Protocols
Current Protocols
Completed Protocols
Current Protocols
| CRC Protocol Number | Project Title | PI Last Name | PI First Name |
| 2009-21 | A Phase 3, Open-Label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion From Prograf Capsules Twice Daily to LCP-TACRO Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients | West | Patricia |
| 2009-18 | Study to evaluate the safety, tolerability and pharmacokinetics of HQK-1001 in subjects with sickle cell disease | Labotka | Richard |
| 2009-15 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck | Epstein | Joel |
| 2009-12 | Clinical Phenotyping Resource and Biobank Core (C-PROBE) | Perumal | Kalyani |
| 2009-10 | Affective Neuroscience of Pediatric Bipolar Disorder | Bishop | Jeff |
| 2009-08 | A Prospective, Multi-center, Randomized, Controlled, Third Party-Blinded Study of Strattice™ Fascial Inlay to Prevent Parastomal Hernia Formation in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies (PriSm) | Singer | Marc |
| 2008-12 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control Studyto Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy | Singer | Marc |
| 2008-11 | A PHASE 2, OPEN-LABEL, MULTI-CENTER, RANDOMIZED TRIAL TO DEMONSTRATE THE PHARMACOKINETICS OF LCP-TACRO TABLETS ONCE DAILY AND PROGRAF® CAPSULES TWICE DAILY IN ADULT DE NOVO KIDNEY TRANSPLANT | West | Patricia |
| 2008-09 | Effects of Corticosteroids on Oral Healing | Enegland | Chris |
| 2008-08 | A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients Who Have Undergone Partial Bowel Resection Surgery | Singer | Marc |
| 2008-06 | Treatment of Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy Walk-PHaSST | Schramufnagel | Dean |
| 2008-05 CIT 07 | Islet Alone - Phase 3 | Oberholzer | Jose |
| 2008-04 CIT06 | Islet After Kidney Transplant | Oberholzer | Jose |
| 2008-03 CIT02 | Strategies to Improve Long Term Islet Graft Survival | Oberholzer | Jose |
| 2008-02 | Safety and Efficacy of Alefacept in de novo Kidney Transplant Patients | West | Patricia |
| 2007-10 | Exertional Hypertension and Vascular Dysfunction | Phillips | Shane |
| 2007-07 | Adipose Tissue and Insulin Resistance in Polycystic Ovary Syndrome | Sam | Susan |
| 2007-03 | Islet Transplantation in Type I Diabetic patients Using the UIC Protocol | Oberholzer | Jose |
| 2007-01 | The Role of Genetic Factors in Traumatic Brain Injury - A Pilot Study | Kraus | Marilyn |
| 2006-10 | Assessment of Oral Loading of EC-MPS in African-American Renal Transplant Recipients Undergoing Rapid Steroid Elimination | West | Patricia |
| 2005-24 | Measuring and Predicting Responses to Atomoxetine (ATX) and Methylphenidate (MPH) | Stein | Mark |
| 2005-14 | Hispanic Chronic Renal Insufficiency Cohort "CRIC" Study | Lash | James |
| 2004-08 | Mechanism of Prostate Cancer Prevention by Lycopene | van Breemen | Richard |
| 2004-02 | The Neuropsychiatry of Traumatic Brain Injury | Kraus | Marilyn |
| 2003-12 | Effects of Endogenous Estrogen and Sex on Cognitive Functioning in Schizophrenia | Maki | Pauline |
| 2003-09 | Chronic Renal Insufficiency Cohort Study | Lash | James |
| 2003-08 | Monoamine receptor function in children with mood disorders | Pandey | Ghanshyam |
| 2003-04 | Effect of oral Contraceptive Use in Cognitive Function | Maki | Pauline |
| 2002-21 | PKC Substrates & transcription factors in mood disorders | Pandey | Ghanshyam |
completed protocols
| CRC Protocol Number | Project Title | PI Last Name | PI First Name |
| 2008-10 | Randomized, double-blind, placebo controlled study of the safety and efficacy of Marinol in patients with obstructive sleep apnea syndrome | Carley | David |
