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Quality systems regulations

L Rodriguez-Prunotto, R Cano-de-la-Cuerda
INTRODUCTION: The incidence of stroke has increased in recent years, highlighting the role of prevention and identification of risk factors, as well as the analysis of their costs. At present, new technologies, specifically mobile applications, are considered as tools with potential benefits in patients with stroke care. AIM: To carry out a systematic review about the information related to potential or specifically designed mobile applications in the field of stroke, in order to classify them and carry out a description of the main characteristics of them...
April 1, 2018: Revista de Neurologia
Marc-Olivier Baradez, Daniela Biziato, Enas Hassan, Damian Marshall
Cell therapies offer unquestionable promises for the treatment, and in some cases even the cure, of complex diseases. As we start to see more of these therapies gaining market authorization, attention is turning to the bioprocesses used for their manufacture, in particular the challenge of gaining higher levels of process control to help regulate cell behavior, manage process variability, and deliver product of a consistent quality. Many processes already incorporate the measurement of key markers such as nutrient consumption, metabolite production, and cell concentration, but these are often performed off-line and only at set time points in the process...
2018: Frontiers in Medicine
P Scott Pine, Steven P Lund, Sanford A Stass, Debra Kukuruga, Feng Jiang, Lynn Sorbara, Sudhir Srivastava, Marc Salit
BACKGROUND: We demonstrate the feasibility of creating a pair of reference samples to be used as surrogates for clinical samples measured in either a research or clinical laboratory setting. The reference sample paradigm presented and evaluated here is designed to assess the capability of a measurement process to detect true differences between two biological samples. Cell-based reference samples can be created with a biomarker signature pattern designed in silico. Clinical laboratories working in regulated applications are required to participate in proficiency testing programs; research laboratories doing discovery typically do not...
March 20, 2018: BMC Biotechnology
Sandeep Kumar Verma, Ashok Kumar Das, Manoj Kumar Patel, Ashish Shah, Vinay Kumar, Saikat Gantait
With the overwhelmingly rapid advancement in the field of nanotechnology, the engineered nanomaterials (ENMs) have been extensively used in various areas of the plant system, including quality improvement, growth and nutritional value enhancement, gene preservation etc. There are several recent reports on the ENMs' influence on growth enhancements, growth inhibition as well as certain toxic impacts on plant. However, translocation, growth responses and stress modulation mechanisms of ENMs in the plant systems call for better and in-depth understanding...
March 3, 2018: Science of the Total Environment
John N Hahladakis, Eleni Iacovidou
While attention on the importance of closing materials loops for achieving circular economy (CE) is raging, the technicalities of doing so are often neglected or difficult to overcome. However, these technicalities determine the ability of materials to be properly recovered and redistributed for reuse or recycling, given the material, component and product (MCP) state and functionality. Materials have different properties that make them useful for various functions and purposes. A transition, therefore, towards a CE would require the utmost exploitation of all available routes that MCPs can be diverted to, based on their design, use and recovery; ideally, enabling a perpetual looping of them in the economy...
March 3, 2018: Science of the Total Environment
Sanaa Al Najjar, Tamer Al Shaer
BACKGROUND: To meet the emerging needs of the increasing numbers of patients with non-communicable diseases and to provide optimum care with optimum contact time and minimum waiting time, as stated in UNRWA guidelines, the mobile phone text messaging system was implemented in UNRWA centres to remind patients of upcoming appointments and to thereby improve the quality of care for vulnerable patients and regulate the work load in the clinics for non-communicable diseases. The aim of this study was to assess the causes for lack of adherence to the appointment system at UNRWA centres...
February 21, 2018: Lancet
Nanae Fukai, Ko Hiraoka, Shigeyuki Kajiki, Yuichi Kobayashi, Chatchai Thanachokswang, Sara Arphorn, Msamichi Uehara, Shigemoto Nakanishi, Koji Mori
We collected information necessary for conducting occupational health activities in Thailand with regard to occupational safety and health management systems (OSHMS). Based on an information collection check sheet developed in our previous research, we conducted a literature research and visited four local business bases, one ISO certification body and two higher educational institutions. The legal framework concerning occupational health in Thailand consists of the Occupational Safety, Health and Environment Act of 2011 and 13 ordinances from the Ministry of Labor under that act...
