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Quality systems regulations

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https://www.readbyqxmd.com/read/28090761/modest-overexpression-of-foxo-maintains-cardiac-proteostasis-and-ameliorates-age-associated-functional-decline
#1
Anna C Blice-Baum, Alexander C Zambon, Gaurav Kaushik, Meera C Viswanathan, Adam J Engler, Rolf Bodmer, Anthony Cammarato
Heart performance declines with age. Impaired protein quality control (PQC), due to reduced ubiquitin-proteasome system (UPS) activity, autophagic function, and/or chaperone-mediated protein refolding, contributes to cardiac deterioration. The transcription factor FOXO participates in regulating genes involved in PQC, senescence, and numerous other processes. Here, a comprehensive approach, involving molecular genetics, novel assays to probe insect cardiac physiology, and bioinformatics, was utilized to investigate the influence of heart-restricted manipulation of dFOXO expression in the rapidly aging Drosophila melanogaster model...
February 2017: Aging Cell
https://www.readbyqxmd.com/read/28088344/design-control-considerations-for-biologic-device-combination-products
#2
Dave Anderson, Roger Liu, J Anand Subramony, Jon Cammack
Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products...
January 11, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28079384/hypoxia-and-h2o2-dual-sensitive-vesicles-for-enhanced-glucose-responsive-insulin-delivery
#3
Jicheng Yu, Chenggen Qian, Yuqi Zhang, Zheng Cui, Yong Zhu, Qundong Shen, Frances S Ligler, John B Buse, Zhen Gu
A glucose-responsive closed-loop insulin delivery system mimicking pancreas activity without long-term side effect has the potential to improve diabetic patients' health and quality of life. Here, we developed a novel glucose-responsive insulin delivery device using a painless microneedle-array patch containing insulin-loaded vesicles. Formed by self-assembly of hypoxia and H2O2 dual-sensitive diblock copolymer, the glucose-responsive polymersome-based vesicles (d-GRPs) can disassociate and subsequently release insulin triggered by H2O2 and hypoxia generated during glucose oxidation catalyzed by glucose specific enzyme...
January 12, 2017: Nano Letters
https://www.readbyqxmd.com/read/28073472/the-interaction-between-cyanobacteria-and-zooplankton-in-a-more-eutrophic-world
#4
REVIEW
Kemal Ali Ger, Pablo Urrutia-Cordero, Paul C Frost, Lars-Anders Hansson, Orlando Sarnelle, Alan E Wilson, Miquel Lürling
As blooms of cyanobacteria expand and intensify in freshwater systems globally, there is increasing interest in their ecological effects. In addition to being public health hazards, cyanobacteria have long been considered a poor quality food for key zooplankton grazers that link phytoplankton to higher trophic levels. While past laboratory studies have found negative effects of nutritional constraints and defensive traits (i.e., toxicity and colonial or filamentous morphology) on the fitness of large generalist grazers (i...
April 2016: Harmful Algae
https://www.readbyqxmd.com/read/28072659/effects-of-transcranial-magnetic-stimulation-on-the-cognitive-control-of-emotion-potential-antidepressant-mechanisms
#5
Crystal Lantrip, Faith M Gunning, Laura Flashman, Robert M Roth, Paul E Holtzheimer
Depression negatively impacts quality of life and is associated with high mortality rates. Recent research has demonstrated that improvement in depression symptoms with transcranial magnetic stimulation (TMS) to the dorsolateral prefrontal cortex (DLPFC) may involve changes in the cognitive control network, a regulatory system modulating the function of cognitive and emotional systems, composed of the DLPFC, dorsal anterior cingulate, and posterior parietal cortices. Transcranial magnetic stimulation to the DLPFC node of the cognitive control network may have antidepressant efficacy via direct effects on cognitive control processes involved in emotion regulation...
January 9, 2017: Journal of ECT
https://www.readbyqxmd.com/read/28069866/trim-proteins-and-diseases
#6
REVIEW
Masashi Watanabe, Shigetsugu Hatakeyama
Ubiquitination is one of the posttranslational modifications that regulates a number of intracellular events including signal transduction, protein quality control, transcription, cell cycle, apoptosis and development. The ubiquitin system functions as a garbage machine to degrade target proteins and as a regulator for several signalling pathways. Biochemical reaction of ubiquitination requires several enzymes including E1, E2 and E3, and E3 ubiquitin ligases play roles as receptors for recognizing target proteins...