| 2008-07 | A Double-Blind, Randomized, Active Comparator Study of LT-NS001 versus Naprosyn for Seven Days in Healthy Subjects with Endoscopic Evaluation | Goldstein | Jay |
| 2007-08 | A Sequential Open-Label Study of the Pharmacokinetics and Safety of Intravenous Carbamazepine Relative to Oral Carbamazepine in Adult Patients with Epilepsy (Ovation Protocol 1015, Amendment #2) | Fischer | James |
| 2007-02 | A Phase II, Open-Label, Multi-Center Prospective, Conversion Study in Stable Kidney Transplant Patients to Compare the Pharmacokinetics of LCP-Tacro Tablets Once-A-Day to Prograf® Capsules Twice-A-Day. | West | Patricia |
| 2006-15 | A Randomized, Open-Label, Comparative 3-way Crossover Study of 23-hour Intragastric pH profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in Hispanic Patients with Symptomatic GERD | Goldstein | Jay |
| 2006-05 | Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period | Pavuluri | Mani |
| 2006-04 | Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT Study) | Stein | Mark |
| 2006-03 | Effect of Partial Vagal-blockade on Social Engagement Behaviors | Porges | Stephen |
| 2006-01 | Sleep Disturbances: A Non Traditional Risk Factor in Chronic Renal Disease II | Lash | James |
| 2005-19 | A Randomized Double-blind, Placebo-controlled, Multicenter Parallel-group Dose Ranging Clinical Trial to Assess the Efficacy and Safety of Org 4419-2 in the Treatment of Obstructive Sleep Apnea/ Hypopnea Syndrome | Carley | David |
| 2005-18 | Effect of Moderate Liver Impairment on the Pharmacokinetics of Saquinavir after Administration of Saquinavir/ Ritonavir 1000/100 mg BID in HIV Patients | Rodvold | Keith |
| 2005-16 | Adipocyte Lipid Metabolism and ApoE Expression | Mazzone | Theodore |
| 2005-15 | Effect of Dried Plum Consumption on Dental Plaque pH | Christine | Wu |
| 2005-10 | Effects of CYP2D6 Genotype on Pain Management with Codeine in Sickle Cell Disease | Shord | Stacy |
| 2005-03 | Pharmacologic Treatments for Sleep Apnea | Carley | David |
| 2005-01 | CJC-1295 (DAC-GRF) effects on pulsatile GH secretion | Frohman | Lawrence |
| 2004-15 | Aberrant Crypt Focus (ACF) Database | Benya | Richard |
| 2004-12 | A Randomized, Open-Label, comparative 3-way Crossover Study of 24-hour Intrgastric pH profile of Once Daily Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at steady State in NSAID-using Patients. | Goldstein | Jay |
| 2004-11 | A Pilot Study of the Interaction among Sleep Apnea, NAFLD and Oxidative Stress | Cotler | Scott |
| 2004-10 | Free Fatty Acid Suppression in a Multiethnic Sample of Postmenopausal Women | Quinn | Lauretta |
| 2004-07 | A Pilot Study to Evaluate the Effect of Omega-3 Fatty Acids on Hepatic Steatosis and Factors Associated with Steatohepatitis | Cotler | Scott |
| 2004-06 | A double-blind, randomized, controlled phase III study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are HSV-1 and -2 seronegative | Novak | Richard |
| 2004-05 | Pilot Test of Actos in Multiple Sclerosis: Safety and Tolerability | Feinstein | Douglas |
| 2004-04 | Phase I Single Dose Pharmacokinetic Study of The Dietary Supplement Lycopene In Capsule Form To Healthy Male Volunteers Between 18 and 45 Years of Age. | Rodvold | Keith |
| 2004-03 | Open Trial of Lamotrigine Monotherapy in Pediatric Bipolar | Pavuluri | Mani |
| 2004-01 | Absolute Near-Infrared Brain Oximeter | Olopade | Christopher |
| 2003-25 | Affective Deficits in Schizophrenia | Herbener | Ellen |
