A Full-Service Clinical Research Organization

Surensky, S. Clinical and Data Management: A Time to Heal. Data Basics. 2016;22(3):7-10 [pdf]

Mangili A, Falutz J, Mamputu J-C, Stepanians M, Hayward B. Predictors of treatment response to tesamorelin, a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat. PLoS ONE 2015;10 (10): e0140358. doi:10.1371/journal.pone.0140358

Rodriguez F, Cannon CP, Steg PG, Kumbhani DJ, Goto S, Smith S, Eagle KA, Ohman EM, Umez-Eronini A, et al. Predictors of long-term adherence to evidence-based cardiovascular disease medications in outpatients with stable atherothrombotic disease: findings from the REACH registry. Clinical Cardiology. 2013;36(12):721-727.

Udel JA, Steg PG, Scirica BM, Eagle KA, Ohman EM, Goto S, Alsheikh-ali AA, Porath A, Corbalan R, Umez-Eronini A, et al. Metabolic syndrome, diabetes mellitus, or both and cardiovascular risk in outpatients with or at risk of atherothrombosis. European Journal of Preventive Cardiology. 2013;0(0):1-10.

Raz I, Bhatt DL, Hirshberg B, Mosenzon O, Scirica BM, Umez-Eronini A, et al. Incidence of pancreatitis and pancreatic cancer in a randomized controlled multicenter trial (SAVOR-TIMI 53) of the dipeptidyl peptidase-4 inhibitor saxagliptin. Diabetes Care. 2014;37(9):2435-2441.

Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini A, et al. Saxagliptin and cardiovascular outcomes in patients with Type 2 diabetes mellitus and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 trial. Diabetes Care, advance online publication. 2014;doi:10.2337/dc14-1850.

Nieminen T, Scirica BM, Pegler JR, Tavares C, Pagotto VP, Kanas AF, Sobrado MF, Nearing BD, Umez- Eronini AA, et al. Relation of t-wave alternans to mortality and nonsustainedventricular tachycardia in patients with non-st-segment elevation acute coronary syndrome from the MERLIN-TIMI 36 trial of ranolazine versus placebo. American Journal of Cardiology. 2014;114(1):17-23.

Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez- Eronini AA, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014;130(18):1579-1599.

Ruff C, Moryusef A, Umez-Eronini A, Hoffman E, Gaudin C, Antman E, et al. Evaluation of the efficacy and safety of otamixaban versus unfractionated heparin+eptifibatide in patients with non-st-elevation acute coronary syndromes by PCI in the SEPIA-ACS1 TIMI 42 trial. Journal of the American College of Cardiology. 2013;61(10_S):E103-E103.

Ruff C, Bhatt D, Ohman E, Eagle K, Alberts M, Wilson P, D'Agostino R, Umez-Eronini A, et al. Long-term risk and prognosis of recurrent cardiovascular events in the REACH registry. Journal of the American College of Cardiology. 2012;59(13s1):E1521-E1521.

Steen DL, Umez-Eronini A, Hoffman EB, Antman EM, Wiviott SD. Utilization of intensive lipid-lowering therapy after an acute coronary syndrome: insights from the Triton-TIMI 38 trial. Circulation. 2013;128(22):Suppl S.

Kato ET, Bhatt D, Steg PG, Im K, Umez-Eronini A, Goto S. Recurrent hospitalization due to heart failure in stable outpatients at risk of or with atherothrombosis. European Heart Journal. 2014;35:Suppl 1, 671.

Scirica BM, Braunwald E, Raz I, Mosenzon O, Cahn A, Lopez-Sendon J, Hirshberg B, Pollack PA, Steg P, Umez-Eronini A, et al. Saxagliptin in patients with prior heart failure - observations from the SAVOR- TIMI 53 trial. Diabetologia. 2014;57:Suppl 1, S86. O'Gorman J, 

Russell H, Li J, Phillips G, Hotermans C, Kurukulasuriya NC, Viglietta V. Effect of Aspirin pretreatment or slow dose titration on the incidence and severity of flushing and gastrointestinal events associated with BG-12 (dimethyl fumarate). Poster presented at: ECTRIMS Poster Session 1, “Treatment of Specific Symptoms”; October 3, 2013; Copenhagen, Denmark.

Russell H, O'Gorman J, Li J, Phillips G, Viglietta V. BG-12 (dimethyl fumarate) with aspirin pretreatment or slow dose titration. Disease Management, Mechanisms, and Treatment. 2013; May: Abstract DX52.

Dawson KT, Nestorov I, Manchanda R, Goldman D, O'Gorman J, Russell H, et al. Bioequivalence of BG-12 administered as a single 240 mg capsule and two 120 mg capsules: findings from a randomized, two-period crossover study. Poster presented as: ECTRIMS; October 12, 2012, Poster P913.

