PubMed Journals Articles About "Dorian Regulatory Affairs" RSS

17:48 EDT 20th October 2017 | BioPortfolio

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Showing "Dorian Regulatory Affairs" PubMed Articles 1–25 of 3,300+

Pharmacovigilance in Russia: current state-of-affairs, challenges, and prospects.

The review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and in Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers...

Patient ratings of Veterans Affairs and affiliated hospitals.

Hospital Compare, a website maintained by CMS, allows comparisons of outcomes and processes of care but not of patient satisfaction for hospitals within the Veteran Affairs (VA) Healthcare System. Therefore, we sought to compare online hospital ratings between VA hospitals and their local affiliated hospitals.

"Where's My Choice?" An Examination of Veteran and Provider Experiences With Hepatitis C Treatment Through the Veteran Affairs Choice Program.

The Department of Veterans Affairs (VA) is the country's largest provider for chronic hepatitis C virus (HCV) infection. The VA created the Choice Program, which allows eligible veterans to seek care from community providers, who are reimbursed by the VA.

Medical providers' knowledge and concerns about opioid overdose education and take-home naloxone rescue kits within Veterans Affairs health care medical treatment settings.

Overdose from opioids is a serious public health and clinical concern. Veterans are at increased risk for opioid overdose compared with the civilian population, suggesting the need for enhanced efforts to address overdose prevention in Department of Veterans Affairs (VA) health care settings, such as primary care clinics.

Validity of code based algorithms to identify primary open angle glaucoma (POAG) in Veterans Affairs (VA) administrative databases.

The validity of the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9) code for primary open angle glaucoma (POAG) in the Department of Veterans Affairs (VA) electronic medical record has not been examined. We determined the accuracy of the ICD-9 code for POAG and developed diagnostic algorithms for the detection of POAG.

Regulatory Fit Improves Fitness for People With Low Exercise Experience.

Considering only 20.8% of American adults meet current physical activity recommendations, it is important to examine the psychological processes that affect exercise motivation and behavior. Drawing from regulatory fit theory, this study examined how manipulating regulatory focus and reward structures would affect exercise performance, with a specific interest in investigating whether exercise experience would moderate regulatory fit effects. We predicted that regulatory fit effects would appear only for pa...

Comparison of Drug Benefits Provided by Veterans Affairs Canada and the Canadian Forces Health Services Group.

Drug benefits are provided at public expense to all actively serving Canadian Armed Forces (CAF) personnel, with ongoing drug coverage offered by Veterans Affairs Canada (VAC) for selected conditions following termination of employment. Differences in drug coverage between these programs could introduce risks for treatment disruption.

Trends in hysterectomy rates among women veterans in the United States Department of Veterans Affairs.

Prior studies demonstrate higher prevalence of hysterectomy among veterans compared to non-veterans. While studies identify overall decreasing hysterectomy rates in the US, none report rates of hysterectomy among women veterans. Given the increasing numbers of women veterans using Veterans Affairs (VA) healthcare, there is an ongoing need to ensure high quality gynecology care. Therefore, it is important to examine current hysterectomy trends, including proportion of minimally invasive surgeries, among vete...

Fit for purpose and modern validity theory in clinical outcomes assessment.

The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is "fit for purpose" when used in clinical trials to support drug approval and product labeling. In this paper, we will provide a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred t...

Opioid Therapy for Chronic Pain: Overview of the 2017 US Department of Veterans Affairs and US Department of Defense Clinical Practice Guideline.

The US Department of Veterans Affairs (VA) and US Department of Defense (DoD) revised the 2010 clinical practice guideline (CPG) for the management of opioid therapy for chronic pain, considering the specific needs of the VA and DoD and new evidence regarding prescribing opioid medication for non-end-of-life-related chronic pain. This paper summarizes the major recommendations and compares them with the US Centers for Disease Control and Prevention (CDC) guideline for prescribing opioids.

Epidemiology and Burden of Influenza in the U.S. Department of Veterans Affairs.

We describe influenza activity in the US Veterans Affairs (VA) population for the 2010-2011 through 2015-2016 seasons and compare with national CDC FluView data. VA confirmed influenza cases ranged from 1,005-11,506 per season; triage calls from 6,090-10,346; outpatient visits from 3,849-13,406; antiviral prescriptions from 3,650-32,826; hospitalizations from 546-4,673; and deaths in hospitalized patients from 17-139. Peak activity was generally the same as observed nationally by the CDC. For the seasons an...

