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https://www.readbyqxmd.com/read/29785887/quality-by-design-process-analytical-technology-gmp-and-regulatory-affairs
#1
Metin Çelik
No abstract text is available yet for this article.
July 2018: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/29783113/automated-uhplc-separation-of-10-pharmaceutical-compounds-using-software-modeling
#2
A Zöldhegyi, H-J Rieger, I Molnár, L Fekhretdinova
Human mistakes are still one of the main reasons of underlying regulatory affairs that in a compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) must be eliminated. To develop smooth, fast and robust methods that are free of human failures, a state-of-the-art automation was presented. For the scope of this study, a commercial software (DryLab) and a model mixture of 10 drugs were subjected to testing. Following AQbD-principles, the best available working point was selected and conformational experimental runs, i...
March 20, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29782188/an-evaluation-of-nivolumab-for-the-treatment-of-metastatic-renal-cell-carcinoma
#3
Kevin Zarrabi, Shenhong Wu
The treatment paradigm for metastatic renal cell carcinoma (mRCC) has undergone a revolution with the rapid market approval of multiple agents over a three-year period. The immunogenicity of RCC provided the biological rationale to assess the clinical efficacy of nivolumab, an immune checkpoint inhibitor. Nivolumab is approved for second-line treatment after failure of angiogenesis targeted therapy and in combination therapy with ipilimumab for previously untreated intermediate or poor-risk advanced renal cell carcinoma...
May 21, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29781656/veterans-experiences-initiating-va-based-mental-health-care
#4
Michelle J Bovin, Christopher J Miller, Christopher J Koenig, Jessica M Lipschitz, Kara A Zamora, Patricia B Wright, Jeffrey M Pyne, James F Burgess
Military veterans who could benefit from mental health services often do not access them. Research has revealed a range of barriers associated with initiating United States Department of Veterans Affairs (VA) care, including those specific to accessing mental health care (e.g., fear of stigmatization). More work is needed to streamline access to VA mental health-care services for veterans. In the current study, we interviewed 80 veterans from 9 clinics across the United States about initiation of VA mental health care to identify barriers to access...
May 21, 2018: Psychological Services
https://www.readbyqxmd.com/read/29778256/hepatitis-c-care-in-the-department-of-veterans-affairs-building-a-foundation-for-success
#5
REVIEW
Pamela S Belperio, Maggie Chartier, Rachel I Gonzalez, Angela M Park, David B Ross, Tim R Morgan, Lisa I Backus
The Department of Veterans Affairs (VA) has made significant progress in treating hepatitis C virus, experiencing more than a 75% reduction in veterans remaining to be treated since the availability of oral direct-acting antivirals. Hepatitis C Innovation Teams use lean process improvement and system redesign, resulting in practice models that address gaps in care. The key to success is creative improvements in veteran access to providers, including expanded use of nonphysician providers, video telehealth, and electronic technologies...
June 2018: Infectious Disease Clinics of North America
https://www.readbyqxmd.com/read/29773256/-emergency-nurse-a-speciality-whose-name-says-it-all
#6
Benoît Jézéquel
Proposal no. 10 in French Senate information report no. 685, drawn up by the Social Affairs Commission on hospital emergency departments, opens the debate regarding the creation of an emergency nursing speciality. Does this represent progress for the profession or an inadapted measure? The complex situation of emergency departments raises the need for methodological thinking on this subject.
May 2018: Soins; la Revue de Référence Infirmière
https://www.readbyqxmd.com/read/29770249/snorkel-rapid-training-data-creation-with-weak-supervision
#7
Alexander Ratner, Stephen H Bach, Henry Ehrenberg, Jason Fries, Sen Wu, Christopher Ré
Labeling training data is increasingly the largest bottleneck in deploying machine learning systems. We present Snorkel, a first-of-its-kind system that enables users to train state-of- the-art models without hand labeling any training data. Instead, users write labeling functions that express arbitrary heuristics, which can have unknown accuracies and correlations. Snorkel denoises their outputs without access to ground truth by incorporating the first end-to-end implementation of our recently proposed machine learning paradigm, data programming...
November 2017: Proceedings of the VLDB Endowment
https://www.readbyqxmd.com/read/29770211/the-performance-of-select-universities-of-medical-sciences-based-on-the-components-affecting-medical-education
#8
Mehdi Tayebi Arasteh, Behrooz Pouragha, Masume Bagheri Kahkesh
Background:  Every educational institution requires an evaluation system in order to find out about the quality and desirability of its activities, especially if it is a complex and dynamic environment. The present study was conducted to evaluate the educational performance of schools affiliated to Alborz University of Medical Sciences to help improve their performance. Methods:  This descriptive analytical study was conducted in six schools affiliated to Alborz University of Medical Sciences in April 2016-October 2016 and October 2016-April 2017...
