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Clinical Trials and Open Protocols

Currently the Health System is participating in 55 clinical studies.

Cardiology
Boffetti, Paul, MD
SNHMC IRB
  • Treatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome
Schwartz, Steven, MD
SNHMC IRB
  • A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) who are medically managed-the TRILOGY ACS study
  • Double-blind, randomized placebo-controlled study, to evaluate the effects of R04607381 (Dalcetrapib) on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS)
Central IRB
  • A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction
  • BRADYCARE Advanced BRADYCARdia Device Feature Utilization and Clinical Outcomes
  • A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients with Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).
Colon and Rectal Surgery
Friel, John, MD
Central IRB
  • Previstage GCC for Colorectal Cancer Staging and Prognosis
Dermatology
Posnick, Robert, MD
SNHMC IRB
  • Observational Post Marketing Safety Surveillance Registry of Enbrel (Etanercept) for the Treatment of Psoriasis
  • A Multicenter, Open Registry of Patients with Psoriasis Who Are Candidates for Systemic Therapy Including Biologics (PSOLAR)
  • ESPRIT: A 10 year, Post-Marketing, Observational, Registry of HUMIRA in Adult Patients with Chronic Plague Psoriasis
Endocrinology
Silver, Robert, MD
Central IRB
  • The Impact of LY2189265 versus Insulin Glargine Both in Combination with Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly Administration of LY2189265 in Diabetes-4)
  • A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
  • The Impact of LY2189265 versus Metformin on Glycemic Control In Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly Administration of LY2189265 in Diabetes-3)
  • Dual Action of Liraglutide and insulin degludec in type 2 diabetes; A trial comparing the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in subjects with type 2 diabetes; A 26 week randomised, parallel three-arm, open-label, multi-center, multinational treat-to-target trial comparing fixed ratio combination of insulin degludec and liraglutide versus insulin degludec or liraglutide alone, in subjects with type 2 diabetes treated with 1-2 oral anti-diabetic drugs (OADs) Phase: Phase IIIb
  • A prospective, randomized, open-label comparison of a long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult patients with Type 1 Diabetes Mellitus: The ELEMENT 1 Study
  • A prospective, randomized, double-blind comparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patients with Type 2 Diabetes Mellitus: The ELEMENT 2 Study
  • An Open Label, Randomized Comparison of the Immunogenicity Safety of Wockhardt’s Insulin analogue Glargine (Glaritus) with Sanofi Aventis’ Insulin analogue Glargine (Lantus) in Type 1 diabetic patients 
  • A comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination with Oral Anti-HyperGlycemia Medications in Insulin Naïve Type 2 diabetes Mellitus:  A Double-Blind, Randomizzed Study:  The IMAGINE 2 Study  Phase:  III
  • An evaluation of the Burden of Illness among Adults in the US with Peripheral and Central Neuropathic Pain
  • The Impact of LY2605541 versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Insulin Lispro:  a Double-Blind, Randomized, 26 week study the IMAGINE 4 Study
  • The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro:  a Double-Blind, Randomized, 52 week study the IMAGINE 3 Study
  • LEADER Liraglutide Effect and Action in Diabetes:  Evaluation of cardiovascular outcome results.  A long-term, multi-center, international, randomized, double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events.

  • II A Trial comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec in subjects with type 2 diabetes.  A 26 week randomized, parallel two-arm, double-blind, multi-center, multinational, treat-to-target comparing fixed ratio combination of insulin degludec and liraglutide with insulin degudec in subjects with type 2 diabetes.

  • Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

  • Validation of the Diabetic Peripheral Neurophathic Pain Impact Measure: A Patient reported outcome measure of the Impact of SPNP on Functioning

  • A Comparison of LY2605541 versus Insulin Glargine Alone or in Combination with Pre study Oral Antihyperglycemic Medications in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin: An Open Label, Randomized Study The IMAGINE 5 Study 
     

Foundation and Trauma Surgery
Gupta, Sanjay, MD
SNHMC IRB

  • Non-operative Management of Grade IV and V Blunt Renal Injuries: A ReCONECT (Research Consortium of New England Center for Trauma) study

Foundation Hematology / Oncology
Browne, Marcia, MD
SNHMC IRB

  • Phase II placebo-controlled trial of lisinopril and Coreg CR to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin)
  • Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

