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Our Research

The General Clinical Research Center is engaged in a full range of patient-oriented research. Each month new protocols are reviewed and approved for resource use. The following is a list of research currently approved by the GCRC Advisory Committee. Links to ClinicalTrials.gov for recruitment information are included when available.

Principal Investigator

IRB Protocol Number

Title

Beitelshees, Amber

HP-40291

Uncoupling Protein Polymorphisms and Cardiometabolic Responses to Beta-Blockers

Chen, Wilbur

HP-41209

Influenza CVD 25000: A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of a Single Intramuscular Booster Dose of Inactivated Influenza Vaccine Derived from A/H5N1/Indonesia/05/05 (Clade2) in Healthy Adults 19 Years or Older Who Received Inactivated Influenza Vaccine Derived from A/H5N1/Vietnam/1203/2004 (Clade1) (http://clinicaltrials.gov/ct/show/NCT00680069)

Chen, Wilbur

HP-43474

Influenza CVD 38000: A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a Sanofi Pasteur H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant

Cole, John

HP-43342

Stroke and the Genetics of Thrombomodulin

Counts, Debra

HP-40490

TrialNet
(http://clinicaltrials.gov/ct/show/NCT00097292)

Counts, Debra

HP-43352

New Onset of Type 1 Diabetes Anti-CD20 Clinical Trial
(http://clinicaltrials.gov/ct/show/NCT00279305)

Counts, Debra

HP-41277

Oral Insulin for Prevention of Diabetes in Patients at Risk for Type 1 Diabetes Mellitus (http://clinicaltrials.gov/ct/show/NCT00419562)

Counts, Debra

HP-41399

Epidemiology of Diabetes Intervention and Complications (EDIC) (http://clinicaltrials.gov/ct/show/NCT00360893)

Donner, Thomas

HP-40249

Durable-Response Therapy Evaluation for Early or New-Onset Type 1 Diabetes (DEFEND)

Dowling, Thomas

HP-44028

Pharmacogenomic Study In Hispanic Americans With Diabetes

Edelman, Martin

HP-41372

0804 GCC: A Phase 1 Open Label, Dose Escalation Study to Evaluate the Effect of Four Doses of MAGE-A3/HPV 16 Trojan Peptides 0001 and 0002 Administered Subcutaneously in Combination with Montanide and GM CSF on Immunological Response, Safety, Tolerability, and Preliminary Efficacy in Patients with Squamous Cell Carcinoma of the Head and Neck(http://clinicaltrials.gov/ct2/show/NCT00704041)

Feigenberg, Steven

HP-40817

RTOG 0413 (NSAPB Protocol B-39): A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, Or II Breast Cancer.
(http://clinicaltrials.gov/ct/show/NCT00103181)

Fink, Jeffrey

H-21249

The Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)
(http://clinicaltrials.gov/ct/show/NCT00304148)

Gojo, Ivana

HP-42937

0507 GCC: A Phase 1 Study Of UCN-01 In Combination With Perifosine In Patients With Relapsed And Refractory Acute Leukemias
(http://clinicaltrials.gov/ct/show/NCT00301938)

Hararian, Abdolreza

HP-42869 

B-Cell Depletion by Anti-CD20 in Renal Allograft Recipients Who Develop De Novo Anti-HLA Alloantibodies

Harris, Anthony

HP-42183

Methodological Approaches to Risk Analysis for Emerging Pathogens: Epidemiology of Imipenem-Resistant P. Aeruginosa

Hochberg, Marc

HP-42306

Clinical Center for the Osteoarthritis (OA) Initiative (http://clinicaltrials.gov/ct/show/NCT00080171)

Hong, Elliot

HP-43506

Neuroimaging Studies of Neurophysiological Phenotypes in Schizophrenia

Horenstein, Richard

HP-40836 

A Randomized Controlled Clinical Trial of Clarification of Optimal Anticoagulation Through Genetics

Howell, Charles

HP-42624

Ribavirin Pharmacokinetics, Race and Outcome of Hepatitis C Treatment

Howell, Charles

HP-42926

A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics of Once-Daily Oral E5501 Tablets Used Up to 7 Days in Subjects with Chronic Liver Diseases and  Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

