Major Project Summary

Examples of DCU projects include:

ALIAS: Albumin in Acute Stroke National Institute of Neurological Disorders and Stroke (NINDS: U01 NS40406-04), Ongoing This Phase III Randomized Multicenter clinical trial is conducted to ascertain whether high-dose human albumin therapy confers neuroprotection in acute ischemic stroke. DCU is responsible for the design, coordination, monitoring, data management and evaluation of this international multi-center trial involving 1800 participants enrolled from 70+ clinical centers in the United States and Canada. ALIAS ATACH: Antihypertensive Treatment in Acute Cerebral Hemorrhage National Institute of Neurological Disorders and Stroke (NINDS), Ongoing This multicenter Phase I clinical trial is conducted to assess the feasibility and safety of anti-hypertensive treatment (with nicardipine) for patients with acute hypertension due to intracerebral hemorrhage. DCU is responsible for establishing and maintaining the IS infrastructure, the complete data management and data analysis involving up to 60 participants enrolled at 5 clinical sites. ATACH COBRE: South Carolina Centers of Biomedical Research Excellence for Oral Health National Center for Research Resources (NIH/NCRR: P20RR017696), Ongoing The South Carolina COBRE for Oral Health at the Medical University of South Carolina will train a cadre of targeted researchers who will become established investigators and academic leaders in the continued development of the College of Dental Medicine's oral and craniofacial health research program. DCU has been subcontracted for the IS infrastructure of this study including subject registration, periodontal examination, dental health history and dental chart information, and periotron calibration. COBRE CTN: Southern Consortium Node of the Clinical Trials Network National Institute of Drug Abuse (U 10 DA 13727-01), Completed This Program Project Grant (PPG) allows us to bridge the gap between research concerning effective treatments for substance abuse use disorders and drug abuse treatment in community based settings by partnering academic medical centers and community treatment programs in clinical trials and health services research. DCU has been subcontracted to establish and maintain the IS infrastructure of the Southern Consortium Clinical Trials Network and for the data management for the associated large multicenter studies. EXCEED: Understanding and Eliminating Health Disparities Agency for Healthcare Research and Quality (PO1 HS10871-01), Completed The overall goal of this PPG is to move beyond the identification and description of African American/Caucasian health-related disparities to understanding the disparities within the African American population and identifying solutions designed to address these health issues. DCU has been subcontracted for the IS infrastructure of this PPG and for the data management for these large multicenter studies. EXCEED IMS: Interventional Management of Stroke I NINDS (RO1 NS39160), Completed, 03/2003 This multicenter Phase II clinical trial assesses the futility (or lack thereof) of intravenous plus intra-arterial tPA therapy for acute stroke. DCU services include establishing and maintaining the IS infrastructure, the complete data management and data analysis for this multicenter study involving 80 participants enrolled from 15 clinical centers and 30 sites in the United States and Canada. A total of 2,454 CRFs were collected and processed. Abstracts were presented at the 28th International Stroke Conference in 2003 and primary manuscript has been published. IMS II: Interventional Management of Stroke II NINDS/EKOS Corporation (RO1 NS39160/EKOS), Completed IMS II is a multicenter trial, considered as the second stage of the Phase II evaluation of the IV+IA tPA therapy for acute ischemic stroke. DCU services include statistical design, the IS infrastructure, the complete data management and data analysis for this multicenter study involving 73 participants enrolled from 15 clinical centers and 30 sites in the United States and Canada. IMS III: Interventional Management of Stroke III NIH/NINDS (UO1 NS52220), Ongoing This phase III, randomized, multi-center, open label clinical trial examines whether subjects with an NIHSS greater than or equal to 10 at baseline, treated with a combined intravenous (IV) and intra-arterial (IA) approach to recanalization started within 3 hours of onset are more likely to have a favorable outcome at 3 months as compared to subjects treated with standard IV rt-PA (Activase®) alone. DCU is responsible for the statistical design, monitoring, data management, IS infrastructure and evaluation of this international multi-center trial involving 900 participants enrolled from approximatedly 55 study sites in the United States and Canada. IMS III MIMS: Cancer Staging and Screening Initiative Project 1: RT-PCR Department of Defense Office of Naval Research (N00014-99-1-0784), Completed MIMS is a multi-site prospective cohort study designed to determine whether a screening procedure to detect occult breast cancer micrometastases using reverse transcriptase-polymerase chain reaction (RT-PCR) in the axillary lymph node of patients with primary breast cancer would be a clinically relevant predictor of disease recurrence. DCU is responsible for the design, coordination, monitoring, data management and evaluation of this international multi-center trial involving 550 participants enrolled from 14 clinical centers in the United States, England and Australia. NETT: Neurological Emergencies Treatment Trials Network National Institute of Neurological Disorders and Stroke (U01 NS059041), Ongoing NETT will engage clinicians and providers at the front lines of emergency care to conduct large, simple multicenter clinical trials to answer research questions of clinical importance. The NETT structure will be utilized to achieve economies of scale enabling cost effective, high quality research. The DCU provides statistical and data management support for the multicenter, multiple clinical trials of neurological emergencies to be conducted by the NETT network. NETT OPT-TMS: Optimization of Transcranial Magnetic Stimulation for Depression National Institute of Mental Health (R01 NIMH), Ongoing OPT-TMS requests support for a 4 year, 4 site randomized sham-controlled trial of daily prefrontal repetitive transcranial magnetic stimulation (rTMS) for the acute treatment of major depression. The DCU is the data management center for this multicenter trial and is implementing WebDCU, their web-based electronic data management system, for all data management activities including web-based randomization. OPT-TMS