[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tokyo University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":163},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,79,112,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627304","phase-3-msa-01-in-multiple-system-atrophy-100627304",false,"NCT07446894","MSA-01 in Multiple System Atrophy","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study of MSA-01 in Patients With Multiple System Atrophy","MSA-01_P3","Inclusion Criteria:\n\nAt the time of informed consent\n\n1. Patients diagnosed as 'clinically established' or 'clinically probable' MSA based on the revised MSA diagnostic criteria of the Movement Disorder Society (MDS).\n2. Patients who are able to walk independently or with the use of assistive devices.\n3. Patients who are able to attend outpatient visits at the participating study site.\n\n   At the start of study drug administration\n4. Patients who are able to discontinue the use of CoQ10 supplements.\n\nExclusion Criteria:\n\n1. Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment.\n2. Patients with severe liver disease.\n3. Patients with a known history of hypersensitivity to any component of the investigational drug.\n4. Pregnant women, breastfeeding women, or women who may be pregnant.\n5. Patients who have previously participated in a clinical trial of MSA-01.","ALL","30 Years","79 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate whether MSA-01 slows the progression of multiple system atrophy (MSA) and to assess its safety.\n\nThe primary question is:\n\n• Does MSA-01 slow the progression of motor impairment as measured by UMSARS Part 2 score?\n\nParticipants will be randomly assigned to receive MSA-01 or placebo for 12 months. They will attend regular clinic visits for safety and efficacy assessments and record their medication use and any side effects in a diary.",[28],"Multiple System Atrophy (MSA)","RECRUITING","2026-03-02",{"date":32,"type":33},"2026-03-04","ACTUAL",{"date":35,"type":33},"2026-02-09",{"date":37,"type":22},"2028-03-31",{"name":39,"class":40},"Tokyo University","OTHER",12,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100617872","pilot-cluster-rct-of-an-indirect-contact-mental-health-literacy-program-for-5th-grade-students-100617872","NCT07324265","Pilot Cluster RCT of an Indirect Contact Mental Health Literacy Program for 5th-Grade Students","A Cluster-Randomized Pilot Trial of a School-Based Mental Health Literacy Program With and Without an Indirect Contact Component for 5th-Grade Students","SMHLP-IC","Inclusion Criteria:\n\n* Students enrolled in 5th grade at one of the eight participating public elementary schools in Kanazawa, Japan.\n* Aged 10-11 years old.\n* Passive consent obtained from guardians; verbal assent obtained from children.\n* Able to complete self-report questionnaires.\n\nExclusion Criteria:\n\n* Students whose parents\u002Fguardians opted out of the study.\n\nNote: Students who were absent on the day of the pre-test (T1) were excluded from the analysis population but not from the initial study cohort.",true,"10 Years","11 Years",{"count":54,"type":22},150,[56],"NA","This cluster-randomized pilot trial will evaluate the preliminary effects and feasibility of adding an indirect contact component to a school-based mental health literacy (MHL) lesson for 5th-grade students in a public elementary school in Tokyo, Japan. Four 5th-grade classes (approximately 150 students in total) will be randomized by class (two classes per arm). All students will receive a 45-minute lesson that includes an animated video and educational slides. In the intervention arm, teachers will additionally introduce a short story about a well-known soccer player who experienced and recovered from a mental health condition, serving as an indirect contact element. The control arm will receive the standard lesson without this component.\n\nStudents will complete questionnaires at baseline (T1), immediately after the lesson (T2), and 2-3 months later (T3). The primary outcome is vignette-based social distance toward a peer with mental health problems. Secondary outcomes include mental health knowledge, help-seeking intentions, perceived need for help, intended sources of help. As a pilot study with only four clusters, the trial is not powered to detect small effects; findings will be used to estimate effect sizes and assess feasibility for a future larger-scale trial.",[59,60,61],"Mental Health Literacy","Stigma (Social Distance)","Help-seeking Intention",[63,64,65,66,67,68,69],"Mental health literacy","Stigma reduction","Indirect contact","Social distance","Help-seeking intentions","School-based intervention","Elementary school students","NOT_YET_RECRUITING","2025-12-22",{"date":73,"type":33},"2026-01-07",{"date":75,"type":22},"2025-12-15",{"date":77,"type":22},"2026-08-30",{"name":39,"class":40},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100601119","encapsulation-oriented-vs-timing-oriented-strategies-for-necrotizing-pancreatitis-100601119","NCT07106346","Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis","Encapsulation-oriented Versus Timing-oriented Strategies for the Timing of Endoscopic Ultrasound-guided Drainage in Necrotizing Pancreatitis After Acute Pancreatitis: A Multicenter Randomized Controlled Trial (WONDER-03)","WONDER-03","Inclusion Criteria:\n\n* Patients diagnosed with necrotizing pancreatitis according to the revised Atlanta classification, confirmed by contrast-enhanced CT (plain CT or MRI may be substituted if contrast-enhanced CT is not feasible).\n* Within 28 days of onset of acute pancreatitis.\n* Age ≥ 18 years at the time of consent, regardless of sex.