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Quality systems regulations

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https://www.readbyqxmd.com/read/29330509/transcriptome-analysis-reveals-carbohydrate-mediated-liver-immune-responses-in-epinephelus-akaara
#1
Yunxia Yang, Tao Han, Jia Xiao, Xinyu Li, Jiteng Wang
As the cheapest energy source, carbohydrates are used in fish feeds to improve physical quality and reduce catabolism of proteins and lipids. The liver is the primary organ for metabolism and is also an important site of immune regulation. Here, we investigated the effect of different dietary carbohydrate levels on growth and health by evaluating the liver transcriptome of Epinephelus akaara. In this study, E. akaara juveniles were fed diets containing few (0% corn starch), moderate (18% corn starch), and high (30% corn starch) levels of dietary carbohydrate...
January 12, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29329532/functionality-of-hospital-information-systems-results-from-a-survey-of-quality-directors-at-turkish-hospitals
#2
Mehmet Saluvan, Al Ozonoff
BACKGROUND: We aimed to determine availability of core Hospital Information Systems (HIS) functions implemented in Turkish hospitals and the perceived importance of these functions on quality and patient safety. METHODS: We surveyed quality directors (QDs) at civilian hospitals in the nation of Turkey. Data were collected via web survey using an instrument with 50 items describing core functionality of HIS. We calculated mean availability of each function, mean and median values of perceived impact on quality, and we investigated the relationship between availability and perceived importance...
January 12, 2018: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/29325407/the-bright-elusive-butterfly-of-value-in-health-technology-development-comment-on-providing-value-to-new-health-technology-the-early-contribution-of-entrepreneurs-investors-and-regulatory-agencies
#3
Trisha Greenhalgh, Nick Fahy, Sara Shaw
The current system of health technology development is characterised by multiple misalignments. The "supply" side (innovation policy-makers, entrepreneurs, investors) and the "demand" side (health policy-makers, regulators, health technology assessment, purchasers) operate under different - and conflicting - logics. The system is less a "pathway" than an unstable ecosystem of multiple interacting sub-systems. "Value" means different things to each of the numerous actors involved. Supply-side dynamics are built on fictions; regulatory checks and balances are designed to assure quality, safety and efficacy, not to ensure that technologies entering the market are either desirable or cost-effective...
May 29, 2017: International Journal of Health Policy and Management
https://www.readbyqxmd.com/read/29318338/-software-as-medical-devices-medical-apps-tasks-requirements-and-experiences-from-the-point-of-view-of-a%C3%A2-competent-authority
#4
REVIEW
Arno Terhechte
Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed...
January 9, 2018: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/29316798/regulation-of-mitophagy-by-the-ubiquitin-pathway-in-neurodegenerative-diseases
#5
Shyamal Desai, Meredith Juncker, Catherine Kim
Mitophagy is a cellular process by which dysfunctional mitochondria are degraded via autophagy. Increasing empirical evidence proposes that this mitochondrial quality-control mechanism is defective in neurons of patients with various neurodegenerative diseases such as Ataxia Telangiectasia, Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis. Accumulation of defective mitochondria and the production of reactive oxygen species due to defective mitophagy have been identified as causes underlying neurodegenerative disease pathogenesis...
January 1, 2018: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/29315588/the-health-nutrition-dimension-a-methodological-approach-to-asses-the-nutritional-sustainability-of-the-typical-agro-food-products-and-the-mediterranean-diet
#6
Elena Azzini, Giuseppe Maiani, Aida Turrini, Federica Intorre, Gabriella Lo Feudo, Roberto Capone, Francesco Bottalico, Hamid El Bilali, Angela Polito
BACKGROUND: The aim of this paper is to work out a methodological approach for the evaluation nutritional sustainability of typical agro-food products, representing the Mediterranean eating habits and included in the Mediterranean food pyramid. RESULTS: For each group of foods, were identified different suitable and easily measurable indicators. Two macro-indicators were used to assess the nutritional sustainability of each product. The first macro-indicator called "business distinctiveness" takes into account the application of different regulations and standards regarding quality, safety and traceability as well as the origin of raw materials...
