83 results match your criteria: "P.R.K.; and Jefferson Medical College[Affiliation]"

SARS-CoV-2 Variants and Vaccines.

N Engl J Med

July 2021

From the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (P.R.K., M.G.); the Department of Biostatistics, University of Washington, Seattle (T.R.F.); the Department of Biostatistics, University of Florida, Gainesville (I.M.L.); the Nuffield Department of Population Health, University of Oxford (R.P., V.B.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), Oxford, and the Global Health Programme, Chatham House (D.L.H.), and the Coalition for Epidemic Preparedness Innovations (J.P.C.), London - all in the United Kingdom; the Howard College School of Law, University of KwaZulu-Natal, Durban (J.A.S.), and the Wits Reproductive Health and HIV Institute, Johannesburg (H.R.) - both in South Africa; the Dalla Lana School of Public Health, University of Toronto, Toronto (J.A.S.); the Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv, Israel (R.D.B.); the Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany (C.M.-F.); the World Health Organization Collaborating Centre for Reference and Research on Influenza, Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia (K.S.); and the World Health Organization, Geneva (S.B., A.-M.R., R.G., M.D.V.K., S.S., M.J.R., A.-M.H.-R.).

Viral variants of concern may emerge with dangerous resistance to the immunity generated by the current vaccines to prevent coronavirus disease 2019 (Covid-19). Moreover, if some variants of concern have increased transmissibility or virulence, the importance of efficient public health measures and vaccination programs will increase. The global response must be both timely and science based.

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Foslevodopa/Foscarbidopa: A New Subcutaneous Treatment for Parkinson's Disease.

Ann Neurol

July 2021

Discovery Centralized Medicinal Chemistry, AbbVie Inc., North Chicago, IL.

Objective: The aim was to demonstrate that continuous s.c. infusion of a soluble levodopa (LD)/carbidopa (CD) phosphate prodrug combination effectively delivers stable LD exposure via a minimally invasive and convenient mode and has the potential to treat Parkinson's disease (PD) patients who are not well controlled on oral medication.

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Objective: Pulse wave analysis estimates arterial wave reflections relating to left ventricular dysfunction and cardiovascular event risk in adults. Forward and backward waves (Pf and Pb) may improve risk stratification for cardiovascular events. Data in youth are lacking.

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Identification of a Variant in a Family With Arrhythmogenic Cardiomyopathy and Left Ventricular Fibrosis.

Circ Genom Precis Med

February 2021

Cardiovascular Genetics Laboratory, Department of Medicine, Hatter Institute for Cardiovascular Research in Africa, University of Cape Town, South Africa (T.F.S., S.K., Z.B., N.A.B.N., G.S.).

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Placebo-Controlled Trials of Covid-19 Vaccines - Why We Still Need Them.

N Engl J Med

January 2021

The affiliations of the members of the WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation are the Office of Vaccines Research and Review, Food and Drug Administration, Silver Spring (P.R.K.), the School of Medicine, University of Maryland (M.M.L.), and Johns Hopkins University (S.P.), Baltimore, and the National Institute of Allergy and Infectious Diseases, Bethesda (M.N.) - all in Maryland; the Department of Biostatistics (T.R.F.), Fred Hutchinson Cancer Research Center (T.R.F., E.H.), University of Washington, Seattle; the Department of Biostatistics, University of Florida, Gainesville (I.M.L.); the Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (R.P., V.B.); the Indian Council of Medical Research, New Delhi (B.B.); the Faculty of Medicine of the Universidad Nacional Autónoma de México, Mexico City (A.C.); the Coalition for Epidemic Preparedness Innovations, London (J.P.C.); the University of Pennsylvania, Philadelphia (S.S.E., S.P.); the University of the West Indies, Kingston, Jamaica (J.P.F.); the World Health Organization, Geneva (A.M.H.-R., M.J.R., S.S.); the Department of Health Security, Finnish Institute for Health and Welfare, Helsinki (H.M.N.);and the Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg (H.R.), and the Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban (J.S.) - both in South Africa.