| 2003-24 | Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy | Rich | Kenneth |
| 2003-23 | A Double-Blind, Randomized, Comparator-Controlled Study in Subjects with Type 2 Diabetes Mellitus, Comparing the Effects of Pioglitazone HCI vs Glimepiride on the Rate of Progression of Atheroscletoric Disease as Measured by Carotid Intima-Media Thic | Hatipoglu | Betul |
| 2003-22 | Functional Performance in obese, elderly people with COPD | Larson | Janet |
| 2003-21 | Cytochrome P450 2C9 genotype and phenotype in cancer | Shord | Stacy |
| 2003-20 | IFN Resistance in Genotype 1 Infected Patients | Layden | Thomas |
| 2003-19 | Diabetes, Exercise, and Postprandial Oxidative Stress | Quinn | Lauretta |
| 2003-18 | Case-Control Study of Renal Cell Cancer Among Caucasians and African Americans | Davis | Faith |
| 2003-16 | Mechanisms of platelet activation and thrombosis | Du | Xiaoping |
| 2003-15 | An Investigation on the Safety and Effects of St. Johns Wort (Hypericum perforatum) on Women Receiving Estrogen-Containing Oral Contraceptive Agents: A Pilot Study | Lau | Alan |
| 2003-14 | Pharmacokinetics and Pharmacodynamics of Selected Antibiotics During Pregnancy | Fischer | James |
| 2003-11 | Obesity Prevention in African American School Children (Health-Kids Project) | Wang | Youfa |
| 2003-10 | Pupillometric sleepiness in treated sleep disorders | Shaver | Joan |
| 2003-07 | Women's Interagency HIV Study (WIHS) Antiretroviral treatment exposure/intensive pharmacokinetic study | Hershow | Ronald |
| 2003-06 | S100B(beta) Blood Content in Patients Treated with Antidepressants | Manev | Radmilla |
| 2003-05 | A Pilot Phase IB trial of PSA-Peptide Based Specific Active Immunotherapy in HLA-A2+ Patients with Prostate Cancer | Peace | David |
| 2003-02 | Obstructive sleep apnea, cognitive function and functional cerebral studies | Olopade | Christopher |
| 2003-01 | An Open Label Study to Assess the Relative Exposure 250mg Viracept of 625mg | Novak | Richard |
| 2002-19 | Role of host factors in fibrosis progression in HCV infected patients | Layden | Thomas |
| 2002-17 | Nurse managed upper body strength training in COPD | Covey | Margaret |
| 2002-13 | A Large, Simple Trial Comparing Two Strategies for Management of Anti-retroviral Therapy. The SMART study. | Diaz | Mariela |
| 2002-12 | The effects of clotrimazole on cytochrome P450 3A4 activity in normal volunteers | Shord | Stacy |
| 2002-10 | Pediatric Bipolar Disorder: Control trial of Risperidone vs Divalproex Sodium and fMRI assessment of relevant affective circuitry pre and post treatment. | Pavuluri | Mani |
| 2002-07 | Multicenter Vitamin E Trial in Aging Persons with Down Syndrome | Heller | Tamar |
| 2002-06 | Oculomotor and Spatial Cognition Deficits in Schizophrenia | Sweeney | John |
| 2002-03 | Regional adiposity and syndrome X in spinal cord injury | Braunschweig | Carol A |
| 2001-14 | Comparison of bone mineral density between men and women with COPD | Covey | Margaret |
| 2001-13 | Arousal and neuropsychological functioning in schizophrenia | Herbener | Ellen |
| 2001-11 | Human growth hormone in late-onset depression | Janicak | Philip G |
| 2001-08 | Early natural history of HCV infection among intravenous drug users | Hershow | Ronald |
| 2001-07 | MRI scans in schizophrenics with water imbalance | Goldman | Morris |
| 2001-05 | Multiple dose pharmacokinetic study of Lycopene delivered in a well-defined food-based lycopene delivery system | Rodvold | Keith A |
| 2001-04 | Cardiovascular risks in adolescents with diabetes | Faulkner | Melissa S. |