January 9, 2018: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/29315421/development-of-a-new-comprehensive-and-reliable-endometrial-receptivity-map-er-map-er-grade-based-on-rt-qpcr-gene-expression-analysis
#7
M Enciso, J P Carrascosa, J Sarasa, P A Martínez-Ortiz, S Munné, J A Horcajadas, J Aizpurua
STUDY QUESTION: Is it possible to determine the receptivity status of an endometrium by combined quantitative reverse transcription PCR (RT-qPCR) expression analysis of genes involved in endometrial proliferation and immunity? SUMMARY ANSWER: The new ER Map®/ER Grade® test can predict endometrial receptivity status by RT-qPCR using a new panel of genes involved in endometrial proliferation and the maternal immune response associated to embryonic implantation. WHAT IS KNOWN ALREADY: The human endometrium reaches a receptive status adequate for embryonic implantation around Days 19-21 of the menstrual cycle...
January 5, 2018: Human Reproduction
https://www.readbyqxmd.com/read/29311614/closed-loop-control-of-trunk-posture-improves-locomotion-through-the-regulation-of-leg-proprioceptive-feedback-after-spinal-cord-injury
#8
Eduardo Martin Moraud, Joachim von Zitzewitz, Jenifer Miehlbradt, Sophie Wurth, Emanuele Formento, Jack DiGiovanna, Marco Capogrosso, Grégoire Courtine, Silvestro Micera
After spinal cord injury (SCI), sensory feedback circuits critically contribute to leg motor execution. Compelled by the importance to engage these circuits during gait rehabilitation, assistive robotics and training protocols have primarily focused on guiding leg movements to reinforce sensory feedback. Despite the importance of trunk postural dynamics on gait and balance, trunk assistance has comparatively received little attention. Typically, trunk movements are either constrained within bodyweight support systems, or manually adjusted by therapists...
January 8, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29310960/cannabinoid-hyperemesis-syndrome-pathophysiology-and-treatment-in-the-emergency-department
#9
John R Richards
BACKGROUND: Cannabinoid hyperemesis syndrome (CHS) is a challenging clinical disorder. CHS patients frequently present to the emergency department and may require treatment for intractable emesis, dehydration, and electrolyte abnormalities. Thought to be a variant of cyclic vomiting syndrome, CHS has become more prevalent with increasing cannabis potency and use, as enabled by various states having legalized the recreational use of cannabis. OBJECTIVE: This aim of this review is to investigate the pathophysiology of CHS and evaluate the published literature on pharmacologic treatment in the emergency department...
January 5, 2018: Journal of Emergency Medicine
https://www.readbyqxmd.com/read/29310743/how-do-farm-models-compare-when-estimating-greenhouse-gas-emissions-from-dairy-cattle-production
#10
N J Hutchings, Ş Özkan Gülzari, M de Haan, D Sandars
The European Union Effort Sharing Regulation (ESR) will require a 30% reduction in greenhouse gas (GHG) emissions by 2030 compared with 2005 from the sectors not included in the European Emissions Trading Scheme, including agriculture. This will require the estimation of current and future emissions from agriculture, including dairy cattle production systems. Using a farm-scale model as part of a Tier 3 method for farm to national scales provides a more holistic and informative approach than IPCC (2006) Tier 2 but requires independent quality control...
January 9, 2018: Animal: An International Journal of Animal Bioscience
https://www.readbyqxmd.com/read/29301968/engineering-posttranslational-proofreading-to-discriminate-nonstandard-amino-acids
#11
Aditya M Kunjapur, Devon A Stork, Erkin Kuru, Oscar Vargas-Rodriguez, Matthieu Landon, Dieter Söll, George M Church
Incorporation of nonstandard amino acids (nsAAs) leads to chemical diversification of proteins, which is an important tool for the investigation and engineering of biological processes. However, the aminoacyl-tRNA synthetases crucial for this process are polyspecific in regard to nsAAs and standard amino acids. Here, we develop a quality control system called "posttranslational proofreading" to more accurately and rapidly evaluate nsAA incorporation. We achieve this proofreading by hijacking a natural pathway of protein degradation known as the N-end rule, which regulates the lifespan of a protein based on its amino-terminal residue...
