CLINICAL INVESTIGATIONS THE C.O.S.M.I.C. TRIAL"Comparative outcomes study of Metformin intervention vs. conventional approach". BRISTOL MEYERS SQUIBB Cosmic approach. Protocol #cv138-002. Investigator: Nicoleau, A., 1996. P.R.O.T.E.C.T. Study: "Effect of Acarbose on post prandial glucose and the lowering of hemoglobin A1c. Investigator: Nicoleau, A. Bayer Corporation #2670, 1996. PAIN RELIEF STUDY: To evaluate the abuse potential of Ultram, a new unscheduled analgesic for the treatment of chronic pain. Gordon S. Black Corporation. Principal Investigator: Edgar H. Adams, SC.D. # 2371, 1997. R.E.A.C.H.: Rezulin Achieves Glycemic Control; a Multicenter 24-week, Open-Label, Dose Escalation Trial of Rezulin in Combination with insulin or Sulfonylurea in Type 2 Diabetes Mellitus Patients. PARKE DAVIS. 1998 PROTOCOL 991-141 P.O.W.E.R. TRIAL: Prospective Observation with Effectiveness of Ramipril. A nationwide community-based study on ACE inhibitor (Ramipril) versus an angiotensin II inhibitor (losartan). 1998 PROTOCOL # HOE 498/R021 COMMUNITY RESPIRATORY TRACT MICROSURVEILLANCE STUDY. BRISTOL MEYERS SQUIBB. Frequency of occurrence of bacterial causes of respiratory tract infections presenting in doctors offices. Consecutive sampling over a six month period July 1999-dec1999 TEQUIN STUDY. An open-label, multicenter non-comparative study of oral Gatifloxacin in the treatment of community-acquired respiratory tract infections (acute bacterial exacerbation of chronic bronchitis. acute uncomplicated maxillary sinusitis, and pneumonia). BRISTOL-MEYERS-SQUIBB, protocol AI420-088.Feb 2000 April 2000. COHERE. The Coreg Heart Failure Registry. SMITHKLINE BEECHAM.Site number 411.ID 757530.1998- 2000. S.M.A.R.T. trial. (Salmeterol Multicenter Asthma Research Trial) GLAXO-WELCOME Protocol SLGA5011, 2000.A double blind, randomized, placebo-controlled surveillance study of asthma event outcomes in subjects receiving either usual pharmacotherapy of asthma or usual pharmacotherapy plus salmeterol 42 mcg (2puffs) twice daily. T.R.E.A.T. (Telithromycin Respiratory Effectiveness Assessment Trial) AVENTIS PHARMACEUTICAL, protocol HMR3647A/3014 TELITHOMYCIN.January 2002.Randomized, Open-label, Multicenter trial of the safety of oral Telithomycin (KETEC) and Amoxicillin/Clavulonic acid (AUGMENTIN) in outpatients with respiratory tract infections in usual care settings. G.O.A.L. A1C. AVENTIS .protocol HOE 901-4033.Glycemia Optimization with Algorithms and Labs At po1nt of Care. Laboratory testing of hemoglobin A1c and intenseVsStandard monitoring of titration algorithm adherence on glycemic control in type 2 diabetes subjects, who are inadequately controlled on oral anti-hyperglycemic therapy, and starting LANTUS (insulin glargine injection). November 2002. E.X.P.R.E.S.S. EVALUATING PATIENT RESPONSE, EDUCATION, SAFETY AND SATISFACTION.BAYER MARCH 2003.Open-label, non- comparative, multicenter study with sites randomized to receive enrollment kits with or without educational brochures for patients. All patients completed an initial survey, took the study medication for three days, and completed a second survey post-treatment. Patient knowledge of UTI, its treatment, prevention and risk factors were assessed.
