CORE--HUMAN STUDIES

核心——人类研究

• 批准号: 6410315
• 负责人: DENNIS MICHAEL JENSEN
• 金额: $ 14.67万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6410315
• 关键词: biomedical facility; clinical research; endoscopy; gastrointestinal disorder; gastrointestinal function; human subject; human tissue; medical outreach /case finding; patient /disease registry; tissue resource /registry

DESCRIPTION (Adapted from the application) The mission of the Human Studies Core is to provide shared resources, personnel, services, education, and consultation to CURE investigators, trainees, and their collaborators for the study of patients with selected digestive diseases. The primary goal of this core is to facilitate collaboration, education about, and performance of GI clinical trials, human physiological studies, and health service studies in digestive diseases. The traditional focus of the core has been the investigation of peptic diseases and upper GI physiology, including secretion, motility, and hormonal regulation. This focus has been broadened to include the study of other important gastrointestinal illnesses such as complicated ulcer disease, gastroesophageal reflux disease (GERD), Barrett's epithelium, GI hemorrhage, non-ulcer dyspepsia, Helicobacter pylori infection, pre-cancer conditions (gastritis, polyposis, and ulcerative colitis), and inflammatory bowel disease. An overriding theme of the core is the study of the physiology of visceral pain which may be associated with all of these disorders. The importance of this area in GI diseases is highlighted by the impact of GI symptoms on quality of life and demand for health care services. With this in mind, the core has greatly expanded the study of neuroenteric diseases such as irritable bowel syndrome (IBS), non-ulcer dyspepsia, and non-cardiac chest pain. The specific goals of this core are to provide CURE investigators, trainees, and their collaborators with access to: (1) a quality clinical research unit for performance of GI clinical research at a low cost, (2) utilization of fully equipped endoscopy units for GI clinical and physiologic research studies, (3) laboratory services for GI secretory tests, GI motility and pH testing, and H. pylori assessments (ELISA, C-14 breath testing, and histopathology), (4) teaching of clinical research techniques and consultation about study design, data management, statistical analysis, and routine outcomes, (5) tissue and clinical data banks of patients with selected GI diseases (the largest data bases are for GI hemorrhage and functional GI disease), (6) consultation about conducting health services research including design of studies, cost assessments, quality of life instruments, effectiveness studies, and modeling cost-effectiveness studies, (7) specialized equipment for GI studies (such as equipment for ablating Barrett's epithelium or endoscopic ultrasound instruments), (8) psychophysiology and GI motility laboratories for the study of neuroenteric diseases, and (9) utilization of a brain imaging unit for the study of neuroenteric diseases. The instruments and personnel required for these services and functions are expensive, so that sharing them among various investigators in a core is cost effective and promotes collaboration.

描述（根据应用程序改编）人类研究的使命 核心是提供共享资源，人员，服务，教育以及 与治疗调查人员，学员及其合作者的协商 患有选定消化系统疾病的患者的研究。这个主要目标 核心是促进GI的协作，教育和表现 临床试验，人类生理研究和卫生服务研究 消化疾病。核心的传统重点是 对肽疾病和上GI生理学的研究，包括分泌， 运动性和激素调节。该重点已扩大到包括 研究其他重要的胃肠道疾病，例如复杂的溃疡 疾病，胃食管反流疾病（GERD），巴雷特上皮，GI 出血，非脉络膜衰退，幽门螺杆菌感染，前癌症 疾病（胃炎，多杂交和溃疡性结肠炎）和炎症 排便。核心的主要主题是对生理学的研究 可能与所有这些疾病有关的内脏疼痛。这 GI的影响强调了该领域在GI疾病中的重要性 生活质量和医疗服务需求的症状。随之而来的 心理，核心大大扩展了对神经疾病的研究，例如 肠易激综合症（IBS），非脉络膜疾病和非心脏胸部 疼痛。 该核心的具体目标是提供治疗调查人员，学员， 及其合作者可以访问：（1）优质的临床研究部门 为了以低成本进行胃肠道临床研究，（2）完全利用 适用于GI临床和生理学研究的配备内窥镜检查单位，（3） 用于GI分泌测试，GI运动和pH测试的实验室服务以及H. 幽门螺杆菌评估（ELISA，C-14呼吸测试和组织病理学），（4） 有关研究设计的临床研究技术和咨询的教学， 数据管理，统计分析和常规结果，（5）组织和 患有胃肠道疾病的患者的临床数据库（最大的数据 基地是用于胃肠道出血和功能性胃肠道疾病），（6）关于 进行卫生服务研究，包括研究设计，成本 评估，生活质量工具，有效性研究和建模 成本效益研究，（7）用于GI研究的专用设备（例如 消融巴雷特上皮或内窥镜超声的设备 仪器），（8）研究的心理生理学和GI运动实验室 神经性疾病的疾病，（9）利用脑成像单元 神经性疾病的研究。所需的工具和人员 这些服务和功能很昂贵，因此将它们共享 核心的调查人员具有成本效益，并促进了协作。