[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371853":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":48,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":51,"whyStopped":31,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Center for Neurological Studies","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Growth Hormone","EXPERIMENTAL","Norditropin® (somatropin \\[rDNA origin\\] injection) via FlexPro® 30 mg \u002F 3ml strength auto-injector pens (Novo Nordisk Inc).",[13],"Biological: Growth Hormone",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline","PLACEBO_COMPARATOR","Saline-placebo via auto-injector pens (Haselmeier Inc).",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Daily self-injections by subjects:\n\n1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase",[9],[26],"Norditropin® (somatropin [rDNA origin] injection)",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo","Daily self-injections by subjects:\n\n1-year double-blind phase",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Randall R Benson, MD","Vice President and Medical Director","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Vijay M Baragi, Ph.D.","CONTACT","313-228-0930.","103","vijay@neurologicstudies.com",{"name":45,"role":40,"phone":46,"phoneExt":31,"email":47},"John Russell","3132280930","JDR@neurologicstudies.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Center for Neurolgoical Studies (CNS)","RECRUITING","Dearborn","Michigan","48126","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-83.17631,42.32226,{"lat":61,"lon":60},[64,67],{"name":65,"role":40,"phone":66,"phoneExt":31,"email":43},"Vijay Baragi, Ph.D.","313-228-0930",{"name":45,"role":40,"phone":46,"phoneExt":31,"email":47},{"type":69,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[71],{"name":72,"class":73},"Novo Nordisk A\u002FS","INDUSTRY","100371853","phase-2-growth-hormone-replacement-therapy-for-retried-professional-football-players-100371853",false,"NCT04121780","Growth Hormone Replacement Therapy for Retried Professional Football Players","Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency","Inclusion Criteria:\n\n* The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.\n* Former NFL player\n* At least one year since retirement from football\n* Less than 76 years of age\n* Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD\n\nExclusion Criteria:\n\n* History of pre-existing brain disease other than concussion or TBI\n* History of a premorbid disabling condition that interferes with outcome assessments\n* Contraindication to GH therapy\n* Type I and II Diabetes mellitus\n* Active malignant disease\n* Acute critical illness, heart failure, or acute respiratory failure\n* Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.","MALE","18 Years","76 Years",{"count":85,"type":86},42,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).",[92,93,94,95,96,97],"TBI (Traumatic Brain Injury)","Concussion, Brain","Sport Injury","Anterior Pituitary Hyposecretion Syndrome","Hypopituitarism","Growth Hormone Deficiency",[99,100,9,101,102],"TBI","GHD","Norditropin Flexpro","cognition disorders","2023-02-06",{"date":105,"type":106},"2023-02-08","ACTUAL",{"date":108,"type":106},"2019-10-08",{"date":110,"type":86},"2026-09",{"name":5,"class":6},1]