X Chr. Karyotype & Sex Hormones in Turner Syndrome & Premature Ovarian failure

X 通道

• 批准号: 8075884
• 负责人: DARBY THOMPSON
• 金额: $ 0.66万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-11-01 至 2011-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8075884
• 关键词: Acquired Immunodeficiency Syndrome; Area Analyses; Case-Control Studies; Clinical Research; Clinical Trials; Collection; Contractor; Contracts; Data; Databases; Diabetic Retinopathy; Early treatment; Economics; Epidemiology; Evaluation; Extramural Activities; Eye; Eye diseases; Gonadal Steroid Hormones; Healthcare; Intramural Research; Karyotype; Medicare; Monitor; Natural History; Outcomes Research; Premature Ovarian Failure; Quality-of-Life Assessment; Reporting; Research Design; Risk; Specific qualifier value; Symptoms; Turner' s Syndrome; Uveitis; Vision Disorders; Woman; Work; X Chromosome; cost effectiveness; data management; design; eye dryness; follow-up; patient safety; preclinical study

Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome and Premature Ovarian Failure Clinical Protocol support contract designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. Objective of Clinical Protocol: Women with premature ovarian failure (POF) are at risk for dry eye. In addition, some women with Turner syndrome (TS) report dry eye symptoms. This study will determine how many women with TS have dry eye, compared to women with POF and women without these conditions.

X 染色体核型和性激素对特纳综合征和卵巢早衰的眼部影响 临床方案支持合同旨在为开发、设计、解释和评估临床试验、流行病学和自然史研究获得外部支持。此外，还将提供涉及眼部疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究设计以及这些研究数据的收集、分析和解释，以及支持和监测患者安全和随访上。承包商还应为指定的临床研究数据库、成本效益和经济分析、生活质量评估和结果研究提供工作说明书中所述的分析和数据管理支持。这将包括但不限于以下领域： 医疗保险和其他医疗保健数据库的分析；评估现有的 NEI 数据库，例如中央 NEI 校内研究数据库、眼病病例对照研究、早期治疗糖尿病视网膜病变研究、弗雷明汉眼科研究以及校内艾滋病和葡萄膜炎数据库。 临床方案的目标： 患有卵巢早衰（POF）的女性有患干眼症的风险。此外，一些患有特纳综合症（TS）的女性报告有干眼症状。这项研究将确定与患有 POF 的女性和没有干眼症的女性相比，有多少患有 TS 的女性患有干眼症。