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This randomized control trial assessed the post-intervention and 18-month follow-up effects of a 6-month dietary approaches to stop hypertension (DASH)-focused behavioral nutrition intervention, initiated in clinic with subsequent telephone and mail contact, on blood pressure (BP) and endothelial function in adolescents with elevated BP. Adolescents (n=159) 11 to 18 years of age with newly diagnosed elevated BP or stage 1 hypertension treated at a hospital-based clinic were randomized. DASH participants received a take-home manual plus 2 face-to-face counseling sessions at baseline and 3 months with a dietitian regarding the DASH diet, 6 monthly mailings, and 8 weekly and then 7 biweekly telephone calls focused on behavioral strategies to promote DASH adherence.

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The Effect of Simulated Visual Field Loss on Optokinetic Nystagmus.

Transl Vis Sci Technol

February 2020

School of Optometry & Vision Science, University of Auckland, Auckland, New Zealand.

Purpose: Assessment of functional vision across the visual field is hampered by a reliance on patients' subjective judgement of the presence of a stimulus, and the accompanying demands (time and attention) this places on them. As a first step toward determining whether an objective measure of an involuntary eye movement (optokinetic nystagmus [OKN]) could provide an objective measure of field loss, we determined how various measures of OKN depend on the extent of simulated visual field loss (SVFL).

Methods: We used infrared eye-tracking to measure the eye movements of 16 healthy participants viewing horizontally translating 2-dimensional noise patterns over trials of varying contrasts and different levels of SVFL.

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Background: Patients with atrial fibrillation on oral anticoagulation (OAC) undergoing cardiac catheterization face risks for embolic and bleeding events, yet information on strategies to mitigate these risks in contemporary practice is lacking.

Methods: We aimed to describe the clinical/procedural characteristics of a contemporary cohort of patients with atrial fibrillation on OAC who underwent cardiac catheterization. Use of bleeding avoidance strategies and bridging therapy were described and outcomes including death, stroke, and major bleeding at 30 days and 1 year were compared by OAC type.

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Background: Atrial fibrillation (AF) adversely impacts health-related quality of life (hrQoL). While some patients demonstrate improvements in hrQoL, the factors associated with large improvements in hrQoL are not well described.

Methods: We assessed factors associated with a 1-year increase in the Atrial Fibrillation Effect on Quality-of-Life score of 1 SD (≥18 points; 3× clinically important difference), among outpatients in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation I registry.

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Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.

N Engl J Med

April 2020

From the Department of Biostatistics, University of Florida, Gainesville (N.E.D., I.M.L.); the World Health Organization, Geneva (P.-S.G., A.M.H.-R.); the Department of Biostatistics, University of California, Los Angeles (R.B.); the Department of Biostatistics, Yale University, New Haven, CT (F.W.C.); the Department of Statistics (C.A.D.) and the Centre for Tropical Medicine and Global Health (P.H.), University of Oxford, Oxford, the Medical Research Council (MRC) Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London (C.A.D.), and the MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine (P.G.S.), London, and the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.) - all in the United Kingdom; the Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (S.S.E.); the Department of Biostatistics, University of Washington (T.R.F., M.E.H.), and the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (M.E.H.) - both in Seattle; the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring (P.R.K.), and the Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda (M.C.N.) - both in Maryland; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of Congo (S.M., J.-J.M.-T.); and the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute (R.W.), and the Department of Biostatistics, Harvard T.H. Chan School of Public Health (R.W., V.D.G.) - both in Boston.

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Background: The role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established.

Hypothesis: We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone.

Methods: We assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post-ablation, based on a post hoc analysis of the ATHENA study.

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Background: Studies evaluating the effects of atrial fibrillation (AF) catheter ablation versus antiarrhythmic therapy on outcomes have shown mixed results. In addition, guidelines recommend continuing oral anticoagulation (OAC) after ablation for those at risk of stroke, but real-world data are lacking.

Methods: We evaluated outcomes including death, myocardial infarction, stroke or systemic embolism, intracranial bleeding, major bleeding, and hospitalization in patients undergoing AF ablation compared with a propensity score matched cohort of patients treated with anti-arrhythmic medications only in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation registries.

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Biological Characterization of F508delCFTR Protein Processing by the CFTR Corrector ABBV-2222/GLPG2222.