January 7, 2017: Journal of Biochemistry
https://www.readbyqxmd.com/read/28067194/mapping-actions-to-improve-access-to-medicines-for-mental-disorders-in-low-and-middle-income-countries
#7
C Barbui, T Dua, K Kolappa, B Saraceno, S Saxena
AIMS: In recent years a number of intergovernmental initiatives have been activated in order to enhance the capacity of countries to improve access to essential medicines, particularly for mental disorders. In May 2013 the 66th World Health Assembly adopted the World Health Organization (WHO) Comprehensive Mental Health Action Plan 2013-2020, which builds upon the work of WHO's Mental Health Gap Action Programme. Within this programme, evidence-based guidelines for mental disorders were developed, including recommendations on appropriate use of medicines...
January 9, 2017: Epidemiology and Psychiatric Sciences
https://www.readbyqxmd.com/read/28065195/programming-maternal-and-child-overweight-and-obesity-in-the-context-of-undernutrition-current-evidence-and-key-considerations-for-low-and-middle-income-countries
#8
Lindsay M Jaacks, Justine Kavle, Abigail Perry, Albertha Nyaku
The goals of the present targeted review on maternal and child overweight and obesity were to: (i) understand the current situation in low- and middle-income countries (LMIC) with regard to recent trends and context-specific risk factors; and (ii) building off this, identify entry points for leveraging existing undernutrition programmes to address overweight and obesity in LMIC. Trends reveal that overweight and obesity are a growing problem among women and children in LMIC; as in Ghana, Kenya, Niger, Sierra Leone, Tanzania and Zimbabwe, where the prevalence among urban women is approaching 50 %...
January 9, 2017: Public Health Nutrition
https://www.readbyqxmd.com/read/28062917/the-enteric-nervous-system-and-the-musculature-of-the-colon-are-altered-in-patients-with-spina-bifida-and-spinal-cord-injury
#9
Marjanne den Braber-Ymker, Martin Lammens, Michel J A M van Putten, Iris D Nagtegaal
Neurogenic bowel dysfunction occurs in a large percentage of adult patients with spina bifida (SB) and spinal cord injury (SCI), significantly affecting their quality of life. Although bowel motility is autonomously regulated by the enteric nervous system (ENS), disruption of the modulation of the ENS by extrinsic innervation as present in many patients with SB and SCI might lead to motility disorders. In order to gain insight in the pathophysiology, we studied histological changes of the neuromuscular structures in the colon of SB and SCI patients...
January 6, 2017: Virchows Archiv: An International Journal of Pathology
https://www.readbyqxmd.com/read/28059698/uk-national-data-guardian-for-health-and-care-s-review-of-data-security-trust-better-security-and-opt-outs
#10
Tom Chan, Concetta Tania Di Iorio, Simon De Lusignan, Daniel Lo Russo, Craig Kuziemsky, Siaw-Teng Liaw
Sharing health and social care data is essential to the delivery of high quality health care as well as disease surveillance, public health, and for conducting research. However, these societal benefits may be constrained by privacy and data protection principles. Hence, societies are striving to find a balance between the two competing public interests. Whilst the spread of IT advancements in recent decades has increased the demand for an increased privacy and data protection in many ways health is a special case...
December 20, 2016: Journal of Innovation in Health Informatics
https://www.readbyqxmd.com/read/28059038/toxicities-of-receptor-tyrosine-kinase-inhibitors-in-cancer-pharmacotherapy-management-with-clinical-pharmacology
#11
Ken-Ichi Fujita, Hiroo Ishida, Yutaro Kubota, Yasutsuna Sasaki
A number of molecularly targeted anticancer drugs that efficiently inhibit receptor tyrosine kinases, so-called receptor tyrosine kinase inhibitors (TKIs), have been developed. Although these receptor TKIs are generally well tolerated, unexpected toxicities sometimes occur in various organs. TKI-induced adverse events not only lower the quality of life of cancer patients but also reduce dose intensity, and sometimes result in treatment discontinuation. To reduce adverse drug events and increase treatment efficacy, oncologists and clinical pharmacologists have made efforts to establish strategies to treat patients via optimal selection and dosing of TKIs...
