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中文摘要
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临床方案支持合同旨在获得开发,设计,解释和评估临床试验,流行病学和自然史研究的校外支持。此外,它将提供涉及眼科疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究的设计和收集,分析和解释这些研究产生的数据,以及支持和监测患者的安全性和随访。承包商还应提供工作说明书中所述的分析和数据管理支持,用于指定的临床研究数据库、成本效益和经济分析、生活质量评估和结局研究。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;现有NEI数据库的评估,如集中的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,Fracket Eye研究,以及校内艾滋病和葡萄膜炎数据库。 临床方案的目的: 本研究的目的是更好地了解各种眼部疾病的发展过程,如葡萄膜炎,结膜,角膜,玻璃体和视网膜疾病,代谢或遗传性眼部疾病或眼部肿瘤,以开发更好的诊断和治疗方法。 需要接受眼科手术治疗眼部疾病或其他累及眼睛的疾病的患者可以参加本研究。通常在眼科手术中被移除和丢弃的眼组织和液体样本将被提供给研究人员进行研究。这些组织将在显微镜下进行检查,并使用复杂的化学和生物测试进行研究。也可以检查血液样品中的免疫细胞。这些研究将有助于更好地了解和诊断各种眼科疾病,并开发更具吸引力的治疗方法
英文摘要
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: The purpose of this study is to better understand the processes involved in the development of various eye conditions, such as uveitis, disorders of the conjunctiva, cornea, vitreous and retina, metabolic or genetic eye diseases or eye tumors, in order to develop better methods of diagnosis and treatment. Patients who require eye surgery to treat an eye disease or other disease in which the eye is involved may participate in this study. Samples of eye tissue and fluid that are normally removed and discarded during eye surgery will instead be given to researchers for study. The tissues will be examined under microscope and studied using sophisticated chemical and biological tests. Immune cells from blood samples may also be examined. These studies will help better understand and diagnose the various eye diseases and to develop more attractive therapies
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Epigenetics, Molecular Genetics, and Biomarkers of Inflammatory Ocular Diseases
  • 批准号:
    7975994
  • 项目类别:
  • 资助金额:
    $13.93万
  • 财政年份:
    2006
  • 负责人:
    DARBY THOMPSON
  • 依托单位:
Pilot: Finasteride Treatment for Chronic Central Serous Chorioretinopathy
  • 批准号:
    7976122
  • 项目类别:
  • 资助金额:
    $7.97万
  • 财政年份:
    2006
  • 负责人:
    DARBY THOMPSON
  • 依托单位:
Age-Related Macular Degeneration: A Genetic Epidemiology Study in the Amish
  • 批准号:
    7963499
  • 项目类别:
  • 资助金额:
    $20.0万
  • 财政年份:
    2006
  • 负责人:
    DARBY THOMPSON
  • 依托单位:
X-Linked Juvenile Retinoschisis - Clinical and Molecular Studies
  • 批准号:
    7976001
  • 项目类别:
  • 资助金额:
    $11.84万
  • 财政年份:
    2006
  • 负责人:
    DARBY THOMPSON
  • 依托单位:
海外基金