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Springfield, OH, United States

Yilmaz Y.,Marmara University | Younossi Z.M.,Moore Research
Clinics in Liver Disease | Year: 2014

Obesity is strongly associated with the prevalence of nonalcoholic fatty liver disease (NAFLD) in adult and pediatric populations. Nutrition, physical activity, and behavioral modifications are critical components of the treatment regimen for all obese patients with NAFLD. Bariatric surgeries that affect or restrict the flow of food through the gastrointestinal tract may improve liver histology in morbidly obese patients with nonalcoholic steatohepatitis (NASH), although randomized clinical trials and quasi-randomized clinical studies are lacking. Early detection of NASH and hepatic fibrosis using noninvasive biochemical and imaging markers that may replace liver biopsy is the current challenge. © 2014 Elsevier Inc. Source


Tang L.,Moore Research | Thakuriah P.V.,University of Illinois at Chicago
Transportation Research Part C: Emerging Technologies | Year: 2012

In this paper, using longitudinal data on route level monthly average weekday ridership in the entire Chicago Transit Authority (CTA) bus system from January 2002 through December 2010, we evaluate the ridership effects of the CTA real-time bus information system. This bus information system is called CTA Bus Tracker and was incrementally implemented on different CTA bus routes from August 2006 to May 2009. To take account of other factors that might affect bus ridership, we also include data on unemployment levels, gas prices, local weather conditions, transit service attributes, and socioeconomic characteristics during the study period. This combined longitudinal data source enables us to implement a quasi-experimental design with statistical controls to examine changes in monthly average weekday ridership, before and after the Bus Tracker system was implemented, on each bus route. Based on a linear mixed model, we found that the provision of Bus Tracker service does increase CTA bus ridership, although the average increase is modest. Further, the study findings suggest that there are temporal variations of the ridership effects among the routes, with the " winning" routes more likely to have the technology implemented in the later phases of the overall " roll-out" period. However, the results are less conclusive regarding geographical variations in the effects of Bus Tracker. © 2012 Elsevier Ltd. Source


Donohue J.F.,University of North Carolina at Chapel Hill | Worsley S.,Respiratory Medicines Development Center | Zhu C.-Q.,GSK | Hardaker L.,Global Clinical Safety and Pharmacovigilance | Church A.,Moore Research
Respiratory Medicine | Year: 2015

Background Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year. Methods In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, dyspnea, quality of life (QoL) and safety. Results UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0-24 h wmFEV1 (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38-110; DB2114930) and 101 mL (63-139; DB2114951) (both p < 0.001). Trough FEV1 improvements were 82 mL (45-119) and 98 mL (59-137) (both p < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL. Conclusions Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL. Clinical trial registration DB2114930/NCT01817764; DB2114951/NCT01879410. © 2015 The Authors. Source


Rittmaster R.S.,Glaxosmithkline | Rittmaster R.S.,Moore Research
Acta Oncologica | Year: 2011

Over the past two decades, many more men are diagnosed with prostate cancer then die of the disease. This increase in diagnosis has led to aggressive treatment of indolent disease in many individuals and has been the impetus for finding a means of reducing the risk of prostate cancer. In the past decade, there have been eight large trials of prostate cancer risk reduction using dietary supplements, 5αα-reductase inhibitors, or anti-estrogens. The only two trials which have demonstrated efficacy are those involving 5αα-reductase inhibitors: the PCPT (finasteride) and REDUCE (dutasteride). This review examines prostate cancer risk reduction, with emphasis on conclusions that can be drawn from these two landmark studies. © 2011 Informa Healthcare. Source


Margolis D.A.,Moore Research | Boffito M.,St Stephens Center | Boffito M.,Imperial College London
Current Opinion in HIV and AIDS | Year: 2015

Purpose of review Long-acting antiretroviral (ARV) agents are currently under development for the treatment of chronic HIV infection. This review focuses on data recently produced on injectable ARVs for patients living with HIV/AIDS and on the patients' perspectives on the use of these agents. Recent findings Crystalline nanoparticle formulations of the nonnucleoside reverse transcriptase inhibitor rilpivirine (TMC278) and of the HIV-1 integrase strand transfer inhibitor cabotegravir (GSK1265744) have progressed into phase II clinical trials as injectable maintenance therapy for patients living with HIV/AIDS with an undetectable viral load. Summary Phase II studies evaluating the coadministration of rilpivirine and cabotegravir intramuscularly to HIVinfected individuals with an undetectable viral load are currently underway. Rilpivirine and cabotegravir are characterized by different mechanisms of action against HIV and a favorable drug interaction profile, providing a rationale for coadministration. The high potency and low daily dosing requirements of oral cabotegravir and rilpivirine facilitate long-acting formulation development. Intramuscular dosing is preceded by an oral lead-in phase to assess safety and tolerability in individual participants. In addition to assessing the safety of injectable therapies in ongoing studies, it will be important to evaluate whether differences in drug adherence between injectable and oral therapies lead to different virologic outcomes, including rates of virologic failure and the emergence of resistance. Long-acting formulations may be associated with challenges, such as the management of adverse effects with persistent drug concentrations and the risk of virologic resistance, as drug concentrations decline following discontinuation. © 2015 Wolters Kluwer Health, Inc. All rights reserved. Source

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