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DCU projects include:

ALFSG: Acute Liver Failure Study Group Registry
National Institute of Diabetes and Digestive And Kidney Diseases (NIDDK), Ongoing
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    Project Info
  • This registry study is conducted to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy
  • DCU services include IS infrastructure, the complete data management and data analysis for this multicenter study involving 2000+ participants enrolled from approximately 20 clinical centers in the United States.
  • Principal Investigators:
    • William M. Lee, M.D., PI., University of Texas - Southwestern Medical Center at Dallas
    • Valerie Durkalski, Ph.D., Co-PI, DCU Director, Associate Professor of Public Health Sciences, Medical University of South Carolina

ALIAS 2: Albumin in Acute Stroke Part 2
National Institute of Neurological Disorders and Stroke (NINDS: U01 NS40406-04), Ongoing
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    Project Info
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    Protocol
  • 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 1100 participants enrolled from 100 clinical centers in the United States and Canada.
  • Principal Investigators:
    • Myron D. Ginsberg, M.D., Study Chair, Peritz Scheinberg Professor of Neurology, University of Miami School of Medicine
    • Michael D. Hill, M.D., M.Sc., FRCPC, Canadian Co-PI, Associate Professor, Calgary Stroke Program
    • Yuko Y. Palesch, Ph.D., Biostatistics Co-PI, Interim Chair, Professor of Public Health Sciences, Medical University of South Carolina

ATACH-II: Antihypertensive Treatment in Acute Cerebral Hemorrhage
National Institute of Neurological Disorders and Stroke (NINDS), Ongoing
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    Project Info
  • This Phase III randomized multicenter clinical trial is conducted to determine the therapeutic benefit of intensive SBP treatment compared with standard SBP treatment for patients with acute intracerebral hemorrhage.
  • DCU is responsible for the statistical design, monitoring, data management, IS infrastructure and evaluation of this international multi-center trial involving up to 1280 participants enrolled from 100+ clinical sites.
  • Principal Investigators:
    • Adnan I. Qureshi, M.D., Clinical Coordinating Center PI, Professor of Neurology, Neurosurgery, and Radiology, University of Minnesota
    • Yuko Y. Palesch, Ph.D., Statistics and Data Coordination Center PI, Interim Chair, Professor of Public Health Sciences, Medical University of South Carolina

COBRE: South Carolina Centers of Biomedical Research Excellence for Oral Health
National Center for Research Resources (NIH/NCRR: P20RR017696), Completed
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    Project Info
  • 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.
  • Principal Investigators:
    • Keith L. Kirkwood, DDS, PhD., PI, Director of Core A - Administration
    • Salinas, Carlos F, DMD., Co-PI, Director of Clinical Resources Core
    • Slate, Elizabeth H, PhD., Co-PI, Director, Biostatistics Core, Medical University of South Carolina

EPISOD: Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction Trial
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ongoing
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    Project Info
  • The EPISOD Trial is a two-arm parallel, randomized, double-blinded, sham-controlled, multicenter Phase III clinical trial for adults 18 to 65 years of age diagnosed with SOD III to ascertain whether subjects respond to endoscopic sphincterotomy.
  • The DCU provides study design, data management, IS infrastructure and statistical analysis of this multi-center trial involving 200+ SOD III patients enrolled.
  • Principal Investigators:
    • Peter B. Cotton M.D., Study Group Chair, Professor of Gastroenterology & Hepatology, Medical University of South Carolina
    • Valerie Durkalski, Ph.D., PI, DCU Director, Associate Professor of Public Health Sciences, Medical University of South Carolina

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.

IMS III: Interventional Management of Stroke III
National Institute of Neurological Disorders and Stroke (NINDS: U01 NS52220 U01 NS054630), Completed
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    Project Info
  • 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 50+ study sites in the United States, Canada and Australia.
  • Principal Investigators:
    • Joseph P. Broderick, M.D., Neurology PI, University of Cincinnati
    • Thomas A. Tomsick, M.D., Neuroradiology PI, University of Cincinnati
    • Yuko Y. Palesch, Ph.D., Data Management and Statistics Center PI, Interim Chair, Professor of Public Health Sciences, Medical University of South Carolina

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.

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.

POINT: Platelet-Oriented Inhibition in New TIA and minor ischemic stroke Trial
National Institute for Neurological Disorders and Stroke (NINDS: 1U01S062835-01A1), Ongoing
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    Project Info
  • This trial is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel compared to placebo when therapy is initiated within 12 hours of onset.
  • DCU is a Statistical and Data Management Center (SDMC), which provides statistical design and analysis, data management and IS infrastructure.
  • Principal Investigators:

PRIDE: Prolonging Remission in Depressed Elderly Trial
National Institute of Mental Health (NIMH), Ongoing
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    Project Info
  • This study will determine, in a multicenter, randomized clinical trial, whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission and in improving quality of life for older adults with severe mood disorders than pharmacotherapy alone.
  • DCU is responsible for the study monitoring, data management, and information system infrastructure of this international multi-center trial involving 320 participants enrolled from 7 study sites in the United States.
  • Principal Investigators:
    • Charles Kellner, MD, Study Co-PI, Mount Sinai School of Medicine
    • Sarah H. Lisanby, MD, Study Co-PI, Duke University, Columbia University and New York State Psychiatric Institute
    • Rebecca G. Knapp, Ph.D., Data Center PI, Professor of Public Health Sciences, Medical University of South Carolina

ProTECT: Progesterone for the Treatment of Traumatic Brain Injury Trial
National Institute for Neurological Disorders and Stroke (NINDS: 1U01NS062778), Ongoing
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    Project Info
  • This study will determine the efficacy of administering intravenous (IV) progesterone versus placebo for treating victims of moderate to severe acute TBI.
  • DCU is the Statistical and Data Management Center (SDMC), which provides statistical design and analysis, data management and IS infrastructure.
  • Principal Investigators:
    • David W. Wright, MD, PI, Director, Emergency Neurosciences, Emory University
    • Yuko Y. Palesch, Ph.D. , SDMC PI, Interim Chair, Professor of Public Health Sciences, Medical University of South Carolina

RAMPART: the Rapid Anticonvulsant Medication Prior to Arrival Trial
National Institute for Neurological Disorders and Stroke (NINDS: 5U01NS056975-02), Ongoing
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    Project Info
  • This is a double-blind randomized non-inferiority clinical trial of the efficacy of IM midazolam versus IV lorazepam in the prehospital treatment of status epilepticus by paramedics.
  • DCU is a Statistical and Data Management Center (SDMC), which provides statistical design and analysis, data management and IS infrastructure.
  • Principal Investigators:
    • Robert Silbergleit, MD, PI, Associate Professor, Department of Emergency Medicine, University of Michigan
    • Daniel H Lowenstein, MD, Co-PI, Director of the Epilepsy Center, University of California, San Francisco
    • Valerie Durkalski, Ph.D., Co-PI, DCU Director, Associate Professor of Public Health Sciences, Medical University of South Carolina
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