2018: F1000Research
https://www.readbyqxmd.com/read/29768309/the-impact-of-a-change-in-the-price-of-va-health-care-on-utilization-of-va-and-medicare-services
#9
Richard E Nelson, Bret Hicken, Megan Vanneman, Chuan-Fen Liu, Randall Rupper
INTRODUCTION: The passage of the Veterans Access, Choice, and Accountability Act of 2014 has expanded the non-Veteran Affairs (VA) care options for eligible US Veterans. In order for these new arrangements to provide the best care possible for Veterans, it is important to understand the relationship between VA and non-VA care options. The purpose of this study was to use another recent VA policy change, one that increased the reimbursement rate that eligible Veterans receive for travel for health care to VA, to understand the use of VA and Medicare services among Medicare-enrolled Veterans...
May 15, 2018: Medical Care
https://www.readbyqxmd.com/read/29766728/-euthanasia-legal-comparison-in-selected-european-countries
#10
Adam Doležal
This article deals with the subject of euthanasia (all its forms) and other end-of-life decisions, such as assisted suicide, withdrawing and whithholding life-sustaining treatments. Among other things, the article will also deal with the issue of the offense of Homicide by the Victims Request. Based on an empirical historical method, the article compares the various selected legal orders. From this analysis, it draws some conclusions that have an impact on ethical discourse. First of all, the terminology is defined in the article, which is very important in this area...
2018: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/29766478/-time-for-cluster-c-personality-disorders-state-of-the-art
#11
J Hutsebaut, E M C Willemsen, H L Van
BACKGROUND: Compared to cluster B personality disorders, the assessment and treatment of people with obsessive-compulsive, dependent, and avoidant personality disorders (cluster C) is given little attention in the field of research and clinical practice. AIM: Presenting the current state of affairs in regard to cluster C personality disorders. METHOD: A systematic literature search was conducted using the main data bases. RESULTS: Cluster C personality disorders are present in approximately 3-9% of the general population...
2018: Tijdschrift Voor Psychiatrie
https://www.readbyqxmd.com/read/29762272/differences-in-experiences-with-care-between-homeless-and-nonhomeless-patients-in-veterans-affairs-facilities-with-tailored-and-nontailored-primary-care-teams
#12
Audrey L Jones, Leslie R M Hausmann, Stefan Kertesz, Ying Suo, John P Cashy, Maria K Mor, James H Schaefer, Adi V Gundlapalli, Adam J Gordon
BACKGROUND: Homeless patients describe poor experiences with primary care. In 2012, the Veterans Health Administration (VHA) implemented homeless-tailored primary care teams (Homeless Patient Aligned Care Team, HPACTs) that could improve the primary care experience for homeless patients. OBJECTIVE: To assess differences in primary care experiences between homeless and nonhomeless Veterans receiving care in VHA facilities that had HPACTs available (HPACT facilities) and in VHA facilities lacking HPACTs (non-HPACT facilities)...
May 12, 2018: Medical Care
https://www.readbyqxmd.com/read/29760299/exploring-the-public-private-and-company-size-differences-in-employees-work-characteristics-and-burnout-data-analysis-of-a-nationwide-survey-in-taiwan
#13
Wan-Yu Yeh, Ching-Ying Yeh, Chiou-Jong Chen
Distinct differences exist between public-private sector organizations with respect to the market environment and operational objectives; furthermore, among private sector businesses, organizational structures and work conditions often vary between large- and small-sized companies. Despite these obvious structural distinctions, however, sectoral differences in employees' psychosocial risks and burnout status in national level have rarely been systematically investigated. Based on 2013 national employee survey data, 15,000 full-time employees were studied...
May 15, 2018: Industrial Health
https://www.readbyqxmd.com/read/29759929/entacapone-and-prostate-cancer-in-parkinson-s-disease-patients-a-large-veterans-affairs-healthcare-system-study
#14
Jacqueline M Major, Diane Dong, Francesca Cunningham, Kunthel By, Kwan Hur, David C Shih, Rong Jiang, Gerald D Podskalny, XiangMing Wei, Simone Pinheiro, Steven T Bird, Stephine Keeton, David J Graham
BACKGROUND: An increased incidence of prostate cancer was observed in Parkinson's disease (PD) patients treated with entacapone during a pre-approval randomized clinical trial; the relation has not been robustly investigated in the U.S. ambulatory setting. OBJECTIVE: To investigate whether entacapone is associated with prostate cancer and to assess whether the associations are correlated with advanced disease at the time of cancer diagnosis. METHODS: Using data from the Department of Veterans Affairs healthcare system, new-user cohorts were created of PD patients treated with add-on entacapone or add-on dopamine agonist/monoamine oxidase B inhibitors between January 2000 and December 2014...