Sheikh S, Nestorov I, Russell H, O'Gorman J, Huang R, Milne G, et al. Safety, tolerability, and pharmacokinetics of BG-12 administered with and without aspirin: key findings from a randomized, double-blind, placebo-controlled trial in healthy volunteers. Neurology. 2012;78:P04.136.

Hayward B, Stanworth S, Stepanians M, Mangili A.  Predictors of prevalence and reduction of VAT in HIV-infected patients. Poster presented at:  The 14th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV; July 19-21, 2012; Washington, D.C.; Poster P012.

LaVallee NStepanians M. Hypothesis testing. Wiley Encyclopedia of Clinical Trials. Wiley Online Library, 2008.

Freedman M, Hughes B, Mikol D, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A. Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison.European Neurology. 2008;60(1):1-11.

Unverzagt FW, Kasten L, Johnson KE, Rebok GW, Marsiske M, Koepke KM, et al. Effect of memory impairment on training outcomes in ACTIVE. J Int Neuropsychol Soc. 2007;13(6):953-60.

Nelson H, Kemp J, Strek M, Berger W, Casale T, Dube L, Walten-Bowen K, LaVallee NStepanians M. The efficacy of zileuton controlled-release tablets administered twice daily in the treatment of moderate persistent asthma: a 3-month randomized controlled study. Annals of Allergy, Asthma and Immunology. 2007;(7):178-184.

Watkins PB, Maddrey WC, Schenker S, Dube LM, Walton-Bowen K, Cameron CM, Kasten L. Clinical pattern of zileuton-associated liver injury: results of a 12-month study in patients with chronic asthma. Drug Safety. 2007;30(9):805-815.

Wenzel S, Busse W, Calhoun W, Panettieri R, Peters-Golden M, Dube L, Walton-Bowen K, Russell HHarris J. The safety and efficacy of zileuton controlled-release (CR) tablets as adjunctive therapy to usual care (UC) in the treatment of moderate persistent asthma: a 6-Month randomized controlled study. J Asthma. 2007;44(4):305-10.

Traboulsee A, AL-Sabbagh A, Bennett R, Chang P, Glanzman R, Russell H, Li DKB. An analysis of 48-week data from the EVIDENCE study on MRI T2 burden of disease with subcutaneously-administered interferon beta-1a 44 mcg three-times-weekly than with interferon beta-1a 30 mcg administered intramuscularly once-weekly. Abstract submitted to: American Academy of Neurology, 59th Annual Meeting, 2007, Boston, Massachusetts.

Herbert J, Jakubowska-Sadowska JRussell HKasten L, Layer N, Glueck A, Fromm J, Del Bene M. The timed tandem walk as a measure of mild impairment in patients with multiple sclerosis. Poster presented at: 58th Annual Meeting of the American Academy of Neurology; April 1–8, 2006, San Diego,California.

Larson MJ, Zhang A, Smith K, Kasten L. Access to services: multiple perspectives from adults with substance abuse disorders in Massachusetts. Adm Policy Ment Health. 2005;32(4):357-71.

Krug N, Hohlfeld JM, Geldmacher H, Larbig M, Heermann R, LaVallee N, et al. Effect of ioteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit. Allergy. 2005;60(3):354-359.

Hermann R, Locher M, Siebert-Weigel M, LaVallee N, Derendorf H, Hochhaus G. Intranasal loteprednol etabonate in healthy male subjects: pharmacokinetics and effects on endogenous cortisol. Journal of Clinical Pharmacology. 2004;44:510-519.

Castaldo R, Celli B, Gomez F, LaVallee N, Souhrada J, Hanrahan J. A comparison of 5-day courses of dirithromycin and azithromycin in the Treatment of acute exacerbations of chronic obstructive pulmonary disease. Clinical Therapeutics. 2003;25(2):1-15.

Friedlaender M, Harris JLaVallee NRussell H, Shilstone J. Evaluation of the onset and duration of effect of azelastine eye drops (0.05%) versus placebo in patients with allergic conjunctivitis using an allergen challenge model. Opthalmology. 2000;107(12):2152-2157.

Martin R, Kraft M, Beaucher W, Kiechel F, Sublett J, LaVallee N, Shilstone J. Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma. Annals of Allergy, Asthma, & Immunology. 1999;83(2):121-126.

Sankoh AJ, Huque MF, Russell H, D’Agostino RB, Sr. Global two groups multiple endpoint adjustment methods applied to clinical trials. Drug Information Journal. 1999;33:119-140.

Rosenthal R, Berger W, Bronsky E, Dockhorn R, Korenblat P, Lampl K, Lumry W, Pollard S, Raphael G, Rohr C, Shapiro G, Valentine M, Wanderer A, Fleming L, LaVallee NStepanians M, et al. Tri-Nasal triamcinolone acetonide nasal spray 200 and 400 mcg qd versus placebo and Nasacort triamcinolone acetonide nasal aerosol 440 mcg qd in patients suffering from seasonal allergic rhinitis during the grass season. American Journal of Rhinology. 1998;12(6):427-433.