\n* Provided written informed consent from the patient or a legally authorized representative after sufficient explanation.\n* Patients who are either hospitalized or being followed as outpatients at participating study institutions.\n\nExclusion Criteria:\n\n* Unknown date of onset of acute pancreatitis.\n* Patients who have already undergone transluminal drainage with stent placement for necrotizing pancreatitis.\n* Diagnosis of chronic pancreatitis.\n* Patients for whom endoscopic treatment is deemed unsafe.\n* Pregnant women.\n* Patients deemed inappropriate for the study by the principal investigator or sub-investigator.","18 Years",{"count":89,"type":22},224,[56],"This multicenter, randomized controlled trial (WONDER-03 study) investigates the optimal timing for endoscopic ultrasound (EUS)-guided drainage in patients with necrotizing pancreatitis. Although current guidelines recommend delaying drainage until at least four weeks after the onset of acute pancreatitis to allow for encapsulation of necrosis, recent observational data suggest that the degree of encapsulation itself may more strongly influence treatment success and safety. In this trial, patients are randomly assigned to one of two groups: an encapsulation-oriented group, in which EUS-guided drainage is performed when imaging confirms ≥80% encapsulation of the necrotic collection with symptoms, and a timing-oriented group, in which drainage is performed at four to five weeks after disease onset, regardless of encapsulation status. The primary endpoint is clinical success within 180 days, defined as both radiologic resolution of necrosis and improvement in symptoms. Secondary endpoints include adverse event rates, recurrence of fluid collections, technical and clinical success rates, and healthcare resource use. This study aims to determine whether a strategy based on encapsulation leads to better clinical outcomes than the conventional time-based approach and may help establish a new evidence-based treatment algorithm for necrotizing pancreatitis.",[93,94,95,96,97],"Walled Off Necrosis","Pancreatitis","Acute Necrotic Collection","Necrotizing Pancreatitis","Pancreatitis, Acute Necrotizing",[99,100,93,101,102],"Endosonography","Drainage","necrotizing pancreatitis","pancreatitis","2025-07-30",{"date":105,"type":33},"2025-08-06",{"date":107,"type":22},"2025-08-05",{"date":109,"type":22},"2028-07-31",{"name":39,"class":40},36,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100526306","wonder-02-trial-plastic-stent-vs-lumen-apposing-metal-stent-for-pancreatic-pseudocysts-100526306","NCT06133023","WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts","WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial","Inclusion Criteria:\n\n* Patients with pancreatic pseudocyst(s) defined by the revised Atlanta classification\n* The longest diameter of a targeted pseudocyst ≥ 5 cm\n* Patients requiring drainage for symptoms associated with a pseudocyst (e.g., infection, gastrointestinal symptoms including abdominal pain, or jaundice)\n* Patients aged 18 years or older\n* Written informed consent obtained from patients or their representatives\n\nExclusion Criteria:\n\n* A pseudocyst that is inaccessible via the EUS-guided approach\n* A plastic or lumen-apposing metal stent in situ\n* Coagulopathy (e.g., platelet count \\\u003C 50,000\u002Fmm3 or prothrombin time international normalised ratio \\[PT-INR\\] \\>1.5)\n* Users of antithrombotic agents that cannot be discontinued according to the Japan Gastroenterological Endoscopy Society \\[JGES\\] guidelines\n* Patients who do not tolerate endoscopic procedures\n* Pregnant women",{"count":120,"type":22},80,[56],"Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), the use of a LAMS is limited by its high costs and specific adverse events compared to plastic stent placement. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.",[124,94,125],"Pancreatic Fluid Collection","Pancreatic Pseudocyst",[99,100,127,125],"Stents","2023-11-09",{"date":130,"type":33},"2023-11-15",{"date":132,"type":22},"2023-11",{"date":134,"type":22},"2033-09",{"name":39,"class":40},26,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100473977","immediate-necrosectomy-vs-step-up-approach-for-walled-off-necrosis-100473977","NCT05451901","Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis","Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)","WONDER-01","Inclusion Criteria:\n\n* Patients with WON defined according to the revised Atlanta classification\n* The longest diameter of WON is 4 cm or larger\n* Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice\n* Patients who need drainage for WON\n* Age of 18 years or older\n* Patients or their representatives provide informed consent\n* Patients who visit or are hospitalized at the participating institutions\n\nExclusion Criteria:\n\n* WON inaccessible by EUS-guided approach\n* AXIOS stent has already been placed into the WON prior to the enrollment\n* Severe coagulopathy; Platelet count \\\u003C 50,000\u002Fmm3 or prothrombin time international normalized ratio (PT-INR) \\>1.5\n* Patients on antithrombotic agents which cannot be managed according to the \"guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)\"\n* Patients who cannot tolerate endoscopic procedures\n* Pregnant women\n* Patients considered inappropriate for inclusion by investigators",{"count":146,"type":22},70,[56],"Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and\u002For additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.",[124,150,97,125],"Walled-off Necrosis",[99,100,127,152,153],"Endoscopic necrosectomy","Step-up approach","2022-10-26",{"date":156,"type":33},"2022-10-27",{"date":158,"type":33},"2022-07-29",{"date":160,"type":22},"2031-04-11",{"name":39,"class":40},21,""]