Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT00281034
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2006-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020520', 'term': 'Brain Infarction'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2069}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-10', 'studyFirstSubmitDate': '2006-01-23', 'studyFirstSubmitQcDate': '2006-01-23', 'lastUpdatePostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score of SF-36', 'timeFrame': '0, 8 week, 24 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brain infarction', 'SF-36', 'HRQOL', 'Japan', 'Post-stroke syndrome'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '20145390', 'type': 'DERIVED', 'citation': 'Shinohara Y; OASIS Study Group. Factors affecting health-related quality of life assessed with the SF-36v2 health survey in outpatients with chronic-stage ischemic stroke in Japan--cross-sectional analysis of the OASIS study. Cerebrovasc Dis. 2010;29(4):361-71. doi: 10.1159/000281834. Epub 2010 Feb 9.'}]}, 'descriptionModule': {'briefSummary': '1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan\n2. Chronic brain infarction in Japan is better than EU/USA', 'detailedDescription': 'Period:2005-2007\n\nObservation Time:baseline, 8week, 24week\n\nmatters investigated:\n\n1. QOL determination using SF-36 v2\n2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Univercity, Main hospital, general Hospital,0pen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients whose last attack occurred more than 1 month ago\n2. Outpatients (including hospitalization for rehabilitation)\n3. Japanese nationality\n4. Patients who consented to participate in this study\n5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction\n\nExclusion Criteria:\n\n1. Patients who cannot read, understand and fill in the questionnaire by themselves\n2. Patients who idle their time away\n3. Patients who are hospitalized\n4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction\n5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study'}, 'identificationModule': {'nctId': 'NCT00281034', 'briefTitle': 'OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyorin Pharmaceutical Co.,Ltd'}, 'officialTitle': 'Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)', 'orgStudyIdInfo': {'id': 'OASIS-2005'}, 'secondaryIdInfos': [{'id': 'oasis-2007'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'OASIS Study Group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '190-8531', 'city': 'Tachikawa', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital', 'geoPoint': {'lat': 35.7091, 'lon': 139.41891}}], 'overallOfficials': [{'name': 'Yukito Shinohara, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin Pharmaceutical Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital', 'investigatorFullName': 'Yukito Shinohara', 'investigatorAffiliation': 'Kyorin Pharmaceutical Co.,Ltd'}}}}