D’Agostino RB Sr, Weintraub M, Russell HStepanians M, D’Agostino RB Jr, Cantilena LR Jr, et al. The effectiveness of antihistamines in reducing the severity of runny nose and sneezing: a meta-analysis. Clinical Pharmacology & Therapeutics. 1998;64(6):79-596.

D’Agostino RB Sr, Russell H. Centroid method, factor analysis. Encyclopedia of Biostatistics. 1998;1:592-593.

D’Agostino RB Sr, Russell H. Cluster analysis, variables. Encyclopedia of Biostatistics. 1998;1:731-739.

D’Agostino RB Sr, Russell H. Cluster score. Encyclopedia of Biostatistics. 1998;1:746-747.

D’Agostino RB Sr, Russell H. Communality in factor analysis. Encyclopedia of Biostatistics. 1998; 1:794-795.

D’Agostino RB Sr, Russell H. Confirmatory factor analysis. Encyclopedia of Biostatistics. 1998; 1: 897-898.

D’Agostino RB Sr, Russell H. Factor. Encyclopedia of Biostatistics. 1998;2:1473-1474.

D’Agostino RB Sr, Russell H. Factor analysis, second order. Encyclopedia of Biostatistics. 1998;2:1482-1484.

D’Agostino RB Sr, Russell H. Factor loading matrix. Encyclopedia of Biostatistics. 1998;2:1484-1486.

D’Agostino RB Sr, Russell H. Factor scores. Encyclopedia of Biostatistics. 1998;2:1487-1488.

D’Agostino RB Sr, Russell H. Multiple endpoints, multivariate global tests. Encyclopedia of Biostatistics. 1998;4:2749-2762.

D’Agostino RB Sr, Russell H. Multiple endpoints, p level procedures. Encyclopedia of Biostatistics. 1998;4:2762-2772.

D’Agostino RB Sr, Russell H. Multivariate Bartlett test. Encyclopedia of Biostatistics. 1998;4: 2843-2844.

D’Agostino RB Sr, Russell H. Numerical taxonomy. Encyclopedia of Biostatistics. 1998;4: 3095.

D’Agostino RB Sr, Russell H. Primary factors, primary axes and reference vectors. Encyclopedia of Biostatistics. 1998;5:3503-3505.

D’Agostino RB Sr, Russell H. Scree test. Encyclopedia of Biostatistics. 1998;5:3975-3976.

D’Agostino RB Sr, Russell H. Simple structure. Encyclopedia of Biostatistics. 1998;5:4101-4102.

Kamada A, Wiener M, LaVallee N, Scott M, Selner J, Szefler S. A pharmacokinetic comparison of two oral liquid glucocorticoid formulations. Pharmacotherapy. 1997;17(2):353-356.

D’Agostino RB, Russell H. Measuring effectiveness: what to expect without a randomized control group. Medical Care. 1995;33:95-105.

Kashket S, Mengshoel KJ, Cancro L, Stepanians M, D'Agostino RB. Validation of the intraoral delta Ip system and use of the system to test the efficacy of Mentadent dentifrice. Journal of Clinical Dentistry. 1994;5:110-¬113.

Jones J, LaVallee N, Alman J, Sinclair C, Garcia R. Caries incidence in patients with dementia.Gerodontology. 1993;10(2):76-82.

D’Agostino RB, Massaro J, Russell H, Cabral H. Strategies for dealing with multiple treatment comparisons in confirmatory clinical trials. Drug Information Journal. 1993;27:625-641.

D'Agostino RB, Kannel WB, Stepanians MD'Agostino LC. Efficacy and tolerability of lovastatin in hypercholesterolemia in patients with systemic hypertension. The American Journal of Cardiology. 1993;71(1):82-7.

Stefos T, LaVallee N, Holden F. Fairness in prospective payment: a clustering approach. Health Services Research. 1992;27(2):239-261.

D'Agostino RB, Kannel WB, Stepanians M, D'Agostino LC. Efficacy and tolerability of lovastatin in hypercholesterolemic women. Clinical Therapeutics. 1992;14(3):390-5.

D'Agostino RB, Kannel WB, Stepanians M, D'Agostino LC. Efficacy and tolerability of lovastatin in elderly hypercholesterolemic patients. Clinical Therapeutics. 1992;14(1):68-76.

D'Agostino RB, Kannel WB, Stepanians M, D'Agostino LC. A comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia. The American Journal of Cardiology. 1992;69(1):28-34.

Kannel WB, D'Agostino RB, Stepanians M, D'Agostino LC. Efficacy and tolerability of lovastatin in a six-month study: analysis by gender, age and hypertensive status. The American Journal of Cardiology. 1990;66(8):1B-10B.

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