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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.

Principal InvestigatorIRB Protocol NumberTitle
Ahmed, Zubair MD HP-64793 Genetics of Eye Disorders
Banagan, Kelly MD HP-65869 Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim ®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process 
Britt, Edward MD  HP-72840 A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Britt, Edward MD HP-69887 A Randomized, Open-Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium Avium Complex (MAC) that are Refractory to Treatment
Bromberg, Jonathan MD HP-71439 A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients.
Brotman, Rebecca PhD, MPH HP-61371 Effect of Lubricant use on the Vaginal Microbiome: A Study before and after Transvaginal Ultrasound Scans (TVUS)
Chuong, Michael MD HP-61752 GCC 1458 - IMMU-107-04  An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Ade+nocarcinoma Who
Received at Least Two Prior Treatments (PANCRIT-1) IND#11380
Chuong, Michael MD HP-61752 GCC 1458 - IMMU-107-04  An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) IND#11380
Chuong, Michael MD HP-61752 GCC 1458 - IMMU-107-04  An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose
Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) IND#11380
Davis, Stephen MBBS HP-68487 Hypoglycemia Associated Autonomic Dysfunction Dose Response of Epinephrine
Davis, Stephen MD HP-64405 Hypoglycemia Associated Autonomic Dysfunction.  The Effects of Differing Levels of Hypoglycemia on the Fibrinolytic, Endothelial, and pro Inflammatory Responses in Healthy Individuals
Diaz, Jose MD HP-66763 A Phase IIa Open-label, Randomized Study to Compare the Safety, Tolerability, Pharmacokinetics (PK) and Phamacodynamics (PD) of NM-IL-12 (rHulL-12) to Standard of Care in Subjects with Open Surgical Wounds Following Colostomy Takedown Allowed to Heal by Secondary Intention
El Metwally, Dina MD HP-63232 A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial Exploringthe Efficacy and Safety of Intra-nasal Administration of FE 202767 Increasing Milk Production in Maternal Subjects with Preterm Delivery and Inadequate Milk Production
El-Kamary, Samer MD HP-63835 Absolute Bio Availability/Pharmacokinetic and Residual Drug Analysis of Duragesic® Transdermal System and Generic Fentanyl Transdermal
System in Health Adults
Feigenberg, Stephen MD HP-61460 RTOG 1306: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
Feigenberg, Steven MD HP-62552 A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in
Combination with Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplati+n Consolidation in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC)
Feigenberg, Steven MD  HP-67345 NRG BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
Feigenberg, Steven MD HP-67540 Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
Feigenberg, Steven MD  HP-68531 A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients with Brain Metastases 
Feigenberg, Steven MD  HP-67647 Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC
Feigenberg, Steven MD  HP-61460 RTOG 1306: A Randomized Phase II Study of Individualized Combined
Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
Feller, Erika MD HP-58592 Mechanical Circulatory Support Device (MCSD) Database
Fink, Jeffrey MD HP-63289 CRIC - Visceral Adiposity and Physical Fitness in CKD (CRIC VAP)
Fink, Jeffrey MD HP-63289 CRIC - Visceral Adiposity and Physical Fitness in CKD (CRIC VAP)
Fink, Jeffrey MD, MS HP-73074 Is there a digital divide in Chronic Kidney Disease (CKD)?
Griffith, Bartley MD HP-62976 Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients 
Hafer-Macko, Charlene MD HP-56025 Aerobic Training to Improve Energy Utilization and Antioxidant Capacity in Stroke
Haririan, Abdolreza MD HP-65452 A Randomized Double-blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cinryze®  (C1 Esterase Inhibitor [human]) for
the Treatment of Acute Antibody-Mediated Rejection in Kidney Transplant Patients 
Haririan, Abdolreza MD, MPH  HP-71271 1683GCC: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir. SHP620-303.