Jain, Ajay

HP-43996

Fc Receptor Polymorphisms in Colon Cancer Patients and in-vitro Antibody Dependent Cellular Cytotoxicity (ADCC) against KRAS mutant and nonmutant tumors

Johnson, Jennifer

HP-41043

Understanding Resistance Mechanisms in Fecal Microorganisms

Johnson, Jennifer

HP-41044

Antimicrobial Resistant Mechanisms from Clinical Cultures

Katzel, Leslie

HP-41271 

Healthy Aging In Neighborhoods of Diversity Across the Life Span (HANDLS) Scan

Kotloff, Karen

HP-43021

Influenza 35000:  A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels

Kwok, Young

HP-40841

RTOG 0534 - A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy (http://clinicaltrials.gov/ct/show/NCT00567580)

Kwok, Young

HP-42116

RTOG 0614: A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy

Kwok, Young

HP-42390

RTOG 0825 - Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Kwok, Young

HP-43116

RTOG 0539 Phase II Trial Of Observation For Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

Kwok, Young

HP-43489

RTOG 0621: Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

Lyke, Kiersten

HP-43946

Malaria CVD 17000:  Interventional Plasmodium Falciparum Malaria Challenge Model Utilizing the NF54 Strain of Parasite Transmitted by Aseptic A. Stephensi Mosquitoes to Healthy Malaria-Naïve Adult Volunteers

Lyke, Kiersten

HP-41298

Use of Preserved Specimens From Completed International Malaria Trials

McDiarmid, Melissa

HP-40728

Follow-up & Monitoring of Gulf War Veterans with Fragments of Depleted Uranium & Other Sources of Depleted Uranium Exposure

Mendley, Susan

HP-42179

Chronic Kidney Disease in Children Study (CKID)
(http://clinicaltrials.gov/ct/show/NCT00327860)

Mendley, Susan

HP-42408

Impact of a Multidisciplinary Weight Reduction Intervention on Blood Pressure and Non-Classical Cardiovascular Risk Factors in Obese Children and Adolescents

Noguiera, Joseph

HP-43529

Study of Heart and Renal Protection (SHARP) A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Effects of Lipid-Lowering Therapy With Simvastatin and Ezetimibe Compared With Placebo on the Time to a First Cardiovascular Event (Myocardial Infarction, Stroke, Angioplasty, Bypass Surgery, or Cardiac Death) in Patients With Chronic Kidney Disease (CKD)

Oswald, Lynn

H-30104

Dopamine and Risks for Drug Abuse

Panigrahi, Pinaki

H-29171

Prevention of Neonatal Infection in The Indian Community Setting Using Probiotics

Pierson, Richard

H-27115

Mechanisms Of Galtko Lung Xenograft Injury

Polli, James

HP-30734

Evaluation of Biopharmaceutics Classification System Class 3 Drugs for Possible Biowaivers

Polli, James

HP-43432

Impact of Formulation on Ciprofloxacin Oral Absorption

Postolache, Teodor

HP-43574

Light Treatment for Winter SAD: Metabolic Effects and Prediction of Antidepressant Response by Immediate Improvement (http://clinicaltrials.gov/ct2/show/NCT00742365)

Reeves, Gloria

HP-43695

Investigating Metabolic Side Effects of Antipsychotic Medications in Children

Reeves, Gloria

HP-43939

IMPACT: Improving Metabolic Parameters of Antipsychotic Child Treatment

Regine, William

HP-41455

RTOG 0822: A Phase II\I Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination with Capecitabine and Oxaliplatin for Patients with Locally Advanced Rectal Cancer (http://clinicaltrials.gov/ct2/show/NCT00613080)

Roghmann, Mary-Claire

HP-40957

Longitudinal Study of the Human Anterior Nares Microbiome

Royak-Schaler, Renee

HP-40396

A Lowfat Eating Plan to Manage Weight Gain Among African American Breast Cancer Survivors