Hakimian, Roger, MD
SNHMC IRB
  • A Randomized, Phase III Study of Standard Dosing versus Longer dosing Interval of Zoledronic Acid in Metastatic Cancer
  • The Men’s Eating and Living (MEAL) Study:  A randomized trial of diet to alter disease progression in prostate cancer on active surveillance
Central IRB
  • Prospective study to investigate the relationship between physician-assessed Febrile Neutopenia (FN) risk probability score and prediction tool FN risk probability score for patients with non-myeloid malignancies
Rao, Gautami, MD
SNHMC IRB
  • Observational Cohort Study: Chemotherapy decisions and outcomes in women age 65 or older with operable, newly diagnosed breast cancer
  • Phase III randomized clinical trial of standard adjuvant endocrine therapy+/-chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2-negative breast Cancer with recurrence score (RS) of 25 or less
Gastroenterology
Elvanides, Harry , MD
Central IRB
  • A non-interventional long term post-marketing registry of patients treated with Certolizumab Pegol (Cimzia) for Crohn's Disease

Humanitarian Device Exemption
Boffetti, Paul, MD
SNHMC IRB
  • Jostent GraftMaster stent for treatment of perforation as defined as free contrast extravasation in the pericardium, native coronary vessels or saphenous vein grafts greater than 2.75mm in diameter
Infectious Disease
Granok, Alexander, MD
SNHMC IRB
  • Treatment of Chagas disease using benznidazole (Radanil)
Larmouth, Janice
SNHMC IRB
  • PAICAP:  Preventing Avoidable Infectious Complications by Adjusting Payment
Laboratory
Rooney, George
SNHMC IRB
  • Epidemiology on Non-Melanoma Skin Cancer in New Hampshire

Neonatology
Hermansen, Marcus, MD
SNHMC IRB
  • Pregnancy Health Interview Study (formerly the Birth Defects Study)
Neurosurgery of Southern New Hampshire
Fleischer, Gary MD
SNHMC IRB
  • Analysis of bioactivity and progenitor cell composition of bone marrow aspirates
  • Review of neuropraxia incidence in direct lateral approach anterior spine fusion patients
Nursing
Fetzer, Susan
SNHMC IRB
  • Graduated elastic Compression Stockings: Do patients receive the correct sizes?

Pediatrics
Fredenburg, David, MD
SNHMC IRB

  • Parent's Perception of Children's Weight and Height and Lifestyle/Habit Factors Affecting Children's Weights
Plastic Surgery
Chatson, George, MD
SNHMC IRB
  • MentorGel Implant PAS (Post Approval Study)
Radiology
Levine, Matthew , MD
SNHMC IRB
  • Radiation Protection in the Era of Helical CT
Rheumatology
Gorman, John, MD
SNHMC IRB
  • RALLY:  National Data Bank (NDB) for Rheumatic Disease
Central IRB
  • A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept versus Subcutaneous Adalimumab, Both with Background Methotrexate, in Biologic-Naive Subjects with Rheumatoid Arthritis
  • A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Rsponse to one or more TNF-a-Inhibitors.
  • A Phase 4, Mulit-center, Randomized, 52-Week Study to Evaluate the Routine Assessment of Patient Index Data (RAPID3) Compared to the Clinical Disease Activity Index (CDAI) to Prospectively Predict Treatment Success at 52 Weeks Based on a Treatment Decision at Week 12 in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Certolizumab Pegol (CZP)
  • A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)
  • Evaluation of Acterma Risk Evaluation and Mitigation Strategy (REMS) Communication Program
  • A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
  • Long Term Allopurinal Safety Study Evaluating Outcomes in Gout Patients
Contact the IRB
Lisa A. Bonneau, MSED
Institutional Review Board Administrator
Human Protections Administrator
Southern New Hampshire Medical Center IRB
8 Prospect St.
PO Box 2014
Nashua, NH 03061-2014
Office: 603-577-2963
Fax: 603-577-2772
Lisa.Bonneau@snhmc.org


Learn About the Institutional Review Board
The primary responsibility of the IRB is to protect the rights and welfare of human research subjects involved in medical and health related research studies.



2012 IRB Meetings
Noon - 1:30pm
8 Prospect St.
Nashua Room
Nashua, NH

Submission Deadlines and Meeting Dates
1/14/12 for 1/18/12
2/1/12 for 2/15/12
3/7/12 for 3/21/12
4/4/12 for 4/18/12
5/2/12 for 5/16/12
6/6/12 for 6/20/12
7/4/12 for 7/18/12
8/29/12 for 9/12/12*
10/3/12 for 10/17/12
11/14/12 for 11/28/12

*9/12/12 Pelham Room 
2014 © Copyright Southern New Hampshire Health System, 8 Prospect St., Nashua, NH 03060
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