Himelhoch, Seth MD, MPH HP-62925 Optimizing Smoking Cessation Treatments in Smokers Living with HIV/AIDS
Laurens, Matthew  MD HP-67430 A Phase 1 Trial to Evaluate the Safety and Infectivity of Direct Venous Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum (7G8 and NF54) Sporozoites in Non-immune Adults in Baltimore, USA
Leung, Jocelyn MD HP-65963 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, Regn2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants
Lyke, Kirsten MD HP-65608 Clinical Trial of PfSPZ Vaccine Administered by Direct Venous Inoculation: Dose Optimization with Heterologous Challenge in Healthy Malaria-Naïve Adults
Lyke, Kirsten MD  HP-62294 A Phase 1 / 2, Randomized, Observer-Blind Study of Varying Injection Schedules of a Tetravalent  Dengue Virus Purified Inactivate Vaccine
(TDENV-PIV) with AS03B Adjuvant and Placebo in Healthy Adults in the US
Mikdashi, Jamal MD HP-55910 STARA: Stopping Anti-Tumor Necrosis Factor (TNF) Agents in Rheumatoid arthritis
Mishra, Mark MD HP-66909 A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Giloblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)
Narayan, Mayur MD HP-61699 A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administraton of 5.0g Idarucizumab (BI 655075) in Patients Treated with Dabigatran
Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures
Nichols, Elizabeth MD HP-68789 NRG-GY006: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer
Nichols, Elizabeth MD HP-63720 RTOG 1203: A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical
Cancer (Time-C)
Polli, James PhD HP-66926 Characterization of Epilepsy Patients At-Risk for Adverse Outcomes Related to Switching Antiepileptic Drug Products: Aim 2
Polli, James PhD, RPH HP-73251 Blood for Development of Blood Iron Assay
Prior, Steven MD HP-61679 Activity of Improve Outcomes in Peripheral Arterial Disease
Prior, Steven MD HP-59151 Post-Revascularization Rehabilitation to Improve Function in Veterans with Peripheral Arterial Disease (PAD) 
Rajagopalan, Sanjay MBBS HP-57047 Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis (MIRACULOUS) Trial
Rajagopalan, Sanjay MBBS HP-64670 Exercise MRI evaluation of HIV-PAH Longitudinal Determinants (EXHALTED)
Redfield, Robert MD  HP-68569  GS-US-380-1489; A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretrovial Treatment-Naïve Adults
Reed, Robert MD HP-67273 Beta-Blockers for the Prevention of Acute Exacerbations of COPD
Reed, Robert MD HP-73344 Intervention Study In Overweight Patients with COPD
Reed, Robert MD HP- 63798 Multicenter, Randomized, Active-Controlled Efficacy and Safety Study Comparing Extended Duration Betrixaban with Standard of Care Enoxaparin for the Prevention of Venous Thromboembolism in Acute Medically Ill Patients
Reed, Robert MD
(Deferred from April
GAC Meeting)
HP-63798 Multicenter, Randomized, Active-Controlled Efficacy and Safety Study Comparing Extended Duration Betrixaban with Standard of Care Enoxaparin for the Prevention of Venous Thromboembolism in Acute Medically Ill Patient
Rogers, Valerie PhD, RN HP-58407 Biomarkers of Airway Inflammation and Asthma Control in Children with Comorbid Sleep-Disordered Breathing
Ryan, Alice MD HP-62067 Resistive Training Combined with Nutritional Therapy after Stroke
Sachdeva, Ashutosh HP-71316 A Multicenter, Prospective, Open-Label, Single-Arm Clinical Study of the Safety and Feasibility of Using Navigational Bronchoscopy to Perform Interstitial Photodynamic Therapy using Photorin®  as Treatment in Subjects with Unresectable Stage IA Peripheral Non-Small Cell Lung Cancer (NSCLC)
Sajadi, Mohammad MD HP-47617 Plasma and White Blood Cell Donation for HIV-1 Broadly Neutralizing Antibodies
Sausville, Edward MD HP-67337 Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients with Newly Diagnosed Glioblastoma
Silver, Kristi MD HP-66668 A Phase III, Randomized, Double blind, Placebo-Controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses
of Empaglifozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients with Type 1 Diabetes Mellitus (EASE-3)
Silver, Kristi MD HP-66033 A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Empagliflozin (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Hypertensive Black/African American Patients with Type 2 Diabetes Mellitus
Stinchcomb, Audra MD HP-67033 Evaluation of the Bioavailability of Lidocaine Dermal Products  
Stinchcomb, Audra PhD HP-67047 Evaluation of the Bioavailability of Diclofenac Dermal Products
Thom, Kerri MD HP-65497 Clinical Validation of an Antibiotic Dosing Calculator in Critically Ill Patients
Ting, Tricia MD HP- 61801 An Open-Label, Randomized, Crossover Pharmaco-kinetic Study to Determine Relative Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat ®) in Patients with Refractory Epilepsy (Cohort 1) 
Tkaczuk Katherine MD HP-71556 1683GCC: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with LIV-1-Positive Metastatic Breast Cancer
Watnick, Terry MD  HP-64971 TAME-PKD:Trial of Administration of Metformin-Polycystic Kidney Disease
Watnick, Terry MD HP-61455 A Phase 3b, Multi-Center, Open Label Trial to Evaluate the Long Term Safety of Immediate-Release Tolvaptan (OPC 41061, 30 mg to 120
mg/day, Split Dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease 
Woodworth, Graeme MD  HP-61820 A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96) HSPPC-96) (NSC #725085, Alliance IND #15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone
in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)