sexual Dysfunction, Physiological","Urinary Incontinence",[568],"Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder","2022-04-12",{"date":571,"type":49},"2022-04-13",{"date":573,"type":21},"2022-04",{"date":575,"type":21},"2028-04-01",{"name":549,"class":56},{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":57},"100358617","effects-of-exercise-therapy-and-soft-brace-on-knee-osteoarthritis-100358617","NCT03949400","Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis","Inclusion Criteria:\n\nAssigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish\n\nExclusion Criteria:\n\nNot mentally able to reply to the questionnaire",{"count":115,"type":21},"The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).",[586,34,587,588,589,590,591,592,593],"Rehabilitation","Pain","Knee Brace","Outcome Assessment (Health Care)","Recovery of Function","Patient Reported Outcome Measures","Adults","Osteoarthritis, Knee","2019-05-10",{"date":596,"type":49},"2019-05-14",{"date":598,"type":49},"2018-04-24",{"date":600,"type":21},"2029-05-20",{"name":602,"class":56},"University College of Northern Denmark"]