January 4, 2018: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29298661/de-novo-transcriptome-sequencing-and-analysis-of-male-and-female-swimming-crab-portunus-trituberculatus-reproductive-systems-during-mating-embrace-stage-ii
#12
Zhengfei Wang, Linxia Sun, Weibing Guan, Chunlin Zhou, Boping Tang, Yongxu Cheng, Jintian Huang, Fujun Xuan
BACKGROUND: The swimming crab Portunus trituberculatus is one of the most commonly farmed crustaceans in China. As one of the most widely known and high-value edible crabs, it crab supports large crab fishery and aquaculture in China. Only large and sexually mature crabs can provide the greatest economic benefits, suggesting the considerable effect of reproductive system development on fishery. Studies are rarely conducted on the molecular regulatory mechanism underlying the development of the reproductive system during the mating embrace stage in this species...
January 3, 2018: BMC Genetics
https://www.readbyqxmd.com/read/29290754/effects-of-recent-energy-system-changes-on-co2-projections-for-the-united-states
#13
Carol S Lenox, Daniel H Loughlin
Recent projections of future United States carbon dioxide (CO2) emissions are considerably lower than projections made just a decade ago. A myriad of factors have contributed to lower forecasts, including reductions in end-use energy service demands, improvements in energy efficiency, and technological innovations. Policies that have encouraged these changes include renewable portfolio standards, corporate vehicle efficiency standards, smart growth initiatives, revisions to building codes, and air and climate regulations...
September 21, 2017: Clean Technologies and Environmental Policy
https://www.readbyqxmd.com/read/29289556/chronopathophysiological-implications-of-orexin-in-sleep-disturbances-and-lifestyle-related-disorders
#14
REVIEW
Hiroshi Tsuneki, Tsutomu Wada, Toshiyasu Sasaoka
Sleep, a mysterious behavior, has recently been recognized as a crucial factor for health and longevity. The daily sleep/wake cycle provides the basis of biorhythms controlling whole-body homeostasis and homeodynamics; therefore, disruption of sleep causes several physical and psychological disorders, including cardiovascular disease, obesity, diabetes, cancer, anxiety, depression, and cognitive dysfunction. However, the mechanism linking sleep disturbances and sleep-related disorders remains unknown. Orexin (also known as hypocretin) is a neuropeptide produced in the hypothalamus...
December 28, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29289483/challenges-and-future-for-the-delivery-of-growth-hormone-therapy
#15
Andrés Caicedo, Ron Rosenfeld
Growth hormone (GH) has multiple roles in sustaining human development and homeostasis. Its pulsatile secretion stimulates growth and contributes to an equilibrium in a process tightly regulated and coordinated by many organs. GH deficiency is a medical condition affecting all ages, with not only significant consequences in the health of the patient but also impact on the quality of life. This review gathers the different strategies used today with a glance at future technologies to treat GH deficiency. We present key aspects for consideration when developing new methods to deliver GH, mimicking or replacing its pulsatile activity...
December 17, 2017: Growth Hormone & IGF Research
https://www.readbyqxmd.com/read/29288083/poly-ethylene-co-vinyl-alcohol-is-a-suitable-substrate-for-human-olfactory-neuroepithelial-cell-differentiation-in-vitro-through-a-defined-regulatory-pathway
#16
Sheng-Tien Li, Tai-Horng Young, Tsung-Wei Huang
Olfactory dysfunction significantly influences patients' life quality, but currently has no adequate treatment. Poly (ethylene-co-vinyl alcohol) (EVAL) mediates cell adhesion, growth and modulates differentiation of neural stem cells. However, whether EVAL is a suitable substrate to establish an in vitro culture system that can promote development and differentiation of human olfactory neuroepithelial cells (HONCs) remains unexplored. This study isolates and cultures HONCs on controls and EVAL films for 21 days...
