[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":58,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":58,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":41,"whyStopped":58,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rapamycin treatment group","EXPERIMENTAL","All enrolled patients receive treatment with sirolimus (rapamycin), administered in capsule form at a dosage of 0.5 mg per capsule. The capsules, provided by North China Pharmaceutical under the trade name Yixinke, were stored at room temperature. The prescribed regimen involved a daily oral dosage of 1.5 mg for a duration of four weeks.\n\nSirolimus (rapamycin) bioavailability can be affected by food, based on preliminary results of prior drug use. To maintain consistent blood drug concentrations, sirolimus should be taken with or without food on a constant basis. Grapefruit juice slows CYP3A4-mediated metabolism of sirolimus and potentially enhances P-gp-mediated retrograde transport of sirolimus from the small intestinal epithelium to the intestinal lumen. Therefore, it should not be consumed concurrently with sirolimus.",[13],"Drug: Rapamycin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Rapamycin","All enrolled patients receive treatment with sirolimus (rapamycin)#The prescribed regimen involved a daily oral dosage of 1.5 mg for a duration of four weeks.",[9],[21],"Sirolimus",[23,26],{"name":24,"affiliation":5,"role":25},"Runfa Tian, MD","STUDY_DIRECTOR",{"name":27,"affiliation":5,"role":28},"Guoyi Gao, MD","STUDY_CHAIR",[30,35],{"name":24,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","15910996812","+86","trftc@126.com",{"name":27,"role":31,"phone":36,"phoneExt":33,"email":37},"13801874393","gao3@sina.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54,55],{"name":24,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":27,"role":31,"phone":36,"phoneExt":33,"email":37},{"type":57,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",null,"100559414","phase-2-the-safety-and-efficacy-of-rapamycin-on-communicating-hydrocephalus-secondary-to-intraventricular-hemorrhage-100559414",false,"NCT06563817","The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage","A Prospective, Multi-center, Open-label Study to Observe the Efficacy and Safety of Rapamycin in the Treatment of Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage","Saturn","Inclusion Criteria:\n\n1. Patients with ventricular dilatation due to intraventricular hemorrhage who clinically present with any one or more of new gait disturbances, cognitive deficits, and urinary incontinence after remission of intraventricular hemorrhage symptoms, and whose brain imaging shows an Evans index (EI) of ≥0.3\n2. Age ≥ 18 years and ≤ 70 years\n3. Signed informed consent form\n\nExclusion Criteria:\n\n1. Participation in another medical trial\n2. Have other disease that may affect the patient's symptoms (including gait disturbance, cognitive impairment, urinary incontinence)\n3. Allergy to the investigational drug\n4. Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)\n5. Reduced kidney function with GFR \\\u003C 50\n6. Concomitant treatment with strong CYP3A4\u002F5 inducers or inhibitors, such as diltiazem, ketoconazole, or rifampicin.\n7. Active or uncontrolled chronic infection\n8. Women who are pregnant or breastfeeding\n9. Patients who are bedridden or require urinary catheters for extended periods of time.","ALL","18 Years","70 Years",{"count":71,"type":72},53,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This prospective, multicenter, open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage. Additionally, the underlying pathogenic mechanisms associated with this particular type of hydrocephalus will be investigated in greater depth, and populations that may benefit from rapamycin therapy will be identified.",[78,79,80,81],"Communicating Hydrocephalus","Cerebral Intraventricular Hemorrhage","Secondary Normal Pressure Hydrocephalus","Post Hemorrhagic Hydrocephalus",[78,79,17,80,81],"2024-08-18",{"date":85,"type":86},"2024-08-21","ACTUAL",{"date":88,"type":72},"2024-08",{"date":90,"type":72},"2025-07",{"name":5,"class":6},1]