Nctid:
NCT00001367
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009422", "term"=>"Nervous System Diseases"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>4100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"1993-09-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02-07", "lastUpdateSubmitDate"=>"2024-08-16", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"to screen patients with neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols", "timeFrame"=>"ongoing", "description"=>"The goal is to screen patients with neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols. No investigational treatments will be administered on this protocol and the NIH physicians will be playing a consultative role to the patient s primary physician."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Healthy Volunteer", "Nervous System Disease", "Natural History"], "conditions"=>["Nervous System Disease", "Healthy Volunteer"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1993-N-0202.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"This protocol is a screening and natural history protocol, which allows for evaluation of\n\npatients and families where neurological conditions are present for enrollment into other\n\nstudies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.", "detailedDescription"=>"This protocol is a screening and natural history protocol, which allows for evaluation of\n\npatients and families where neurological conditions are present for enrollment into other\n\nstudies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"2 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The following population groups may participate: - Subjects with neurological disorders who are 2 years old or older, - Family members who are 2 years old or older of people with a neurological disorder, - Healthy volunteers who are 18 years old or older.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n* Patients with neurological disorders and subjects with a family history of neurological conditions OR\n* Healthy volunteers: People age 18 or older who are generally in good health.\n\nEXCLUSION CRITERIA:\n\n* Patients \\<2 years old.\n* Employees of HMCS in NINDS."}, "identificationModule"=>{"nctId"=>"NCT00001367", "briefTitle"=>"Diagnosis and History Study of Patients With Different Neurological Conditions", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Diagnosis and Natural History Protocol for Patients With Different Neurological Conditions", "orgStudyIdInfo"=>{"id"=>"930202"}, "secondaryIdInfos"=>[{"id"=>"93-N-0202"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"family members", "description"=>"Family Members who are 2 years old or older of people with a neurological disorder"}, {"label"=>"healthy volunteers", "description"=>"healthy volunteers age 18 and older"}, {"label"=>"patients", "description"=>"subjects with neurological disorders who are 2 years old or older"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "role"=>"CONTACT", "email"=>"ccopr@nih.gov", "phone"=>"800-411-1222", "phoneExt"=>"TTY dial 711"}], "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "centralContacts"=>[{"name"=>"Vivian S Koo", "role"=>"CONTACT", "email"=>"vivian.koo@nih.gov", "phone"=>"(301) 435-8518"}, {"name"=>"Debra J Ehrlich, M.D.", "role"=>"CONTACT", "email"=>"debra.ehrlich@nih.gov", "phone"=>"(301) 443-7888"}], "overallOfficials"=>[{"name"=>"Debra J Ehrlich, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Institute of Neurological Disorders and Stroke (NINDS)"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>".This protocol was written before creating sharing plans was required. We do share data with other protocols done by our group to avoid having to repeat procedures, but there is no official \"research\" done in this protocol, so it is unlikely that we will need to share any IPD elsewhere. If there is, we will consider it on a case-by-case basis."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
