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中文摘要
翻译
临床研究核心是翻译中心不可或缺的组成部分,因为它的设计目的是:1)帮助研究人员访问、选择和招募囊性纤维化患者,并为临床试验控制患者,并管理中心的患者资源。2)协助研究人员规划和执行临床试验;3)监督和/或执行试验和程序,包括质量控制。4)监督生物标本的收集和处理,包括SAL液和细胞样本、鼻灌洗液/细胞和鼻腔上皮细胞的碎屑、痰(诱导和咳出)、呼出的冷凝液、血液、尿液和粪便,5)维护从现有和既往患者中收集的样本和组织库6)维护克利夫兰CF中心自成立以来从未见过的所有患者的数据库(总共1619名患者;348名活跃患者),以便为临床试验和研究、追溯临床研究以及与各种国家数据库合作选择患者。7)促进将基础科学研究人员的发现转化为临床研究,包括制定适用于具体研究的结果衡量标准;并聘请基础科学家调查临床实践或临床研究中发现的问题。这一核心使我们具有良好特征的患者群体可用于临床研究,并促进我们基础科学实验室的想法从工作台到床边的翻译。Core支持的临床项目还会产生假说,这些假说又会被送回基础科学实验室进行更详细的研究。
英文摘要
The Clinical Studies Core is an integral component the Translational Center as it is designed to 1) Assist investigators in accessing, selecting, and recruiting cystic fibrosis and control patients for clinical trials and to husband the patient resources of the Center. 2) Assist investigators in the planning and execution of clinical trials, 3) Provide oversight and/or performance of tests and procedures, including quality control. 4) Provide oversight of collection and processing of biologic specimens, including SAL fluid and cell samples, nasal lavage fluid/cells and nasal epithelial cells from scrapping, sputum (induced and expectorated), exhaled breath condensate, blood, urine, and stool, 5) Maintain a specimen and tissue bank of samples collected from current arid former patients 6) Maintain the database for all patients ever seen at the Cleveland CF Center since its inception (1619 total patients; 348 active patients) for purposes of patient selection for clinical trials and studies, retrospective clinical studies and cooperation with various national databases. 7) Facilitate the translation of discoveries made by basic science investigators into clinical investigation where applicable, including the development of outcome measures appropriate for specific studies; and to engage basic scientists to investigate questions identified in clinical practice or clinical studies. This Core makes available our well-characterized patient population for clinical studies and facilitates the bench to bedside translation of ideas from our basic science labs. The Core-supported clinical projects also generate hypotheses that are in turn returned to basic science labs for more detailed investigation.
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Mouse Models
  • 批准号:
    8705743
  • 项目类别:
  • 资助金额:
    $8.24万
  • 财政年份:
    2013
  • 负责人:
    Mitchell L Drumm
  • 依托单位:
Animal Model Resources for Cystic Fibrosis
  • 批准号:
    8181444
  • 项目类别:
  • 资助金额:
    $56.04万
  • 财政年份:
    2011
  • 负责人:
    Mitchell L Drumm
  • 依托单位:
Animal Model Resources for Cystic Fibrosis
  • 批准号:
    8290282
  • 项目类别:
  • 资助金额:
    $52.57万
  • 财政年份:
    2011
  • 负责人:
    Mitchell L Drumm
  • 依托单位:
Animal Model Resources for Cystic Fibrosis
  • 批准号:
    8688376
  • 项目类别:
  • 资助金额:
    $50.48万
  • 财政年份:
    2011
  • 负责人:
    Mitchell L Drumm
  • 依托单位:
海外基金