J Pharmacol Exp Ther

January 2020

AbbVie Inc., iSAT, North Chicago, Illinois (A.K.S., Y.F., C.B., S.A., A.M.M., A.M.S., Y.J., T.R.N., T.A.V., B.L., X.B.S., X.W., W.G., P.R.K., C.T.); Dalton Cardiovascular Research Center, University of Missouri, Columbia, Missouri (T.-C.H.); Department of Cell Biology and University of North Carolina Cystic Fibrosis Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (H.Y.R., D.C.); and Galapagos NV, Mechelen, Belgium (K.C.).

Cystic fibrosis (CF) is the most common monogenic autosomal recessive disease in Caucasians caused by pathogenic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (). Significant small molecule therapeutic advances over the past two decades have been made to target the defective CFTR protein and enhance its function. To address the most prevalent defect of the defective CFTR protein (i.

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General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.

Clin Pharmacol Ther

January 2020

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration-sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session.

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Objective: High Lp(a) (lipoprotein[a]) cause cardiovascular disease (CVD) in a primary prevention setting; however, it is debated whether high Lp(a) lead to recurrent CVD events. We tested the latter hypothesis and estimated the Lp(a)-lowering needed for 5 years to reduce CVD events in a secondary prevention setting. Approach and Results: From the CGPS (Copenhagen General Population Study; 2003-2015) of 58 527 individuals with measurements of Lp(a), 2527 aged 20 to 79 with a history of CVD were studied.

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Background The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011.

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Blood pressure (BP) tracking (maintaining a BP percentile) across life is not well defined but is important in predicting which children will become hypertensive adults. We computed BP tracking in subjects with BP measured in childhood and adulthood and performed logistic regression to determine the ability of childhood BP to predict adult hypertension (N=5035, 46.7 years, 74.

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The recent study deals with the synthesis and characterization of silver nanoparticles bounded to Selaginella bryopteris (Sanjeevini) Plant extract (SPE) as reducing and capping agents. Selaginella bryopteris plant extract silver nanoparticles (SPE@Ag-NPs) was characterized by PXRD, UV-Vis., FESEM, TEM and EDX.

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Background and Purpose- Heme and iron are considered to be key factors responsible for secondary insults after intracerebral hemorrhage (ICH). Our previous study showed that LRP1 (low-density lipoprotein receptor-related protein-1)-Hx (hemopexin) facilitates removal of heme. The TLR7 (Toll-like receptor 7)-BTK (Bruton tyrosine kinase)-CRT (calreticulin) pathway regulates the expression of LRP1-Hx.

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A derivative of naphthaquinone, 2-((1,5-dimethyl-3-oxo-2-phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino)naphthalene-1,4-dione (DPDHN) was synthesized from lawsone by ultrasound accelerated technique. The compound was characterized by elemental analysis, IR, UV-vis, NMR and mass spectral studies. Single crystal X-ray diffraction studies revealed that the compound crystallized in monoclinic space group P2/c.

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Absence of Myocardial Fibrosis Predicts Favorable Long-Term Survival in New-Onset Heart Failure.

Circ Cardiovasc Imaging

September 2018

Royal Brompton Hospital, London, United Kingdom (A.G., S.R., B.P.H., N.A.I., K.M., J.K., C.S., P.R.K., J.G.F.C., M.R.C., R.G.A., D.J.P., S.K.P.).

Background: Myocardial fibrosis, identified by late gadolinium enhancement cardiovascular magnetic resonance, predicts outcomes in chronic heart failure (HF). Its prognostic significance in new-onset HF and reduced left ventricular ejection fraction (LVEF) is unclear. We investigated whether the pattern and extent of fibrosis predict survival in new-onset HF and reduced LVEF of initially uncertain pathogenesis.

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Background: Traditional continuous glucose monitoring (CGM) provides detailed information on glucose patterns and trends to inform daily diabetes management decisions, which is particularly beneficial for patients with a history of hypoglycemia unawareness. However, a high level of patient adherence (≥70%) is required to achieve clinical benefits. The aim of this study was to assess the impact of real-world patient nonadherence and early discontinuation on healthcare resource use.

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