January 5, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28057193/weekday-and-weekend-food-advertising-varies-on-children-s-television-in-the-usa-but-persuasive-techniques-and-unhealthy-items-still-dominate
#12
M J Vilaro, T E Barnett, A M Watson, J W Merten, A E Mathews
OBJECTIVE: In 2006, food industry self-regulatory efforts aimed to balance the mix of food advertisements to limit children's exposure to unhealthy food products. An update to these efforts proposed to eliminate all unhealthy advertisements during peak child viewing times and implement uniform nutrition criteria by December, 2013. Marketing techniques are not currently addressed in self-regulatory efforts. The food industry's pledge prompted researchers to conduct a content analysis to assess nutritional quality and presence of persuasive marketing techniques in child-directed food and beverage advertisements...
January 2017: Public Health
https://www.readbyqxmd.com/read/28054655/unique-local-bone-tissue-characteristics-in-iliac-crest-bone-biopsy-from-adolescent-idiopathic-scoliosis-with-severe-spinal-deformity
#13
Zhiwei Wang, Huanxiong Chen, Y Eric Yu, Jiajun Zhang, Ka-Yee Cheuk, Bobby K W Ng, Yong Qiu, X Edward Guo, Jack C Y Cheng, Wayne Y W Lee
Adolescent idiopathic scoliosis is a complex disease with unclear etiopathogenesis. Systemic and persistent low bone mineral density is an independent prognostic factor for curve progression. The fundamental question of how bone quality is affected in AIS remains controversy because there is lack of site-matched control for detailed analysis on bone-related parameters. In this case-control study, trabecular bone biopsies from iliac crest were collected intra-operatively from 28 severe AIS patients and 10 matched controls with similar skeletal and sexual maturity, anthropometry and femoral neck BMD Z-score to control confounding effects...
January 5, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28054230/tumor-necrosis-factor-alpha-and-pregnancy-focus-on-biologics-an-updated-and-comprehensive-review
#14
REVIEW
Jaume Alijotas-Reig, Enrique Esteve-Valverde, Raquel Ferrer-Oliveras, Elisa Llurba, Josep Maria Gris
Tumor necrosis factor-α (TNF-α) is a central regulator of inflammation, and TNF-α antagonists may be effective in treating inflammatory disorders in which TNF-α plays a major pathogenic role. TNF-α has also been associated with inflammatory mechanisms related to implantation, placentation, and pregnancy outcome. TNF-α is secreted by immune cells and works by binding to TNFR1 and TNFR2 cell receptors. TNF-α is also related to JAK/STAT pathways, which opens up hypothetical new targets for modifying. The accurate balance between Th1 cytokines, mainly TNF-α, Th17, and Th2, particularly IL-10 is essential to achieve good obstetric outcomes...
January 4, 2017: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/28050999/retaining-health-workforce-in-rural-and-underserved-areas-of-india-what-works-and-what-doesn-t-a-critical-interpretative-synthesis
#15
REVIEW
Sonu Goel, Federica Angeli, Nidhi Bhatnagar, Neetu Singla, Manoj Grover, Hans Maarse
BACKGROUND: Human resource for health is critical in quality healthcare delivery. India, with a large rural population (68.8%), needs to urgently bridge the gaps in health workforce deployment between urban and rural areas. METHODS: We did a critical interpretative synthesis of the existing literature by using a predefined selection criteria to assess relevant manuscripts to identify the reasons for retaining the health workforce in rural and underserved areas. We discuss different strategies for retention of health workforce in rural areas on the basis of four major retention interventions, viz...
July 2016: National Medical Journal of India
https://www.readbyqxmd.com/read/28048520/we-a-brc-03-lessons-learned-iroc-audits
#16
D Followill
: Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047986/su-f-t-234-quality-improvements-in-the-electronic-medical-record-of-patients-treated-with-high-dose-rate-brachytherapy
#17
T Diener, D Wilkinson
PURPOSE: To improve workflow efficiency and patient safety by assessing the quality control documentation for HDR brachytherapy within our Electronic Medical Record System (Mosaiq). METHODS: A list of parameters based on NRC regulations, our quality management program (QMP), recommendations of the ACR and the American Brachytherapy Society, and HDR treatment planning risks identified in our previous FMEA study was made. Next, the parameter entries were classified according to the type of data input-manual, electronic, or both...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047772/we-a-brc-00-the-quality-gap
#18
Jatinder Palta
: Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047117/we-a-brc-01-introduction-to-the-certificate-course
#19
J Palta
: Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28046454/we-a-brc-02-lessons-learned-clinical-trials-and-operations
#20
S Evans
: Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted...
June 2016: Medical Physics
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