Characterization of noncoding regulatory DNA in the human genome.

Genetic variants associated with common diseases are usually located in noncoding parts of the human genome. Delineation of the full repertoire of functional noncoding elements, together with efficient methods for probing their biological roles, is therefore of crucial importance. Over the past decade, DNA accessibility and various epigenetic modifications have been associated with regulatory functions. Mapping these features across the genome has enabled researchers to begin to document the full complement...

Addressing the Opioid Epidemic in the United States: Lessons From the Department of Veterans Affairs.

The Minorities Affairs Committee of the American Society for Cell Biology-Fostering the Professional Development of Scientists from Underrepresented Minority Backgrounds.

As part of its mission, the American Society for Cell Biology (ASCB) works to increase diversity in the scientific workforce, in part through the work of its Minorities Affairs Committee. It is for this reason that the ASCB was happy to welcome the special September 2016 issue of CBE-Life Sciences Education (LSE) focused on broadening participation. As a response to this special issue, we update our ASCB community and LSE readership on the society's efforts to broaden participation of underrepresented minor...

Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.

To evaluate the safety-related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012.

The G-box transcriptional regulatory code in Arabidopsis.

Plants have significantly more transcription factor (TF) families than animals and fungi, and plant TF families tend to contain more genes-these expansions are linked to adaptation to environmental stressors (Shiu et al., 2005; Charoensawan et al., 2010). Many TF family members bind to similar or identical sequence motifs, such as G-boxes (CACGTG), so it is difficult to predict regulatory relationships. We determine that the flanking sequences near G-boxes help determine in vitro specificity, but that this ...

Drivers of Continuing Education Learning Preferences for Veterans Affairs Women's Health Primary Care Providers.

Documented gaps in health professionals' training in women's health are a special concern for continuing education (CE). In the Veterans Affairs (VA) health care system, women veterans are a numerical minority, preferably assigned to designated women's health primary care providers (DWHPs). DWHPs need to maintain their knowledge and skills in women's health topics, in addition to general internal medicine topics. We explored drivers of VA DWHPs' learning preferences for women's health topics-ie, factors whi...

cis-Regulatory Circuits Regulating NEK6 Kinase Overexpression in Transformed B Cells Are Super-Enhancer Independent.

Alterations in distal regulatory elements that control gene expression underlie many diseases, including cancer. Epigenomic analyses of normal and diseased cells have produced correlative predictions for connections between dysregulated enhancers and target genes involved in pathogenesis. However, with few exceptions, these predicted cis-regulatory circuits remain untested. Here, we dissect cis-regulatory circuits that lead to overexpression of NEK6, a mitosis-associated kinase, in human B cell lymphoma. W...

Cohort Profile: The HIV Atlanta Veterans Affairs Cohort Study (HAVACS).

TMPRSS2-ERG Alters the cis-Regulatory Landscape and Activates NOTCH.

In TMPRSS2-ERG-positive prostate tumors, ERG establishes new clusters of regulatory elements (CORE).

Quality of mitral valve surgery at the United States Department of Veterans Affairs.

New Department of Veterans Affairs and Department of Defense Guidelines on Pain Management With Opioids: Comment and Concern.

T Follicular Regulatory Cells in Mice and Men.

It has long been known that CD4 T cells are necessary to provide help to B cells, triggering a germinal center (GC) reaction where affinity maturation and isotype switching occurs. However, the nature of the dedicated CD4 helper T cells, known as T follicular helper (Tfh), was only recently described. Here, we review the biology and function of the recently described T follicular regulatory (Tfr) cells, another CD4 T cell population also found within GCs but with regulatory function and characteristics. Tfr...

Recent graduate places at Northern Ireland dinner.

Helena Cotton, BVA Public Affairs Manager, explains how recent graduates can get involved with BVA's annual dinners.

MicroRNA-mediated regulatory circuits: outlook and perspectives.

MicroRNAs have been found to be necessary for regulating genes implicated in almost all signaling pathways, and consequently their dysfunction influences many diseases, including cancer. Understanding of the complexity of the microRNA-mediated regulatory network has grown in terms of size, connectivity and dynamics with the development of computational and, more recently, experimental high-throughput approaches for microRNA target identification. Newly developed studies on recurrent microRNA-mediated circui...

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