| 2001-01 | A Phase I study of black cohosh and red clover in healthy menopausal women | Shulman | Lee |
| 2000-08 | Pharmacokinetics-pharmacodynamics of once-a-day daily dosing of intravenous levofloxacin and metronidazole in healthy adult male subjects and healthy female subjects who can not become pregnant | Rodvold | Keith A |
| 2000-06 | Gender differences in the expression of heart failure | Dunlap | Stephanie |
| 2000-05 | Exercise adherence among adults with Down Syndrome/Mental retardation | Heller | Tamar |
| 1999-20 | Detection of clonazepam and 7-aminoclonazepam in hair and urine | Negrusz | Adam |
| 1999-18 | Clozapine and neuroendocrine dysfunction in schizophrenia | Goldman | Morris |
| 1999-15 | Interferon resistance in African-Americans with HCV | Layden | Thomas J |
| 1999-14 | TSH receptor autoimmunity in thyroid disease | Prabhakar | Bellur |
| 1999-12 | Compliance to home-based vs community-based exercise program | Rimmer | James H |
| 1999-11 | Radiation-induced thyroid cancer: susceptibility factors | Schneider | Arthur B |
| 1999-10 | Hyperglycemia and collagen metabolism in man | Brodsky | Irwin G |
| 1999-08 | Natural history of ultrasound-detected radiation-induced thyroid neoplasms | Schneider | Arthur B |
| 1999-04 | Carbohydrate craving: Behavioral and psychological features | Spring | Bonnie |
| 1999-03 | Resistance exercise training in younger adults with type 2 DM | Quinn | Lauretta |
| 1999-02 | Pharmacokinetic study of lycopene in healthy male volunteers | Sosman | Jeffrey A |
| 1998-21 | Atypical and early onset Type 2 DM in minority children | Lipton | Rebecca B |
| 1998-20 | Diamond study subproject on complications of IDDM | Lipton | Rebecca B |
| 1998-18 | Fluoxetine as a quit smoking aid for depression-prone smokers | Spring | Bonnie |
| 1998-17 | Milk availability and lactation status in mothers of preterm & term infants | Hill | Pamela D |
| 1998-12 | Human hematopoietic stem cell and gene therapy/Cytokine regulation of human eosinophil proteins | Ackerman | Steven |
| 1998-11 | Molecular biology and functions of eosinophil proteins | Ackerman | Steven J |
| 1998-10 | Phosphorylation of myocardial proteins in diabetic cardiomyopathy | Buttrick | Peter M |
| 1998-06 | Interferon Aalfacon-1 induction regimens vs. standard regimen in HCV | Layden | Thomas J |
| 1998-04 | Mechanism of neuroendocrine defects in schizophrenia | Goldman | Morris |
| 1998-03 | DNA oxidation prevention with lycopene | van Breemen | Richard B |
| 1998-02 | Serotonin receptors and suicidal ideation | Pandey | Ghanshyam N |
| 1998-01 | Center on health promotion research for persons with disabilities | Rimmer | James H |
| 1997-12 | A nursing study of sleep and fibromyalgia in mid-life women | Shaver | Joan |
| 1997-08 | Etiology and hormonal criteria of 3B-HSD deficiency disorder | Pang | Songya |
| 1997-07 | Glucocorticoid feedback in polydipsic hyponatremic schizophrenics | Goldman | Morris |
| 1997-06 | Validity of insulin sensitivity estimates in obese subjects with NIDDM | Quinn | Lauretta |
| 1997-03 | Cooperative clinical trails in adult transplantation | Lash | James P |
| 1996-05 | Age-associated alterations in human "natural killer" cell system | Krishnaraj | Rajabather |
| 1996-04 | Diabetes Prevention Trial I | Brodsky | Irwin G |
| 1995-10 | Inspiratory muscle strength in COPD | Larson | Janet |
| 1995-08 | African-American study of kidney disease and HTN | Lash | James P |
| 1994-08 | Nutritional modification and protein synthesis in IDDM | Brodsky | Irwin G |
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