May 5, 2018: Parkinsonism & related Disorders
https://www.readbyqxmd.com/read/29759512/drug-eluting-stents-versus-bare-metal-stents-in-saphenous-vein-grafts-a-double-blind-randomised-trial
#15
Emmanouil S Brilakis, Robert Edson, Deepak L Bhatt, Steven Goldman, David R Holmes, Sunil V Rao, Kendrick Shunk, Bavana V Rangan, Kreton Mavromatis, Kodangudi Ramanathan, Anthony A Bavry, Santiago Garcia, Faisal Latif, Ehrin Armstrong, Hani Jneid, Todd A Conner, Todd Wagner, Judit Karacsonyi, Lauren Uyeda, Beverly Ventura, Aaron Alsleben, Ying Lu, Mei-Chiung Shih, Subhash Banerjee
BACKGROUND: Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. METHODS: Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices...
May 11, 2018: Lancet
https://www.readbyqxmd.com/read/29759263/a-bedside-computerized-decision-support-tool-for-intravenous-insulin-infusion-management-in-critically-ill-patients
#16
Evan D Telford, Andrew J Franck, Andrew L Hendrickson, Nicole Maltese Dietrich
Intravenous (IV) insulin infusions using a validated protocol are the recommended method for blood glucose control in critically ill patients. Computerized decision-support tools improve quality over manual paper-based protocols. However, nonproprietary computerized tools targeting the recommended blood glucose range of 140-180 mg/dL are not readily available. A bedside computerized decision-support tool was developed at a US Department of Veterans Affairs health system to assist the nursing staff with the management of patients requiring IV insulin infusion...
May 2018: Joint Commission Journal on Quality and Patient Safety
https://www.readbyqxmd.com/read/29759055/results-of-a-coordinated-specialty-care-program-for-early-psychosis-and-predictors-of-outcomes
#17
Ilana Nossel, Melanie M Wall, Jennifer Scodes, Leslie A Marino, Sacha Zilkha, Iruma Bello, Igor Malinovsky, Rufina Lee, Marleen Radigan, Thomas E Smith, Lloyd Sederer, Gyojeong Gu, Lisa Dixon
OBJECTIVE: This study prospectively evaluated outcomes of OnTrackNY, a statewide coordinated specialty care (CSC) program for treatment of early psychosis in community settings, as well as predictors of outcomes. METHODS: The sample included 325 individuals ages 16-30 with recent-onset nonaffective psychosis who were enrolled in OnTrackNY and who had at least one three-month follow-up. Clinicians provided data at baseline and quarterly up to one year. Domains assessed included demographic and clinical characteristics, social and occupational functioning, medications, suicidality and violence, hospitalization, and time to intervention...
May 15, 2018: Psychiatric Services: a Journal of the American Psychiatric Association
https://www.readbyqxmd.com/read/29756791/individual-and-group-cognitive-processing-therapy-effectiveness-across-two-veterans-affairs-posttraumatic-stress-disorder-treatment-clinics
#18
Kristen E Lamp, Kimberly M Avallone, Kelly P Maieritsch, Katherine R Buchholz, Sheila A M Rauch
OBJECTIVE: In accordance with Veterans Affairs (VA) policy, VA posttraumatic stress disorder (PTSD) clinics offer evidence-based treatments including cognitive processing therapy (CPT). To facilitate access to care, CPT is offered in both group and individual formats in many VA PTSD clinics. Group and individual delivery of CPT have been directly compared in active duty samples, but these findings have not been extended to VA populations. The present article directly compares the effectiveness of group and individual CPT with a written trauma account (CPT+A) across two VA PTSD clinics...
May 14, 2018: Psychological Trauma: Theory, Research, Practice and Policy
https://www.readbyqxmd.com/read/29756480/tracheoesophageal-prosthesis-use-is-associated-with-improved-overall-quality-of-life-in-veterans-with-laryngeal-cancer
#19
Ramya S Patel, Tiffany Mohr, Christine Hartman, Carol Stach, Andrew G Sikora, Jose P Zevallos, Vlad C Sandulache
OBJECTIVES: Veterans have an increased risk of laryngeal cancer, yet their oncologic and functional outcomes remain understudied. We sought to determine the longitudinal impact of tracheoesophageal puncture and voice prosthesis on quality-of-life measures in veterans following total laryngectomy (TL). METHODS: We performed a cross-sectional analysis of TL patients (n = 68) treated at the Michael E. DeBakey Veterans Affairs Medical Center using the Voice Handicap Index (VHI), MD Anderson Dysphagia Index (MDADI), and University of Washington Quality of Life Index (UW-QOL)...
May 1, 2018: Annals of Otology, Rhinology, and Laryngology
https://www.readbyqxmd.com/read/29752701/pain-agreements-and-healthcare-utilization-in-a-veterans-affairs-primary-care-population-a-retrospective-chart-review
#20
Cynthia Kay, Erica Wozniak, Alice Ching, Joanne Bernstein
INTRODUCTION: The prevalence of chronic pain is enormous. In America, the management of chronic pain and opioids remains a critical focus. Guidelines recommend pain agreements as part of the management of chronic pain and opioids; however, evidence of improvement in patient outcomes is lacking. An aspect of patient outcome includes utilization of healthcare resources, such as emergency department visits and hospitalizations. It remains uncertain whether the use of pain agreements lessens healthcare utilization...
May 11, 2018: Pain and Therapy
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