Core-- Clinical Core

临床核心的任务是提供必要的人员、设施和组织结构，以生成临床数据库并为项目1、2、3、4和5收集患者标本。这些资源将支持核心内的个别协议，促进研究者之间的互动，并为临床研究项目的制定、执行和数据分析提供一个有凝聚力的框架。临床方案旨在利用目前可用于诊断评估和管理急性肺损伤（ALl）和急性呼吸窘迫综合征（ARDS）的最佳策略。具体目标是：

The mission of the Clinical Core is to provide the personnel, facilities, and organizational structure necessary to generate the clinical database and collect patient specimens for Projects 1,2,3,4, and 5. These resources will support individual protocols within the Core, facilitate interactions between investigators, and provide a cohesive framework for the formulation, execution, and data analysis of clinical research projects. The clinical protocol is designed to utilize the best strategies currently available for diagnostic assessment and management of acute lung injury (ALl) and acute respiratory distress syndrome (ARDS). Specific aims are: 1. To manage the clinical studies involving patients with ALI/ARDS including: a) Identify eligible patients, obtain informed consent, enroll and follow patients in a standardized protocol b) Collect clinical data to provide characterization of case mix, severity of illness, and risk stratification c) Prospectively classify patients into etiologic subgroups of ALI/ARDS d) Ensure patient safety through protocol compliance, study monitoring and reporting to the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB) 2. To procure cells and biological fluids for individual investigators: a) Perform bronchoaiveolar lavage (BAL) and blood collection in patients with ALI/ARDS, in ventilated patients without lung injury and in normal volunteers 3. To manage a clinical study utilizing GM-CSF in ARDS patients three days post meeting ALI/ARDS criteria: a) Identify eligible patients, obtain informed consent, enroll and follow patients b) Safely store, prepare and administer GM-CSF to patients randomized to receive study drug c) Ensure patient safety through protocol compliance, study monitoring and reporting to the institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB) 4. To provide data management services to individual investigators: a) Organize and manage the clinical database b) Advise on study design, sample size calculations and selection of appropriate outcome variables c) Allow etiologic subgroup specific interpretation of molecular biologic data d) Assist with statistical applications and data analysis.