2018: Journal of UOEH
Xiao-Ying Fu, Hui-Min Guo, Wei Cong, Xiang-Cai Meng
The increasing demand of Chinese materia medica could not be supplied by wild resource, and the cultivated medicinal materials become popular, which led to decreased quality of many medicinal materials due to the difference of the circumstance between the wild and the cultivated. How to improve quality becomes key points of Chinese medicine resource. The leaves of Scutellaria baicalensis were sprayed with H₂O₂, the activities of superoxide dismutase (SOD) and catalase (CAT) changed little, but there had been a marked decrease of peroxidase (POD) and ascorbic oxidase (APX), which showed that the antioxidase system declined...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Helmut Trimmel, Christoph Beywinkler, Sonja Hornung, Janett Kreutziger, Wolfgang G Voelckel
BACKGROUND: Competence in emergency airway management is key in order to improve patient safety and outcome. The scope of compulsory training for emergency physicians or paramedics is quite limited, especially in Austria. The purpose of this study was to review the difficult airway management performance of an emergency medical service (EMS) in a region that has implemented a more thorough training program than current regulations require, comprising 3 months of initial training and supervised emergency practice and 3 days/month of on-going in-hospital training as previously reported...
March 16, 2018: International Journal of Emergency Medicine
Julia Pietilä, Elina Helander, Ilkka Korhonen, Tero Myllymäki, Urho M Kujala, Harri Lindholm
BACKGROUND: Sleep is fundamental for good health, and poor sleep has been associated with negative health outcomes. Alcohol consumption is a universal health behavior associated with poor sleep. In controlled laboratory studies, alcohol intake has been shown to alter physiology and disturb sleep homeostasis and architecture. The association between acute alcohol intake and physiological changes has not yet been studied in noncontrolled real-world settings. OBJECTIVE: The aim of this study was to assess the effects of alcohol intake on the autonomic nervous system (ANS) during sleep in a large noncontrolled sample of Finnish employees...
March 16, 2018: JMIR Mental Health
Elisea De Somma, Rajiv W Jain, Kelvin W C Poon, Kaitlyn A Tresidder, Julia P Segal, Nader Ghasemlou
There is mounting scientific evidence showing the importance of innate biological rhythms on disease onset and progression. Perhaps the most important of these is the circadian rhythm, a cycle of oscillations lasting approximately 24 hours. Recent work has shown that circadian rhythms are intrinsically linked to the immune system in a bidirectional fashion, and disruption of these cycles can contribute to changes in pathology and quality of life (including fatigue, mood, and disability). This is particularly true in diseases of the nervous and immune systems...
March 13, 2018: Neuroscience and Biobehavioral Reviews
Yimin Wang, Fang Ye, Chanyan Huang, Faling Xue, Yingyuan Li, Shaowei Gao, Zeting Qiu, Si Li, Qinchang Chen, Huaqiang Zhou, Yiyan Song, Wenqi Huang, Wulin Tan, Zhongxing Wang
BACKGROUND: Neuropathic pain is one of the common complications after spinal cord injury (SCI), affecting patients' life quality. The molecular mechanism for neuropathic pain after SCI is still unclear. We aimed to discover potential genes and MicroRNAs(miRNAs) related to neuropathic pain by bioinformatics method. METHODS: Microarray data of GSE69901 were obtained from Gene Expression Omnibus (GEO) database. Peripheral blood samples from patients with or without neuropathic pain after spinal cord injury (SCI) were collected...
March 15, 2018: Clinical Journal of Pain
H Rachidi, H Latrache
BACKGROUND: Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. OBJECTIVE: This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. METHOD: It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food...
March 12, 2018: Revue D'épidémiologie et de Santé Publique
Jane Barlow, Nadeeja Ins Herath, Christine Bartram Torrance, Cathy Bennett, Yinghui Wei
BACKGROUND: The first three years of a child's life are a key period of physical, physiological, cognitive and social development, and the caregiver-infant relationship in early infancy plays an important role in influencing these aspects of development. Specifically, caregiver attunement facilitates the move from coregulation to self-regulation; a parent's ability to understand their infant's behaviour as communication is a key part of this process. Early, brief interventions such as the Neonatal Behavioral Assessment Scale (NBAS) or Neonatal Behavioral Observation (NBO) system are potential methods of improving outcomes for both infant and caregiver...
