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（改编自应用程序）人类研究的使命 核心是提供共享的资源、人员、服务、教育和 向CURE研究人员、受训人员及其合作者提供咨询， 对选定消化系统疾病患者的研究。这个的主要目标 核心是促进地理信息系统的合作、教育和绩效 临床试验、人体生理学研究和卫生服务研究， 消化系统疾病核心的传统焦点一直是 研究消化系统疾病和上消化道生理学，包括分泌， 运动和激素调节。这一重点已扩大到包括 研究其他重要的胃肠道疾病，如复杂性溃疡 疾病，胃食管反流病（GERD），Barrett上皮，GI 出血、非溃疡性消化不良、幽门螺杆菌感染、癌前病变 疾病（胃炎、息肉病和溃疡性结肠炎）和炎性 肠道疾病。一个压倒一切的主题的核心是研究的生理 内脏疼痛可能与所有这些疾病有关。的 这一领域在胃肠道疾病中的重要性突出表现在胃肠道疾病的影响， 症状对生活质量和医疗服务需求的影响。出于这种 核心大大扩展了对神经肠道疾病的研究， 肠易激综合征（IBS）、非溃疡性消化不良和非心源性胸部 痛苦 该核心的具体目标是为CURE研究人员、受训人员， 及其合作者可获得：（1）高质量的临床研究单位 为了以低成本进行GI临床研究，（2）充分利用 配备用于GI临床和生理学研究的内窥镜设备，（3） 胃肠道分泌试验、胃肠道蠕动和pH值试验以及H. 幽门螺杆菌评估（ELISA、C-14呼气试验和组织病理学），（4） 临床研究技术教学和研究设计咨询， 数据管理、统计分析和常规结局，（5）组织和 选定GI疾病患者的临床数据库（最大数据 基础是胃肠道出血和功能性胃肠道疾病），（6）咨询有关 开展卫生服务研究，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）GI研究专用设备（如 切除巴雷特上皮或内窥镜超声的设备 仪器），（8）用于研究的心理生理学和GI运动实验室 神经肠道疾病，和（9）利用脑成像单元， 神经肠道疾病的研究。所需的仪器和人员 这些服务和功能是昂贵的，因此在各种服务和功能之间共享它们是不可能的。 核心调查员具有成本效益，并促进合作。