R.E.A.L.I.S.E.Real Life Safety and Efficacy. A post-marketing surveillance study on LEVITRA (VARDENAFIL) study number 100477 October 2003.Bayer pharmaceutical corporation. G.0.T. Glycemia Optimization Treatment: To assess the safety of glucose control as measured by the frequency of severe hypoglycemia events using dosing algorithms based on different fasting blood glucose goals with LANTUS (insulin glargine) in adult individuals with type 2 diabetes who have not achieved the target A1c goal of <7% with oral hypoglycemia agents: A randomized, open label, parallel-design trial. Protocol number HOE 901/4045.Aventis Pharmaceuticals. March 2004 BIBLIOGRAPHY Contributor and Reviewer, Geriatrics Certification and Recertification Examination 1997 (American Board of Internal Medicine). Osler-Weber-Rendu Disease (Hereditary Hemorrhagic Telangiectasia) “Images in Clinical Medicine." (New England Journal of Medicine) Aryel Nicoleau, M.D. and Carl A. Nicoleau, M.D., Ph.D. June 10 1999 vol 340 number 23 p1800 Aryel Nicoleau, M.D., Antihypertensive Medication (Journal of the American Geriatrics Society) June 1998, VOL 46 791-792
Contributor and Reviewer, Geriatrics Certification Examination 1998 (American Board of Internal Medicine) Aryel Nicoleau, M.D., Barry Kaplan, M.D., Ph.D., Jean D. Balzora, M.D. Hemoglobin SC & Multiple Myeloma. (American Journal of Hematology) March 1999 vol60 250-251(A 62-year-old female with hemoglobin SC and Multiple Myeloma - one of eight cases in the current literature!) Case discussion and review. Reviewer, Geriatrics Certification Exam in 2000, (American board of Internal Medicine). Aryel Nicoleau, M.D.Carl A. Nicoleau, M.D., PhD, Jean D. Balzora M.D. Subclinical Hypothyroidism in a biethnic population. Journal of the American Geriatrics Society. February 2000, vol.48, p233. Abstract Grading Consultant ISHIB 2000 (International Society for Hypertension In Blacks.) Puerto Rico July 2000. Elderly African Americans and the influenza vaccine: The impact of the primary care physician. Aryel Nicoleau, M.D., Carl A. Nicoleau M.D., Ph.D., Jean Balzora, M.D., Aruoriwo Oboh, M.D., Naushin Siddiqui, M.D., Carl Rosenberg, Ph.D.Journal of the American Medical Directors Association.2001; 2:p56-59. Reviewer and contributor, Geriatrics Certification exam 2001, (American board of Internal Medicine). COREG HEART FAILURE REGISTRY (COHERE): CHARACTERISTICS OF PARTICIPATING PHYSICIANS, THEIR PATIENTS, AND DOSE-TITRATION EXPERIENCE. Joseph A Franciosa.William T Abraham, Michael Fowler, Edward M Gilbert, Barry Greenberg, Barry M Massie, Mary Ann Lukas, Jeanenne J Nelson and the COHERE PARTICIPATING PHYSICIANS.Abstract presented at the HEART FAILURE SOCIETY OF AMERICA (HFSA) ANAHEIM, NOVEMBER 2001.
CARVEDILOL INITIATION BY COMMUNITY PHYSICIANS IN COHERE: COMPARISON WITH U.S.CARVEDILOL TRIALS AND COMPASSIONATE USE PROTOCOLS.Barry M Masse, Barry Greenberg, Edward M Gilbert, Michael Fowler, William T Abraham, Joseph A Franciosa, Mary Ann Lukas, Jeanenne J Nelson and the COHERE PARTICIPATING PHYSICIANS.Abstract presented at the AMERICAN COLLEGE OF CARDIOLOGY, ATLANTA, march 2002. Aryel Nicoleau, M.D., Jean D.Balzora, M.D., Mohammed Chowdhury, M.D., Daisy Saw, M.D., Michel Nussbaum, M.D., Daniel Lorber, M.D.: Flatulence and carpopedal spasm: more than social embarrassment. An unusual but interesting presentation of celiac sprue in a 61-year-old female. Quaterly Journal of Medicine 2004; 97:105-106 Beta-Blocker therapy for heart failure outside the clinical trial setting: Findings of a community-based registry. Joseph A.Franciosa, M.D., Barry M. Massie, M.D., Mary Ann Lukas, M.D., Jeanenne J. Nelson, Ph D., Sandra Lottes, PharmD, William T. Abraham, M.D., Michael Fowler, M.D., Edward M. Gilbert, M.D., and Barry Greenberg, M.D., for the COHERE participant physicians. American Heart Journal 2004; 148:718-26 Abstract grading consultant ISHIB 2007(International Society for Hypertension in Blacks) Florida June 2007 Extra-adrenal pheochromocytoma twelve years in the making. Internal medicine journal Aryel Nicoleau,M.D.,Steven Siskind,M.D.,Christine Resta,M.D.,James Turner,M.D,Moora Noordhoorn,M.D.,Daisy Saw,M.D.Internal Medicine Journal 2008; 38:8-69
MINUTES OF THE 137th MEETING OF THE THERAPEUTIC ADVISORY SERVICE Held on Tuesday, 26th February 2013 Apologies: Prof I Squire, Ms C Clarke, Dr L Dabydeen, Mr P Golightly, Dr P Topham, Dr A Palfreeman, Mr M Qualie, Dr B Collett, Ms L Gant, Mr D Harris, Ms J Islam, Mrs S Khalid 1 Minutes of last Meeting Dr N Langford and Ms B Pattani attended, with these additions Minutes