March 14, 2018: Cochrane Database of Systematic Reviews
Marlysa B Sullivan, Matt Erb, Laura Schmalzl, Steffany Moonaz, Jessica Noggle Taylor, Stephen W Porges
Yoga therapy is a newly emerging, self-regulating complementary and integrative healthcare (CIH) practice. It is growing in its professionalization, recognition and utilization with a demonstrated commitment to setting practice standards, educational and accreditation standards, and promoting research to support its efficacy for various populations and conditions. However, heterogeneity of practice, poor reporting standards, and lack of a broadly accepted understanding of the neurophysiological mechanisms involved in yoga therapy limits the structuring of testable hypotheses and clinical applications...
2018: Frontiers in Human Neuroscience
Ornella Franzese, Maria Luisa Barbaccia, Enzo Bonmassar, Grazia Graziani
Since the introduction of highly active antiretroviral therapy more than 2 decades ago, HIV-related deaths have dramatically decreased and HIV infection has become a chronic disease. Due to the inability of antiretroviral drugs to eradicate the virus, treatment of HIV infection requires a systemic lifelong therapy. However, even when successfully treated, HIV patients still show increased incidence of age-associated co-morbidities compared with uninfected individuals. Virus- induced immunosenescence, a process characterized by a progressive decline of immune system function, contributes to the premature ageing observed in HIV patients...
March 13, 2018: Chemotherapy
Ruijie Liu, Youfeng Zhang, Jun Wang, Qiqi Pan, Yingqi Luo, Yujie Sun, Qingzhe Jin, Xingguo Wang
Contamination sources of polycyclic aromatic hydrocarbons (PAHs) in the raw material, oil production and storage processes of wood-pressed rapeseed oil were investigated in this study. The results showed that benzo[a]pyrene (BaP) and PAH4 (sum of BaP, benzo[a]fluoranthene, benzo[b]fluoranthene and chrysene) were unevenly distributed in the kernel (0.56-0.98 and 2.84-8.64 μg/kg, respectively) and hull (1.53-3.17 and 13.49-22.31 μg/kg, respectively) of the rapeseed raw materials. The contents of BaP and PAH4 continuously increased during the process of wood-pressed rapeseed oil, ranging from 2...
March 14, 2018: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
Jee Youn Hwang, Kesavan Markkandan, Mun Gyeong Kwon, Jung Soo Seo, Seung-Il Yoo, Seong Don Hwang, Maeng-Hyun Son, Junhyung Park
Olive flounder (Paralichthys olivaceus) is one of the most valuable marine aquatic species in South Korea and faces tremendous exposure to the viral hemorrhagic septicemia virus (VHSV). Given the growing importance of flounder, it is therefore essential to understand the host defense of P. olivaceus against VHSV infection, but studies on its immune mechanism are hindered by the lack of genomic resources. In this study, the P. olivaceus was infected with disease-causing VHSV isolates, ADC-VHS2012-11 and ADC-VHS2014-5 which showed moderate virulent (20% mortality) and high virulent (65% mortality), in order to investigate the effect of difference in pathogenicity in head kidney during 1, 3, 7 days of post-infection using Illumina sequencing...
March 9, 2018: Fish & Shellfish Immunology
Aditi Kulkarni, Jessica Chen, Sandra Maday
Neurons are particularly dependent on robust quality control pathways to maintain cellular homeostasis and functionality throughout their extended lifetime. Failure to regulate protein and organelle integrity is linked to devastating neurodegenerative diseases. Autophagy is a lysosomal degradation pathway that maintains homeostasis by recycling damaged or aged cellular components. Autophagy has important functions in development of the nervous system, as well as in neuronal function and survival. In fact, defects in autophagy underlie neurodegeneration in mice and humans...
March 9, 2018: Current Opinion in Neurobiology
Yiqing Yang, Ruiqiong Guo, Kristen Gaffney, Miyeon Kim, Shaima Muhammednazaar, Wei Tian, Boshen Wang, Jie Liang, Heedeok Hong
ATP-dependent protein degradation mediated by AAA+ proteases is one of the major cellular pathways for protein quality control and regulation of functional networks. While a majority of studies of protein degradation have focused on water-soluble proteins, it is not well understood how membrane proteins with abnormal conformation are selectively degraded. The knowledge gap stems from the lack of an in vitro system in which detailed molecular mechanisms can be studied as well as difficulties in studying membrane protein folding in lipid bilayers...
March 12, 2018: Journal of the American Chemical Society
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