December 26, 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/29283238/molecular-mechanisms-of-action-of-gas-transmitters-no-co-and-h2s-in-smooth-muscle-cells-and-effect-of-no-generating-compounds-nitrates-and-nitrites-on-average-life-expectancy
#17
S V Gusakova, L V Smagliy, Y G Birulina, I V Kovalev, V Nosarev, I V Petrova, V P Reutov
Gaseous signaling molecules (gas transmitters) take an especial position among the numerous signaling molecules involved in the regulation of both intracellular processes that occur in different types of cells and cell-cell interactions. At present time, gas transmitters include three molecules whose enzymatic systems of synthesis and degradation, physiological action and intracellular effectors, the change of which under the action of gas transmitters may result in physiological and/or pathophysiological effects are well- determined...
January 2017: Uspekhi Fiziologicheskikh Nauk
https://www.readbyqxmd.com/read/29280409/challenges-of-using-new-and-repurposed-drugs-for-the-treatment-of-multidrug-resistant-tuberculosis-in-children
#18
H Simon Schaaf, Anthony J Garcia-Prats, Lindsay McKenna, James A Seddon
New and repurposed antituberculosis drugs are urgently needed to more safely and effectively treat multidrug-resistant (MDR) tuberculosis (TB) in children. Multiple challenges limit timely access to new MDR-TB treatments in children. Areas covered: Diagnosis of MDR-TB in children remains a barrier, with few children with MDR-TB diagnosed and treated. Other barriers to timely access to new and repurposed drugs are discussed, and include delayed initiation of paediatric trials, limited funding for paediatric drug development, fragmented regulatory systems and operational challenges...
December 27, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/29279266/academy-of-nutrition-and-dietetics-revised-2017-scope-of-practice-for-the-nutrition-and-dietetics-technician-registered
#19
Denise Andersen, Shari Baird, Denise L Chapel, Alana D Cline, Shyamala N Ganesh, Margaret Garner, Barbara L Grant, Kathryn K Hamilton, Krista Jablonski, Sherri L Jones, Alexandra G Kazaks, Susan H Konek, Kelly K Leonard, Kimi G McAdam, Beth N Ogata, Egondu M Onuoha, Gretchen Y Robinson, Darrin W Schmidt, Nancy G Walters, Pauline Williams, Pamela Wu, Karen Hui, Carol Gilmore, Mujahed Khan, Dana Buelsing, Sharon M McCauley
The Academy of Nutrition and Dietetics (Academy) is the world's largest organization of food and nutrition professionals and the association that represents credentialed nutrition and dietetics practitioners-nutrition and dietetics technicians, registered (NDTRs) and registered dietitian nutritionists (RDNs). An NDTR's scope of practice in nutrition and dietetics has flexible boundaries to capture the depth and breadth of the individual's practice. The NDTR's practice expands with advances in many areas, including nutrition, food production, food safety, food systems management, health care, public health, community health, and information and communication technology...
December 23, 2017: Journal of the Academy of Nutrition and Dietetics
https://www.readbyqxmd.com/read/29278917/experiences-with-unregulated-respite-care-among-family-caregivers-of-children-dependent-on-respiratory-technologies
#20
Krista Keilty, David Nicholas, Enid Selkirk
Increasingly, children with respiratory conditions who are dependent on medical technology (e.g. ventilators and tracheostomies) are cared for at home by family caregivers who are at risk for significant health, financial and social burdens. In many jurisdictions, access to quality respite is varied and often the availability of regulated (nursing) providers is insufficient. Rather than go without, some families have secured alternative and unregulated providers to supplement formal home care systems. The purpose of this study was to explore the experiences of family caregivers of children dependent on respiratory technologies who have used unregulated providers for in-home respite care...
January 1, 2017: Journal of Child Health Care: for Professionals Working with Children in the Hospital and Community
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