General Clinical Research Center

全科临床研究中心

基本信息

批准号：
7821393
负责人：
ERIK L HEWLETT
金额：
$ 493.14万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-05-01 至 2013-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7821393
关键词：
General Clinical Research Center

项目摘要

This Clinical Center will provide supportfor state-of-the-art clinical research activities for 962 SCO patients at St. Christopher's Hospital for Children (SCHC), Thomas Jefferson University Hospital (TJUH), Kosair Children's Hospital (KCH), and duPont Children's Hospital (DCH). Three of these sites (SCHC, KCH, TJUH) are currently part of the Marian Anderson Comprehensive (MAC) Sickle Cell Center and currently lead enrollment in several of the phase l/ll/lll Inter-Center studies sponsored by the Comprehensive Centers, also under the direction of Dr Dampier and Ms Rockstein through the MAC Center's Clinical Core. The Center PI and Center Chief Clinical coordinator at St. Christopher's Hospital are both credentialed by the Association of Clinical Research Professionals (Clinical Trial Investigator, and CRA certifications respectively) and have a several year record of successful coordination and supervision of research activities at the various Center sites. The proposed network clinical trials address important issues in clinical care of SCO patients. The first study is a phase IV of headache management that will build on descriptive and epidemiologic data being gather as part of the C-data project of the Comprehensive Center's Network. This study proposes a 4 month placebo controlled RCT of prophylactic therapy (amitryptline with or without CBT training) in children aged 7- 17 years with ¿ 2 headaches per month in the preceding 3 months, while a companion study will evaluate the effectiveness of amitriptyline or divalproex ER in reducing the number of days of recurrent headaches in a 4 month double blind, parallel treatment, placebo-controlled trial of adults with ¿ 2 migraine headaches per month. The second clinical trial will examine the efficacy of two alternative morphine PCA dosing regimens in comparison to a standard PCA therapy. It will also determine whether variations in morphine pharrnaco- cinetics, in morphine pharmacodynamics as determined by pharmacogenetics, or subject psychosocial 'actors, alter the efficacy of the various PCA regimens. An Outcomes Core is also proposed which will focus on developing a variety of outcome measures and descriptive clinical information to,support the appropriate , conduct of high quality clinical trials of therapies for sickle cell-related pain. The performance of these studies will advance the clinical understanding of sickle cell-related pain and its consequences. Their results will stimulate the development of innovative clinical trials of sickle pain.

该临床中心将为962名SCO患者提供最新的临床研究活动的支持位于Kosair的Thomas Jefferson大学医院（TJUH）的圣克里斯托弗儿童医院（SCHC）儿童医院（KCH）和杜邦儿童医院（DCH）。其中三个站点（SCHC，KCH，TJUH）目前是Marian Anderson综合（MAC）镰状细胞中心的一部分，目前领导在综合中心赞助的几个阶段L/LL/LL中心研究中的注册，也在Dampier博士和Rockstein博士的指导下，MAC中心的临床核心。中心pi 圣克里斯托弗医院的中心首席临床协调员均由协会认证临床研究专业人员（分别临床试验研究者和CRA认证），并具有在各个中心成功协调和研究研究活动的几年记录站点。提出的网络临床试验解决了SCO患者临床护理中的重要问题。第一个研究是标头管理的IV阶段，它将以描述性和流行病学数据为基础作为综合中心网络的C-DATA项目的一部分收集。这项研究提出了4个月预防性治疗的安慰剂控制RCT（有或不接受CBT培训的Amitryptline）在7--的儿童中在前3个月中，每月2个标题为17年，而伴侣研究将评估阿米替林或divalproex er的有效性减少了重复的标题天数 4个月的双盲，平行治疗，安慰剂对照试验的成年人»2个偏头痛的成年人月。第二项临床试验将检查两种替代吗啡PCA剂量方案的效率与标准PCA疗法进行比较。它还将确定吗啡pharrnaco-的变化是否存在 Cinetics，在吗啡药效学中，由药物遗传学确定或主题心理社会 '参与者，改变了各种PCA方案的效率。还提出了结果核心在制定各种结果指标和描述性临床信息时，支持适当的，对镰状细胞相关疼痛的疗法进行高质量的临床试验。这些研究的表现将提高对镰状细胞相关疼痛及其的临床理解结果。他们的结果将刺激镰状疼痛的创新临床试验的发展。

项目成果

期刊论文数量（640）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Preservation of growth hormone pulsatility despite pituitary pathology, surgery, and irradiation.

DOI：
10.1210/jcem.82.7.4103
发表时间：
1997-07
期刊：
The Journal of clinical endocrinology and metabolism
影响因子：
0
作者：
A. Toogood;R. Nass;S. Pezzoli;P. O'Neill;M. Thorner;S. Shalet
通讯作者：
A. Toogood;R. Nass;S. Pezzoli;P. O'Neill;M. Thorner;S. Shalet

Autonomic dysfunction independently predicts poor cardiovascular outcomes in asymptomatic individuals with type 2 diabetes in the DIAD study.

DOI：
10.1177/2050312114568476
发表时间：
2015
期刊：
SAGE open medicine
影响因子：
2.3
作者：
Chyun DA;Wackers FJ;Inzucchi SE;Jose P;Weiss C;Davey JA;Heller GV;Iskandrian AE;Young LH;DIAD Investigators
通讯作者：
DIAD Investigators

Patients with Nonalcoholic Steatohepatitis and Advanced Liver Disease Have the Lowest Cardiorespiratory Fitness.

DOI：
10.1007/s10620-022-07809-w
发表时间：
2023-06
期刊：
DIGESTIVE DISEASES AND SCIENCES
影响因子：
3.1
作者：
Dahmus, Jessica;Hummer, Breianna;Rivas, Gloriany;Schmitz, Kathryn;Caldwell, Stephen H.;Argo, Curtis K.;Schreibman, Ian;Stine, Jonathan G.
通讯作者：
Stine, Jonathan G.

Obesity blunts microvascular recruitment in human forearm muscle after a mixed meal.