Clinical Studies

临床研究

• 批准号: 7288639
• 负责人: MICHAEL W. KONSTAN
• 金额: $ 21.42万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7288639
• 关键词: Adverse event; Advisory Committees; Basic Science; Biological Process; Blood; Bronchial Lavages; Bronchoalveolar Lavage; Budgets; Cells; Chloride Ion; Chlorides; Clinical; Clinical Research; Clinical Trials; Collection; Contracts; Cystic Fibrosis; DEXA; Data; Databases; Development; Diffusion; Documentation; Epithelial; Epithelial Cells; Exercise stress test; Exhalation; Feces; Gases; Husband; Imaging Techniques; Industry; Infant; Investigation; Iron binding capacity measurement; Irrigation; Liquid substance; Measurement; Metabolic; Nasal Lavage Fluid; Nitric Oxide; Nose; Oscillometry; Outcome Measure; Patient Selection; Patients; Plasma; Plethysmography; Population; Population Research; Preparation; Procedures; Process; Protocols documentation; Pulmonary function tests; Purpose; Quality Control; Radiology Specialty; Recruitment Activity; Reporting; Research Ethics Committees; Research Personnel; Resources; Retrospective Studies; Sampling; Schedule; Scientist; Services; Source; Specimen; Spirometry; Sputum; Standards of Weights and Measures; Sweat test; Testing; Thoracic Radiography; Tissue Banks; Tissues; Translations; United States Food and Drug Administration; Urine; Walking; bench to bedside; design; performance tests; research study

The Clinical Studies Core 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 BAL 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 and former patients 6) Maintain the database for all patients ever seen at the Cleveland CF Center since its inception (1558 total patients; 360 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. This is an integral component of the Translational Center.

临床研究核心旨在1）协助研究者访问、选择和招募囊性 纤维化和对照患者进行临床试验，并节约中心的患者资源。2)协助 研究者参与临床试验的规划和执行，3）监督和/或执行 测试和程序，包括质量控制。4)监督生物制品的收集和处理 样本，包括BAL液和细胞样本、鼻灌洗液/细胞和鼻上皮细胞， 刮痧、痰（诱导和咳出）、呼出气冷凝液、血液、尿液和粪便。第五章） 维护从当前和以前的患者中收集的样本的标本和组织库6）维护 克利夫兰CF中心自成立以来所有患者的数据库（共1558名患者; 360名 活跃患者），用于临床试验和研究的患者选择，回顾性临床研究， 与各国数据库的合作。7)促进基础科学发现的翻译 科学研究者参与临床研究（如适用），包括结局的制定 采取适合具体研究的措施;并请基础科学家调查所确定的问题 在临床实践或临床研究中。该核心使我们的特征良好的患者人群可用 用于临床研究，并促进了从我们的基础科学实验室的想法到床边的翻译。的 核心支持的临床项目还产生假设，这些假设又被送回基础科学实验室， 更详细的调查。这是翻译中心的一个组成部分。