[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383003":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":100,"collaborators":20,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":20,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":20,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Dexamethasone","EXPERIMENTAL","The restrictive DEX regimen is applied from referral to the neurosurgical center until discharge. All administered steroids will be stopped immediately after study inclusion.\n\nIf one or more of the previously defined failure criteria occurs, patients will be treated with DEX.",[13],"Drug: Dexamethasone",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dexamethasone","restrictive use of DEX, based on standardized clinical and radiological criteria.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Andreas Raabe, MD","Inselspital Bern, Department of Neurosurgery","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Johannes Goldberg, MD","CONTACT","+41316322409","johannes.goldberg@insel.ch",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Nicole Söll, CDM","+41316323164","nicole.soell@insel.ch",[37,55,68,84],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kantonsspital St. Gallen","NOT_YET_RECRUITING","Sankt Gallen","St.Gallen","9007","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],9.37477,47.42391,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":20,"phoneExt":20,"email":54},"Marian Neidert, MD","marian.neidert@kssg.ch",{"facility":56,"status":39,"city":57,"state":20,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Universitätsspital Basel","Basel","4031",{"type":46,"coordinates":60},[61,62],7.57327,47.55839,{"lat":62,"lon":61},[65],{"name":66,"role":29,"phone":20,"phoneExt":20,"email":67},"Gregor Hutter, MD","Gregor.Hutter@usb.ch",{"facility":69,"status":70,"city":71,"state":20,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Department of Neurosurgery","RECRUITING","Bern","3010",{"type":46,"coordinates":74},[75,76],7.44744,46.94809,{"lat":76,"lon":75},[79,80,81],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},{"name":82,"role":83,"phone":20,"phoneExt":20,"email":20},"Johannes Goldberg","SUB_INVESTIGATOR",{"facility":85,"status":39,"city":86,"state":20,"zip":87,"country":43,"countryCode":44,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Universitätsspital Zürich","Zurich","8091",{"type":46,"coordinates":89},[90,91],8.55,47.36667,{"lat":91,"lon":90},[94,97],{"name":95,"role":29,"phone":20,"phoneExt":20,"email":96},"Vincens Kälin, MD","Vincens.Kaelin@usz.ch",{"name":98,"role":29,"phone":20,"phoneExt":20,"email":99},"Carki Serra, MD","Carlo.Serra@usz.ch",{"type":101,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100383003","restrictive-use-of-dexamethasone-in-glioblastoma-100383003",false,"NCT04266977","Restrictive Use of Dexamethasone in Glioblastoma","RESDEX","Inclusion Criteria:\n\n* Newly diagnosed supratentorial contrast enhancing lesion suspicious of glioblastoma without major mass effect, amenable to surgical resection\n* Age 18 - 90 years\n* Midline Shift ≤ 3mm\n* GCS ≥ 14\n* NIHSS ≤ 3\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Infratentorial lesions, brainstem lesions, multifocal lesions\n* Therapy with steroids for \\>1 day before inclusion\n* Need for treatment with steroids due to any other disease\n* Contraindications to the administration of Dexamethasone\n* Pregnancy or breastfeeding","ALL","18 Years","90 Years",{"count":113,"type":114},50,"ESTIMATED","INTERVENTIONAL",[117],"NA","The administration of steroids, most commonly dexamethasone (DEX), has established as standard of care during treatment of glioblastoma (GBM) and is widely used during the entire course of the disease including pre- and postoperative management, chemo- and radiotherapy. The primary purpose is to reduce tumor-associated vasogenic edema and to prevent or treat increased intracranial pressure. However, steroids are also linked to a multitude of adverse side effects that may affect survival of GBM patients such as major immunosuppression. The use of steroids during radiotherapy is associated with reduced overall- and progression-free survival and has been identified as an independent poor prognostic factor. Despite these findings, the suspicion of GBM often triggers the administration of DEX in routine clinical practice, regardless of neurological symptoms, tumor size, or extension of cerebral edema. The purpose of this study is to assess whether selected GBM patients can be treated safely with a restrictive DEX regimen from referral to the neurosurgical center until discharge.\n\nThe primary objective is to determine the failure rate of a restrictive DEX regimen defined as edema or mass effect leading to any of the following: GCS deterioration ≥ 2 points, NIHSS increase ≥ 3 points, increase of midline Shift ≥ 2mm, or any surgical rescue procedure for increasing mass effect.",[120,17,121],"Glioblastoma","Steroids","2025-07-03",{"date":124,"type":125},"2025-07-09","ACTUAL",{"date":127,"type":125},"2020-05-08",{"date":129,"type":114},"2028-04",{"name":5,"class":6},4]