课题基金 / 基金详情

FAST-AS - NEW EXPERIMENTAL MEDICINE STUDIES: FAST-FAIL TRIALS IN AUTISM SPECTRUM

FAST-AS - NEW EXPERIMENTAL MEDICINE STUDIES: FAST-FAIL TRIALS IN AUTISM SPECTRUM
FAST-AS - 新的实验医学研究：自闭症谱系的快速失败试验
批准号：
8741855
负责人：
X X
金额：
$231.21万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
项目状态：
已结题
起止时间：
2013-08-29 至 2014-12-28
来源：
https://reporter.nih.gov/project-details/8741855
关键词：
Autistic DisorderCertificate of ConfidentialityClinicalClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesCommunicationCommunitiesData SetDatabasesDevelopmentEnrollmentInformation SystemsInformed ConsentInstitutional Review BoardsManuscriptsMeasuresMedicineNational Institute of Mental HealthOutcome MeasurePreparationProgress ReportsProtocols documentationPublicationsRegistriesResearchResearch InfrastructureSiteTestingTrainingUnited States National Library of MedicineWritingdisabilityprimary outcomeprotocol developmentresponsesocialyoung adult

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中文摘要
翻译
这项倡议将利用一种化合物的开发，在患有社会残疾的青壮年自闭症受试者中进行测试。开展开办/筹备活动，包括但不限于获得所有监管部门的批准和最后敲定议定书。一旦被批准继续进行，进行临床机制临床试验的中试证明。提交的交付成果包括季度技术进展报告、手稿、全国自闭症研究交付成果数据库、最终数据集和其他材料。应使用具体措施来确定纳入的主题，并将其作为变化的主要结果衡量标准。还应对对照受试者进行测试，以建立与自闭症受试者反应进行比较的基线。
英文摘要
This initiative will leverage the development of a compound to test it in young adult autistic subjects with social disabilities. Conduct start-up/preparatory activities including but not limited to obtaining all regulatory approvals and finalizing the protocol. Once approved to proceed, conduct pilot Proof of Clinical Mechanism Clinical Trial. Deliverables to be submitted include quarterly technical progress reports, Manuscript, National Database for Autism Research Deliverable, and Final Dataset and Other Materials. Specific measures shall be used to identify subjects for inclusion, and as a primary outcome measure of change. Control subjects shall also be tested to establish a baseline with which to compare the autistic subjects¿ responses.
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