Rus, Violeta

HP-43673

A Multi-Center, Open-Label, Continuation Trial of Lymphostat-B Antibody (Monoclonal Anti-BLys Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) who Completed the Phase 2 Protocol LBSL02 (http://clinicaltrials.gov/ct/show/NCT00583362)

Russell, James

HP-42940 

Improving Neuropathy and Mobility in Subjects with Early Diabetes

Sausville, Edward

HP-42617

A Phase 1 Study of AFP464 (Aminoflavone Prodrug) in Patients with Advanced Solid Tumors(http://clinicaltrials.gov/ct/show/NCT00369200)

Sausville, Edward

HP-42962

A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients with Advanced Solid Malignancies
(http://clinicaltrials.gov/ct/show/NCT00413686)

Sausville, Edward

HP-40559

Treatment of Melanoma With Wild-Type P53 and Detectable A 100b Using Pentamidine: A Phase II Trial with Correlative Biomarker Endpoints (http://clinicaltrials.gov/ct/show/NCT00729807)

Sausville, Edward

HP-40036

A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors

Scharf, Steven

HP-40820

Collection of Blood for Future Genetic Testing

Scharf, Steven

HP-42560

The Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
(http://clinicaltrials.gov/ct/show/NCT00325897)

Scharf, Steven

HP-40166

Pneumococcal Vaccine Response in Chronic Obstructive Pulmonary Disease
(http://clinicaltrials.gov/ct/show/NCT00457977)

Seliger, Stephen

HP-42780

An Observational Study of Subclinical Ischemic Brain Disease and Cognitive Dysfunction in Chronic Kidney Disease

Shuldiner, Alan

HP-43419

Pharmacogenomics of Anti-Platelet Interventions (PAPI) Study

Shuldiner, Alan

HP-40355

Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

Silver, Kristi

HP-40159

Effects of a Steroid Challenge on Glucose Tolerance

Smith, Barbara

HP-43898

The Effects of Resistive or Aerobic Exercise and a Nutrition (RAN) Program on Body Composition, Blood Pressure, Functional Status and Mood in University Employees

Snitker, Soren

HP-43497 

Pharmacogenomics of Thiazolidinediones

Suntha, Mohan

HP-40359

RTOG 0617 - A Randomized Phase III Comparison of Standard- Dose (60 GY) Versus High-Dose (74 GY) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer (http://clinicaltrials.gov/ct/show/NCT00533949)

Suntha, Mohan

HP-41290

RTOG 0436 - A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated Without Surgery (http://clinicaltrials.gov/ct2/show/NCT00655876)

Suntha, Mohan

HP-43264

RTOG 0619: A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck

Tacket, Carol

HP-42991

Norwalk CVD 5000 - Randomized Double-Blind Placebo-Controlled Phase 1, Safety And Immunogenicity Study Of Two Dosages Of Intranasal Norwalk Virus-Like Particle Vaccine (Norwalk VLP Antigen, MPL, Chitosan, Mannitol, Sucrose) Compared To Adjuvant/Excipients (MPL, Chitosan, Mannitol, And Sucrose) And To Placebo (Empty Device) (LV01-102)

Tacket, Carol

HP-40023

Longitudinal Study of the Human Intestinal Microbiome Before and After Antibiotic Administration

Tracy, Kate

HP-42266 

Epidemiology of HPV Infection in Malian Women

von Rosenvinge, Erik

HP-40446 

The Role of Biofilm in Clostridium Difficile-Associated Disease

Watson, Douglas

HP-41077

IMPAACT P 1066: A Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent Aids Clinical Trials Group (IMPAACT) to Evaluate the Safety, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress, MK-0518) iN HIV-1 Infected Children and Adolescents

Watson, Douglas

HP-41328

PHACS Adolescent Master Protocol (AMP)

Watson, Douglas

HP-42309

IMPAACT 1026S: Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy

Weir, Matthew

HP-43605

ALTOLD - Assessing Long Term Outcomes of Living Donation

Wolf, Jeffrey

HP-40999

GCC 0608: Phase I Study of Intra-Tumoral Injection of Dendritic Cells for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (http://clinicaltrials.gov/ct/show/NCT00492947)

Wozniak, Marcella

HP-40110

A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke