Impact of axial burnup profile on criticality safety of ANPP spent fuel cask

International Nuclear Information System (INIS)

Bznuni, S.

2006-01-01

Criticality safety assessment for WWER-440 NUHOMS cask with spent nuclear fuel from Armenian NPP has been performed. The cask was designed in such way that the neutron multiplication factor k eff must be below 0,95 for all operational modes and accident conditions. Usually for criticality analysis, fresh fuel approach with the highest enrichment is taken as conservative assumption as it was done for ANPP. NRSC ANRA in order to improve future fuel storage efficiency initiated research with taking into account burn up credit in the criticality safety assessment. Axial burn up profile (end effect) has essential impact on criticality safety justification analysis. However this phenomenon was not taken into account in the Safety Analysis Report of NUHOMS spent fuel storage constructed on the site of ANPP. Although ANRA does not yet accept burn up credit approach for ANPP spent fuel storage, assessment of impact of axial burnup profile on criticality of spent fuel assemblies has important value for future activities of ANRA. This paper presents results of criticality calculations of spent fuel assemblies with axial burn up profile. Horizontal burn up profile isn't taken account since influence of the horizontal variation of the burn up is much less than the axial variation. The actinides and actinides + fission products approach are discussed. The calculations were carried out with STARBUCS module of SCALE 5.0 code package developed at Oak Ridge National laboratory. SCALE5.0 sequence CSAS26 (KENO-VI) was used for evaluation the k eff for 3-D problems. Obtained results showed that criticality of ANPP spent fuel cask is very sensitive to the end effect

The Nuclear Safety Convention - does it confirm existing German law, and update international law?

International Nuclear Information System (INIS)

Lindemann, C.

1995-01-01

Some selected examples are discussed that are intended to answer the question of whether the NSC in its essence represents a development in confirmation of existing German nuclear law, and whether, assuming its coming into effect, this Convention will mean a step forward in the development of international law. The author examines the value of this codification of international law as such, and some of the obligations and standards such as retrofitting measures or shutdown of reactors below safety standard, and continues with briefly discussing the relationship between the NSC and nuclear liability law, the planned provisions for radiological protection in Art. 15, and the obligations for transboundary notification of safety-relevant events. These stipulations are analysed in comparison to existing international law, and with a view to their implementation under German law. Some provisions of the NSC that are based on standards of international technical guidance are compared with German regulatory guides. (orig./HP) [de

Improved Safety and Efficacy of Small-Bore Feeding Tube Confirmation Using an Electromagnetic Placement Device.

Science.gov (United States)

Powers, Jan; Luebbehusen, Michael; Aguirre, Lillian; Cluff, Julia; David, Mary Ann; Holly, Vince; Linford, Lorraine; Park, Nancy; Brunelle, Rocco

2018-04-01

Early enteral nutrition has been shown to decrease complications and improve patient outcomes. Post pyloric feeding is recommended for patients with gastric intolerance or at high risk for aspiration. Feeding tube placement can be challenging and pose risk of pulmonary complications. Reliance on radiographic confirmation for feeding tube placement exposes the patient to radiation. Electromagnetic placement device (EMPD) may offer a method to minimize pulmonary complications, increase successful placement, and decrease radiation exposure to the patient. The purpose of this study was to evaluate the safety and efficacy of using EMPD verification, instead of routine abdominal radiographic confirmation, for small-bore feeding tube placement. Variables evaluated were adverse events, utilization of radiographs for confirmation, and success rate of feeding tube placement in the ordered location. Two time frames were reviewed. In a 1-year period, 3754 small-bore feeding tubes were placed using EMPD, with zero adverse events noted. Radiographic confirmation was utilized in 0%-29.2% of the EMPD placed tubes. Successful placement of feeding tubes using EMPD ranged from 94%-99.6%. During a 5-year period, 7081 EMPD feeding tubes were evaluated. One adverse event, pneumothorax, occurred during the placement of these 7081 tubes, for a rate of 0.014%. Feeding tube placement confirmation is safe and efficacious via EMPD providing an effective method of feeding tube placement with a success rate >94% into the desired location. EMPD is an accurate verification method of distal tip location, eliminating the need for routine abdominal radiographic confirmation. © 2018 American Society for Parenteral and Enteral Nutrition.

Assessment of oral safety profile of aqueous extract blend of three ...

African Journals Online (AJOL)

... did not reveal any pathological changes attributable to treatment with the spice blend extract. Conclusions: These findings indicate that oral consumption of a spice blend of garlic, ginger and cayenne pepper in humans may be safe. Keywords: Spice blend, Toxicity, Histology, Marker enzymes, Medicinal, Safety profile ...

Obtention to the methodology for evaluation to the confirmation of the hazardous wastes safety isolation

International Nuclear Information System (INIS)

Peralta, J.L.; Gil, R.; Castillo, R.; Leyva, D.

2003-01-01

Taking into account, the practical experience of the safety assessment in the radioactive wastes management, the International Atomic Energy Agency (IAEA) recommendations in this topics, the norms and national and international legislation about noxious substances to the environment and their restriction limits, the best international practices and approaches of isolation hazardous wastes sites, a Methodology is developed (Cuba particular conditions) to obtaining and/or confirmation of the hazardous wastes safety isolation, as a tool able to carry out the assessment of facilities to build and all installation and/or place where hazardous wastes isolated from the environment. The Methodology, embraces the evaluation of technical, economic and social topics, allowing to develop an integral safety assessment which allows to estimate the environment possible impact for hazardous waste isolation (radioactive and non radioactive); Just are shown in this paper the selection approaches for the obtaining and/or evaluation of the best site, the steps description to continue for the definition of the main scenarios and the models to take into account in the valuation of the possible liberation and pathway to the environment of the non radioactive pollutants. The main contribution of this Methodology resides in the creation of a scientific-technique necessary guide for the evident demand of carrying out the most organized, effective and hazardous wastes safety management

Method of calculating the safety factor profile on the HT-7 tokamak

International Nuclear Information System (INIS)

Zhang Xianmei; Lu Yuancheng; Wan Baonian

2001-01-01

A method of calculating the safety factor profile on the HT-7 tokamak has been described. It is derived from Maxwell's equations, among which the authors mainly use two of them: one is the magnetic field diffusion equation, and the other is Ampere's Law. This method can be also used to evaluate the safety factor on other devices with a circular cross sections. It is helpful to the study of the plasma MHD behavior on the HT-7 tokamak

Safety factor profile dependence of turbulent structure formation in relevant to internal transport barrier relaxation

International Nuclear Information System (INIS)

Tokunaga, S.; Yagi, M.; Itoh, S.-I.; Itoh, K.

2009-01-01

Full text: It is widely understood that the improved confinement mode with transport barrier is necessary to achieve the self-ignition condition in ITER. The negative magnetic shear, mean ExB flow shear, and zonal flow are considered to play important roles for ITB formation. In our previous study, it is found that the non-linear interaction between the meso-scale modes produces non-local energy transfer to the off-resonant mode in the vicinity of q min surface and brings global relaxation of the temperature profile involving ITB collapse. Experimental studies indicate that a relationship exists between the ITB formation and safety factor q-profile, with a reversed magnetic shear (RS) configuration. Transitional ITB events occur on the low-order rational resonant surface. The ITB shape and location depend on the q-profile and q min position. These observations indicate that the q-profile might play an essential role in determining the turbulent structure. In this study, the effect of safety factor profile on the ion temperature gradient driven drift wave (ITG) turbulence is investigated using a global non-linear simulation code based on the gyro-fluid model. A heat source and toroidal momentum source are introduced. Dependence of safety factor profiles on ITB formation and its stability is examined to clarify the influence of the radial distribution of the rational surfaces and the q min value. It is found that the nonlinearly excited meso-scale mode in the vicinity of q min depends on the value of q min . A detailed analysis of the structure selection rule is in progress. (author)

Demonstration of Risk Profiling for promoting safety in SME´s

DEFF Research Database (Denmark)

Jørgensen, Kirsten; Duijm, Nijs Jan; Troen, Hanne

2011-01-01

Purpose – The purpose of this paper is to identify and assess the risks and potential risks that may lead to accidents. It aims to look at how to improve risk assessment within SMEs for the benefit of all staff. Design/methodology/approach – The research included results from a Dutch project which...... identifies accident risks and safety barriers that are presented in a huge database and risk calculator. The method was first to develop a simple way of accessing this enormous amount of data, second, to develop a tool to observe risks and safety barriers in SMEs and to investigate the usefulness...... of the developed tools in real life, third, to collect data on risks and safety barriers in SMEs for two occupations by following 20 people for three days each and to create a risk profile for each occupations. Findings – The result is a simple way to go through all types of risks for accidents – a tool for risk...

Efficacy and Safety Profile of Tricyclo-DNA Antisense Oligonucleotides in Duchenne Muscular Dystrophy Mouse Model

Directory of Open Access Journals (Sweden)

Karima Relizani

2017-09-01

Full Text Available Antisense oligonucleotides (AONs hold promise for therapeutic splice-switching correction in many genetic diseases. However, despite advances in AON chemistry and design, systemic use of AONs is limited due to poor tissue uptake and sufficient therapeutic efficacy is still difficult to achieve. A novel class of AONs made of tricyclo-DNA (tcDNA is considered very promising for the treatment of Duchenne muscular dystrophy (DMD, a neuromuscular disease typically caused by frameshifting deletions or nonsense mutations in the gene-encoding dystrophin and characterized by progressive muscle weakness, cardiomyopathy, and respiratory failure in addition to cognitive impairment. Herein, we report the efficacy and toxicology profile of a 13-mer tcDNA in mdx mice. We show that systemic delivery of 13-mer tcDNA allows restoration of dystrophin in skeletal muscles and to a lower extent in the brain, leading to muscle function improvement and correction of behavioral features linked to the emotional/cognitive deficiency. More importantly, tcDNA treatment was generally limited to minimal glomerular changes and few cell necroses in proximal tubules, with only slight variation in serum and urinary kidney toxicity biomarker levels. These results demonstrate an encouraging safety profile for tcDNA, albeit typical of phosphorothiate AONs, and confirm its therapeutic potential for the systemic treatment of DMD patients. Keywords: antisense oligonucleotides, Duchenne muscular dystrophy, preclinical, splice switching, tcDNA-AONs

Safety against formation of through cracks of profiled fibre-reinforced cement sheets for roofing

DEFF Research Database (Denmark)

Hansen, Klavs Feilberg; Stang, Birgitte Friis Dela

2009-01-01

  Loads due to wind, snow or traffic on a roof determine the requirements to the strength and stiffness properties of profiled sheets for roofing. Apart from these loads, locked-in stresses can occur due to differences in temperature and moisture strains in the profiled sheets and the wooden laths...... supporting the sheets. These tensile and compressive stresses are induced in the sheets if they are firmly fastened to the laths with fastening screws. The purpose of this investigation was to analyse the safety of the profiled sheets in transmitting these loads without the formation of through cracks...

The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

Science.gov (United States)

Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

2016-01-01

With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Safety factor profile control in a tokamak

CERN Document Server

Bribiesca Argomedo, Federico; Prieur, Christophe

2014-01-01

Control of the Safety Factor Profile in a Tokamak uses Lyapunov techniques to address a challenging problem for which even the simplest physically relevant models are represented by nonlinear, time-dependent, partial differential equations (PDEs). This is because of the  spatiotemporal dynamics of transport phenomena (magnetic flux, heat, densities, etc.) in the anisotropic plasma medium. Robustness considerations are ubiquitous in the analysis and control design since direct measurements on the magnetic flux are impossible (its estimation relies on virtual sensors) and large uncertainties remain in the coupling between the plasma particles and the radio-frequency waves (distributed inputs). The Brief begins with a presentation of the reference dynamical model and continues by developing a Lyapunov function for the discretized system (in a polytopic linear-parameter-varying formulation). The limitations of this finite-dimensional approach motivate new developments in the infinite-dimensional framework. The t...

Modifying locally the safety profile to improve the confinement of magnetic field lines in tokamak plasmas

International Nuclear Information System (INIS)

Constantinescu, D.; Firpo, M.-C.

2012-01-01

Using Hamiltonian models for the magnetic field lines, we propose a methodology to improve their confinement through the creation of transport barriers. A local modification of the safety profile creating a low-shear zone is shown to be sufficient to locally enhance drastically the regularity of the magnetic field lines without requesting a reversed shear. The optimal benefits of low-shear are obtained when the value q 0 of the safety profile in the low-shear zone is sufficiently far from the main resonance values m/n with low m and n, in the case of large enough values of those (m, n) mode amplitudes. A practical implementation in tokamak plasmas should involve electron cyclotron current drive to locally modify the magnetic shear. (paper)

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

Science.gov (United States)

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

NSC confirms principles for safety review on Radioactive Waste Burial Facilities

International Nuclear Information System (INIS)

Anon.

1988-01-01

The Nuclear Safety Commission authorized the scope of Principles for Safety Examination on Radioactive Waste Burial Facilities as suitable, the draft report for which was established by the Special Committee on Safety Standards of Radioactive Waste (Chairman Prof. Masao Sago, Science University of Tokyo) and reported on March 10 to the NSC. The principles include the theory that the facility must be controlled step by step, corresponding to the amount of radioactivity over 300 to 400 years after the burial of low-level solid radioactive waste with site conditions safe even in the event of occurrence of a natural disaster. The principles will be used for administrative safety examination against the application of the business on low-level radioactive waste burial facility which Japan Nuclear Fuel Industries, Inc. is planning to install at Rokkashomura, Aomori Prefecture. (author)

Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

Directory of Open Access Journals (Sweden)

M. Varenna

2013-10-01

Full Text Available The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.

Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

Science.gov (United States)

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; De Maeyer, J H; Stanghellini, V

2012-04-01

The nonselective 5-HT(4) receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT(4) agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006-2008 and DDW 2008-2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT(4) agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT(4) agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT(1) receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT(4) agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT(4) agonists with no hERG or 5-HT(1) affinity (renzapride, clebopride, mosapride). 5-HT(4) agonists for GI disorders differ in chemical structure and selectivity for 5-HT(4) receptors. Selectivity for 5-HT(4) over non-5-HT(4) receptors may influence the agent's safety and overall risk-benefit profile. Based on available evidence, highly selective 5-HT(4) agonists may offer improved safety to treat patients with impaired GI motility. © 2012 Blackwell Publishing Ltd.

Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

Science.gov (United States)

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

2012-01-01

Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

Relative safety profiles of high dose statin regimens

Directory of Open Access Journals (Sweden)

Carlos Escobar

2008-06-01

Full Text Available Carlos Escobar, Rocio Echarri, Vivencio BarriosDepartment of Cardiology, Hospital Ramón y Cajal, Madrid, SpainAbstract: Recent clinical trials recommend achieving a low-density lipoprotein cholesterol level of <100 mg/dl in high-risk and <70 mg/dl in very high risk patients. To attain these goals, however, many patients will need statins at high doses. The most frequent side effects related to the use of statins, myopathy, rhabdomyolysis, and increased levels of transaminases, are unusual. Although low and moderate doses show a favourable profile, there is concern about the tolerability of higher doses. During recent years, numerous trials to analyze the efficacy and tolerability of high doses of statins have been published. This paper updates the published data on the safety of statins at high doses.Keywords: statins, high doses, tolerability, liver, muscle

Postmarketing cohort study to assess the safety profile of oral dexketoprofen trometamol for mild to moderate acute pain treatment in primary care.

Science.gov (United States)

Carne, Xavier; Rios, Jose; Torres, Ferran

2009-10-01

Recently, new concerns on the safety profile of nonsteroidal anti-inflammatory drugs (NSAIDs) have been raised by the European Medicines Agency (EMEA) and other regulatory authorities. The safety profile of oral dexketoprofen trometamol for the treatment of acute mild to moderate pain of different causes in actual conditions of use in the primary care setting was assessed. A prospective cohort study was designed to evaluate the tolerability of dexketoprofen compared with other commonly prescribed analgesics. Medications were given according to specifications in the summary of product characteristics. The intensity of pain was assessed at baseline and at days 1 and 7 of drug treatment using a 100-mm visual analog scale (VAS). Adverse events (AEs) were recorded. A total of 7,337 patients (median age [IQR] = 46 [33-61] years) were included in the study comparing dexketoprofen (n = 5,429), diclofenac (n = 485), ibuprofen (n = 479), paracetamol (n = 459), metamizole (n = 207), aceclofenac (n = 103), naproxen (n = 74), piroxicam (n = 69) and dexibuprofen (n = 32). The reasons for use were: musculoskeletal disorders, headache, dysmenorrhea and odontalgia. Treatment compliance was very high. Metamizole-paracetamol and dexketoprofen showed the lowest prevalence of AEs (2.7% and 3.6%, respectively), while aceclofenac-diclofenac showed the highest prevalence (8.2%) (P dexketoprofen, 1.57 (0.79-3.13) for ibuprofen and dexibuprofen, 2.31 (0.64-8.27) for naproxen, 2.63 (0.85-8.15) for piroxicam and 3.37 (1.87-6.06) for aceclofenac-diclofenac. These results confirm the safety of oral treatment with dexketoprofen in patients with acute pain of various etiologies observed in previous studies and support the use of dexketoprofen as a first-line drug for the approved therapeutic indications. Copyright 2009 Prous Science, S.A.U. or its licensors. All rights reserved.

New geometric design consistency model based on operating speed profiles for road safety evaluation.

Science.gov (United States)

Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

2013-12-01

To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

Directory of Open Access Journals (Sweden)

Moataz Alhaj

2016-01-01

Full Text Available Rift Valley Fever (RVF is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA, a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control.

Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

Science.gov (United States)

Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

2017-07-01

Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Recent RF Experiments and Application of RF Waves to Real-Time Control of Safety Factor Profile in JT-60U

International Nuclear Information System (INIS)

Suzuki, T.; Isayama, A.; Ide, S.; Fujita, T.; Oikawa, T.; Sakata, S.; Sueoka, M.; Hosoyama, H.; Seki, M.

2005-01-01

Two topics of applications of RF waves to current profile control in JT-60U are presented; application of lower-hybrid (LH) waves to safety factor profile control and electron cyclotron (EC) waves to neo-classical tearing mode (NTM) control. A real-time control system of safety factor (q) profile was developed. This system, for the first time, enables 1) real time evaluation of q profile using local magnetic pitch angle measurement by motional Stark effect (MSE) diagnostic and 2) control of current drive (CD) location (ρCD) by controlling the parallel refractive index N parallel of LH waves through control of phase difference (Δφ) of LH waves between multi-junction launcher modules. The method for real-time q profile evaluation was newly developed, without time-consuming reconstruction of equilibrium, so that the method requires less computational time. Safety factor profile by the real-time calculation agrees well with that by equilibrium reconstruction with MSE. The control system controls ρCD through Δφ in such a way to decrease the largest residual between the real-time evaluated q profile q(r) and its reference profile qref(r). The real-time control system was applied to a positive shear plasma (q(0)∼1). The reference q profile was set to monotonic positive shear profile having qref(0)=1.3. The real-time q profile approached to the qref(r) during application of real-time control, and was sustained for 3s, which was limited by the duration of the injected LH power. Temporal evolution of current profile was consistent with relaxation of inductive electric field induced by theoretical LH driven current. An m/n=3/2 NTM that appeared at βN∼3 was completely stabilized by ECCD applied to a fully-developed NTM. Precise ECCD at NTM island was essential for the stabilization. ECCD that was applied to resonant rational surface (q=3/2) before an NTM onset suppressed appearance of NTM. In order to keep NTM intensity below a level, ECCD before the mode onset was

Recurrent Acute Respiratory Infections in Children: Effectiveness and Safety of Phytotherapy

Directory of Open Access Journals (Sweden)

V. P. Vavilova

2015-01-01

Full Text Available Recurrent respiratory infections in children lead to physical development disorders, formation of chronic nidi of infection, failure of adaptive mechanisms and degradation o immunobiological resisting barriers; this causes development of new diseases. Results of the presented non interventional clinical study confirm high safety profile and effectiveness of a therapeutic phytopreparation for recurrent respiratory infections. 

Toxicity and Safety Profiles of Methanolic Extract of Pistacia integerrima J. L. Stewart ex Brandis (PI for Wistar Rats

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Gotmi Sharwan

2016-09-01

Full Text Available Objectives: The goals of this research were to evaluate acute (single-dose and sub-acute (repeated-dose toxicity profiles of methanolic extract of Pistacia integerrima J. L. Stewart ex Brandis (PI for Wistar rats and to assess the safety profile of PI by observing physiological changes, mortality, changes in body weight

Safety profile of the 9-valent HPV vaccine

DEFF Research Database (Denmark)

Moreira, Edson D; Block, Stan L; Ferris, Daron G

2016-01-01

OBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6....... More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive...... for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS: The most common AEs (≥5%) experienced by 9vHPV vaccine recipients...

Input-profile-based software failure probability quantification for safety signal generation systems

International Nuclear Information System (INIS)

Kang, Hyun Gook; Lim, Ho Gon; Lee, Ho Jung; Kim, Man Cheol; Jang, Seung Cheol

2009-01-01

The approaches for software failure probability estimation are mainly based on the results of testing. Test cases represent the inputs, which are encountered in an actual use. The test inputs for the safety-critical application such as a reactor protection system (RPS) of a nuclear power plant are the inputs which cause the activation of protective action such as a reactor trip. A digital system treats inputs from instrumentation sensors as discrete digital values by using an analog-to-digital converter. Input profile must be determined in consideration of these characteristics for effective software failure probability quantification. Another important characteristic of software testing is that we do not have to repeat the test for the same input value since the software response is deterministic for each specific digital input. With these considerations, we propose an effective software testing method for quantifying the failure probability. As an example application, the input profile of the digital RPS is developed based on the typical plant data. The proposed method in this study is expected to provide a simple but realistic mean to quantify the software failure probability based on input profile and system dynamics.

Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

OpenAIRE

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

2012-01-01

Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) an...

Core radial power profile effect on system and core cooling behavior during reflood phase of PWR-LOCA with CCTF data

International Nuclear Information System (INIS)

Akimoto, Hajime; Iguchi, Tadashi; Murao, Yoshio

1985-01-01

In the reactor safety assessment during reflood phase of a PWR-LOCA, it is assumed implicitly that the core thermal hydraulic behavior is evaluated by the one-dimensional model with an average power rod. In order to assess the applicability of the one-dimensional treatment, integral tests were performed with various core radial power profiles using the Cylindrical Core Test Facility (CCTF) whose core includes about 2,000 heater rods. The CCTF results confirm that the core radial power profile has weak effect on the thermal hydraulic behavior in the primary system except core. It is also confirmed that the core differential pressure in the axial direction is predicted by the one-dimensional core model with an average power rod even in the case with a steep radial power profile in the core. Even though the core heat transfer coefficient is dependent on the core radial power profile, it is found that the error of the peak clad surface temperature calculation is less than 15 K using the one-dimensional model in the CCTF tests. The CCTF results support the one-dimensional treatment assumed in the reactor safety assessment. (author)

Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial.

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Jörg Täubel

Full Text Available Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This study was conducted to evaluate the pharmacokinetics (PK, pharmacodynamics (PD, safety and tolerability of rupatadine in healthy Japanese subjects after single and multiple oral doses.In this randomised, double-blind, placebo-controlled study, 27 male and female healthy Japanese subjects were administered single and multiple escalating rupatadine dose of 10, 20 and 40 mg or placebo. Blood samples were collected at different time points for PK measurements and subjects were assessed for safety and tolerability. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP, reaction time (RT, spatial working memory (SWM and visual analogue scales (VAS.Exposure to rupatadine as measured by Cmax and AUC was found to increase in a dose dependent manner over the dose range of 10-40 mg for both single and multiple dose administration. The safety assessments showed that all treatment related side effects were of mild intensity and there were no serious adverse events (SAEs or withdrawals due to treatment-emergent adverse events (TEAEs in this study. The therapeutic dose of rupatadine did not show any CNS impairment in any of the cognitive tests.This study demonstrated that rupatadine is safe and well tolerated by Japanese healthy subjects. The PK-PD profile confirmed previous experience with rupatadine.

Soundness confirmation through cold test of the system equipment of HTTR

International Nuclear Information System (INIS)

Ono, Masato; Shinohara, Masanori; Iigaki, Kazuhiko; Tochio, Daisuke; Nakagawa, Shigeaki; Shimazaki, Yosuke

2014-01-01

HTTR was established at the Oarai Research and Development Center of Japan Atomic Energy Agency, for the purpose of the establishment and upgrading of high-temperature gas-cooled reactor technology infrastructure. Currently, it performs a safety demonstration test in order to demonstrate the safety inherent in high-temperature gas-cooled reactor. After the Great East Japan Earthquake, it conducted confirmation test for the purpose of soundness survey of facilities and equipment, and it confirmed that the soundness of the equipment was maintained. After two years from the confirmation test, it has not been confirmed whether the function of dynamic equipment and the soundness such as the airtightness of pipes and containers are maintained after receiving the influence of damage or deterioration caused by aftershocks generated during two years or aging. To confirm the soundness of these facilities, operation under cold state was conducted, and the obtained plant data was compared with confirmation test data to evaluate the presence of abnormality. In addition, in order to confirm through cold test the damage due to aftershocks and degradation due to aging, the plant data to compare was supposed to be the confirmation test data, and the evaluation on abnormality of the plant data of machine starting time and normal operation data was performed. (A.O.)

Psychosocial influences on safety climate: evidence from community pharmacies.

Science.gov (United States)

Phipps, Denham L; Ashcroft, Darren M

2011-12-01

To examine the relationship between psychosocial job characteristics and safety climate. Cross-sectional survey. Community pharmacies in Great Britain. Participants A random sample of community pharmacists registered in Great Britain (n = 860). Survey instruments Effort-reward imbalance (ERI) indicator and Job Content Questionnaire (JCQ). Main outcome measures Pharmacy Safety Climate Questionnaire (PSCQ). The profile of scores from the ERI indicated a relatively high risk of adverse psychological effects. The profile of scores from the JCQ indicated both high demand on pharmacists and a high level of psychological and social resources to meet these demands. Path analysis confirmed a model in which the ERI and JCQ measures, as well as the type of pharmacy and pharmacist role, predicted responses to the PSCQ (χ(2)(36) = 111.38, p demand) accounted for the effect of job characteristics on safety climate ratings; each had differential effects on the PSCQ scales. The safety climate in community pharmacies is influenced by perceptions of job characteristics, such as the level of job demands and the resources available to meet these demands. Hence, any efforts to improve safety should take into consideration the effect of the psychosocial work environment on safety climate. In addition, there is a need to address the presence of work-related stressors, which have the potential to cause direct or indirect harm to staff and service users. The findings of the current study provide a basis for future research to improve the safety climate and well-being, both in the pharmacy profession and in other healthcare settings.

Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States

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Jara M

2015-12-01

Full Text Available Michele Jara, Thomas Aquilina, Peter Aupperle, Adrian L Rabinowicz Acorda Therapeutics, Inc., Ardsley, NY, USA Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine outside the US, 10 mg twice daily, was approved by the US Food and Drug Administration (FDA in January 2010 to improve walking in people with multiple sclerosis, as determined by an increase in walking speed. Objective: To provide a descriptive analysis of reported adverse events (AEs for commercially available dalfampridine-ER from March 2010 through March 31, 2015. Methods: Five-year postmarketing data for dalfampridine-ER were available from the exposure of approximately 107,000 patients in the US (103,700 patient-years. Commonly reported AEs (≥2% of all reported AEs and serious AEs were determined. The incidence of reported seizures was determined and the events were further investigated. Results: Among the 107,000 patients exposed to dalfampridine-ER (70% female; mean age 52.1, the most common AEs were dizziness (3.7%, insomnia (3.2%, balance disorder (3%, fall (2.4%, headache (2.4%, nausea (2.1%, and urinary tract infection (2%. Other common AEs were drug ineffectiveness (5.8%, gait disturbance (4.6%, and inappropriate dosing (3.1%. Serious AEs included rare anaphylactic reactions (five cases and drug hypersensitivity reactions (eight cases. A total of 657 seizure cases were reported (6.3/1,000 patient-years; of these, 324 were medically confirmed (3.1/1,000 patient-years. Incidence of reported seizures was stable over time. Duration of treatment prior to a seizure ranged from a single dose to >4 years; 12% of the seizures occurred within a week of starting treatment. Conclusion: The 5-year US postmarketing safety data of dalfampridine-ER is consistent with the safety profile observed in clinical trials. Incidence of reported seizures remained stable over time. Since commercial availability in March 2010, a

[Safety profile of zolpidem: two studies of 3805 patients by Swiss practitioners].

Science.gov (United States)

Ganzoni, E; Gugger, M

1999-06-24

Evaluation and treatment of insomnia are frequent procedures in the physician's everyday practice, since many patients seek medical treatment for this condition. Knowledge of pharmacological therapeutical alternatives is therefore decisive, in order to identify the most efficaceous and safe therapy for the patient among the available hypnotics. The short-acting hypnotic zolpidem has been investigated in Switzerland in two multicenter safety studies in ambulatory practice. In the first study 8.9% (n = 125 of 1,972 treated patients), and in the second 7.2% of the patients (n = 175 of 1,833 treated patients) reported an adverse event. The most frequent events were related to the central nervous system (CNS) (somnolence, headache, confusion, vertigo); gastrointestinal and cutaneous symptoms were the most frequent non CNS-dependent effects. New, unknown or serious adverse events were not found and no specific risk factor or population at risk was identified. The safety profile of zolpidem is consistent with its known pharmacological properties, the results of previous clinical trials and the international experience obtained in large patients groups.

Analysis of some accident conditions in confirmation of the HTGR safety

Energy Technology Data Exchange (ETDEWEB)

Grebennik, V. N.; Grishanin, E. I.; Kukharkin, N. E.; Mikhailov, P. V.; Pinchuk, V. V.; Ponomarev-Stepnoy, N. N.; Fedin, G. I.; Shilov, V. N.; Yanushevich, I. V. [Gosudarstvennyj Komitet po Ispol' zovaniyu Atomnoj Ehnergii SSSR, Moscow. Inst. Atomnoj Ehnergii

1981-01-15

This report concerns some accident conditions for the HTGR-50 demonstrational reactor which along with the safety features common to the typical HTGR differs in design. The analyses carried out on the accident situations showed that due to the high heat capacity of the graphite core and negative temperature effect of the reactivity the HTGR-50 reactor is effectively selfcontrolled at different perturbations of the reactivity and has low sensitivity to the failure of the core cooling. The primary circuit depressurization accident should be thoroughly studied because of the dangerous consequences i.e. the core overheating and the reactivity release into the environment. As a whole, the studies now in progress show that the problem of the HTGR safety can be successfully solved.

Analysis of some accident conditions in confirmation of the HTGR safety

International Nuclear Information System (INIS)

Grebennik, V.N.; Grishanin, E.I.; Kukharkin, N.E.; Mikhailov, P.V.; Pinchuk, V.V.; Ponomarev-Stepnoy, N.N.; Fedin, G.I.; Shilov, V.N.; Yanushevich, I.V.

1981-01-01

This report concerns some accident conditions for the HTGR-50 demonstrational reactor which along with the safety features common to the typical HTGR differs in design. The analyses carried out on the accident situations showed that due to the high heat capacity of the graphite core and negative temperature effect of the reactivity the HTGR-50 reactor is effectively selfcontrolled at different perturbations of the reactivity and has low sensitivity to the failure of the core cooling. The primary circuit depressurization accident should be thoroughly studied because of the dangerous consequences i.e. the core overheating and the reactivity release into the environment. As a whole, the studies now in progress show that the problem of the HTGR safety can be successfully solved

The French methodology for EBS confirmation and demonstration

International Nuclear Information System (INIS)

Plas, F.; Voinis, S.; Mayer, S.

2007-01-01

The December 30, 1991 French Waste Act entrusted ANDRA, the French national agency for radioactive waste management, with the task of assessing the feasibility of deep geological disposal of high- and medium-level long-lived waste (HLW and ILW, respectively C-waste and B-waste types in French) plus spent fuel (CU in French). In that context, the 'Dossier 2005 Argile' submitted by ANDRA presents the feasibility assessment - with regard to the technical capacity to accommodate all wastes, to reversibility, and to safety - of a radioactive waste disposal in a clay formation studied at the Meuse/Haute-Marne URL. This report was built upon an iterative approach between site characterisation, design, modelling, phenomenological analysis and safety analysis, in which two principles always guided the elaboration of the safety case: the principle of robustness - repository components must maintain their functionality given reasonable solicitations, taking into account uncertainties on the nature and level of these solicitations; and the principle of demonstrability - safety must be verified without requiring complex demonstrations, and based on multiple lines of evidence/argument (numerical simulation, qualitative arguments such as use of natural analogues, experiments and technological demonstrators). In that respect, the EBS definition, demonstration and confirmation of design is a part of the overall safety case. The 'Dossier 2005 Argile' was submitted to three independent peer reviews. The aim. of this article is to present the methodology that ANDRA implemented in the context of 'Dossier 2005 Argile' for defining, demonstrating and confirming the EBS design as well as the future programme with respect with the new Act of 28 June 2006. (author)

Safety confirmation study of TRUEX solvent by accelerating rate calorimeter (ARC)

International Nuclear Information System (INIS)

Sato, Yoshihiko; Hirumachi, Suguru; Takeda, Shinso; Kanazawa, Yoshito; Sasaya, Shinji

1999-02-01

In order to confirm the engineering safety on the TRUEX solvent (mixed solvent of CMPO/TBP/n-dodecane) for separating the transuranics from high-level activity liquid waste in advanced nuclear fuel recycling technological R and D, thermal behavior and pressure behavior in heating PUREX solvent (mixed solvent of 30% TBP-n-dodecane), TRUEX solvent and in the exothermic reaction of TRUEX solvent etc. and nitric acid in sealed adiabatic system which was severer condition than actual plant were measured by using accelerating rate calorimeter (ARC). The Arrhenius parameters (activation energy and frequency factor) which are necessary for the evaluation of reaction rate was examined from the measurement data in ARC. Analytical method and analysis condition of reaction products were examined in order to clarify chemical form of reaction products in exothermic reaction between solvent and nitric acid in ARC, and the qualitative evaluation was carried out. Main results are shown in the following. 1) TBP, CMPO, n-dodecane and 10 M nitric acid hardly exothermed in the simple substance. 2) On the solvent phase after the solvent contacted with 10 M nitric acid and the equilibrium has been attained (single-phase sample), the heat quantity per unit sample weight of the TRUEX solvent tended to be bigger than that of the PUREX solvent when heat quantity was evaluated in ARC. However, on the mixed sample of solvent and 10 M nitric acid enclosed in a sample container simultaneously (two phase system sample), the heat quantity per unit solvent weight was almost equivalent for PUREX solvent and TRUEX solvent. 3) The kinetic analysis was carried out, and on the TBP-10 M nitric acid single-phase sample, the activation energy of the reaction was evaluated to be 118 kJ/mol. Its activation energy was approximately equal to 112 kJ/mol by Nichols. The reaction rate constant was calculated, and it was shown that reaction rate constants of PUREX solvent-10 M nitric acid single-phase sample and

Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches.

Science.gov (United States)

Madureira, Ana Raquel; Nunes, Sara; Campos, Débora A; Fernandes, João C; Marques, Cláudia; Zuzarte, Monica; Gullón, Beatriz; Rodríguez-Alcalá, Luís M; Calhau, Conceição; Sarmento, Bruno; Gomes, Ana Maria; Pintado, Maria Manuela; Reis, Flávio

2016-01-01

Rosmarinic acid (RA) possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe) delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL) were evaluated for cell (lymphocytes) viability, necrosis and apoptosis, and antioxidant/prooxidant effects upon DNA. Wistar rats were orally treated for 14 days with vehicle (control) and with Witepsol or Carnauba nanoparticles loaded with RA at 1 and 10 mg/kg body weight/d. Blood, urine, feces, and several tissues were collected for analysis. Free and loaded RA, at 0.15 mg/mL, presented a safe profile, while genotoxic potential was found for the higher dose (1.5 mg/mL), mainly by necrosis. Our data suggest that both types of nanoparticles are safe when loaded with moderate concentrations of RA, without in vitro genotoxicity and cytotoxicity and with an in vivo safety profile in rats orally treated, thus opening new avenues for use in nutraceutical applications.

Safety assessment of genetically modified rice expressing human serum albumin from urine metabonomics and fecal bacterial profile.

Science.gov (United States)

Qi, Xiaozhe; Chen, Siyuan; Sheng, Yao; Guo, Mingzhang; Liu, Yifei; He, Xiaoyun; Huang, Kunlun; Xu, Wentao

2015-02-01

The genetically modified (GM) rice expressing human serum albumin (HSA) is used for non-food purposes; however, its food safety assessment should be conducted due to the probability of accidental mixture with conventional food. In this research, Sprague Dawley rats were fed diets containing 50% (wt/wt) GM rice expressing HSA or non-GM rice for 90 days. Urine metabolites were detected by (1)H NMR to examine the changes of the metabolites in the dynamic process of metabolism. Fecal bacterial profiles were detected by denaturing gradient gel electrophoresis to reflect intestinal health. Additionally, short chain fatty acids and fecal enzymes were investigated. The results showed that compared with rats fed the non-GM rice, some significant differences were observed in rats fed with the GM rice; however, these changes were not significantly different from the control diet group. Additionally, the gut microbiota was associated with blood indexes and urine metabolites. In conclusion, the GM rice diet is as safe as the traditional daily diet. Furthermore, urine metabonomics and fecal bacterial profiles provide a non-invasive food safety assessment rat model for genetically modified crops that are used for non-food/feed purposes. Fecal bacterial profiles have the potential for predicting the change of blood indexes in future. Copyright © 2014 Elsevier Ltd. All rights reserved.

Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement.

Science.gov (United States)

Vleugels, Michel; Cheng, Ru-Fong; Goldstein, Jeffrey; Bangerter, Keith; Connor, Viviane

algorithm of TVU and/or modified HSG confirmation testing 3 months after Essure placement can determine that a woman can rely on the device for permanent birth control. The adverse events observed are consistent with the known safety profile of Essure. (clinicaltrials.gov: NCT01327105.). Copyright © 2017 American Association of Gynecologic Laparoscopists. All rights reserved.

Direct measurements of safety factor profiles with motional Stark effect for KSTAR tokamak discharges with internal transport barriers

Science.gov (United States)

Ko, J.; Chung, J.

2017-06-01

The safety factor profile evolutions have been measured from the plasma discharges with the external current drive mechanism such as the multi-ion-source neutral beam injection for the Korea Superconducting Tokamak Advanced Research (KSTAR) for the first time. This measurement has been possible by the newly installed motional Stark effect (MSE) diagnostic system that utilizes the polarized Balmer-alpha emission from the energetic neutral deuterium atoms induced by the Stark effect under the Lorentz electric field. The 25-channel KSTAR MSE diagnostic is based on the conventional photoelastic modulator approach with the spatial and temporal resolutions less than 2 cm (for the most of the channels except 2 to 3 channels inside the magnetic axis) and about 10 ms, respectively. The strong Faraday rotation imposed on the optical elements in the diagnostic system is calibrated out from a separate and well-designed polarization measurement procedure using an in-vessel reference polarizer during the toroidal-field ramp-up phase before the plasma experiment starts. The combination of the non-inductive current drive during the ramp-up and shape control enables the formation of the internal transport barrier where the pitch angle profiles indicate flat or slightly hollow profiles in the safety factor.

Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update.

Science.gov (United States)

Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

2016-06-22

Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making.

Yield and Safety Profile of Ultrasound Guided Fine Needle Aspiration Cytology (FNAC) of Lymph Nodes

International Nuclear Information System (INIS)

Sattar, A.; Wahab, S.; Javed, A.; Shamim, S. H.

2016-01-01

Objective: To determine the re-biopsy rate, positive yield and safety profile of ultrasound guided fine needle aspiration cytology (FNAC) in cervical lymph nodes in terms of its complications and repeat procedures. Study Design: An analytical study. Place and Duration of Study: Department of Vascular and Interventional Radiology, Dow University Hospital, Dow University of Health Sciences, Karachi, from June to December 2013. Methodology: Eighty neck swellings, which were found to be lymph nodes on ultrasound, underwent ultrasound guided FNAC, from outpatients. Lymph nodes which were included in the study were those that were not easily palpable, located near major blood vessels, where patient refused of direct palpation and wanted image guided FNAC, those directly sent by physician for image guided FNAC and where blind biopsy remained inconclusive. Patients who refused on explanation or did not give consent were excluded. Complications and repeat biopsy were noted. Result: This study consisted of 80 cases, of which 51 cases (63.75 percentage) were female and 29 cases (36.25 percentage) were male. Repeat biopsy was required in 1 case (1.6 percentage). There were no procedure-related complications. A total of 44 cases (55 percentage) revealed evidence suggesting or confirming the existence of tuberculosis. Rest of the others showed other benign lesions, reactive lymphadenopathy and malignancy. Conclusion: Ultrasound guided FNAC is a safe procedure with low re-biopsy rate that aids diagnosis. The predominant cause of cervical lymphadenopathy in this study was tuberculous lymphadenitis. (author)

Diclofenac topical solution compared with oral diclofenac: a pooled safety analysis

Directory of Open Access Journals (Sweden)

Roth SH

2011-06-01

Full Text Available Sanford H Roth1, Philip Fuller21Arizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USA; 2Medical Affairs, Covidien, Hazelwood, MO, USABackground: Topical nonsteroidal anti-inflammatory drug (NSAID formulations, which produce less systemic exposure compared with oral formulations, are an option for the management of osteoarthritis (OA. However, the overall safety and efficacy of these agents compared with oral or systemic therapy remains controversial.Methods: Two 12-week, double-blind, double-dummy, randomized, controlled, multicenter studies compared the safety and efficacy profiles of diclofenac topical solution (TDiclo with oral diclofenac (ODiclo. Each study independently showed that TDiclo had similar efficacy to ODiclo. To compare the safety profiles of TDiclo and ODiclo, a pooled safety analysis was performed for 927 total patients who had radiologically confirmed symptomatic OA of the knee. This pooled analysis included patients treated with TDiclo, containing 45.5% dimethyl sulfoxide (DMSO, and those treated with ODiclo. Safety assessments included monitoring of adverse events (AEs, recording of vital signs, dermatologic evaluation of the study knee, and clinical laboratory evaluation.Results: AEs occurred in 312 (67.1% patients using TDiclo versus 298 (64.5% of those taking ODiclo. The most common AE with TDiclo was dry skin at the application site (24.1% vs 1.9% with ODiclo; P < 0.0001. Fewer gastrointestinal (25.4% vs 39.0%; P < 0.0001 and cardiovascular (1.5% vs 3.5%; P = 0.055 AEs occurred with TDiclo compared with ODiclo. ODiclo was associated with significantly greater increases in liver enzymes and creatinine, and greater decreases in creatinine clearance and hemoglobin (P < 0.001 for all.Conclusions: These findings suggest that TDiclo represents a useful alternative to oral NSAID therapy in the management of OA, with a more favorable safety profile.Keywords: diclofenac, gastropathy

Lower hybrid wave accessibility as a means for current profile control

International Nuclear Information System (INIS)

Briffod, G.; Gormezano, C.; Parlange, F.; Van Houtte, D.

1986-01-01

Powerful ICRH experiments on JET and Neutral Beam Injection of various species on TFTR have recently confirmed the insensitivity of the temperature and safety factor profile shapes to the heating profile and the important role played by the sawtooth activity on the overall performances. In order to overcome these limitations, we propose in this paper, in a Tokamak operating at constant plasma current: to control the resistive part of the current by driving an H.F. current by Lower Hybrid Wave. To act on the current profile, with the constraint that q(o) > 1 by controlling the wave penetration. Constant plasma current Tokamak discharges in which a part of the current is driven by L.H.W. have been extensively studied on PETULA and this mode of operation has proven to be very efficient in stabilizing the sawtooth and M.H.D. activity

Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland—A cross-sectional survey study

Science.gov (United States)

Mascherek, Anna C.

2017-01-01

Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of “climate strength” has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely. PMID:28753633

Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer.

Science.gov (United States)

Lousberg, Laurence; Jerusalem, Guy

2016-01-01

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus-exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

The effects of the non-contingent presentation of safety signals on the elimination of safety behaviors: An experimental comparison between individuals with low and high obsessive-compulsive profiles.

Science.gov (United States)

Angelakis, Ioannis; Austin, Jennifer L

2018-06-01

Safety behaviors, defined as engagement in avoidance within safe environments, are a key symptom of obsessive-compulsive and related disorders. They may interfere with daily functioning and as such their emission should be reduced. The purpose of the current study is to investigate the effects of the non-contingent presentation of safety signals (cues produced by safety behaviors) on reducing safety behaviors in participants self-reporting low and high OCD profiles. In total, 32 participants were asked to play a game to gain points and avoid their loss. After having developed avoidance behavior, evidenced by maintaining all of their earned points, they were exposed to safe environments where no point loss was programmed. In Test 1, safety cues (blue bar) were produced contingent on performing safety behaviors. In Test 2, safety cues were presented continuously without any response requirement. Findings demonstrated that high OCD group displayed higher rates of safety behaviors than low OCD group. However, exposure to the non-contingent presentation of safety signals eliminated their emission in both groups. Future studies need to evaluate the effects of different non-contingent schedules on the suppression of safety behaviors. These findings contribute to the literature by demonstrating that non-contingent introduction of safety signals eliminated safety behaviors completely, even in high OCD participants, who performed safety behavior at higher rates. Such a treatment protocol may ameliorate exposure therapy in which response prevention constitutes a key element and is generally associated with increased drop-out rates. Copyright © 2017 Elsevier Ltd. All rights reserved.

Discovery of safety biomarkers for atorvastatin in rat urine using mass spectrometry based metabolomics combined with global and targeted approach

International Nuclear Information System (INIS)

Kumar, Bhowmik Salil; Lee, Young-Joo; Yi, Hong Jae; Chung, Bong Chul; Jung, Byung Hwa

2010-01-01

In order to develop a safety biomarker for atorvastatin, this drug was orally administrated to hyperlipidemic rats, and a metabolomic study was performed. Atorvastatin was given in doses of either 70 mg kg -1 day -1 or 250 mg kg -1 day -1 for a period of 7 days (n = 4 for each group). To evaluate any abnormal effects of the drug, physiological and plasma biochemical parameters were measured and histopathological tests were carried out. Safety biomarkers were derived by comparing these parameters and using both global and targeted metabolic profiling. Global metabolic profiling was performed using liquid chromatography/time of flight/mass spectrometry (LC/TOF/MS) with multivariate data analysis. Several safety biomarker candidates that included various steroids and amino acids were discovered as a result of global metabolic profiling, and they were also confirmed by targeted metabolic profiling using gas chromatography/mass spectrometry (GC/MS) and capillary electrophoresis/mass spectrometry (CE/MS). Serum biochemical and histopathological tests were used to detect abnormal drug reactions in the liver after repeating oral administration of atorvastatin. The metabolic differences between control and the drug-treated groups were compared using PLS-DA score plots. These results were compared with the physiological and plasma biochemical parameters and the results of a histopathological test. Estrone, cortisone, proline, cystine, 3-ureidopropionic acid and histidine were proposed as potential safety biomarkers related with the liver toxicity of atorvastatin. These results indicate that the combined application of global and targeted metabolic profiling could be a useful tool for the discovery of drug safety biomarkers.

Discovery of safety biomarkers for atorvastatin in rat urine using mass spectrometry based metabolomics combined with global and targeted approach

Energy Technology Data Exchange (ETDEWEB)

Kumar, Bhowmik Salil [Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology, P.O. Box 131, Cheongryang, Seoul 130-650 (Korea, Republic of); University of Science and Technology, (305-333) 113 Gwahangno, Yuseong-gu, Daejeon (Korea, Republic of); Lee, Young-Joo; Yi, Hong Jae [College of Pharmacy, Kyung Hee University, Hoegi-dong, Dongdaemun-gu, Seoul 130-791 (Korea, Republic of); Chung, Bong Chul [Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology, P.O. Box 131, Cheongryang, Seoul 130-650 (Korea, Republic of); Jung, Byung Hwa, E-mail: jbhluck@kist.re.kr [Bioanalysis and Biotransformation Research Center, Korea Institute of Science and Technology, P.O. Box 131, Cheongryang, Seoul 130-650 (Korea, Republic of); University of Science and Technology, (305-333) 113 Gwahangno, Yuseong-gu, Daejeon (Korea, Republic of)

2010-02-19

In order to develop a safety biomarker for atorvastatin, this drug was orally administrated to hyperlipidemic rats, and a metabolomic study was performed. Atorvastatin was given in doses of either 70 mg kg{sup -1} day{sup -1} or 250 mg kg{sup -1} day{sup -1} for a period of 7 days (n = 4 for each group). To evaluate any abnormal effects of the drug, physiological and plasma biochemical parameters were measured and histopathological tests were carried out. Safety biomarkers were derived by comparing these parameters and using both global and targeted metabolic profiling. Global metabolic profiling was performed using liquid chromatography/time of flight/mass spectrometry (LC/TOF/MS) with multivariate data analysis. Several safety biomarker candidates that included various steroids and amino acids were discovered as a result of global metabolic profiling, and they were also confirmed by targeted metabolic profiling using gas chromatography/mass spectrometry (GC/MS) and capillary electrophoresis/mass spectrometry (CE/MS). Serum biochemical and histopathological tests were used to detect abnormal drug reactions in the liver after repeating oral administration of atorvastatin. The metabolic differences between control and the drug-treated groups were compared using PLS-DA score plots. These results were compared with the physiological and plasma biochemical parameters and the results of a histopathological test. Estrone, cortisone, proline, cystine, 3-ureidopropionic acid and histidine were proposed as potential safety biomarkers related with the liver toxicity of atorvastatin. These results indicate that the combined application of global and targeted metabolic profiling could be a useful tool for the discovery of drug safety biomarkers.

Safety-in-numbers

DEFF Research Database (Denmark)

Elvik, Rune; Bjørnskau, Torkel

2017-01-01

Highlights •26 studies of the safety-in-numbers effect are reviewed. •The existence of a safety-in-numbers effect is confirmed. •Results are consistent. •Causes of the safety-in-numbers effect are incompletely known....

Impact of removing mucosal barrier injury laboratory-confirmed bloodstream infections from central line-associated bloodstream infection rates in the National Healthcare Safety Network, 2014.

Science.gov (United States)

See, Isaac; Soe, Minn M; Epstein, Lauren; Edwards, Jonathan R; Magill, Shelley S; Thompson, Nicola D

2017-03-01

Central line-associated bloodstream infection (CLABSI) event data reported to the National Healthcare Safety Network from 2014, the first year of required use of the mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) definition, were analyzed to assess the impact of removing MBI-LCBI events from CLABSI rates. CLABSI rates decreased significantly in some location types after removing MBI-LCBI events, and MBI-LCBI events will be removed from publicly reported CLABSI rates. Published by Elsevier Inc.

Safety update on the use of recombinant activated factor VII in approved indications.

Science.gov (United States)

Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie

2015-06-01

This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Integration profile and safety of an adenovirus hybrid-vector utilizing hyperactive sleeping beauty transposase for somatic integration.

Directory of Open Access Journals (Sweden)

Wenli Zhang

Full Text Available We recently developed adenovirus/transposase hybrid-vectors utilizing the previously described hyperactive Sleeping Beauty (SB transposase HSB5 for somatic integration and we could show stabilized transgene expression in mice and a canine model for hemophilia B. However, the safety profile of these hybrid-vectors with respect to vector dose and genotoxicity remains to be investigated. Herein, we evaluated this hybrid-vector system in C57Bl/6 mice with escalating vector dose settings. We found that in all mice which received the hyperactive SB transposase, transgene expression levels were stabilized in a dose-dependent manner and that the highest vector dose was accompanied by fatalities in mice. To analyze potential genotoxic side-effects due to somatic integration into host chromosomes, we performed a genome-wide integration site analysis using linker-mediated PCR (LM-PCR and linear amplification-mediated PCR (LAM-PCR. Analysis of genomic DNA samples obtained from HSB5 treated female and male mice revealed a total of 1327 unique transposition events. Overall the chromosomal distribution pattern was close-to-random and we observed a random integration profile with respect to integration into gene and non-gene areas. Notably, when using the LM-PCR protocol, 27 extra-chromosomal integration events were identified, most likely caused by transposon excision and subsequent transposition into the delivered adenoviral vector genome. In total, this study provides a careful evaluation of the safety profile of adenovirus/Sleeping Beauty transposase hybrid-vectors. The obtained information will be useful when designing future preclinical studies utilizing hybrid-vectors in small and large animal models.

Dietary feeding of flavokawain A, a Kava chalcone, exhibits a satisfactory safety profile and its association with enhancement of phase II enzymes in mice

Directory of Open Access Journals (Sweden)

Xuesen Li

2014-01-01

Full Text Available Flavokawain A (FKA, a major chalcone in the Kava plant, has recently demonstrated promising anti-cancer activities. A systematic evaluation of FKA's safety profile has not been reported before. In this study, male FVB/N mice were fed with an AIN-76A diet or AIN-76A diet supplemented with 0.6% (6 g/kg food FKA or 0.6% commercial kava root extract (KRE for three weeks. Dietary feeding of FKA did not affect food consumption and body weight. Histopathological examination of liver, kidney, colon, lung, heart, spleen, and thymus revealed no signs of FKA-induced toxicity. Biochemical serum analysis and histological examination confirmed normal organ function in FKA-treated mice. The cytotoxicity profile showed FKA had minimal side effects on bone marrow and small intestinal epithelial cells compared with Adriamycin. In addition, oral feeding of FKA increased activities of both glutathione S-transferase and quinone reductase in the liver, lung, prostate and bladder tissues of mice. In comparison, dietary feeding of 0.6% KRE increased liver/body weight ratio and decreased spleen, thymus, and testis/body weight ratios, as well as induced nodular proliferation in liver tissues. Therefore, dietary feeding FKA showed no adverse effects on major organ function and homeostasis in mice, suggesting the potential of FKA for chemoprevention study of human cancers.

Safety Profile of the Newest Antiepileptic Drugs: A Curated Literature Review.

Science.gov (United States)

Palleria, Caterina; Cozza, Giuseppe; Khengar, Rajeshree; Libri, Vincenzo; De Sarro, Giovambattista

2017-01-01

Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice. However, the main cause of treatment failure is still poor patient compliance due to the occurrence of adverse drug reactions (ADRs) that lead to treatment withdrawal in about 25% of cases before achieving maximal efficacy, and is associated with increasing health care costs. In this Review, we conducted an online database search using Medline, PubMed, Embase, and the Cochrane Online Library to review the available studies highlighting the clinical relevance of side effects, pharmacological interactions, safety and tolerability of the newest AEDs: Brivaracetam (BRV), Cannabidiol (CBD), Eslicarbazepine acetate (ESL), Lacosamide (LCM), and Perampanel (PER). The principal benefit of the newest AEDs, in addition to reduced frequency and seizure severity, is the low number and severity of ADRs reported compared to more historic drugs. Early detection of ADRs could lead to an improvement in patients' quality of life, therefore it is important to monitor ADRs and to adequately perform post marketing surveillance in the clinical practice setting. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Confirmation of radiation pressure effects in laser--plasma interactions

International Nuclear Information System (INIS)

Attwood, D.T.; Sweeney, D.W.; Auerbach, J.M.; Lee, P.H.Y.

1977-10-01

Interferometric data resolved in 1μm and 15 psec confirms the dominant role of radiation pressure during high intensity laser-plasma interactions. Specifically observed manifestations include electron density profiles steepened to 1 μm scale length, clearly defined upper and lower density shelves, and small and large scale deformation of transverse isodensity surfaces

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus.

Science.gov (United States)

Merrill, Joan T; Ginzler, Ellen M; Wallace, Daniel J; McKay, James D; Lisse, Jeffrey R; Aranow, Cynthia; Wellborne, Frank R; Burnette, Michael; Condemi, John; Zhong, Z John; Pineda, Lilia; Klein, Jerry; Freimuth, William W

2012-10-01

To evaluate the safety profile of long-term belimumab therapy combined with standard therapy for systemic lupus erythematosus (SLE) in patients with active disease. Patients who were randomized to receive intravenous placebo or belimumab 1, 4, or 10 mg/kg, plus standard therapy, and completed the initial 52-week double-blind treatment period were then allowed to enter a 24-week open-label extension phase. During the extension period, patients in the belimumab group either received the same dose or were switched to 10 mg/kg and patients in the placebo group were switched to belimumab 10 mg/kg. Patients who achieved a satisfactory response during the 24-week extension period were allowed to participate in the long-term continuation study of monthly belimumab 10 mg/kg. Adverse events (AEs) and abnormal laboratory results were analyzed per 100 patient-years in 1-year intervals. Of the 364 patients who completed the 52-week double-blind treatment period, 345 entered the 24-week extension, and 296 continued treatment with belimumab in the long-term continuation study. Safety data through 4 years of belimumab exposure (1,165 cumulative patient-years) are reported. Incidence rates of AEs, severe/serious AEs, infusion reactions, infections, malignancies, grades 3/4 laboratory abnormalities, and discontinuations due to AEs were stable or declined during 4-year belimumab exposure. The most common AEs included arthralgia, upper respiratory tract infection, headache, fatigue, and nausea. Serious infusion reactions were rare: only 1 occurred during the 4-year followup period. Rates of serious infection decreased from 5.9/100 patient-years to 3.4/100 patient-years, and no specific type of infection predominated. Belimumab added to standard therapy was generally well-tolerated over the 4-year treatment period in patients with SLE, which suggests that belimumab can be administered long term with an acceptable safety profile. Copyright © 2012 by the American College of Rheumatology.

Confirming psychogenic nonepileptic seizures with video-EEG: sex matters.

Science.gov (United States)

Noe, Katherine H; Grade, Madeline; Stonnington, Cynthia M; Driver-Dunckley, Erika; Locke, Dona E C

2012-03-01

The influence of gender on psychogenic nonepileptic seizures (PNES) diagnosis was examined retrospectively in 439 subjects undergoing video-EEG (vEEG) for spell classification, of whom 142 women and 42 men had confirmed PNES. The epileptologist's predicted diagnosis was correct in 72% overall. Confirmed epilepsy was correctly predicted in 94% men and 88% women. In contrast, confirmed PNES was accurately predicted in 86% women versus 61% men (p=0.003). Sex-based differences in likelihood of an indeterminate admission were not observed for predicted epilepsy or physiologic events, but were for predicted PNES (39% men, 12% women, p=0.0002). More frequent failure to record spells in men than women with predicted PNES was not explained by spell frequency, duration of monitoring, age, medication use, or personality profile. PNES are not only less common in men, but also more challenging to recognize in the clinic, and even when suspected more difficult to confirm with vEEG. Copyright © 2012 Elsevier Inc. All rights reserved.

Clinical experience with contrast infusion sonography as an Essure confirmation test.

Science.gov (United States)

Connor, Viviane F

2011-06-01

The purpose of this study was to assess the clinical experience, including the feasibility, safety, compliance, and efficacy, of contrast infusion sonography as an Essure (Conceptus Inc, Mountain View, CA) confirmation test. A retrospective chart review and telephone survey were conducted at an academic multispecialty group. The study participants were women with Essure intervention who underwent contrast infusion sonography, transvaginal sonography, and hysterosalpingography as Essure confirmation tests. The main outcome measures included the feasibility, safety, compliance, and efficacy of contrast infusion sonography as a first-line Essure confirmation test. A total of 118 women had successful bilateral Essure placement. Of the 63 who consented to contrast infusion sonography, 53 (84.1%) had proper bilateral placement and tubal occlusion and were encouraged to rely on Essure. Four were suspected of having unilateral tubal patency; hysterosalpingography in 2 confirmed bilateral tubal occlusion, and 2 were noncompliant with second-line hysterosalpingography. Three patients suspected of having unsatisfactory or uncertain placement on initial transvaginal sonography were encouraged to undergo hysterosalpingography in lieu of contrast infusion sonography, which confirmed unsatisfactory placement in 2 and proper placement and occlusion in 1. Three contrast infusion sonographic procedures could not be completed because of technical issues; therefore, contrast infusion sonography was feasible in 95.2% of the patients (60 of 63). No notable adverse events occurred. Only 17 patients were noncompliant with any confirmation test, yielding an overall compliance rate of 86% (101 of 118). No pregnancies occurred during 669 woman-months of follow-up. The average reimbursement for contrast infusion sonography was US$251.78. Preliminary clinical data suggest that contrast infusion sonography is a feasible, safe, and accurate Essure confirmation test, which is well accepted by

Rapid Identification of Potential Drugs for Diabetic Nephropathy Using Whole-Genome Expression Profiles of Glomeruli

Directory of Open Access Journals (Sweden)

Jingsong Shi

2016-01-01

Full Text Available Objective. To investigate potential drugs for diabetic nephropathy (DN using whole-genome expression profiles and the Connectivity Map (CMAP. Methodology. Eighteen Chinese Han DN patients and six normal controls were included in this study. Whole-genome expression profiles of microdissected glomeruli were measured using the Affymetrix human U133 plus 2.0 chip. Differentially expressed genes (DEGs between late stage and early stage DN samples and the CMAP database were used to identify potential drugs for DN using bioinformatics methods. Results. (1 A total of 1065 DEGs (FDR 1.5 were found in late stage DN patients compared with early stage DN patients. (2 Piperlongumine, 15d-PGJ2 (15-delta prostaglandin J2, vorinostat, and trichostatin A were predicted to be the most promising potential drugs for DN, acting as NF-κB inhibitors, histone deacetylase inhibitors (HDACIs, PI3K pathway inhibitors, or PPARγ agonists, respectively. Conclusion. Using whole-genome expression profiles and the CMAP database, we rapidly predicted potential DN drugs, and therapeutic potential was confirmed by previously published studies. Animal experiments and clinical trials are needed to confirm both the safety and efficacy of these drugs in the treatment of DN.

Strategic use of preference confirmation in group decision making : The role of competition and dissent

NARCIS (Netherlands)

Toma, C.; Gilles, I.; Butera, F.

2013-01-01

The present research investigates the moderating role of goal interdependence and dissent on individual preference confirmation in hidden-profile tasks. We propose that preference confirmation can be used strategically to deal with competition and dissent likely to arise in group decision making. In

Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches

Directory of Open Access Journals (Sweden)

Madureira AR

2016-08-01

Full Text Available Ana Raquel Madureira,1 Sara Nunes,2 Débora A Campos,1 João C Fernandes,2 Cláudia Marques,3 Monica Zuzarte,2 Beatriz Gullón,1 Luís M Rodríguez-Alcalá,1 Conceição Calhau,3,4 Bruno Sarmento,5–7 Ana Maria Gomes,1 Maria Manuela Pintado,1 Flávio Reis2 1Catholic University of Portugal, CBQF – Center for Biotechnology and Fine Chemistry – Associate Laboratory, Faculty of Biotechnology, Porto, Portugal; 2Laboratory of Pharmacology and Experimental Therapeutics, Institute for Biomedical Imaging and Life Sciences (IBILI, Faculty of Medicine, and CNC.IBILI Consortium, University of Coimbra, Coimbra, Portugal; 3Department of Biochemistry, Faculty of Medicine, University of Porto, Porto, Portugal; 4Center for Health Technology and Services Research (CINTESIS, Porto, Portugal; 5Department of Pharmaceutical Sciences, Institute of Health Sciences-North, CESPU, Gandra, Portugal; 6“I3S” Instituto de Investigação e Inovação em Saúde, University of Porto, Porto, Portugal; 7INEB, Institute of Biomedical Engineering, University of Porto, Porto, Portugal Abstract: Rosmarinic acid (RA possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL were evaluated for cell (lymphocytes viability, necrosis and apoptosis, and antioxidant

Road safety performance indicators : country profiles. SafetyNet, Building the European Road Safety Observatory, Workpackage 3, Deliverable 3.7b.

NARCIS (Netherlands)

Riguelle, F. Eksler, V. Holló, P. Morsink, P. Gent, A. van Gitelman, V. Assum, T. & Rackliff, L.

2009-01-01

The EC 6th Framework Integrated Project SafetyNet aims to accelerate the availability and use of harmonised road safety data in Europe. Having such data available throughout Europe would be tremendously beneficial for road safety, since it would enable the evaluation of road safety measures, the

Strategic use of preference confirmation in group decision making: the role of competition and dissent.

Science.gov (United States)

Toma, Claudia; Gilles, Ingrid; Butera, Fabrizio

2013-03-01

The present research investigates the moderating role of goal interdependence and dissent on individual preference confirmation in hidden-profile tasks. We propose that preference confirmation can be used strategically to deal with competition and dissent likely to arise in group decision making. In two studies, participants first received incomplete information about a car accident investigation, and then read a fictitious discussion with two other participants containing full information. The interaction with the fictitious participants was presented either as cooperative or competitive. We predicted and found preference confirmation to be higher in competition than cooperation, when initial preferences were dissenting (Studies 1 & 2), but to be higher in cooperation than in competition, when initial preferences were consensual (Study 2). Also, the increased versus decreased preference confirmation in competition with, respectively, dissent and no dissent were found to be predicted by self-enhancement strategies (Study 2). These findings contribute to a better understanding of the boundary conditions of preference confirmation in hidden profiles and shed a new light on the role of motivated information processing in these tasks. © 2011 The British Psychological Society.

Meta-analysis of pemetrexed plus carboplatin doublet safety profile in first-line non-squamous non-small cell lung cancer studies.

Science.gov (United States)

Okamoto, Isamu; Schuette, Wolfgang H W; Stinchcombe, Thomas E; Rodrigues-Pereira, José; San Antonio, Belén; Chen, Jian; Liu, Jingyi; John, William J; Zinner, Ralph G

2017-05-01

This meta-analysis compared safety profiles (selected drug-related treatment-emergent adverse events [TEAEs]) of first-line pemetrexed plus carboplatin (PCb) area under the concentration-time curve 5 mg/min•mL (PCb5) or 6 mg/min•mL (PCb6), two widely used regimens in clinical practice for advanced non-squamous non-small cell lung cancer. All patients received pemetrexed 500 mg/m 2 every 21 days with either of two carboplatin doses for up to 4-6 cycles. Safety profiles of PCb doses were compared using three statistical analysis methods: frequency table analysis (FTA), generalized linear mixed effect model (GLMM), and the propensity score method. Efficacy outcomes of PCb5 and PCb6 regimens were summarized. A total of 486 patients mainly from the US, Europe, and East Asia were included in the analysis; 22% (n = 105) received PCb5 in one trial and 78% (n = 381) received PCb6 in four trials. The FTA comparison demonstrated that PCb5 vs PCb6 was associated with a statistically significantly lower incidence of TEAEs, including all-grade thrombocytopenia, anemia, fatigue, and vomiting, and grade 3/4 thrombocytopenia. In the GLMM analysis, PCb5 patients were numerically less likely to experience all-grade and grade 3/4 neutropenia, anemia, and thrombocytopenia. The propensity score regression analysis showed PCb5 group patients were significantly less likely than PCb6 group patients to experience all-grade hematologic TEAEs and grade 3/4 thrombocytopenia and anemia. After applying propensity score 1:1 matching, FTA analysis showed that the PCb5 group had significantly less all-grade and grade 3/4 hematologic toxicities. Overall efficacy outcomes, including overall survival, progression-free survival, and response rate, were similar between the two carboplatin doses. Acknowledging the limitations of this meta-analysis of five trials, heterogeneous in patient's characteristics and trial designs, the results show that the PCb5 regimen was generally associated

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

International Nuclear Information System (INIS)

Endrikat, J.; Schwenke, C.; Prince, M.R.

2015-01-01

Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

Evaluation of intestinal phosphate binding to improve the safety profile of oral sodium phosphate bowel cleansing.

Directory of Open Access Journals (Sweden)

Stef Robijn

Full Text Available Prior to colonoscopy, bowel cleansing is performed for which frequently oral sodium phosphate (OSP is used. OSP results in significant hyperphosphatemia and cases of acute kidney injury (AKI referred to as acute phosphate nephropathy (APN; characterized by nephrocalcinosis are reported after OSP use, which led to a US-FDA warning. To improve the safety profile of OSP, it was evaluated whether the side-effects of OSP could be prevented with intestinal phosphate binders. Hereto a Wistar rat model of APN was developed. OSP administration (2 times 1.2 g phosphate by gavage with a 12h time interval induced bowel cleansing (severe diarrhea and significant hyperphosphatemia (21.79 ± 5.07 mg/dl 6h after the second OSP dose versus 8.44 ± 0.97 mg/dl at baseline. Concomitantly, serum PTH levels increased fivefold and FGF-23 levels showed a threefold increase, while serum calcium levels significantly decreased from 11.29 ± 0.53 mg/dl at baseline to 8.68 ± 0.79 mg/dl after OSP. OSP administration induced weaker NaPi-2a staining along the apical proximal tubular membrane. APN was induced: serum creatinine increased (1.5 times baseline and nephrocalcinosis developed (increased renal calcium and phosphate content and calcium phosphate deposits on Von Kossa stained kidney sections. Intestinal phosphate binding (lanthanum carbonate or aluminum hydroxide was not able to attenuate the OSP induced side-effects. In conclusion, a clinically relevant rat model of APN was developed. Animals showed increased serum phosphate levels similar to those reported in humans and developed APN. No evidence was found for an improved safety profile of OSP by using intestinal phosphate binders.

Refactoring Real-Time Java Profiles

DEFF Research Database (Denmark)

Søndergaard, Hans; Thomsen, Bent; Ravn, Anders Peter

2011-01-01

Just like other software, Java profiles benefits from refactoring when they have been used and have evolved for some time. This paper presents a refactoring of the Real-Time Specification for Java (RTSJ) and the Safety Critical Java (SCJ) profile (JSR-302). It highlights core concepts and makes...

Periodic safety review of the experimental fast reactor JOYO. Review of the activity for safety

International Nuclear Information System (INIS)

Maeda, Yukimoto; Kashimura, Youichi; Suzuki, Toshiaki; Isozaki, Kazunori; Hoshiba, Hideaki; Kitamura, Ryoichi; Nakano, Tomoyuki; Takamatsu, Misao; Sekine, Takashi

2005-02-01

Periodic safety review (Review of the activity for safety) which consisted of 'Comprehensive evaluation of operation experience' and Incorporation of the latest technical knowledge' was carried out up to January 2005. 1. Comprehensive evaluation of operation experience. It was confirmed that the effectual activities for safety through the operation of JOYO were carried out in terms of (1) Operation management, (2) Maintenance management, (3) Fuel management, (4) Radiation management, (5) Radioactive waste management, (6) Emergency planning and (7) Feedback of incidents and failures. 2. Reflection of the latest technical knowledge. It was confirmed that the latest technical knowledge including regulation and guide line established by Nuclear Safety Commission of Japan until March 31st. 2003 were properly reflected in impressing the safety of the reactor. As a result, it was evaluated that the activity for safety was carried out effectually, and no additional measure was identified continual safe operation of the reactor. (author)

Investigation of chronic efficacy and safety profile of two potential anti-inflammatory bipyrazole-based compounds in experimental animals

Directory of Open Access Journals (Sweden)

Domiati S

2018-04-01

Full Text Available Souraya Domiati,1 Mohammed Mehanna,2,3 Hanan Ragab,4 Hania Nakkash Chmaisse,1 Ahmed El Mallah5 1Department of Pharmacology and Therapeutics, Faculty of Pharmacy, Beirut Arab University, Beirut, Lebanon; 2Department of Pharmaceutical Technology, Faculty of Pharmacy, Beirut Arab University, Beirut, Lebanon; 3Department of Industrial Pharmacy, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt; 4Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt; 5Department of Pharmacology, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt Purpose: Although nonsteroidal anti-inflammatory drugs are widely used to treat a variety of disorders, their administration is associated with gastrointestinal side effects, acute kidney injury and liver enzymes’ elevation. Accordingly, researchers are encouraged to create novel agents with better safety profile. The aim of the current study was to evaluate the chronic efficacy and safety profile of two compounds previously proven to have acceptable acute anti-inflammatory and analgesic activities.Materials and methods: Doses were determined through formalin-induced mice paw edema-based dose–response curves. Granuloma weight was used to assess the chronic effect of the investigated compounds as compared to the vehicle and diclofenac representing the positive and the negative controls, respectively. Mice kidneys, livers and stomachs were histologically examined. Moreover, troponin I, alanine aminotransferase, aspartate aminotransferase, serum creatinine and blood urea nitrogen levels were measured. Results: The results highlight that the granulomas and exudates developed in mice after 7 days of treatment, with compound I and compound II were significantly lower than that of the negative control group. Moreover, compound I showed significantly better anti-inflammatory effect than diclofenac. Troponin level was undetected in all groups. Histopathological

Manual on quality assurance for the survey, evaluation and confirmation of nuclear power plant sites

International Nuclear Information System (INIS)

1987-04-01

The present Manual on Quality Assurance for the Survey, Evaluation and Confirmation of Nuclear Power Plant Sites contains supporting material and illustrates examples for implementing the requirements contained in the Code of Practice on Quality Assurance for Safety in Nuclear Power Plants to the activities of survey, evaluation and confirmation of nuclear power plant sites. At the same time the Code of Practice for Safety in Nuclear Power Plant Siting, and Safety Guides in the siting series contain requirements and recommendations to implement a quality assurance programme in selected activities of the siting process. This manual is intended to provide guidance and illustrate examples on this implementation. During preparation and reviews of this Manual it was found out that the methodology of implementation of the quality assurance programme in siting activities is still under development. For these reasons it was considered appropriate to publish this Manual as a temporary publication for trial use

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

Science.gov (United States)

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Raising the profile of worker safety: highlights of the 2013 North American Agricultural Safety Summit.

Science.gov (United States)

Nelson, William J; Heiberger, Scott; Lee, Barbara C

2014-01-01

The 2013 North American Agricultural Safety Summit, an unprecedented gathering of industry leaders and safety experts, was held September 25-27 in Minneapolis, MN. Hosted by the industry-led Agricultural Safety and Health Council of America (ASHCA), there were 250 attendees, 82 speakers, 76 abstracts with poster presentations, along with "best practices" videos, genius bars sessions, learning stations, exhibits, breakfast roundtable topics, and receptions. The event was a mix of knowledge, inspiration and networking to enable participants to influence the adoption of safety practices in their home/work settings. Given the agriculture industry's commitment to feed nine billion people, the projected world population by 2050, it is imperative that producers and agribusiness strive to do it safely, humanely and sustainably. Evaluation feedback was very positive, indicating ASHCA's original objectives for the Summit were achieved.

Efficacy and Safety Profile of Diclofenac/Cyclodextrin and Progesterone/Cyclodextrin Formulations: A Review of the Literature Data.

Science.gov (United States)

Scavone, Cristina; Bonagura, Angela Colomba; Fiorentino, Sonia; Cimmaruta, Daniela; Cenami, Rosina; Torella, Marco; Fossati, Tiziano; Rossi, Francesco

2016-06-01

According to health technology assessment, patients deserve the best medicine. The development of drugs associated with solubility enhancers, such as cyclodextrins, represents a measure taken in order to improve the management of patients. Different drugs, such as estradiol, testosterone, dexamethasone, opioids, non-steroidal anti-inflammatories (NSAIDs; i.e. diclofenac), and progesterone are associated with cyclodextrins. Products containing the association of diclofenac/cyclodextrins are available for subcutaneous, intramuscular, and intravenous administration in doses that range from 25 to 75 mg. Medicinal products containing the association of progesterone/cyclodextrins are indicated for intramuscular and subcutaneous injection at a dose equal to 25 mg. The effects of cyclodextrins have been discussed in the solubility profile and permeability through biological membranes of drug molecules. A literature search was performed in order to give an overview of the pharmacokinetic characteristics, and efficacy and safety profiles of diclofenac/hydroxypropyl-β-cyclodextrin (HPβCD) and progesterone/HPβCD associations. The results of more than 20 clinical studies were reviewed. It was suggested that the new diclofenac/HPβCD formulation gives a rapid and effective response to acute pain and, furthermore, has pharmacokinetic and efficacy/safety profiles comparable to other medicinal products not containing cyclodextrins. One of the principal aspects of these new diclofenac formulations is that in lowering the dose (lower than 50 mg) the drugs could be more tolerable, especially in patients with comorbid conditions. Moreover, results of studies investigating the characteristics of progesterone and cyclodextrins showed that the new formulation (progesterone/HPβCD 25 mg solution) has the same bioavailability as other products containing progesterone. It is more rapidly absorbed and allows the achievement of peak plasma concentrations in a shorter time. Finally, the

Clinical and molecular profile of newborns with confirmed or suspicious congenital adrenal hyperplasia detected after a public screening program implementation.

Science.gov (United States)

Kopacek, Cristiane; Prado, Mayara J; da Silva, Claudia M D; de Castro, Simone M; Beltrão, Luciana A; Vargas, Paula R; Grandi, Tarciana; Rossetti, Maria L R; Spritzer, Poli Mara

2018-04-30

To describe the results obtained in a neonatal screening program after its implementation and to assess the clinical and molecular profiles of confirmed and suspicious congenital adrenal hyperplasia cases. A cross-sectional study was conducted. Newborns with suspected disease due to high 17-hydroxyprogesterone levels and adjusted for birth weight were selected. Classical congenital adrenal hyperplasia (salt-wasting and simple virilizing forms) was diagnosed by an increase in 17-hydroxyprogesterone levels as confirmed in the retest, clinical evaluation, and genotype determined by SNaPshot and multiplex ligation-dependent probe amplification. After 24 months, 15 classic congenital adrenal hyperplasia cases were diagnosed in a total of 217,965 newborns, with an estimated incidence of 1:14,531. From 132 patients, seven non-classical and 14 heterozygous patients were screened for CYP21A2 mutations, and 96 patients presented false positives with wild type CYP21A2. On retest, increased 17-hydroxyprogesterone levels were found in classical congenital adrenal hyperplasia patients and showed significant correlation with genotype-related classical genital adrenal hyperplasia. The most frequent mutations were IVS2-13A/C>G followed by gene deletion or rearrangement events in the classical form. In non-classical and heterozygous diseases, p.Val282Leu was the most common mutation. The results underscore the effectiveness of congenital adrenal hyperplasia neonatal screening in the public health system and indicate that the adopted strategy was appropriate. The second sample collection along with genotyping of suspected cases helped to properly diagnose both severe and milder cases and delineate them from false positive patients. Copyright © 2018. Published by Elsevier Editora Ltda.

Safety profile of the intravenous administration of brain-targeted stable nucleic acid lipid particles

Directory of Open Access Journals (Sweden)

Mariana Conceição

2016-03-01

Full Text Available In a clinical setting, where multiple administrations of the therapeutic agent are usually required to improve the therapeutic outcome, it is crucial to assess the immunogenicity of the administered nanoparticles. In this data work, we investigated the safety profile of the repeated intravenous administration of brain-targeted stable nucleic acid lipid particles (RVG-9r-targeted SNALPs. To evaluate local activation of the immune system, we performed analysis of mouse tissue homogenates and sections from cerebellum. To investigate peripheral activation of the immune system, we used serum of mice that were intravenously injected with RVG-9r-targeted SNALPs. These data are related and were discussed in the accompanying research article entitled “Intravenous administration of brain-targeted stable nucleic acid lipid particles alleviates Machado–Joseph disease neurological phenotype” (Conceição et al., in press [1].

Modeling pedestrian crossing speed profiles considering speed change behavior for the safety assessment of signalized intersections.

Science.gov (United States)

Iryo-Asano, Miho; Alhajyaseen, Wael K M

2017-11-01

Pedestrian safety is one of the most challenging issues in road networks. Understanding how pedestrians maneuver across an intersection is the key to applying countermeasures against traffic crashes. It is known that the behaviors of pedestrians at signalized crosswalks are significantly different from those in ordinary walking spaces, and they are highly influenced by signal indication, potential conflicts with vehicles, and intersection geometries. One of the most important characteristics of pedestrian behavior at crosswalks is the possible sudden speed change while crossing. Such sudden behavioral change may not be expected by conflicting vehicles, which may lead to hazardous situations. This study aims to quantitatively model the sudden speed changes of pedestrians as they cross signalized crosswalks under uncongested conditions. Pedestrian speed profiles are collected from empirical data and speed change events are extracted assuming that the speed profiles are stepwise functions. The occurrence of speed change events is described by a discrete choice model as a function of the necessary walking speed to complete crossing before the red interval ends, current speed, and the presence of turning vehicles in the conflict area. The amount of speed change before and after the event is modeled using regression analysis. A Monte Carlo simulation is applied for the entire speed profile of the pedestrians. The results show that the model can represent the pedestrian travel time distribution more accurately than the constant speed model. Copyright © 2017 Elsevier Ltd. All rights reserved.

Off-axis current drive and real-time control of current profile in JT-60U

International Nuclear Information System (INIS)

Suzuki, T.; Ide, S.; Oikawa, T.; Fujita, T.; Ishikawa, M.; Seki, M.; Matsunaga, G.; Hatae, T.; Naito, O.; Hamamatsu, K.; Sueoka, M.; Hosoyama, H.; Nakazato, M.

2008-01-01

Aiming at optimization of current profile in high-β plasmas for higher confinement and stability, a real-time control system of the minimum of the safety factor (q min ) using the off-axis current drive has been developed. The off-axis current drive can raise the safety factor in the centre and help to avoid instability that limits the performance of the plasma. The system controls the injection power of lower-hybrid waves, and hence its off-axis driven current in order to control q min . The real-time control of q min is demonstrated in a high-β plasma, where q min follows the temporally changing reference q min,ref from 1.3 to 1.7. Applying the control to another high-β discharge (β N = 1.7, β p = 1.5) with m/n = 2/1 neo-classical tearing mode (NTM), q min was raised above 2 and the NTM was suppressed. The stored energy increased by 16% with the NTM suppressed, since the resonant rational surface was eliminated. For the future use for current profile control, current density profile for off-axis neutral beam current drive (NBCD) is for the first time measured, using the motional Stark effect diagnostic. Spatially localized NBCD profile was clearly observed at the normalized minor radius ρ of about 0.6-0.8. The location was also confirmed by multi-chordal neutron emission profile measurement. The total amount of the measured beam driven current was consistent with the theoretical calculation using the ACCOME code. The CD location in the calculation was inward shifted than the measurement

Development of the safety evaluation system in the respects of organizational factors and workers' consciousness. Pt. 1. Study of validities of functions for necessary evaluation and results obtained

International Nuclear Information System (INIS)

Takano, Kenichi; Tsuge, Tadafumi; Hasegawa, Naoko; Hirose, Ayako; Sasou, Kunihide

2002-01-01

CRIEPI decided to develop the safety evaluation system to investigate the safety level of the industrial sites due to questionnaires of organizational climate, safety managements, and workers' safety consciousness to workers. This report describes the questionnaire survey to apply to the domestic nuclear power plant for using obtained results as a fundamental data in order to construct the safety evaluation system. This system will be used for promoting safety culture in organizations of nuclear power plants. The questionnaire survey was conducted to 14 nuclear power stations for understanding the present status relating to safety issues. This questionnaire involves 122 items classified into following three categories: (1) safety awareness and behavior of plant personnel; (2) safety management; (3) organizational climate, based on the model considering contributing factor groups to safety culture. Obtained results were analyzed by statistical method to prepare functions of evaluation. Additionally, by applying a multivariate analysis, it was possible to extract several crucial factors influencing safety performance and to find a comprehensive safety indicator representing total organizational safety level. Significant relations were identified between accident rates (both labor accidents and facility failures) and above comprehensive safety indicator. Next, 122 questionnaire items were classified into 20 major safety factors to grasp the safety profiles of each site. This profile is considered as indicating the features of each site and also indicating the direction of progress for improvement of safety situation in the site. These findings can be reflected in developing the safety evaluation system, by confirming the validity of the evaluation method and giving specific functions. (author)

Characteristics of self-rating and rating by others of safety behavior

International Nuclear Information System (INIS)

Fukui, Hirokazu; Yoshida, Michio; Sugiman, Toshio; Watanabe, Toshie

2002-01-01

It is known that in questionnaire surveys in general, behavior that are recognized as socially desirable are more highly rated by the actors themselves than by others. Safety behavior can be viewed as behavior closely related to social desirability. Therefore, in the present study, multiple regression analysis was conducted to examine how the self-rating and rating by others of 'safety confirmation/report', which serves as one of the rating scales of safety climate and criterion for safety behavior rating, are related to other factors of safety climate. The analysis results reveal that the self-rating of 'safety confirmation/report' tends to give better scores than rating by others and is more strongly related to individual factors than organizational environmental factors. Meanwhile, the rating by others of safety confirmation/report' is strongly related to organizational environmental factors and demonstrates little or no link with individual factors. It can be said, therefore, that the rating by others of 'safety confirmation/report' reflects more accurately the influence of the organizational environment concerned than self-rating, and hence is more appropriate as a rating scale for safety climate. (author)

Characteristics of self-rating and rating by others of safety behavior

Energy Technology Data Exchange (ETDEWEB)

Fukui, Hirokazu [Institute of Nuclear Safety System, Inc., Mihama, Fukui (Japan); Yoshida, Michio; Sugiman, Toshio; Watanabe, Toshie [Japan Institute for Group Dynamics, Fukuoka (Japan)

2002-09-01

It is known that in questionnaire surveys in general, behavior that are recognized as socially desirable are more highly rated by the actors themselves than by others. Safety behavior can be viewed as behavior closely related to social desirability. Therefore, in the present study, multiple regression analysis was conducted to examine how the self-rating and rating by others of 'safety confirmation/report', which serves as one of the rating scales of safety climate and criterion for safety behavior rating, are related to other factors of safety climate. The analysis results reveal that the self-rating of 'safety confirmation/report' tends to give better scores than rating by others and is more strongly related to individual factors than organizational environmental factors. Meanwhile, the rating by others of safety confirmation/report' is strongly related to organizational environmental factors and demonstrates little or no link with individual factors. It can be said, therefore, that the rating by others of 'safety confirmation/report' reflects more accurately the influence of the organizational environment concerned than self-rating, and hence is more appropriate as a rating scale for safety climate. (author)

Health Risk of Escherichia coli O157:H7 in Drinking Water and Meat and Meat Products and Vegetables to Diarrhoeic Confirmed and Non-Confirmed HIV/AIDS Patients

Science.gov (United States)

Abong`O, B. O.; Momba, M. N. B.; Rodda, N.

The current study explored the health risk of E. coli O157:H7 to diarrhoeic confirmed and non-confirmed HIV/AIDS patients due to their exposure to presumed ingestion of water, meat products and vegetables ostensibly contaminated with E. coli O157:H7. Strains of E. coli O157:H7 were isolated by enrichment culture and on Cefixime-Telurite Sorbitol MacConkey agar. Average counts of presumptive E. coli O157 were used for dose-response assessment. Probability of infection to confirmed and non-confirmed HIV/AIDS patients was 20 and 27% from meat and meat products, 21% and 15% from vegetables and 100% due to ingestion of 1500 mL person-1 day-1 of water. Drinking water had higher probability of transmitting E. coli O157:H7 infections than meat and meat products and vegetables. Probability of E. coli O157:H7 infections were high for confirmed HIV/AIDS patients than for non-confirmed patients. Water and foods consumed by HIV/AIDS patients should be safe of any microbial contaminants, these waters and foods should as well be investigated for other enteric pathogens to establish their safety.

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.

Science.gov (United States)

Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

2014-05-01

To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010). Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice.

Science.gov (United States)

Yoshizawa, K; Kawai, K; Fujie, M; Suzuki, J; Ogawa, Y; Yajima, T; Yokomori, J

2015-11-01

To evaluate the overall safety profile and clinical effectiveness of tramadol hydrochloride/acetaminophen (TA) combination tablets in Japanese patients with chronic noncancer pain unrelieved by non-opioid drugs for up to 12 weeks in real-world practice. This survey was a multicenter, prospective, longitudinal registry on the use of TA as a newly initiated pain treatment for chronic noncancer pain incurable by non-opioid analgesics that was conducted under the Good Post Marketing Study Practice regulation controlled by the Japan Ministry of Health, Labor and Welfare. Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period. A total of 1316 patients were registered. ADRs were reported in 259 patients (20.5%); most events were nonserious (99.4%), including nausea (n = 87 [6.9%]), constipation (n = 63 [5.0%]), dizziness and somnolence (n = 29 [2.3%] each), and vomiting (n = 21 [1.7%]). No event related to drug dependence or respiratory depression was reported. In addition, 82.8% of patients showed acceptable effectiveness based on PGI at Week 4. Numerical rating scale for intensity of pain and EQ-5D utility scores were improved by -2.7 (SD 2.3) and 0.16 (SD 0.20) at Week 4, respectively, and the improvement was maintained until Week 12. This is a first report to evaluate the risk-benefit profile of TA in Japanese real-world practice using large size registry data. It is suggested that the favorable risk-benefit balance of TA was confirmed for patients with chronic noncancer pain unrelieved by non-opioid drugs in real-world practice. Limitations of this study were those inherent to open-label and non-interventional study designs. This registry survey is registered at umin.ac.jp (identifier: UMIN000015901).

The Concepts of Risk, Safety, and Security: Applications in Everyday Language.

Science.gov (United States)

Boholm, Max; Möller, Niklas; Hansson, Sven Ove

2016-02-01

The concepts of risk, safety, and security have received substantial academic interest. Several assumptions exist about their nature and relation. Besides academic use, the words risk, safety, and security are frequent in ordinary language, for example, in media reporting. In this article, we analyze the concepts of risk, safety, and security, and their relation, based on empirical observation of their actual everyday use. The "behavioral profiles" of the nouns risk, safety, and security and the adjectives risky, safe, and secure are coded and compared regarding lexical and grammatical contexts. The main findings are: (1) the three nouns risk, safety, and security, and the two adjectives safe and secure, have widespread use in different senses, which will make any attempt to define them in a single unified manner extremely difficult; (2) the relationship between the central risk terms is complex and only partially confirms the distinctions commonly made between the terms in specialized terminology; (3) whereas most attempts to define risk in specialized terminology have taken the term to have a quantitative meaning, nonquantitative meanings dominate in everyday language, and numerical meanings are rare; and (4) the three adjectives safe, secure, and risky are frequently used in comparative form. This speaks against interpretations that would take them as absolute, all-or-nothing concepts. © 2015 Society for Risk Analysis.

Food safety knowledge and practices of abattoir and butchery shops and the microbial profile of meat in Mekelle City, Ethiopia

Science.gov (United States)

Haileselassie, Mekonnen; Taddele, Habtamu; Adhana, Kelali; Kalayou, Shewit

2013-01-01

Objective To assess the food safety knowledge and practices in meat handling, and to determine microbial load and pathogenic organisms in meat at Mekelle city. Methods A descriptive survey design was used to answer questions concerning the current status of food hygiene and sanitation practiced in the abattoir and butcher shops. Workers from the abattoir and butcher shops were interviewed through a structured questionnaire to assess their food safety knowledge. Bacterial load was assessed by serial dilution method and the major bacterial pathogens were isolated by using standard procedures. Results 15.4% of the abattoir workers had no health certificate and there was no hot water, sterilizer and cooling facility in the abattoir. 11.3% of the butchers didn't use protective clothes. There was a food safety knowledge gap within the abattoir and butcher shop workers. The mean values of bacterial load of abattoir meat, butcher shops and street meat sale was found to be 1.1×105, 5.6×105 and 4.3×106 cfu/g, respectively. The major bacterial pathogens isolated were Escherichia coli, Staphylococcus aureus and Bacillus cereus. Conclusions The study revealed that there is a reasonable gap on food safety knowledge by abattoir and butcher shop workers. The microbial profile was also higher compared to standards set by World Health Organization. Due attention should be given by the government to improve the food safety knowledge and the quality standard of meat sold in the city. PMID:23646306

Measurement of Food Safety Culture using Survey and Maturity Profiling Tools

OpenAIRE

Jespersen, Lone; Griffiths, Mansel; Maclaurin, Tanya; Chapman, Ben; Wallace, Carol A.

2016-01-01

Organizational culture is defined by dimensions and characteristics that can be used to measure food safety culture in food manufacturing through a food safety maturity model. Maturity models from quality, health care, and information technology have been used since early 1970 and this work presents a novel food safety culture maturity model with five capability areas and food safety pinpointed behaviours specific to functions and levels in a food manufacturing company. A survey tool linked t...

A predictable Java profile

DEFF Research Database (Denmark)

Bøgholm, Thomas; Hansen, Rene Rydhof; Ravn, Anders Peter

2009-01-01

A Java profile suitable for development of high integrity embedded systems is presented. It is based on event handlers which are grouped in missions and equipped with respectively private handler memory and shared mission memory. This is a result of our previous work on developing a Java profile......, and is directly inspired by interactions with the Open Group on their on-going work on a safety critical Java profile (JSR-302). The main contribution is an arrangement of the class hierarchy such that the proposal is a generalization of Real-Time Specification for Java (RTSJ). A further contribution...

Current density profile evolution in JET

International Nuclear Information System (INIS)

Stubberfield, P.M.; Balet, B.; Campbell, D.; Challis, C.D.; Cordey, J.G.; O'Rourke, J.; Hammett, G.; Schmidt, G.L.

1989-01-01

Simulation studies have been made of the current density profile evolution in discharges where the bootstrap current is expected to be significant. The changes predicted in the total current profile have been confirmed by comparison with experimental results. (author) 8 refs., 6 figs

CLASSIFICATION OF THE MGR PERFORMANCE CONFIRMATION DATA ACQUISITION/MONITORING SYSTEM

International Nuclear Information System (INIS)

J.A. Ziegler

1999-01-01

The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) performance confirmation data acquisition/monitoring system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMF 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333PY ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

Safety evaluation of zotepine for the treatment of schizophrenia.

Science.gov (United States)

Riedel, Michael; Musil, Richard; Seemüller, Florian; Spellmann, Ilja; Möller, Hans-Jürgen; Schennach-Wolff, Rebecca

2010-07-01

Atypical antipsychotics have become the first-line treatment for patients suffering from schizophrenia in the industrialized world. Given the frequent necessity of a life-long enduring antipsychotic treatment, the compounds' safety profile is of great importance for patients and caregivers. Zotepine is an antipsychotic with atypical properties and previous data have suggested a very favorable side effect profile. The aim of this review is to provide a broad knowledge base on the safety profile of zotepine deriving from currently available research results published in English medical databases. The focus of this research reports starts in the 1990s with zotepine's approval in Europe. This paper incorporates data on placebo-controlled studies of zotepine as well as studies with comparator compounds also beyond the diagnostic boarder of schizophrenia regarding zotepine's safety. The take home message of this safety evaluation of zotepine is that compared to typical compounds zotepine induces less extrapyramidal side effects; however, in terms of comparing zotepine's safety with other atypical antipsychotics more studies are needed to draw final conclusions.

PWR reload safety evaluation methodology

International Nuclear Information System (INIS)

Doshi, P.K.; Chapin, D.L.; Love, D.S.

1993-01-01

The current practice for WWER safety analysis is to prepare the plant Safety Analysis Report (SAR) for initial plant operation. However, the existing safety analysis is typically not evaluated for reload cycles to confirm that all safety limits are met. In addition, there is no systematic reanalysis or reevaluation of the safety analyses after there have been changes made to the plant. The Westinghouse process is discussed which is in contrast to this and in which the SAR conclusions are re-validated through evaluation and/or analysis of each reload cycle. (Z.S.)

A study on safety climate at nuclear power plants

International Nuclear Information System (INIS)

Fukui, Hirokazu; Yoshida, Michio; Yoshiyama, Naohiro

2001-01-01

In the current study, we define safety climate as an organizational environment that induces members of the organization to give consideration to safety or take safety actions. It is of utmost importance that people holding managerial positions in an organization have a good understanding of the characteristics of the safety climate of the organization and implement safety promotion activities effectively. In the current research, we studied the rating scales and the characteristics of a safety climate. A survey was conducted, targeting technical engineers who belong to the three power stations of Kansai Electric Power Co., Inc. The questionnaire mainly consisted of questions concerning safety measures taken by individuals and questions concerning safety measures taken by the organization, to which the individuals belong. As a result of a factor analysis of the responses, we extracted five factors, namely, 'confidence in knowledge and skill', attitude of supervisors,' 'safety education in workplace', 'clarity of tasks' and 'safety confirmation/report'. In studying the rating scales of the safety climate, we selected five items from each of the above five factors, and used the total scores of the ratings of the five items as scores of each factor. Then, we examined the correlation between scores of personal factors and scores of organizational environment factors. We treated the scores of safety confirmation/report' and 'confidence in knowledge and skill', which are personal factors, as criterion variables, and the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks', which are organizational environment factors, as predictor variables. As a result, we found that levels of 'safety confirmation/report' and 'confidence in knowledge and skill' can be deduced from the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks.' Hence, we have decided to use these three organizational environment

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

Science.gov (United States)

Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

2017-12-01

Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

Control of the tokamak safety factor profile with time-varying constraints using MPC

International Nuclear Information System (INIS)

Maljaars, E.; Felici, F.; De Baar, M.R.; Geelen, P.J.M.; Steinbuch, M.; Van Dongen, J.; Hogeweij, G.M.D.

2015-01-01

A controller is designed for the tokamak safety factor profile that takes real-time-varying operational and physics limits into account. This so-called model predictive controller (MPC) employs a prediction model in order to compute optimal control inputs that satisfy the given limits. The use of linearized models around a reference trajectory results in a quadratic programming problem that can easily be solved online. The performance of the controller is analysed in a set of ITER L-mode scenarios simulated with the non-linear plasma transport code RAPTOR. It is shown that the controller can reduce the tracking error due to an overestimation or underestimation of the modelled transport, while making a trade-off between residual error and amount of controller action. It is also shown that the controller can account for a sudden decrease in the available actuator power, while providing warnings ahead of time about expected violations of operational and physics limits. This controller can be extended and implemented in existing tokamaks in the near future. (paper)

Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

Science.gov (United States)

Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

2017-01-01

Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

Tolerability and safety aspects of mirtazapine.

Science.gov (United States)

Nutt, David J

2002-06-01

The tolerability and safety profile of the noradrenergic and specific serotonergic antidepressant (NaSSA) mirtazapine reflects its unique pharmacological profile. The 5-HT(2) blocking effect contributes towards its anxiolytic effects and benefits on sleep, as well as preventing the sexual dysfunction that may occur with non-specific stimulation of the serotonin system by drugs such as the selective serotonin reuptake inhibitors (SSRIs). In addition, 5-HT(3) blockade by mirtazapine helps to prevent nausea and vomiting. Weight gain is the most commonly reported side-effect of mirtazapine, although there is evidence to suggest that this is not a significant problem during long-term treatment. In conclusion, mirtazapine has a good tolerability and safety profile that demonstrates several benefits over other antidepressants. Copyright 2002 John Wiley & Sons, Ltd.

Innovations in Post-Marketing Safety Research

NARCIS (Netherlands)

Stefánsdóttir, G.

2012-01-01

Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

SEAFP and SEAL: safety and environmental aspects

International Nuclear Information System (INIS)

Gulden, W.; Raeder, J.; Cook, I.

2000-01-01

The Safety and Environmental Assessment of Fusion Power (SEAFP) programme undertaken in the period 1992-1995 formed part of the ongoing effort in the European Fusion Programme to consider the safety and environmental aspects of fusion power. The assessment started with the development of a tokamak fusion power plant model of 3000 MW of fusion power. The analyses of safety included detailed consideration of effluents from normal operation, occupational doses, accidents (concentrating on the worst possible), and waste management. SEAFP was also the starting point for the Safety and Environmental Assessment of Fusion Power -- Long Term Programme (SEAL) initiated within the European Fusion Programme in 1995. SEAL aims at broadening the scope and elaborating selected aspects in more detail. SEAFP and SEAL confirmed the favourable safety and environmental characteristics of fusion power. They also confirmed the need to support these characteristics by dedicated materials development and safety-related design decisions. Recently, a new study on fusion safety (SEAFP-2) has been launched, defined for the time period 1997-1998, using SEAFP and SEAL findings as starting points

Safety and Pharmacokinetic Profiles of Repeated-Dose Micafungin in Children and Adolescents Treated for Invasive Candidiasis

Science.gov (United States)

Benjamin, Daniel K.; Deville, Jaime G.; Azie, Nkechi; Kovanda, Laura; Roy, Mike; Wu, Chunzhang; Arrieta, Antonio

2013-01-01

Background Micafungin is an echinocandin with proven efficacy against a broad range of fungal infections, including those caused by Candida species. Objective To evaluate the safety and pharmacokinetics of once-daily 3 mg/kg and 4.5 mg/kg micafungin in children with proven, probable, or suspected invasive candidiasis. Methods Micafungin safety and pharmacokinetics were assessed in two Phase I, open-label, repeat-dose trials. In Study 2101, children aged 2–16 years were grouped by weight to receive 3 mg/kg (≥25 kg) or 4.5 mg/kg (<25 kg) intravenous micafungin for 10–14 days. In Study 2102, children aged 4 months to <2 years received 4.5 mg/kg micafungin. Study protocols were otherwise identical. Results Safety was analyzed in seventy-eight and nine children in Studies 2101 and 2102, respectively. Although adverse events were experienced by most children (2101: n = 62; 2102: n = 9), micafungin-related adverse events were less common (2101: n = 28; 2102: n = 1), and the number of patients discontinuing due to adverse events was low (2101: n = 4; 2102: n = 1). The most common micafungin-related adverse events were infusion-associated symptoms, pyrexia, and hypomagnesemia (Study 2101), and liver function abnormalities (Study 2102). The micafungin pharmacokinetic profile was similar to that seen in other studies conducted in children, but different than that observed in adults. Conclusions In this small cohort of children, once-daily doses of 3 mg/kg and 4.5 mg/kg micafungin were well tolerated. Pharmacokinetic data will be combined in a population pharmacokinetic analysis to support U.S. dosing recommendations in children. PMID:23958810

PWR AXIAL BURNUP PROFILE ANALYSIS

International Nuclear Information System (INIS)

J.M. Acaglione

2003-01-01

The purpose of this activity is to develop a representative ''limiting'' axial burnup profile for pressurized water reactors (PWRs), which would encompass the isotopic axial variations caused by different assembly irradiation histories, and produce conservative isotopics with respect to criticality. The effect that the low burnup regions near the ends of spent fuel have on system reactivity is termed the ''end-effect''. This calculation will quantify the end-effects associated with Pressurized Water Reactor (PWR) fuel assemblies emplaced in a hypothetical 21 PWR waste package. The scope of this calculation covers an initial enrichment range of 3.0 through 5.0 wt% U-235 and a burnup range of 10 through 50 GWd/MTU. This activity supports the validation of the process for ensuring conservative generation of spent fuel isotopics with respect to criticality safety applications, and the use of burnup credit for commercial spent nuclear fuel. The intended use of these results will be in the development of PWR waste package loading curves, and applications involving burnup credit. Limitations of this evaluation are that the limiting profiles are only confirmed for use with the B andW 15 x 15 fuel assembly design. However, this assembly design is considered bounding of all other typical commercial PWR fuel assembly designs. This calculation is subject to the Quality Assurance Requirements and Description (QARD) because this activity supports investigations of items or barriers on the Q-list (YMP 2001)

A study on safety climate at nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Fukui, Hirokazu [Institute of Nuclear Safety System Inc., Mihama, Fukui (Japan); Yoshida, Michio; Yoshiyama, Naohiro [Japan Institute for Group Dynamics, Fukuoka (Japan)

2001-09-01

In the current study, we define safety climate as an organizational environment that induces members of the organization to give consideration to safety or take safety actions. It is of utmost importance that people holding managerial positions in an organization have a good understanding of the characteristics of the safety climate of the organization and implement safety promotion activities effectively. In the current research, we studied the rating scales and the characteristics of a safety climate. A survey was conducted, targeting technical engineers who belong to the three power stations of Kansai Electric Power Co., Inc. The questionnaire mainly consisted of questions concerning safety measures taken by individuals and questions concerning safety measures taken by the organization, to which the individuals belong. As a result of a factor analysis of the responses, we extracted five factors, namely, 'confidence in knowledge and skill', attitude of supervisors,' 'safety education in workplace', 'clarity of tasks' and 'safety confirmation/report'. In studying the rating scales of the safety climate, we selected five items from each of the above five factors, and used the total scores of the ratings of the five items as scores of each factor. Then, we examined the correlation between scores of personal factors and scores of organizational environment factors. We treated the scores of safety confirmation/report' and 'confidence in knowledge and skill', which are personal factors, as criterion variables, and the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks', which are organizational environment factors, as predictor variables. As a result, we found that levels of 'safety confirmation/report' and 'confidence in knowledge and skill' can be deduced from the scores of 'attitude of supervisors', 'safety

Cardiovascular and heart failure safety profile of vildagliptin: a meta-analysis of 17 000 patients.

Science.gov (United States)

McInnes, G; Evans, M; Del Prato, S; Stumvoll, M; Schweizer, A; Lukashevich, V; Shao, Q; Kothny, W

2015-11-01

To report the cardiovascular (CV) safety profile and heart failure (HF) risk of vildagliptin from a large pool of studies, including trials in high-risk patients with type 2 diabetes mellitus (T2DM), such as those with congestive HF and/or moderate/severe renal impairment. We conducted a retrospective meta-analysis of prospectively adjudicated CV events. Patient-level data were pooled from 40 double-blind, randomized controlled phase III and IV vildagliptin studies. The primary endpoint was occurrence of major adverse CV events (MACEs; myocardial infarction, stroke and CV death). Assessments of the individual MACE components and HF events (requiring hospitalization or new onset) were secondary endpoints. The risk ratio (RR) of vildagliptin (50 mg once- and twice-daily combined) versus comparators (placebo and all non-vildagliptin treatments) was calculated using the Mantel-Haenszel (M-H) method. Of the 17 446 patients, 9599 received vildagliptin (9251.4 subject-years of exposure) and 7847 received comparators (7317.0 subject-years of exposure). The mean age of the patients was 57 years, body mass index 30.5 kg/m(2) (nearly 50% obese), glycated haemoglobin concentration 8.1% and T2DM duration 5.5 years. A MACE occurred in 83 (0.86%) vildagliptin-treated patients and 85 (1.20%) comparator-treated patients, with an M-H RR of 0.82 [95% confidence interval (CI) 0.61-1.11]. Similar RRs were observed for the individual events. Confirmed HF events were reported in 41 (0.43%) vildagliptin-treated patients and 32 (0.45%) comparator-treated patients, with an M-H RR 1.08 (95% CI 0.68-1.70). This large meta-analysis indicates that vildagliptin is not associated with an increased risk of adjudicated MACEs relative to comparators. Moreover, this analysis did not find a significant increased risk of HF in vildagliptin-treated patients. © 2015 John Wiley & Sons Ltd.

Developing patient safety in dentistry.

Science.gov (United States)

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

BWR AXIAL PROFILE

International Nuclear Information System (INIS)

Huffer, J.

2004-01-01

The purpose of this calculation is to develop axial profiles for estimating the axial variation in burnup of a boiling water reactor (BWR) assembly spent nuclear fuel (SNF) given the average burnup of an assembly. A discharged fuel assembly typically exhibits higher burnup in the center and lower burnup at the ends of the assembly. Criticality safety analyses taking credit for SNF burnup must account for axially varying burnup relative to calculations based on uniformly distributed assembly average burnup due to the under-burned tips. Thus, accounting for axially varying burnup in criticality analyses is also referred to as accounting for the ''end effect'' reactivity. The magnitude of the reactivity change due to ''end effect'' is dependent on the initial assembly enrichment, the assembly average burnup, and the particular axial profile characterizing the burnup distribution. The set of bounding axial profiles should incorporate multiple BWR core designs and provide statistical confidence (95 percent confidence that 95 percent of the population is bound by the profile) that end nodes are conservatively represented. The profiles should also conserve the overall burnup of the fuel assembly. More background on BWR axial profiles is provided in Attachment I

New conducted electrical weapons: Electrical safety relative to relevant standards.

Science.gov (United States)

Panescu, Dorin; Nerheim, Max; Kroll, Mark W; Brave, Michael A

2017-07-01

We have previously published about TASER ® conducted electrical weapons (CEW) compliance with international standards. CEWs deliver electrical pulses that can inhibit a person's neuromuscular control or temporarily incapacitate. An eXperimental Rotating-Field (XRF) waveform CEW and the X2 CEW are new 2-shot electrical weapon models designed to target a precise amount of delivered charge per pulse. They both can deploy 1 or 2 dart pairs, delivered by 2 separate cartridges. Additionally, the XRF controls delivery of incapacitating pulses over 4 field vectors, in a rotating sequence. As in our previous study, we were motivated by the need to understand the cardiac safety profile of these new CEWs. The goal of this paper is to analyze the nominal electrical outputs of TASER XRF and X2 CEWs in reference to provisions of all relevant international standards that specify safety requirements for electrical medical devices and electrical fences. Although these standards do not specifically mention CEWs, they are the closest electrical safety standards and hence give very relevant guidance. The outputs of several TASER XRF and X2 CEWs were measured under normal operating conditions. The measurements were compared against manufacturer specifications. CEWs electrical output parameters were reviewed against relevant safety requirements of UL 69, IEC 60335-2-76 Ed 2.1, IEC 60479-1, IEC 60479-2, AS/NZS 60479.1, AS/NZS 60479.2, IEC 60601-1 and BS EN 60601-1. Our study confirmed that the nominal electrical outputs of TASER XRF and X2 CEWs lie within safety bounds specified by relevant standards.

Profiles of bullying victimization, discrimination, social support, and school safety: Links with Latino/a youth acculturation, gender, depressive symptoms, and cigarette use.

Science.gov (United States)

Lorenzo-Blanco, Elma I; Unger, Jennifer B; Oshri, Assaf; Baezconde-Garbanati, Lourdes; Soto, Daniel

2016-01-01

Latino/a youth are at risk for symptoms of depression and cigarette smoking but this risk varies by acculturation and gender. To understand why some youth are at greater risk than others, we identified profiles of diverse community experiences (perceived discrimination, bullying victimization, social support, perceived school safety) and examined associations between profiles of community experience and depressive symptoms, cigarette smoking, acculturation, and gender. Data came from Project Red (Reteniendo y Entendiendo Diversidad para Salud), a school-based longitudinal study of acculturation among 1,919 Latino/a adolescents (52% female; 84% 14 years old; 87% U.S. born). Latent profile analysis (LPA) revealed 4 distinct profiles of community experience that varied by gender and acculturation. Boys were overrepresented in profile groups with high perceived discrimination, some bullying, and lack of positive experiences, while girls were overrepresented in groups with high bullying victimization in the absence and presence of other community experiences. Youth low on both U.S. and Latino/a cultural orientation described high perceived discrimination and lacked positive experiences, and were predominantly male. Profiles characterized by high perceived discrimination and /or high bullying victimization in the absence of positive experiences had higher levels of depressive symptoms and higher risk of smoking, relative to the other groups. Findings suggest that acculturation comes with diverse community experiences that vary by gender and relate to smoking and depression risk. Results from this research can inform the development of tailored intervention and prevention strategies to reduce depression and/or smoking for Latino/a youth. (c) 2016 APA, all rights reserved).

Neural network evaluation of tokamak current profiles for real time control

Science.gov (United States)

Wróblewski, Dariusz

1997-02-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental datais demonstrated.

Neural network evaluation of tokamak current profiles for real time control

International Nuclear Information System (INIS)

Wroblewski, D.

1997-01-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q 0 , minimum value of q, q min , and the location of q min . Very good performance of the trained neural network both for simulated test data and for experimental datais demonstrated. copyright 1997 American Institute of Physics

Perspectives on radioactive waste repository monitoring. Confirmation, compliance, confidence building, and societal vigilance

Energy Technology Data Exchange (ETDEWEB)

Bergmans, Anne [Antwerp Univ. (Belgium). Research Group Society and Environment; Elam, Mark [Gothenburg Univ. (Sweden); Simmons, Peter [East Anglia Univ., Norwich (United Kingdom); Sundqvist, Goeran [Oslo Univ. (Norway)

2012-12-15

Monitoring is now widely seen as a necessary part of programmes for the geological disposal of radioactive waste. However, we find different perspectives on the nature and role of monitoring. Among technical experts it is viewed firstly as a matter of performance confirmation, a tool for validating the safety case underlying repository construction. Among concerned citizens we find a view of monitoring as enabling the critical scrutiny of safety, an instrument for acknowledging uncertainties and detecting emergent problems in a repository. After outlining differing views on questions of whether, why, what, where and for how long to monitor we discuss monitoring in light of constant vigilance as a technical and moral principle of nuclear safety. We suggest that ''how much monitoring'' and ''how should it be organised'' are societal questions and as such need to be broadly discussed.

Review on JMTR safety design for LEU core conversion

International Nuclear Information System (INIS)

Komori, Yoshihiro; Yokokawa, Makoto; Saruta, Toru; Inada, Seiji; Sakurai, Fumio; Yamamoto, Katsumune; Oyamada, Rokuro; Saito, Minoru

1993-12-01

Safety of the JMTR was fully reviewed for the core conversion to low enriched uranium fuel. Fundamental policies for the JMTR safety design were reconsidered based on the examination guide for safety design of test and research reactors, and safety of the JMTR was confirmed. This report describes the safety design of the JMTR from the viewpoint of major functions for reactor safety. (author)

Safety of bisphosphonates

DEFF Research Database (Denmark)

Pazianas, Michael; Abrahamsen, Bo

2011-01-01

and their safety profile has withstood the challenges of the harsh clinical reality and widespread use. Certainly, the esophageal or gastric irritation caused by the oral preparations is an established adverse effect, the risk of which can be reduced by the recommended routine of taking the medication. From...

E-Area Low-Level Waste Facility Vadose Zone Model: Confirmation of Water Mass Balance for Subsidence Scenarios

Energy Technology Data Exchange (ETDEWEB)

Dyer, J. A. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

2017-11-30

In preparation for the next revision of the E-Area Low-Level Waste Facility (LLWF) Performance Assessment (PA), a mass balance model was developed in Microsoft Excel to confirm correct implementation of intact- and subsided-area infiltration profiles for the proposed closure cap in the PORFLOW vadose-zone model. The infiltration profiles are based on the results of Hydrologic Evaluation of Landfill Performance (HELP) model simulations for both intact and subsided cases.

Repository performance confirmation

International Nuclear Information System (INIS)

Hansen, Francis D.

2011-01-01

Repository performance confirmation links the technical bases of repository science and societal acceptance. This paper explores the myriad aspects of what has been labeled performance confirmation in U.S. programs, which involves monitoring as a collection of distinct activities combining technical and social significance in radioactive waste management. This paper is divided into four parts: (1) A distinction is drawn between performance confirmation monitoring and other testing and monitoring objectives; (2) A case study illustrates confirmation activities integrated within a long-term testing and monitoring strategy for Yucca Mountain; (3) A case study reviews compliance monitoring developed and implemented for the Waste Isolation Pilot Plant; and (4) An approach for developing, evaluating and implementing the next generation of performance confirmation monitoring is presented. International interest in repository monitoring is exhibited by the European Commission Seventh Framework Programme 'Monitoring Developments for Safe Repository Operation and Staged Closure' (MoDeRn) Project. The MoDeRn partners are considering the role of monitoring in a phased approach to the geological disposal of radioactive waste. As repository plans advance in different countries, the need to consider monitoring strategies within a controlled framework has become more apparent. The MoDeRn project pulls together technical and societal experts to assimilate a common understanding of a process that could be followed to develop a monitoring program. A fundamental consideration is the differentiation of confirmation monitoring from the many other testing and monitoring activities. Recently, the license application for Yucca Mountain provided a case study including a technical process for meeting regulatory requirements to confirm repository performance as well as considerations related to the preservation of retrievability. The performance confirmation plan developed as part of the

Safety assessment of starch-based personal care products: Nanocapsules and pickering emulsions.

Science.gov (United States)

Marto, J; Pinto, P; Fitas, M; Gonçalves, L M; Almeida, A J; Ribeiro, H M

2018-03-01

The safety profile of the ingredients used in topical dosage forms and its evaluation is an issue of utmost importance. A suitable equilibrium between safety and efficacy is crucial before promoting a dermatological product. The aim of this work was to assess the safety and biological effects of starch-based vehicles (St-BV) used in such products. The hazard, exposure and dose-response assessment were used to characterize the risk of each ingredient. The EpiSkin™ assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the St-BV was studied using biophysical measurements in human volunteers during 28 days, showing that all ingredients and their combinations were safe for the consumer. Tissue viability determined using the EpiSkin™ testing reached values between 84.0 ± 5.0% and 98.0 ± 8.6% after application of St-BV, which were considered as non-irritant to the skin. These observations were confirmed by the in vivo studies where the St-BV did not induce any sensitization on the volunteers, being safe for human use. Moreover, St-BV increased skin hydration and microcirculation, emerging as an attractive alternative to chemical raw materials. Copyright © 2018 Elsevier Inc. All rights reserved.

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

Science.gov (United States)

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Safety-analysis report for packaging (SARP) general-purpose heat-source module 750-Watt shipping container

International Nuclear Information System (INIS)

Whitney, M.A.; Burgan, C.E.; Blauvelt, R.K.; Zocher, R.W.; Bronisz, S.E.

1981-01-01

The SARP includes discussions of structural integrity, thermal resistance, radiation shielding and radiological safety, nuclear criticality safety, and quality control. Extensive tests and evaluations were performed to show that the container will function effectively with respect to all required standards and when subjected to normal transportation conditions and the sequence of four hypothetical accident conditions (free drop, puncture, thermal, and water immersion). In addition, a steady state temperature profile and radiation profile were measured using two heat sources that very closely resemble the GPHS. This gave an excellent representation of the GPHS temperature and radiation profile. A nuclear criticality safety analysis determined that all safety requirements are met

Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

Science.gov (United States)

Gyekye, Seth Ayim; Haybatollahi, Mohammad

2014-01-01

This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

Fire safety regulations and licensing

International Nuclear Information System (INIS)

Berg, H.P.

1998-01-01

Experience of the past tow decades of nuclear power plant operation and results obtained from modern analytical techniques confirm that fires may be a real threat to nuclear safety and should receive adequate attention from the design phase throughout the life of the plant. Fire events, in particular influence significantly plant safety due to the fact that fires have the potential to simultaneously damage components of redundant safety-related equipment. Hence, the importance of fire protection for the overall safety of a nuclear power plant has to be reflected by the fire safety regulations and to be checked during the licensing process of a plant as well as during the continuous supervision of the operating plant

Demonstrating a correlation between the maturity of road safety practices and road safety incidents.

Science.gov (United States)

Amador, Luis; Willis, Christopher Joseph

2014-01-01

The objective of this study is to demonstrate a correlation between the maturity of a country's road safety practices and road safety incidents. Firstly, data on a number of road injuries and fatalities for 129 countries were extracted from the United Nations Global Status on Road Safety database. These data were subdivided according to road safety incident and accident causation factors and normalized based on vehicular fleet (per 1000 vehicles) and road network (per meter of paved road). Secondly, a road safety maturity model was developed based on an adaptation of the concept of process maturity modeling. The maturity of countries with respect to 10 road safety practices was determined through the identification of indicators recorded in the United Nations Global Status of Road Safety Database. Plots of normalized road safety performance of the 129 countries against their maturity scores for each road safety practice as well as an aggregation of the road safety practices were developed. An analysis of variance was done to determine the extent of the correlation between the road safety maturity of the countries and their performance. In addition, a full Bayesian analysis was done to confirm the correlation of each of the road safety practices with injuries and fatalities. Regression analysis for fatalities, injuries, and combined accidents identified maturity with respect to road safety practices associated with speed limits and use of alternative modes as being the most significant predictors of traffic fatalities. A full Bayesian regression confirms that there is a correlation between the maturity of road safety practices and road safety incidents. Road safety practices associated with enforcement of speed limits and promotion of alternative modes are the most significant road safety practices toward which mature countries have concentrated their efforts, resulting in a lower frequency of fatalities, injury rates, and property damage accidents. The authors

Motor carrier industry profile study : financial and operating performance profiles by industry segment, 2001-2002.

Science.gov (United States)

2004-09-01

This report profiles the motor carrier industry and its significant operating segments. It is one of a series of reports analyzing various aspects of the motor carrier industry. Other reports in the series focus on the safety performance of the indus...

Safety and Efficacy of Argatroban in the Management of Heparin-Induced Thrombocytopenia

Directory of Open Access Journals (Sweden)

Bernd Saugel

2011-01-01

Full Text Available Heparin-induced thrombocytopenia (HIT is a life-threatening adverse reaction to heparin therapy that is characterized by thrombocytopenia and an increased risk of venous and arterial thrombosis. According to guidelines, in patients with strongly suspected or confirmed HIT all sources of heparin have to be discontinued and an alternative, nonheparin anticoagulant for HIT treatment must immediately be started. For both the prophylaxis of thrombembolic events in HIT and the treatment of HIT with thrombosis the direct thrombin inhibitor argatroban is approved in the United States. The objective of this review is to describe the mechanism of action and the pharmacokinetic profile of argatroban, to characterize argatroban regarding its safety and therapeutic efficacy and to discuss its place in therapy in HIT.

A promising oral fucoidan-based antithrombotic nanosystem: development, activity and safety

Science.gov (United States)

da Silva, L. C. R. P.; Todaro, V.; do Carmo, F. A.; Frattani, F. S.; de Sousa, V. P.; Rodrigues, C. R.; Sathler, P. C.; Cabral, L. M.

2018-04-01

Fucoidan-loaded nanoparticles emerge as great candidates for oral anticoagulant therapy, due to increases in the bioavailability and circulation time of this natural anticoagulant. Crosslinks between chitosan chains are performed using glutaraldehyde to confer higher gastric pH resistance to nanoparticle matrices. In this work, chitosan-fucoidan nanoparticles, without (NpCF) and with glutaraldehyde crosslink (NpCF 1% and NpCF 2%), were prepared to evaluate their anticoagulant, antithrombotic and hemorrhagic profiles. Nanoparticles were characterized by average diameter (AD), polydispersity index, zeta potential, Fourier transform infrared spectroscopy and fucoidan in vitro release. Anticoagulant and antithrombotic activities were determined by in vitro and in vivo models, respectively. Hemorrhagic profile was in vivo evaluated by tail bleeding assay. Preparations showed nanometric and homogeneous ADs. Zeta potentials of NpCF and NpCF 1% were stable over the gastrointestinal pH range, which was confirmed by low fucoidan release in gastric and enteric media. In pH 7.4, NpCF and NpCF 1% demonstrated fucoidan release of 65.5% and 60.6%, respectively, within the first 24 h. In comparison to fucoidan, NpCF and NpCF 1% showed increased in vitro anticoagulant activity. A significant difference in the oral antithrombotic profile of NpCF 1% was found in comparison to fucoidan. Bleeding profile of NpCF and NpCF 1% showed no differences to the control group, indicating the safety of these systems. Surprisingly, the oral antithrombotic profile of commercially available fucoidan, from Fucus vesiculosus, has not been previously determined, which reveals new possibilities. In this work, significant advances were observed in the anticoagulant and antithrombotic profiles of fucoidan through the preparation of NpCF 1%.

Neural network evaluation of tokamak current profiles for real time control (abstract)

Science.gov (United States)

Wróblewski, Dariusz

1997-01-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental data is demonstrated.

Neural network evaluation of tokamak current profiles for real time control (abstract)

International Nuclear Information System (INIS)

Wroblewski, D.

1997-01-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q 0 , minimum value of q, q min , and the location of q min . Very good performance of the trained neural network both for simulated test data and for experimental data is demonstrated. copyright 1997 American Institute of Physics

KHNP special safety review

International Nuclear Information System (INIS)

Lee, Tae-Ho; Lee, Bang-Jin; Lee, Soung-Hee; Park, Goon-Cherl

2009-01-01

Commemorating the 30 year anniversary of commercial nuclear power plant operation in KOREA, Korea Hydro and Nuclear Power Co., Ltd. (KHNP) has conducted a Special Safety Review (SSR) of its 20 operating units to understand their safety performance and to identify any areas that need improvement. The SSR reviewed all 20 operating units for 2 weeks per site. Areas that were reviewed are Safety Margins, Plant Performance, Employee Safety, Employee Performance and Performance Improvement Process. Each review team consisted of international and domestic members. The international reviewers were from IAEA, WANO and INPO. The domestic reviewers consisted of professors, Engineering Company, Research Institute and KHNP experts. The review confirmed safe and reliable operations of the 20 nuclear units. The common understanding resulted from the SSR is as follows. Firstly, KHNP corporate and its plants confirmed and shared mutual understanding on recurring areas for improvements, especially in the areas of Organizational Effectiveness, Industrial Safety, Human Performance, Configuration Management, Operations, Equipment Performance and Material Condition. Secondly, KHNP understood that plant and department level performances are directly related to the leadership and competency of the management team including supervisors. Thirdly, the strengths of individual stations that consistently have produced good results need to be shared with the other KHNP stations. Finally, KHNP learned that strong corporate leadership and support are needed to resolve most of the areas for improvement since they are common to all KHNP stations. (author)

Study on Rail Profile Optimization Based on the Nonlinear Relationship between Profile and Wear Rate

Directory of Open Access Journals (Sweden)

Jianxi Wang

2017-01-01

Full Text Available This paper proposes a rail profile optimization method that takes account of wear rate within design cycle so as to minimize rail wear at the curve in heavy haul railway and extend the service life of rail. Taking rail wear rate as the object function, the vertical coordinate of rail profile at range optimization as independent variable, and the geometric characteristics and grinding depth of rail profile as constraint conditions, the support vector machine regression theory was used to fit the nonlinear relationship between rail profile and its wear rate. Then, the profile optimization model was built. Based on the optimization principle of genetic algorithm, the profile optimization model was solved to achieve the optimal rail profile. A multibody dynamics model was used to check the dynamic performance of carriage running on optimal rail profile. The result showed that the average relative error of support vector machine regression model remained less than 10% after a number of training processes. The dynamic performance of carriage running on optimized rail profile met the requirements on safety index and stability. The wear rate of optimized profile was lower than that of standard profile by 5.8%; the allowable carrying gross weight increased by 12.7%.

Radiation Safety for Sustainable Development

International Nuclear Information System (INIS)

2015-10-01

The objective of radiation safety is Assessments of Natural Radioactivity and its Radiological. The following topics were discussed during the conference: AFROSAFE Championing Radiation Safety in Africa, Radiation Calibration, and Development and Validation of a Laser Induced Breakdown Spectrometry Method for Cancer Detection and Characterization. Young Generation in NUCLEAR Initiative to Promote Nuclear Science and Technology, Radiation Protection Safety Culture and Application of Nuclear Techniques in Industry and the Environment were discuss. Rapid Chemometric X-Ray Fluorescence approaches for spectral Diagnostics of Cancer utilizing Tissue Trace Metals and Speciation profiles. Fundamental role of medical physics in Radiation Therapy

DIPS space exploration initiative safety

International Nuclear Information System (INIS)

Dix, T.E.

1991-01-01

The Dynamic Isotope Power Subsystem has been identified for potential applications for the Space Exploration Initiative. A qualitative safety assessment has been performed to demonstrate the overall safety adequacy of the Dynamic Isotope Power Subsystem for these applications. Mission profiles were defined for reference lunar and martian flights. Accident scenarios were qualitatively defined for all mission phases. Safety issues were then identified. The safety issues included radiation exposure, fuel containment, criticality, diversion, toxic materials, heat flux to the extravehicular mobility unit, and disposal. The design was reviewed for areas where safety might be further improved. Safety would be improved by launching the fuel separate from the rest of the subsystem on expendable launch vehicles, using a fuel handling tool during unloading of the hot fuel canister, and constructing a cage-like structure around the reversible heat removal system lithium heat pipes. The results of the safety assessment indicate that the DIPS design with minor modifications will produce a low risk concept

Social network in patient safety: Social media visibility

Directory of Open Access Journals (Sweden)

Azucena Santillán García

2011-11-01

Full Text Available Internet social network (social media is a powerful communication tool, and its use is expanding significantly. This paper seeks to know the current state of visibility in online social networks of active citizen talking about patient safety. This is an observational cross-sectional study whose target population is the websites Facebook, Twitter and Tuenti in Spain. By three consecutive cuts social profiles were found using the searching terms “seguridad+paciente” and “safety+patient”. There were found 5 profiles on Facebook that met the search criteria, 6 on Twitter and none were found on Tuenti. It is concluded that although there is evidence of the rise of social networking, citizen network involved in patient safety appears not to be significantly represented within the social networks examined.

Safety culture in nuclear power plants

International Nuclear Information System (INIS)

Weihe, G. von; Pamme, H.

2003-01-01

Experience shows that German nuclear power plants have always been operated reliably and safely. Over the years, the safety level in these plants has been raised considerably so that they can stand any comparison with other countries. This is confirmed by the two reports published by the Federal Ministry for the Environment on the nuclear safety convention. Behind this, there must obviously stand countless appropriate 'good practices' and a safety management system in nuclear power plants. (orig.) [de

Safety profiles of Tripterygium wilfordii Hook F: a systematic review and meta-analysis

Directory of Open Access Journals (Sweden)

Chi Zhang

2016-11-01

Full Text Available Objective: Tripterygium wilfordii Hook F (TwHF is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs. We aimed to undertake a clinically informative, systematic safety profile of TwHF.Methods: We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs. Results: We screened 4,137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8% in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95%CI 11.9%, 14.9%, 11.7% (95% CI 10.3%, 13.3%, 7.8% (95%CI 6.3%-9.5%, 6.5% (95%CI 5.7%-7.4% and 4.9% (95%CI 1.6%, 14.3%, respectively. The prevalence of irregular menstruation (IM was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03. TwHF use has lower risk of weight gain (OR 0.12 [95%CI 0.04 to 0.39] and hair loss (OR 0.37 [95% CI 0.18 to 0.78]. Furthermore, long-term aspirin use (> 6 months has a higher AEs incidence (31.0% [95% CI 24.5%-38.5%].Conclusion: Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF.

Is road safety management linked to road safety performance?

Science.gov (United States)

Papadimitriou, Eleonora; Yannis, George

2013-10-01

This research aims to explore the relationship between road safety management and road safety performance at country level. For that purpose, an appropriate theoretical framework is selected, namely the 'SUNflower' pyramid, which describes road safety management systems in terms of a five-level hierarchy: (i) structure and culture, (ii) programmes and measures, (iii) 'intermediate' outcomes'--safety performance indicators (SPIs), (iv) final outcomes--fatalities and injuries, and (v) social costs. For each layer of the pyramid, a composite indicator is implemented, on the basis of data for 30 European countries. Especially as regards road safety management indicators, these are estimated on the basis of Categorical Principal Component Analysis upon the responses of a dedicated road safety management questionnaire, jointly created and dispatched by the ETSC/PIN group and the 'DaCoTA' research project. Then, quasi-Poisson models and Beta regression models are developed for linking road safety management indicators and other indicators (i.e. background characteristics, SPIs) with road safety performance. In this context, different indicators of road safety performance are explored: mortality and fatality rates, percentage reduction in fatalities over a given period, a composite indicator of road safety final outcomes, and a composite indicator of 'intermediate' outcomes (SPIs). The results of the analyses suggest that road safety management can be described on the basis of three composite indicators: "vision and strategy", "budget, evaluation and reporting", and "measurement of road user attitudes and behaviours". Moreover, no direct statistical relationship could be established between road safety management indicators and final outcomes. However, a statistical relationship was found between road safety management and 'intermediate' outcomes, which were in turn found to affect 'final' outcomes, confirming the SUNflower approach on the consecutive effect of each layer

[Efficacy and safety profile of cranberry in infants and children with recurrent urinary tract infection].

Science.gov (United States)

Fernández-Puentes, V; Uberos, J; Rodríguez-Belmonte, R; Nogueras-Ocaña, M; Blanca-Jover, E; Narbona-López, E

2015-06-01

Cranberry prophylaxis of recurrent urinary tract infection in infants has proven effective in the experimental model of the adult. There are few data on its efficacy, safety and recommended dose in the pediatric population. A controlled, double-blind Phase III clinical trial was conducted on children older than 1 month of age to evaluate the efficacy and safety of cranberry in recurrent urinary tract infection. The assumption was of the non-inferiority of cranberry versus trimethoprim. Statistical analysis was performed using Kaplan Meier analysis. A total of 85 patients under 1 year of age and 107 over 1 year were recruited. Trimethoprim was prescribed to 75 patients and 117 received cranberry. The cumulative rate of urinary infection associated with cranberry prophylaxis in children under 1 year was 46% (95% CI; 23-70) in children and 17% (95% CI; 0-38) in girls, effectively at doses inferior to trimethoprim. In children over 1 year-old cranberry was not inferior to trimethoprim, with a cumulative rate of urine infection of 26% (95% CI; 12-41). The cranberry was well tolerated and with no new adverse effects. Our study confirms that cranberry is safe and effective in the prophylaxis of recurrent urinary tract infection in infants and children. With the doses used, their efficiency is not less than that observed for trimethoprim among those over 1 year-old. (Clinical Trials Registry ISRCTN16968287). Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

[Karachi Nuclear Power Plant (KANUPP), Safety Management

Energy Technology Data Exchange (ETDEWEB)

Hasan, S M [Karachi Nuclear Power Plant (KANUPP), Karachi (Pakistan)

1997-12-01

The present regime for CANDU safety management in Pakistan has evolved in line with contemporary international practice, and is essential adequate to ensure the continued safety of KANUPP and other future CANDU reactors, as confirmed by international reviews as well. But the small size of Pakistan nuclear power program poses limitations in developing - expert judgment in analysis of in-service inspection data; and own methodology for CANDU safety analysis.

[Karachi Nuclear Power Plant (KANUPP), Safety Management

International Nuclear Information System (INIS)

Hasan, S.M.

1997-01-01

The present regime for CANDU safety management in Pakistan has evolved in line with contemporary international practice, and is essential adequate to ensure the continued safety of KANUPP and other future CANDU reactors, as confirmed by international reviews as well. But the small size of Pakistan nuclear power program poses limitations in developing - expert judgment in analysis of in-service inspection data; and own methodology for CANDU safety analysis

Visualizing variations in organizational safety culture across an inter-hospital multifaceted workforce.

Science.gov (United States)

Kobuse, Hiroe; Morishima, Toshitaka; Tanaka, Masayuki; Murakami, Genki; Hirose, Masahiro; Imanaka, Yuichi

2014-06-01

To develop a reliable and valid questionnaire that can distinguish features of organizational culture for patient safety across subgroups such as hospitals, professions, management/non-management positions and units/wards. We developed a Hospital Organizational Culture Questionnaire based on a conceptual framework incorporating items from a review of existing literature. The questionnaire was administered to hospital staff including doctors, nurses, allied health personnel, and administrative staff at six public hospitals in Japan. Reliability and validity were assessed through exploratory factor analysis, multitrait scaling analysis, Cronbach's alpha coefficient and multiple regression analysis using staff-perceived achievement of safety as the response variable. Discriminative power across subgroups was assessed with radar chart profiling. Of the 3304 hospital staff surveyed, 2924 (88.5%) responded. After exploratory factor analysis and multitrait analysis, the finalized questionnaire was composed of 24 items in the following eight dimensions: improvement orientation, passion for mission, professional growth, resource allocation prioritization, inter-sectional collaboration, responsibility and authority, teamwork, and information sharing. Construct validity and internal consistency of dimensions were confirmed with multitrait analysis and Cronbach's alpha coefficients, respectively. Multiple regression analysis showed that improvement orientation, passion for mission, resource allocation prioritization and information sharing were significantly associated with higher achievement in safety practices. Our questionnaire tool was able to distinguish features of safety culture among different subgroups. Our questionnaire demonstrated excellent validity and reliability, and revealed distinct cultural patterns among different subgroups. Quantitative assessment of organizational safety culture with this tool may further the understanding of associated characteristics of

Validation of a Blood-Based Laboratory Test to Aid in the Confirmation of a Diagnosis of Schizophrenia

NARCIS (Netherlands)

E. Schwartz (Emanuel); R. Izmailov (Rauf); M. Spain (Michael); A. Barnes (Anthony); J.P. Mapes (James); P.C. Guest (Paul); H. Rahmoune (Hassan); S. Pietsch (Sandra); F.M. Leweke (Marcus); M. Rothermundt (Matthias); J. Steiner (Johann); D. Koethe (Dagmar); L. Kranaster (Laura); P. Ohrmann (Patricia); T. Suslow (Thomas); Y. Levin (Yishai); B. Bogerts (Bernhard); N.J.M. van Beveren (Nico); G. McAllister (George); N. Weber (Natalya); D. Niebuhr (David); D. Cowan (David); R.H. Yolken (Robert); S. Bahn (Sabine)

2010-01-01

textabstractAbstract: We describe the validation of a serum-based test developed by Rules-Based Medicine which can be used to help confirm the diagnosis of schizophrenia. In preliminary studies using multiplex immunoassay profiling technology, we identified a disease signature comprised of 51

A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers

Directory of Open Access Journals (Sweden)

Oyoo George O

2011-03-01

Full Text Available Abstract Background Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. A phase I evaluation was conducted to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers. Methods Twenty five healthy adult volunteers were recruited and admitted to receive a 5 mg dose of methotrexate/day/5 days. Pharmacokinetics blood sampling was carried out at 2, 4, 6, 12 and 24 hours following each dose. Nausea, vomiting, oral ulcers and other adverse events were solicited during follow up of 42 days. Results The mean age of participants was 23.9 ± 3.3 years. Adherence to protocol was 100%. No grade 3 solicited adverse events were observed. However, one case of transiently elevated liver enzymes, and one serious adverse event (not related to the product were reported. The maximum concentration (Cmax was 160-200 nM and after 6 hours, the effective concentration (Ceff was Conclusion Low-dose methotraxate had an acceptable safety profile. However, methotrexate blood levels did not reach the desirable Ceff of 250-400-nM required to clear malaria infection in vivo. Further dose finding and safety studies are necessary to confirm suitability of this drug as an anti-malarial agent.

Natural tracer profiles across argillaceous formations: the Claytrac project

International Nuclear Information System (INIS)

Mazurek, M.; Alt-Epping, P.; Gimi, Th.; Niklaus Waber, H.; Bath, A.; Gimmi, Th.

2009-01-01

Disposal of high-level radioactive waste and spent nuclear fuel in engineered facilities, or repositories, located deep underground in suitable geological formations is being developed worldwide as the reference solution to protect humans and the environment both now and in the future. An important aspect of assessing the long-term safety of deep geological disposal is developing a comprehensive understanding of the geological environment in order to define the initial conditions for the disposal system as well as to provide a sound scientific basis for projecting its future evolution. The transport pathways and mechanisms by which contaminants could migrate in the surrounding host rock are key elements in any safety case. Relevant experiments in laboratories or underground test facilities can provide important information, but the challenge remains in being able to extrapolate the results to the spatial and temporal scales required for performance assessment, which are typically tens to hundreds of metres and from thousands to beyond a million years into the future. Profiles of natural tracers dissolved in pore water of argillaceous rock formations can be considered as large-scale and long-term natural experiments which enable the transport properties to be characterised. The CLAYTRAC Project on Natural Tracer Profiles Across Argillaceous Formations was established by the NEA Clay Club to evaluate the relevance of natural tracer data in understanding past geological evolution and in confirming dominant transport processes. Data were analysed for nine sites to support scientific understanding and development of geological disposal. The outcomes of the project show that, for the sites and clay-rich formations that were studied, there is strong evidence that solute transport is controlled mainly by diffusion. The results can improve site understanding and performance assessment in the context of deep geological disposal and have the potential to be applied to other

Radiation safety requirements for radionuclide laboratories

International Nuclear Information System (INIS)

1993-01-01

In accordance with the section 26 of the Finnish Radiation Act (592/91) the safety requirements to be taken into account in planning laboratories and other premises, which affect safety in the use of radioactive materials, are confirmed by the Finnish Centre for Radiation and Nuclear Safety. The guide specifies the requirements for laboratories and storage rooms in which radioactive materials are used or stored as unsealed sources. There are also some general instructions concerning work procedures in a radionuclide laboratory

Study on possibility of plasma current profile determination using an analytical model of tokamak equilibrium

International Nuclear Information System (INIS)

Moriyama, Shin-ichi; Hiraki, Naoji

1996-01-01

The possibility of determining the current profile of tokamak plasma from the external magnetic measurements alone is investigated using an analytical model of tokamak equilibrium. The model, which is based on an approximate solution of the Grad-Shafranov equation, can set a plasma current profile expressed with four free parameters of the total plasma current, the poloidal beta, the plasma internal inductance and the axial safety factor. The analysis done with this model indicates that, for a D-shaped plasma, the boundary poloidal magnetic field prescribing the external magnetic field distribution is dependent on the axial safety factor in spite of keeping the boundary safety factor and the plasma internal inductance constant. This suggests that the plasma current profile is reversely determined from the external magnetic analysis. The possibility and the limitation of current profile determination are discussed through this analytical result. (author)

Correlation of genetic variability with safety of mumps vaccine Urabe AM9 strain.

Science.gov (United States)

Amexis, G; Fineschi, N; Chumakov, K

2001-08-15

The Urabe AM9 strain of mumps vaccine live is known for its genetic instability and some vaccines derived from this strain were withdrawn from the market due to an excessive number of vaccine-associated parotitis and meningitis cases. To identify the molecular basis of this instability, we determined complete nucleotide sequences of several stocks of the Urabe strain used for vaccine production by different manufacturers and of two clinical isolates from cases of vaccine-associated meningitis. In contrast to previously published studies relating the Lys335 --> Glu mutation in the viral HN gene with neurovirulence of mumps virus, we could not confirm any association of this mutation with the safety of mumps vaccine. Each of the three vaccine stocks studied had its own characteristic profile of mutations that was identified by cDNA sequencing and quantitated by mutant analysis by PCR and restriction enzyme cleavage. Determination of the mutational profile of mumps vaccine lots could allow vaccine manufacturers to characterize seed viruses and monitor the consistency of vaccine production to prevent emergence of virulent revertants.

Assessment of current safety evaluation analysis on reflood behavior during PWR-LOCA by using CCTF data

International Nuclear Information System (INIS)

Iguchi, Tadashi; Murao, Yoshio; Akimoto, Hajime; Okubo, Tsutomu; Sugimoto, Jun; Hojo, Tsuneyuki.

1987-01-01

This paper describes an assessment result on conservatism of current safety analysis concerning reflood behavior during a LOCA in a PWR by using the experimental data with cylindrical core test facility (CCTF) performed at Japan Atomic Energy Research Institute (JAERI). WREM code is selected for a representative of current safety analyses. The predicted peak clad temperature with the WREM code was higher than the data, and it was confirmed that the WREM code had the overall conservatism against CCTF data. The WREM code predicted the reasonable core boundary conditions and it was found that the conservatism of the code came mainly from the calculations on the incore thermal hydraulics and clad temperature. In addition, it was found that the conservatism of the WREM code against the CCTF data could be attributed to the neglection of horizontal fluid mixing between subchannels, the neglection of the heat transfer enhancement due to the radial core power profile, and the usage of the heat transfer correlations conservative against CCTF data. (author)

Defining safety goals. 2. Basic Consideration on Defining Safety Goals

International Nuclear Information System (INIS)

Hakata, T.

2001-01-01

The purpose of this study is to develop basic safety goals that are rational and consistent for all nuclear facilities, including nuclear power plants and fuel cycle facilities. Basic safety goals (risk limits) by an index of radiation dose are discussed, which are based on health effects of detriment and fatality and risk levels presumably accepted by society. The contents of this paper are the personal opinions of the author. The desirable structure of safety goals is assumed to be 'basic safety goals plus specific safety goals (or supplemental safety goals) for each sort of facility, which reflects their characteristics'. The requisites of the basic safety goals must include (a) rational bases (scientific and social), (b) comprehensiveness (common to all sorts of nuclear facilities covering from normal to accidental conditions), and (c) applicability. To meet the requirements, the basic safety goals might have to be a risk profile expression by an index of radiation dose. The societal rationality is consideration of absolute risk levels (10 -6 or 10 -7 /yr) and/or relative risk factors (such as 0.1% of U.S. safety goals) that the general public accepts as tolerable. The following quantitative objectives are adopted in this study for protection of average individuals in the vicinity of a nuclear facility: 1. The additive annual radiation dose during normal operation must be -4 /yr (health detriment), 2x10 -6 /yr (latent cancer and severe hereditary effects), and 10 -7 /yr (acute fatality) from the statistics in Japan. The radiation effects on human beings are determined by recommendations of UNSCEAR (Ref. 1) and ICRP. The health effects considered are non-severe stochastic health detriment, i.e., detectable opacities of lens of eye (threshold 5 0.5 to 2 Sv), depression of hematopoiesis of bone marrow (0.5 Sv), and depression of reproductive capability (temporary sterility of testes ) (0.15 Sv). The LD 50/60 of acute fatality is ∼4 Sv, and fatalities by latent

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads

Science.gov (United States)

Thompson, Kirrilly; Matthews, Chelsea

2015-01-01

Simple Summary Riding horses on roads can be dangerous, but little is known about accidents and near misses. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey, mostly attributed to speed. Whilst our findings confirmed factors identified overseas, we also identified issues around road rules, hand signals and road rage. This paper suggests strategies for improving the safety of horses, riders and other road users. Abstract Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles; (2) harmonising laws regarding passing horses; (3) mandating personal protective equipment; (4) improving road signage; (5) comprehensive data collection; (6) developing mutual understanding amongst road-users; (7) safer road design and alternative riding spaces; and (8) increasing investment

Curcuma longa L. as a therapeutic agent in intestinal motility disorders. 2: Safety profile in mouse.

Science.gov (United States)

Micucci, Matteo; Aldini, Rita; Cevenini, Monica; Colliva, Carolina; Spinozzi, Silvia; Roda, Giulia; Montagnani, Marco; Camborata, Cecilia; Camarda, Luca; Chiarini, Alberto; Mazzella, Giuseppe; Budriesi, Roberta

2013-01-01

Curcuma extract exerts a myorelaxant effect on the mouse intestine. In view of a possible use of curcuma extract in motor functional disorders of the gastrointestinal tract, a safety profile study has been carried out in the mouse. Thirty mice were used to study the in vitro effect of curcuma on gallbladder, bladder, aorta and trachea smooth muscular layers and hearth inotropic and chronotropic activity. The myorelaxant effect on the intestine was also thoroughly investigated. Moreover, curcuma extract (200 mg/Kg/day) was orally administered to twenty mice over 28 days and serum liver and lipids parameters were evaluated. Serum, bile and liver bile acids qualitative and quantitative composition was were also studied. In the intestine, curcuma extract appeared as a not competitive inhibitor through cholinergic, histaminergic and serotoninergic receptors and showed spasmolytic effect on K(+) induced contraction at the level of L type calcium channels. No side effect was observed on bladder, aorta, trachea and heart when we used a dose that is effective on the intestine. An increase in gallbladder tone and contraction was observed. Serum liver and lipids parameters were normal, while a slight increase in serum and liver bile acids concentration and a decrease in bile were observed. Although these data are consistent with the safety of curcuma extract as far as its effect on the smooth muscular layers of different organs and on the heart, the mild cholestatic effect observed in absence of alteration of liver function tests must be further evaluated and the effective dose with minimal side effects considered.

Step Density Profiles in Localized Chains

Science.gov (United States)

De Roeck, Wojciech; Dhar, Abhishek; Huveneers, François; Schütz, Marius

2017-06-01

We consider two types of strongly disordered one-dimensional Hamiltonian systems coupled to baths (energy or particle reservoirs) at the boundaries: strongly disordered quantum spin chains and disordered classical harmonic oscillators. These systems are believed to exhibit localization, implying in particular that the conductivity decays exponentially in the chain length L. We ask however for the profile of the (very slowly) transported quantity in the steady state. We find that this profile is a step-function, jumping in the middle of the chain from the value set by the left bath to the value set by the right bath. This is confirmed by numerics on a disordered quantum spin chain of 9 spins and on much longer chains of harmonic oscillators. From theoretical arguments, we find that the width of the step grows not faster than √{L}, and we confirm this numerically for harmonic oscillators. In this case, we also observe a drastic breakdown of local equilibrium at the step, resulting in a heavily oscillating temperature profile.

A predictable Java profile - rationale and implementations

DEFF Research Database (Denmark)

Søndergaard, Hans; Bøgholm, Thomas; Hansen, Rene Rydhof

A Java profile suitable for development of high integrity embedded systems is presented. It is based on event handlers which are grouped in missions and equipped with respectively private handler memory and shared mission memory. This is a result of our previous work on developing a Java profile......, and is directly inspired by interactions with the Open Group on their on-going work on a safety critical Java profile (JSR-302). The main contribution is an arrangement of the class hierarchy such that the proposal is a generalization of Real-Time Specification for Java (RTSJ). A further contribution...

Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON(®)-TB Gold (+) Kenyan adults without evidence of tuberculosis.

Science.gov (United States)

Walsh, Douglas S; Owira, Victorine; Polhemus, Mark; Otieno, Lucas; Andagalu, Ben; Ogutu, Bernhards; Waitumbi, John; Hawkridge, Anthony; Shepherd, Barbara; Pau, Maria Grazia; Sadoff, Jerald; Douoguih, Macaya; McClain, J Bruce

2016-05-05

In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON(®)-TB Gold In-Tube test (QFT-G)(-) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(-) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(-) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects. Published by Elsevier Ltd.

Comparing cultural profiles of MCR operators with those of non-MCR operators working in domestic Nuclear Power Plants

International Nuclear Information System (INIS)

Park, Jinkyun; Jung, Wondea

2015-01-01

Operation experience of complex socio-technical systems such as Nuclear Power Plants (NPPs) shows that most significant events are attributable to human error. Thus, various kinds of Human Reliability Analysis (HRA) techniques were used to manage human error for safety-critical tasks. However, a lack of available HRA data is a critical issue in conducting an HRA. For this reason, many researchers have tried to provide HRA data extracted from simulated emergency conditions. Unfortunately, it is still doubtful to directly use these HRA data because different operational cultures may result in different human performances even under a similar task context. From this concern, previous studies claimed that Main Control Room (MCR) operators working in different NPPs share very similar cultural profile. In order to confirm this claim, the culture profiles of operating personnel (i.e., non-MCR and MCR operators) working in domestic NPPs are compared. As a result, although some discrepancies are observed, it is positive to say that operating personnel of NPPs share similar cultural profiles to some extent. This result can be regarded as the first step to provide technical underpinnings that are helpful for understanding human performance data collected from different countries. - Highlights: • National and organizational culture of MCR and non-MCR operators are compared. • Organizational culture profiles are almost identical. • National culture profiles are not quite different overall. • Operating personnel in Nuclear Power Plants seems to share similar cultural profiles

Poloidal magnetic field profile measurements on the microwave tokamak experiment using far-infrared polarimetry

International Nuclear Information System (INIS)

Rice, B.W.

1992-09-01

The measurement of plasma poloidal magnetic field (B) profiles in tokamaks with good temporal and spatial resolution has proven to be a difficult but important measurement. A large range of toroidal confinement phenomena is expected to depend sensitively on the radial variation of B including the tearing instability, sawtooth oscillations, disruptions, and transport. Experimental confirmation of theoretical models describing these phenomena has been hampered by the lack of detailed B measurements. A fifteen chord far-infrared (FIR) polarimeter has been developed to measure B in the Microwave Tokamak, Experiment (MTX). Polarimetry utilizes the well known Faraday rotation effect, which causes a rotation of the polarization of an FIR beam propagating in the poloidal plane. The rotation angle is proportional to the component of B parallel to the beam. A new technique for determining the Faraday rotation angle is introduced, based on phase measurements of a rotating polarization ellipse. This instrument has been used successfully to measure B profiles for a wide range of experiments on MTX. For ohmic discharges, measurements of the safety factor on axis give q 0 ∼ 0.75 during sawteeth and q 0 > 1 without sawteeth. Large perturbations to the polarimeter signals correlated with the sawtooth crash are observed during some discharges. Measurements in discharges with electron cyclotron heating (ECH) show a transition from a hollow to peaked J profile that is triggered by the ECH pulse. Current-ramp experiments were done to perturb the J profile from the nominal Spitzer conductivity profile. Profiles for initial current ramps and ramps starting from a stable equilibrium have been measured and are compared with a cylindrical diffusion model. Finally, the tearing mode stability equation is solved using measured J profiles. Stability predictions are in good agreement with the existence of oscillations observed on the magnetic loops

Active SMS-based influenza vaccine safety surveillance in Australian children.

Science.gov (United States)

Pillsbury, Alexis; Quinn, Helen; Cashman, Patrick; Leeb, Alan; Macartney, Kristine

2017-12-18

Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p safety profile between brands. Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety of steel vessel Magnox pressure circuits

International Nuclear Information System (INIS)

Stokoe, T.Y.; Bolton, C.J.; Heffer, P.J.H.

1991-01-01

The maintenance of pressure circuit integrity is fundamental to nuclear safety at the steel vessel Magnox stations. To confirm continued pressure circuit integrity the CEGB, as part of the Long Term Safety Review, has carried out extensive assessment and inspection in recent years. The assessment methods and inspection techniques employed are based on the most modern available. Reactor pressure vessel integrity is confirmed by a combination of arguments including safety factors inferred from the successful pre-service overpressure test, leak-before-break analysis and probabilistic assessment. In the case of other parts of the pressure circuits that are more accessible, comprising the boiler shells and interconnecting gas duct work, in-service inspection is a major element of the safety substantiation. The assessment and inspection techniques and the materials property data have been underpinned for many years by extensive research and development programmes and in-reactor monitoring of representative samples has also been undertaken. The paper summarises the work carried out to demonstrate the long term integrity of the Magnox pressure circuits and provides examples of the results obtained. (author)

EPRI program in water reactor safety

International Nuclear Information System (INIS)

Loewenstein, W.B.; Gelhaus, F.; Gopalakrishnan, A.

1975-01-01

The basis for EPRI's water reactor safety program is twofold. First is compilation and development of fundamental background data necessary for quantified light-water reactor (LWR) safety assurance appraisals. Second is development of realistic and experimentally bench-marked analytical procedures. The results are expected either to confirm the safety margins in current operating parameters, and to identify overly conservative controls, or, in some cases, to provide a basis for improvements to further minimize uncertainties in expected performance. Achievement of these objectives requires the synthesis of related current and projected experimental-analytical projects toward establishment of an experimentally-based analysis for the assurance of safety for LWRs

49 CFR 655.61 - Action when an employee has a verified positive drug test result or has a confirmed alcohol test...

Science.gov (United States)

2010-10-01

... drug test result or has a confirmed alcohol test result of 0.04 or greater, or refuses to submit to a... drug test result or has a confirmed alcohol test result of 0.04 or greater, or refuses to submit to a... performing a safety-sensitive function. (3) If an employee refuses to submit to a drug or alcohol test...

164 original article profile of institutional infrastructure

African Journals Online (AJOL)

Dr Oboro VO

At this level is the most critical health services delivery point, with an ... Methods: The objectives of this study were to assess the universal precaution profile of primary health care .... Availability of safety training and monitoring schedule.

Phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a comparison of safety profiles.

Science.gov (United States)

Locatelli, Francesco; Del Vecchio, Lucia; Violo, Leano; Pontoriero, Giuseppe

2014-05-01

Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help control phosphorus levels. Although effective at lowering serum phosphorus, they all have safety issues that need to be considered when selecting which one to use. This paper reviews the use of phosphate binders in patients with CKD on dialysis, with a focus on safety and tolerability. In addition to the more established agents, a new resin-based phosphate binder, colestilan, is discussed. Optimal phosphate control is still an unmet need in CKD. Nonetheless, we now have an extending range of phosphate binders available. Aluminium has potentially serious toxic risks. Calcium-based binders are still very useful but can lead to hypercalcemia and/or positive calcium balance and cardiovascular calcification. No long-term data are available for the new calcium acetate/magnesium combination product. Lanthanum is an effective phosphate binder, but there is insufficient evidence about possible long-term effects of tissue deposition. The resin-based binders, colestilan and sevelamer, appear to have profiles that would lead to less vascular calcification, and the main adverse events seen with these agents are gastrointestinal effects.

Development and improvement of safety analysis code for geological disposal

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

In order to confirm the long-term safety concerning geological disposal, probabilistic safety assessment code and other analysis codes, which can evaluate possibility of each event and influence on engineered barrier and natural barrier by the event, were introduced. We confirmed basic functions of those codes and studied the relation between those functions and FEP/PID which should be taken into consideration in safety assessment. We are planning to develop 'Nuclide Migration Assessment System' for the purpose of realizing improvement in efficiency of assessment work, human error prevention for analysis, and quality assurance of the analysis environment and analysis work for safety assessment by using it. As the first step, we defined the system requirements and decided the system composition and functions which should be mounted in them based on those requirements. (author)

Patterns for Safety-Critical Java Memory Usage

DEFF Research Database (Denmark)

Rios Rivas, Juan Ricardo; Nilsen, Kelvin; Schoeberl, Martin

2012-01-01

Scoped memories are introduced in real-time Java profiles in order to make object allocation and deallocation time and space predictable. However, explicit scoping requires care from programmers when dealing with temporary objects, passing scope-allocated objects as arguments to methods, and retu......Scoped memories are introduced in real-time Java profiles in order to make object allocation and deallocation time and space predictable. However, explicit scoping requires care from programmers when dealing with temporary objects, passing scope-allocated objects as arguments to methods...... are illustrated by implementations in the safety-critical Java profile....

Country nuclear power profiles. 2000 ed

International Nuclear Information System (INIS)

2001-03-01

implemented and the profiles are supporting programmatic needs within the IAEA. It is noted that there also exist other less formal profiles on specific subjects of nuclear power in the Agency, e.g. Safety Profiles (NS Safety Co-ordination), Waste Management Profiles (NEFW), Fuel Cycle Profiles (NEFW)

Safety research activities on radioactive waste management in JNES

International Nuclear Information System (INIS)

Otsuka, Ichiro; Aoki, Hiroomi; Suko, Takeshi; Onishi, Yuko; Masuda, Yusuke; Kato, Masami

2010-01-01

Research activities in safety regulation of radioactive waste management are presented. Major activities are as follows. As for the geological disposal, major research areas are, developing 'safety indicators' to judge the adequacy of site investigation results presented by an implementer (NUMO), compiling basic requirements of safety design and safety assessment needed to make a safety review of the license application and developing an independent safety assessment methodology. In proceeding research, JNES, Japan Atomic Energy Agency (JAEA) and the National Institute of Advanced Industrial Science and Technology (AIST) signed an agreement of cooperative study on geological disposal in 2007. One of the ongoing joint studies under this agreement has been aimed at investigating regional-scale hydrogeological modeling using JAEA's Horonobe Underground Research Center. In the intermediate depth disposal, JNES conducted example analysis of reference facility and submitted the result to Nuclear Safety Commission of Japan (NSC). JNES is also listing issues to be addressed in the safety review of the license application and tries to make criteria of the review. Furthermore, JNES is developing analysis tool to evaluate long term safety of the facility and conducting an experiment to investigate long term behavior of engineered barrier system. In the near surface disposal of waste package, it must be confirmed by a regulatory inspector whether each package meets safety requirements. JNES continuously updates the confirmation methodology depending on new processing technologies. The clearance system was established in 2005. Two stages of regulatory involvement were adapted, 1) approval for measurement and judgment methods developed by the nuclear operator and 2) confirmation of measurement and judgment results based on approved methods. JNES is developing verification methodology for each stage. As for decommissioning, based on the regulatory needs and a research program

A study on development strategy of atomic safety organization for atomic environment

Energy Technology Data Exchange (ETDEWEB)

Lee, Sung Bok; Jeong, Ji Hun; Kim Tae Hee; Lee, Seung Hyuk; Woo, Eun Jung [Konkuk Univ., Seoul (Korea, Republic of)

2005-02-15

The objective of this research is to suggest some strategies which can make the safety of atomic power possible and reinforce the nuclear regulatory system. It will contribute to the expansion and settlement of nuclear safety culture by making the public understand well about the safety of nuclear energy, and searching public relations and incentive strategies. In addition, since the nuclear environment is changing rapidly, the necessity of cooperation between the public and the private has veen mostly required. So we need to develop the effective administrative system based on their cooperation. Therefore, it will examine the function of organization established, operation system, and also social network closely connected with the nuclear safety. Moreover, by analyzing the change of regulatory environment and present safety confirmation of nuclear energy, it will devise the new safety confirmation system of nuclear energy.

Safety analysis for 'Fugen'

International Nuclear Information System (INIS)

1997-10-01

The improvement of safety in nuclear power stations is an important proposition. Therefore also as to the safety evaluation, it is important to comprehensively and systematically execute it by referring to the operational experience and the new knowledge which is important for the safety throughout the period of use as well as before the construction and the start of operation of nuclear power stations. In this report, the results when the safety analysis for ''Fugen'' was carried out by referring to the newest technical knowledge are described. As the result, it was able to be confirmed that the safety of ''Fugen'' has been secured by the inherent safety and the facilities which were designed for securing the safety. The basic way of thinking on the safety analysis including the guidelines to be conformed to is mentioned. As to the abnormal transient change in operation and accidents, their definition, the events to be evaluated and the standards for judgement are reported. The matters which were taken in consideration at the time of the analysis are shown. The computation programs used for the analysis were REACT, HEATUP, LAYMON, FATRAC, SENHOR, LOTRAC, FLOOD and CONPOL. The analyses of the abnormal transient change in operation and accidents are reported on the causes, countermeasures, protective functions and results. (K.I.)

The safety of istradefylline for the treatment of Parkinson's disease.

Science.gov (United States)

Müller, Thomas

2015-05-01

Antagonism of the A2A receptor improves motor behavior in patients with Parkinson's disease (PD), according to results of clinical studies which confirm findings of previous experimental research. The xanthine derivative, istradefylline , has the longest half-life out of the available A2A receptor antagonists. Istradefylline easily crosses the blood-brain barrier and shows a high affinity to the human A2A receptor. This narrative review aims to discuss the safety and tolerability of istradefylline against the background of the currently available drug portfolio for the treatment of PD patients. Istradefylline was safe and well tolerated in clinical trials, which have focused on l-DOPA-treated PD patients. The future of istradefylline as a complementary drug for modulation of the dopaminergic neurotransmission also relies on its potential to act like an l-DOPA plus dopamine agonist sparing future treatment alternative and to reduce the risk of predominant l-DOPA-related onset of motor complications in addition to its direct ameliorating effect on motor symptoms. Dopamine-substituting drugs may dose-dependently produce systemic side effects, particularly onset of hypotension and nausea by peripheral dopamine receptor stimulation. Istradefylline does not interfere with these peripheral receptors and therefore shows a good safety and tolerability profile.

RADWASS update. Radioactive Waste Safety Standards Programme

International Nuclear Information System (INIS)

Delattre, D.

2000-01-01

By the late 1980s, the issue of radioactive wastes and their management was becoming increasingly politically important. The IAEA responded by establishing a high profile family of safety standards, the Radioactive Waste Safety Standards (RADWASS). By this means, the IAEA intended to draw attention to the fact that well-established procedures for the safe management of radioactive wastes already were in place. The programme was intended to establish an ordered structure for safety documents on waste management and to ensure comprehensive coverage of all relevant subject areas. RADWASS documents are categorized under four subject areas - discharges, predisposal, disposal, and environmental restoration. The programme is overseen through a formalized review and approval mechanism that was established in 1996 for all safety standards activities. The Waste Safety Standards Committee (WASSC) is a standing body of senior regulatory officials with technical expertise in radioactive waste safety. To date, three Safety Requirements and seven Safety Guides have been issued

Monitoring product safety in the postmarketing environment.

Science.gov (United States)

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease

Directory of Open Access Journals (Sweden)

William Seiple

2016-01-01

Full Text Available Background. Parkinson’s disease (PD progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months’ prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n=121 or ropinirole (n=125 for 2 years. Comprehensive ophthalmologic assessments (COA included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71–1.60. Mean changes from baseline in Unified Parkinson’s Disease Rating System parts II+III total scores (pramipexole: 1 year, −4.1±8.9, and 2 years, −0.7±10.1, and ropinirole: 1 year, −3.7±8.2, and 2 years, −1.7±10.5 and Hoehn–Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.

Mucosal barrier injury laboratory-confirmed bloodstream infection: results from a field test of a new National Healthcare Safety Network definition.

Science.gov (United States)

See, Isaac; Iwamoto, Martha; Allen-Bridson, Kathy; Horan, Teresa; Magill, Shelley S; Thompson, Nicola D

2013-08-01

To assess challenges to implementation of a new National Healthcare Safety Network (NHSN) surveillance definition, mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI). Multicenter field test. Selected locations of acute care hospitals participating in NHSN central line-associated bloodstream infection (CLABSI) surveillance. Hospital staff augmented their CLABSI surveillance for 2 months to incorporate MBI-LCBI: a primary bloodstream infection due to a selected group of organisms in patients with either neutropenia or an allogeneic hematopoietic stem cell transplant with gastrointestinal graft-versus-host disease or diarrhea. Centers for Disease Control and Prevention (CDC) staff reviewed submitted data to verify whether CLABSIs met MBI-LCBI criteria and summarized the descriptive epidemiology of cases reported. Eight cancer, 2 pediatric, and 28 general acute care hospitals including 193 inpatient units (49% oncology/bone marrow transplant [BMT], 21% adult ward, 20% adult critical care, 6% pediatric, 4% step-down) conducted field testing. Among 906 positive blood cultures reviewed, 282 CLABSIs were identified. Of the 103 CLABSIs that also met MBI-LCBI criteria, 100 (97%) were reported from oncology/BMT locations. Agreement between hospital staff and CDC classification of reported CLABSIs as meeting the MBI-LCBI definition was high (90%; κ = 0.82). Most MBI-LCBIs (91%) occurred in patients meeting neutropenia criteria. Some hospitals indicated that their laboratories' methods of reporting cell counts prevented application of neutropenia criteria; revised neutropenia criteria were created using data from field testing. Hospital staff applied the MBI-LCBI definition accurately. Field testing informed modifications for the January 2013 implementation of MBI-LCBI in the NHSN.

Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI

Directory of Open Access Journals (Sweden)

Chuchalin Alexander

2013-01-01

observational study had risk factors for poor outcome, justifying use of moxifloxacin. The safety profile of moxifloxacin and its value as an antibiotic treatment were confirmed. Physicians complied with the recommended 400 mg once-daily dose in a large proportion of patients, confirming the advantages of this simple dosing regimen. Trial registration ClinicalTrials.gov identifier: NCT00846911

Utilization of thin-layer chromatography for confirmational sampling during remedial excavation

International Nuclear Information System (INIS)

Burton, P.J.

1996-01-01

Thin-layer chromatography (TLC) is a simple, efficient, inexpensive, and accurate method of chemical analysis. This method is applicable to field testing for confirming the limits of excavation during excavation of petroleum, oil, and/or lubricant (POL) contamination. Traditionally, excavation at contaminated sites suffers from a time delay due to the need to obtain laboratory confirmation of the limits of excavation. All suspected contaminated material is removed for stockpiling or remediation. The remaining soils need to be sampled to confirm that no contaminated material remains in the excavation. The site scientist collects samples and sends them out for analysis at a certified laboratory. The laboratory requires, even for a rush order, several days to analyze the samples. This time delay interferes with the efficiency of the operation. The excavations either have to be left open (which is a safety hazard) or reopened if additional material must be excavated. TLC samples can be collected and analyzed in several hours allowing for a short turnaround time for analytical results. The TLC method can be easily performed by a technician. Results of a case study from a subarctic Alaskan site will be reported. Simple operational TLC procedures will be shared. The equipment required for TLC analysis will be outlined. Correlation data between TLC and laboratory analysis will be presented

Competence in confirming correct placement of nasogastric feeding tubes amongst FY1 doctors

OpenAIRE

Lee, Sindy; Mason, Eleanor

2013-01-01

Foundation year one (FY1) doctors are required to confirm correct placement of nasogastric (NG) feeding tubes on chest radiography on a regular basis. Many FY1s do not receive formal training during medical school or during the FY1 year. Multiple incidents of harm to patients, including death, resulting from incorrect placement of an NG feeding tube have been reported to the National Patient Safety Agency (NPSA) since 2005. Our audit assessed the confidence and knowledge of FY1 doctors in cor...

Confirming LBV Candidates Through Variability: A Photometric and Spectroscopic Monitoring Study

Science.gov (United States)

Stringfellow, Guy; Gvaramadze, Vasilii

2013-02-01

Luminous Blue Variable (LBV) stars represent an extremely rare class of luminous massive stars with high mass loss rates. The paucity ( 12) of confirmed Galactic LBV precludes determining a solid evolutionary connection between LBV and other intermediate (e.g. Ofpe/WN9, WNL) phases in the life of very massive stars. We've been conducting an optical/near-IR spectral survey of a large subset of central stars residing within newly discovered it Spitzer nebulae and have identified over two dozen new candidate LBVs (cLBVs) based on spectral similarity alone; confirming them as bona fide LBVs requires demonstrating 1-3 mag photometric and spectroscopic variability. This marks a significant advancement in the study of massive stars, far outweighing the return from many studies searching for LBVs and WRs the past several decades. Monitoring from semesters 2011B-2012A already has confirmed one new cLBV as a bona fide LBV. We propose to continue optical-IR photometric monitoring of these cLBVS with the 1.3m. Chiron, replacing the RC spectrograph on the 1.5m, now allows high-resolution optical spectroscopic monitoring of bright cLBVs, 11 of which are proposed herein. Spectra are important for understanding the physics driving photometric variability, properties of the wind, and allow analysis of line profiles.

Methods and Effects of Safety Enhancement in Korean PSR

International Nuclear Information System (INIS)

Kim, Young Gab; Park, Jong Woon

2009-01-01

Periodic Safety Review (PSR) is a comprehensive study on a nuclear power plant safety, taking into account aspects such as operational history, ageing, safety analyses and advances in code and standards since the time of construction. In Korea, PSRs have been performed for 20 units and have been effectively used to obtain an overall view of actual plant safety to determine reasonable and practical modifications that should be made in order to obtain a higher level of safety approaching that of modern plants. Among many safety enhancements achieved from Korean PSRs, new safety analyses are the important methods to confirm plant safety by increasing safety margin for specific safety issues. Methods and effects of safety enhancements applied in Korean PSRs are reviewed in this paper in light of new safety analyses to obtain additional safety margins

The profile of quantitative risk indicators in Krsko NPP

International Nuclear Information System (INIS)

Vrbanic, I.; Basic, I.; Bilic-Zabric, T.; Spiler, J.

2004-01-01

During the past decade strong initiative was observed which was aimed at incorporating information on risk into various aspects of operation of nuclear power plants. The initiative was observable in activities carried out by regulators as well as utilities and industry. It resulted in establishing the process, or procedure, which is often referred to as integrated decision making or risk informed decision making. In this process, engineering analyses and evaluations that are usually termed traditional and that rely on considerations of safety margins and defense in depth are supplemented by quantitative indicators of risk. Throughout the process, the plant risk was most commonly expressed in terms of likelihood of events involving damage to the reactor core and events with radiological releases to the environment. These became two commonly used quantitative indicators or metrics of plant risk (or, reciprocally, plant safety). They were evaluated for their magnitude (e.g. the expected number of events per specified time interval), as well as their profile (e.g. the types of contributing events). The information for quantitative risk indicators (to be used in risk informing process) is obtained from plant's probabilistic safety analyses or analyses of hazards. It is dependable on issues such as availability of input data or quality of model or analysis. Nuclear power plant Krsko has recently performed Periodic Safety Review, which was a good opportunity to evaluate and integrate the plant specific information on quantitative plant risk indicators and their profile. The paper discusses some aspects of quantitative plant risk profile and its perception.(author)

Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.

Directory of Open Access Journals (Sweden)

Sophia Gailhardou

2016-07-01

Full Text Available A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged <9 years in the CYD-TDV group compared with the placebo group was not observed for participants aged ≥9 years. In Year 4, this imbalance in participants aged <9 years was less marked, giving an overall lower risk of dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target

Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults

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Emanuele Montomoli

2018-03-01

Full Text Available Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs. This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs, to enhance protection against circulating influenza B viruses. This review describes the results obtained from seven phase III clinical trials evaluating the immunogenicity, safety, and lot-to-lot consistency of a new quadrivalent split-virion influenza vaccine (Vaxigrip Tetra® formulated by adding a second B strain to the already licensed TIV. Since Vaxigrip Tetra was developed by means of a manufacturing process strictly related to that used for TIV, the data on the safety profile of TIV are considered supportive of that of Vaxigrip Tetra. The safety and immunogenicity of Vaxigrip Tetra were similar to those of the corresponding licensed TIV. Moreover, the new vaccine elicits a superior immune response towards the additional strain, without affecting immunogenicity towards the other three strains. Vaxigrip Tetra is well tolerated, has aroused no safety concerns, and is recommended for the active immunization of individuals aged ≥6 months. In addition, preliminary data confirm its immunogenicity and safety even in children aged 6–35 months and its immunogenicity in older subjects (aged 66–80 years.

Safety, immunogenicity, and efficacy of the ML29 reassortant vaccine for Lassa fever in small non-human primates✩

Science.gov (United States)

Lukashevich, Igor S.; Carrion, Ricardo; Salvato, Maria S.; Mansfield, Keith; Brasky, Kathleen; Zapata, Juan; Cairo, Cristiana; Goicochea, Marco; Hoosien, Gia E.; Ticer, Anysha; Bryant, Joseph; Davis, Harry; Hammamieh, Rasha; Mayda, Maria; Jett, Marti; Patterson, Jean

2008-01-01

A single injection of ML29 reassortant vaccine for Lassa fever induces low, transient viremia, and low or moderate levels of ML29 replication in tissues of common marmosets depending on the dose of the vaccination. The vaccination elicits specific immune responses and completely protects marmosets against fatal disease by induction of sterilizing cell-mediated immunity. DNA array analysis of human peripheral blood mononuclear cells from healthy donors exposed to ML29 revealed that gene expression patterns in ML29-exposed PBMC and control, media-exposed PBMC, clustered together confirming safety profile of the ML29 in non-human primates. The ML29 reassortant is a promising vaccine candidate for Lassa fever. PMID:18692539

Safety-Culture Exploration in Taiwan’s Metal Industries: Identifying the Workers’ Background Influence on Safety Climate

Directory of Open Access Journals (Sweden)

Shu-Chiang Lin

2017-10-01

Full Text Available The present study aims to assess the safety-climate level in Taiwan’s metal industries, as well as to identify the influence of workers’ backgrounds on the safety climate. An earlier report showed that a poor safety culture was related to the cause of accidents in Taiwan’s traditional manufacturing industries. This study surveyed a total of 839 workers who voluntarily participated and completed the safety-culture questionnaires. These workers were from a Taiwanese metal company and its five satellite companies. Three safety-climate factors, namely safety perception, safety communication and safety-management systems, were assessed. Confirmatory factor analysis (CFA was conducted by developing structural equation modeling to ensure the questionnaire’s validity. The influence of workers’ backgrounds on the safety climate was identified by using one-way ANOVA. The reliability result of the questionnaire was above the acceptable level. The overall safety-climate score was 4.22 out of a five-point scale for safety perception, 4.23 for safety-management systems and 3.97 for safety communication. The scores indicate a good level of safety climate, with room for improvement in safety communication. Additionally, the influence of workers’ backgrounds on the safety climate was confirmed. Based on the validity test, it was also found that the questionnaire could be improved by reconstructing its questions in its development process in order to increase the safety-climate model’s reliability and validity, as well as its model fit.

[Safety management in pathology laboratory: from specimen handling to confirmation of reports].

Science.gov (United States)

Minato, Hiroshi; Nojima, Takayuki; Nakano, Mariko; Yamazaki, Michiko

2011-03-01

Medical errors in pathological diagnosis give a huge amount of physical and psychological damage to patients as well as medical staffs. We discussed here how to avoid medical errors in surgical pathology laboratory through our experience. Handling of surgical specimens and diagnosing process requires intensive labor and involves many steps. Each hospital reports many kinds of accidents or incidents, however, many laboratories share common problems and each process has its specific risk for the certain error. We analyzed the problems in each process and concentrated on avoiding misaccessioning, mislabeling, and misreporting. We have made several changes in our system, such as barcode labels, digital images of all specimens, putting specimens in embedding cassettes directly on the endoscopic biopsied specimens, and using a multitissue control block as controls in immunohistochemistry. Some problems are still left behind, but we have reduced the errors by decreasing the number of artificial operation as much as possible. A pathological system recognizing the status of read or unread the pathological reports by clinician are now underconstruction. We also discussed about quality assurance of diagnosis, cooperation with clinicians and other comedical staffs, and organization and method. In order to operate riskless work, it is important for all the medical staffs to have common awareness of the problems, keeping careful observations, and sharing all the information in common. Incorporation of an organizational management tool such as ISO 15189 and utilizing PDCA cycle is also helpful for safety management and quality improvement of the laboratory.

Safety analysis of a high temperature gas-cooled reactor

International Nuclear Information System (INIS)

Shimazu, Akira; Morimoto, Toshio

1975-01-01

In recent years, in order to satisfy the social requirements of environment and safety and also to cope with the current energy stringency, the installation of safe nuclear power plants is indispensable. Herein, safety analysis and evaluation to confirm quantitatively the safety design of a nuclear power plant become more and more important. The safety analysis and its methods for a high temperature gas-cooled reactor are described, with emphasis placed on the practices by Fuji Electric Manufacturing Co. Fundamental rule of securing plant safety ; safety analysis in normal operation regarding plant dynamic characteristics and radioactivity evaluation ; and safety analysis at the time of accidents regarding plant response to the accidents and radioactivity evaluation are explained. (Mori, K.)

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

Science.gov (United States)

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2014-10-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Summary of NRC LWR safety research programs on fuel behavior, metallurgy/materials and operational safety

International Nuclear Information System (INIS)

Bennett, G.L.

1979-09-01

The NRC light-water reactor safety-research program is part of the NRC regulatory program for ensuring the safety of nuclear power plants. This paper summarizes the results of NRC-sponsored research into fuel behavior, metallurgy and materials, and operational safety. The fuel behavior research program provides a detailed understanding of the response of nuclear fuel assemblies to postulated off-normal or accident conditions. Fuel behavior research includes studies of basic fuel rod properties, in-reactor tests, computer code development, fission product release and fuel meltdown. The metallurgy and materials research program provides independent confirmation of the safe design of reactor vessels and piping. This program includes studies on fracture mechanics, irradiation embrittlement, stress corrosion, crack growth, and nondestructive examination. The operational safety research provides direct assistance to NRC officials concerned with the operational and operational-safety aspects of nuclear power plants. The topics currently being addressed include qualification testing evaluation, fire protection, human factors, and noise diagnostics

Applying principles from safety science to improve child protection.

Science.gov (United States)

Cull, Michael J; Rzepnicki, Tina L; O'Day, Kathryn; Epstein, Richard A

2013-01-01

Child Protective Services Agencies (CPSAs) share many characteristics with other organizations operating in high-risk, high-profile industries. Over the past 50 years, industries as diverse as aviation, nuclear power, and healthcare have applied principles from safety science to improve practice. The current paper describes the rationale, characteristics, and challenges of applying concepts from the safety culture literature to CPSAs. Preliminary efforts to apply key principles aimed at improving child safety and well-being in two states are also presented.

Impact of the Road Profile on Vehicle Deceleration

Directory of Open Access Journals (Sweden)

Vidas Žuraulis

2012-11-01

Full Text Available The article analyzes the impact of the longitudinal road profile on the efficiency of car braking estimated applying deceleration value. Different formulas are used for theoretical calculations, and therefore experimental brakes in different road slopes were performed to obtain the most accurate results. Deceleration, as one of the most important safety parameters, depends on the technical condition of the braking system, road conditions and structural and dynamic properties of the other car. Road alignments can significantly affect car manageability, because of weight transfer and extra track resistance, which may change the overall balance of the car and affect the nature of dynamic characteristics that may vary from certain critical values. The results of corrections to deceleration dependence on the road profile can be used for investigating traffic accidents, optimizing traffic control arrangements and implementing advanced systems for automotive active safety.

Safety and injury profile of conducted electrical weapons used by law enforcement officers against criminal suspects.

Science.gov (United States)

Bozeman, William P; Hauda, William E; Heck, Joseph J; Graham, Derrel D; Martin, Brian P; Winslow, James E

2009-04-01

Conducted electrical weapons such as the Taser are commonly used by law enforcement agencies. The safety of these weapons has been the subject of scrutiny and controversy; previous controlled studies in animals and healthy humans may not accurately reflect the risks of conducted electrical weapons used in actual conditions. We seek to determine the safety and injury profile of conducted electrical weapons used against criminal suspects in a field setting. This prospective, multicenter, observational trial tracked a consecutive case series of all conducted electrical weapon uses against criminal suspects at 6 US law enforcement agencies. Mandatory review of each conducted electrical weapon use incorporated physician review of police and medical records. Injuries were classified as mild, moderate, or severe according to a priori definitions. The primary outcome was a composite of moderate and severe injuries, termed significant injuries. Conducted electrical weapons were used against 1,201 subjects during 36 months. One thousand one hundred twenty-five subjects (94%) were men; the median age was 30 years (range 13 to 80 years). Mild or no injuries were observed after conducted electrical weapon use in 1,198 subjects (99.75%; 95% confidence interval 99.3% to 99.9%). Of mild injuries, 83% were superficial puncture wounds from conducted electrical weapon probes. Significant injuries occurred in 3 subjects (0.25%; 95% confidence interval 0.07% to 0.7%), including 2 intracranial injuries from falls and 1 case of rhabdomyolysis. Two subjects died in police custody; medical examiners did not find conducted electrical weapon use to be causal or contributory in either case. To our knowledge, these findings represent the first large, independent, multicenter study of conducted electrical weapon injury epidemiology and suggest that more than 99% of subjects do not experience significant injuries after conducted electrical weapon use.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

Science.gov (United States)

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

The pharmacokinetics and safety profile of oral ganciclovir in combination with trimethoprim in HIV- and CMV-seropositive patients

Science.gov (United States)

Jung, Donald; AbdelHameed, Magdy H; Hunter, John; Teitelbaum, Philip; Dorr, Albert; Griffy, Kay

1999-01-01

Aims We investigated the pharmacokinetics and safety profile of oral ganciclovir coadministered with trimethoprim in HIV-and CMV-seropositive patients. Methods In an open-label, randomized, 3-way crossover study, 12 adult males received oral ganciclovir 1000 mg every 8h, oral trimethoprim 200 mg once daily, or both drugs concomitantly in a sequence of three 7-day treatment periods. Pharmacokinetic parameters were determined and adverse events recorded for each treatment. Results The presence of trimethoprim significantly decreased CLr (12.9%, P = 0.0068) and increased t1/2 (18.1%, P = 0.0378) of ganciclovir. However, these changes are unlikely to be clinically meaningful. There were no statistically significant changes in trimethoprim pharmacokinetic parameters in the presence of ganciclovir, with the exception of a 12.7% increase in Cmin. Ganciclovir was well tolerated when administered alone or in combination with trimethoprim. Conclusions There was no clinically significant pharmacokinetic interaction between oral ganciclovir and trimethoprim when coadministered. PMID:10215748

Installation Restoration Program, Phase II - Confirmation/Quantification Stage I, Moody Air Force Base, Georgia.

Science.gov (United States)

1985-12-01

Confirmation/Quantification. Moody AFB- GA _____ S12. PERSONAL AUTHOR(S) .. ’ Steinberg J.A. and Thiess, W.G. 13.& TYPE OF REPORT 13b. TIME COVERED 14I. DATE...2.3.2 Soils On the high ground western portion of the base, the surface soils are mostly in the Tifton series. The soil profile consists of about 2 to...Florida Department of Environmental Regulation FWQS Florida Water Quality Standards gpd Gallons per day gpm Gallons per minute GC Gas chromatograph

Technical features of ABWR safety systems

International Nuclear Information System (INIS)

Sugisaki, Toshihiko; Tominaga, Kenji; Horiuchi, Tetsuo

1986-01-01

The engineering safety facilities of ABWRs have been disigned so as to have many excellent characteristics such as safety, reliability and economy, reflecting the merit of adopting new technology such as internal pumps and new control rod driving mechanism, and coupled with the safety peculiar to BWRs. In this paper, about ECCS, containment vessels and others which compose the engineering safety facilities of ABWRs, the characteristics related to the safety owing to the adoption of internal pumps and others, and the evaluation of the performance at the time of various accidents are discussed. As the results of safety evaluation, it was clarified that due to the safety peculiar to ABWRs and the characteristics of the safety facilities, the large increases of safety, reliability and economy have been planned in the ABWRs, and for example, core flooding can be maintained even at the time of a hypothetical loss of coolant accident. BWRs have the simple system constitution, good self controllability, large natural circulation ability, simple operation control method and excellent ability of confining heat and radioactivity. BWRs have three safety functions to stop reactors, to remove heat from reactors, and to confine radioactive substances. These functions of ABWRs were evaluated, and very high safety was confirmed. (Kako, I.)

Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.

Science.gov (United States)

Camporeale, Angelo; Porsdal, Vibeke; De Bruyckere, Katrien; Tanaka, Yoko; Upadhyaya, Himanshu; Deix, Claudia; Deberdt, Walter

2015-01-01

The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18-77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13-17%, diastolic blood pressure 37-40%, heart rate 42-43%) compared to placebo (systolic blood pressure 8-13%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder. © The Author(s) 2014.

Safety Culture Enhancement Project. Final Report. A Field Study on Approaches to Enhancement of Safety Culture

Energy Technology Data Exchange (ETDEWEB)

Lowe, Andrew; Hayward, Brent (Dedale Asia Pacific, Albert Park VIC 3206 (Australia))

2006-08-15

results of the Safety Culture Perceptions Questionnaire conducted with site managers to access their opinions about the adequacy of the local safety culture; - a framework of safety-related competencies for managers, representing desirable actions for leading and promoting a positive safety culture; - results of an evaluation survey completed by participants at the conclusion of the Management Workshops to assess the utility of this activity. Section 4 of the report, Recommendations for Future Action, highlights nine proposed activities that could be undertaken to build on the outcomes from this project, to support the enhancement of safety culture within the Swedish nuclear industry in the longer term. Specifically, these recommendations propose actions to: 1. Introduce formal processes to ensure the ongoing development of safety related competencies amongst industry managers. 2. Strengthen the resources, contribution, value and profile of Man Technology Organisation (MTO) expertise within nuclear industry sites, in order to promote a better understanding of human performance issues, enhance error management and accident prevention capabilities. 3. Identify ways to embed existing positive safety culture attributes, in an environment of considerable workforce changes resulting from increasing use of contractors and (expected) retirements amongst an ageing industry employee population. 4. Standardise and improve aspects of incident and accident investigation processes and analysis methodologies currently used, to improve information sharing and optimise learning. 5. Implement harmonised MTO / human factors awareness training programs at appropriate levels for all nuclear industry personnel. 6. Formalise the application of applied teamwork training (as per the principles of Crew Resource Management training in aviation) for NPP Control Room Operators, Maintenance workers and other employees working in safety-critical teams. 7. Increase the use of simulation training to

GPR56-Related Polymicrogyria: Clinicoradiologic Profile of 4 Patients.

Science.gov (United States)

Desai, Neelu A; Udani, Vrajesh

2015-11-01

Bilateral frontoparietal polymicrogyria is an autosomal recessive cortical malformation associated with abnormalities of neuronal migration, white matter changes, and mild brainstem and cerebellar abnormalities. Affected patients present with delayed milestones, intellectual disability, epilepsy, ataxia, and eye movement abnormalities. The clinicoradiologic profile resembles congenital muscular dystrophy. However, no muscle disease or characteristic eye abnormalities of congenial muscular dystrophy are detected in these children. GPR56 is the only confirmed gene associated with bilateral frontoparietal polymicrogyria. Antenatal diagnosis is possible if the index case is genetically confirmed. Four patients from different Indian families with a distinct clinicoradiologic profile resembling congenital muscular dystrophy with mutations in the GPR56 gene are described. © The Author(s) 2015.

Safety of PEGylated recombinant human full-length coagulation factor VIII (BAX 855) in the overall context of PEG and PEG conjugates.

Science.gov (United States)

Stidl, R; Fuchs, S; Bossard, M; Siekmann, J; Turecek, P L; Putz, M

2016-01-01

BAX 855 is a PEGylated human full-length recombinant factor VIII (rFVIII) based on licensed rFVIII (ADVATE). The applied PEGylation technology has been optimized to retain functionality of the FVIII molecule, improve its pharmacokinetic properties and allow less frequent injections while maintaining efficacy. The aim of this study was to confirm that the excellent safety profile of ADVATE remains unchanged after PEGylation. Non-clinical safety studies with BAX 855 and its respective unbound polyethylene glycol (PEG) were conducted in several species. The distribution of a single dose of radiolabelled BAX 855 was further investigated in rats. Publically available safety data on PEG alone and PEGylated biomolecules were summarized and reviewed for specific safety findings attributable to PEG or PEGylated biopharmaceuticals. Safety pharmacology studies in rabbits and macaques and repeated dose toxicity studies in rats and macaques identified no safety issues. Results of a distribution study in rats administered radiolabelled BAX 855 showed that radioactivity was completely excreted; urine was the major elimination route. A 28-day study in rats dosed with the unbound PEG constituent (PEG2ru20KCOOH) of BAX 855 showed no adverse or non-adverse effects. Safety data for PEG and PEG-protein conjugates indicate no safety concerns associated with PEG at clinically relevant dose levels. Although vacuolation of certain cell types has been reported in mammals, no such vacuolation was observed with BAX 855 or with the unbound PEG constituent. Non-clinical safety evaluation of PEG and BAX 855 identified no safety signals; the compound is now in clinical development for the treatment of patients with haemophilia A. © 2015 Baxalta Innovations GmbH. Haemophilia Published by John Wiley & Sons Ltd.

Diclofenac: an update on its mechanism of action and safety profile.

Science.gov (United States)

Gan, Tong J

2010-07-01

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) with relative equipotency. However, extensive research shows the pharmacologic activity of diclofenac goes beyond COX inhibition, and includes multimodal and, in some instances, novel mechanisms of action (MOA). Literature retrieval was performed through PubMed/MEDLINE (through May 2009) using combinations of the terms diclofenac, NSAID, mechanism of action, COX-1, COX-2, and pharmacology. Reference citations resulting from publications identified in the literature search were reviewed when appropriate. This article reviews the established, putative, and emerging MOAs of diclofenac; compares the drug's pharmacologic and pharmacodynamic properties with other NSAIDs to delineate its potentially unique qualities; hypothesizes why it has been chosen for further recent formulation enhancement; and evaluates the potential effect of its MOA characteristics on safety. Research suggests diclofenac can inhibit the thromboxane-prostanoid receptor, affect arachidonic acid release and uptake, inhibit lipoxygenase enzymes, and activate the nitric oxide-cGMP antinociceptive pathway. Other novel MOAs may include the inhibition of substrate P, inhibition of peroxisome proliferator activated receptor gamma (PPARgamma), blockage of acid-sensing ion channels, alteration of interleukin-6 production, and inhibition of N-methyl-D-aspartate (NMDA) receptor hyperalgesia. The review was not designed to compare MOAs of diclofenac with other NSAIDs. Additionally, as the highlighted putative and emerging MOAs do not have clinical data to demonstrate that these models are

NUMO's approach for long-term safety assessment - 59404

International Nuclear Information System (INIS)

Ebashi, Takeshi; Kaku, Kenichi; Ishiguro, Katsuhiko

2012-01-01

One of NUMO's policies for ensuring safety is staged and flexible project implementation and decision-making based on iterative confirmation of safety. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; a key aspect is uncertainty management. This paper presents NUMO's basic strategies for long-term safety assessment based on the above policy. NUMO's approach considering Japanese boundary conditions is demonstrated as a starting-point for evaluating the long-term safety of an actual site. In Japan, the Act on Final Disposal of Specified Radioactive Waste states that the siting process shall consist of three stages. The Nuclear Waste Management Organization of Japan (NUMO) is responsible for geological disposal of vitrified high-level waste and some types of TRU waste. NUMO has chosen to implement a volunteer approach to siting. NUMO decided to prepare the so-called 2010 technical report, which sets out three safety policies, one of which is staged project implementation and decision-making based on iterative confirmation of safety. Based on this policy, NUMO will gradually integrate relevant interdisciplinary knowledge to build a safety case when a formal volunteer application is received that would allow site investigations to be initiated. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; one of a key aspect is uncertainty management. This paper presents the basic strategies for NUMO's long-term safety assessment based on the above policy. In concrete terms, the common procedures involved in safety assessment are applied in a stepwise manner, based on integration of knowledge obtained from site investigations/evaluations and engineered measures. The results of the safety assessment are then reflected in the planning of site investigations and engineered

Added Diagnostic Value of Cerebrospinal Fluid Biomarkers for Differential Dementia Diagnosis in an Autopsy-Confirmed Cohort.

Science.gov (United States)

Niemantsverdriet, Ellis; Feyen, Bart F E; Le Bastard, Nathalie; Martin, Jean-Jacques; Goeman, Johan; De Deyn, Peter Paul; Bjerke, Maria; Engelborghs, Sebastiaan

2018-01-01

Differential dementia diagnosis remains a challenge due to overlap of clinical profiles, which often results in diagnostic doubt. Determine the added diagnostic value of cerebrospinal fluid (CSF) biomarkers for differential dementia diagnosis as compared to autopsy-confirmed diagnosis. Seventy-one dementia patients with autopsy-confirmed diagnoses were included in this study. All neuropathological diagnoses were established according to standard neuropathological criteria and consisted of Alzheimer's disease (AD) or other dementias (NONAD). CSF levels of Aβ1 - 42, T-tau, and P-tau181 were determined and interpreted based on the IWG-2 and NIA-AA criteria, separately. A panel of three neurologists experienced with dementia made clinical consensus dementia diagnoses. Clinical and CSF biomarker diagnoses were compared to the autopsy-confirmed diagnoses. Forty-two patients (59%) had autopsy-confirmed AD, whereas 29 patients (41%) had autopsy-confirmed NONAD. Of the 24 patients with an ambiguous clinical dementia diagnosis, a correct diagnosis would have been established in 67% of the cases applying CSF biomarkers in the context of the IWG-2 or the NIA-AA criteria respectively. AD CSF biomarkers have an added diagnostic value in differential dementia diagnosis and can help establishing a correct dementia diagnosis in case of ambiguous clinical dementia diagnoses.

Summary of CCTF test results - assessment of current safety evaluation analysis on reflood behaviour during a LOCA in a PWR with cold-leg-injection-type ECCS

International Nuclear Information System (INIS)

Iguchi, Tadashi; Murao, Yoshio; Sugimoto, Jun; Akimoto, Hajime; Okubo, Tsutomu; Hojo, Tsuneyuki

1988-01-01

The conservatism of the current safety analysis was assessed by comparing the predicted results with cylindrical core test facility (CCTF) test results performed at JAERI. The WREM code was selected for the assessment. The overall conservatism of the WREM code on the peak clad temperature prediction was confirmed against CCTF EM test which simulated the typical initial and boundary conditions in the safety evaluation analysis. The WREM code predicted the reasonable core boundary conditions and the conservatism of the code came mainly from the core calculation. The conservatism of the WREM code against CCTF data could be attributed to the following three points: (i) no horizontal mixing assumption between subchannels at each elevation, (ii) no modeling on heat transfer enhancement caused by the radial core power profile, (iii) usage of conservative heat transfer correlations in the code. (orig./HP)

Assessment of the Safety of Some On-The-Shelf Canned Food ...

African Journals Online (AJOL)

There is also the possibility of these organisms posing food safety issues and pharmaceutical risks in case of possible out break, assayed through plasmid profiling of the culture-dependent isolates. A major concern in this study is the lack of adherence to food safety regulations. The products still been marketed on the ...

Drug safety evaluation of defibrotide.

Science.gov (United States)

Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

2013-01-01

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

Safety profile of multielectrode-phased radiofrequency pulmonary vein ablation catheter and irrigated radiofrequency catheter.

Science.gov (United States)

Wasmer, K; Foraita, P; Leitz, P; Güner, F; Pott, C; Lange, P S; Eckardt, L; Mönnig, G

2016-01-01

Silent cerebral lesions with the multielectrode-phased radiofrequency (RF) pulmonary vein ablation catheter (PVAC(®)) have recently been investigated. However, comparative data on safety in relation to irrigated RF ablation are missing. One hundred and fifty consecutive patients (58 ± 12 years, 56 female) underwent first pulmonary vein isolation (PVI) for atrial fibrillation (61% paroxysmal) using PVAC(®) (PVAC). Procedure data as well as in-hospital complications were compared with 300 matched patients who underwent PVI using irrigated RF (iRF). Procedure duration (148 ± 63 vs. 208 ± 70 min; P drainage n = 0 vs. n = 6] occurred more frequently using iRF. Two patients in each group developed a TIA (1.3% vs. 0.6%). Of note, four of five thromboembolic events in the PVAC group (two TIAs and three transient ST elevations during ablation) occurred when all 10 electrodes were used for ablation. Pulmonary vein isolation using PVAC as a 'one-shot-system' has a comparable complication rate but a different risk profile. Pericardial effusion and tamponade occurred more frequently using iRF, whereas thromboembolic events were more prevalent using PVAC. Occurrence of clinically relevant thromboembolic events might be reduced by avoidance of electrode 1 and 10 interaction and uninterrupted anticoagulation, whereas contact force sensing for iRF might minimize pericardial effusion. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

PECULIARITIES OF CONSTRUCTION PROFILES OF SECURITY SYSTEMS OF INFORMATION SYSTEMS

Directory of Open Access Journals (Sweden)

Olga V. Lukinova

2015-01-01

Full Text Available Examines the specific issues of building functional and technological profiles of the security systems to ensure the safety of information systems in the paradigm of functional standardization; shows a view of the system of protection based on the model of OSE/RM; studied the composition and structure of the concept of "defense mechanism" for the purpose of profiling third instalment correction representation of the system of protection.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

The second periodic safety review report of Tokai Reprocessing Plant [JAEA-Technology--2016-007-PT1

International Nuclear Information System (INIS)

Shirai, Nobutoshi; Miura, Yasushi; Tachibana, Ikuya; Omori, Satoru; Wake, Junichi; Fukuda, Kazuhito; Nakano, Takafumi; Nagasato, Yoshihiko

2016-07-01

The periodic safety review of Tokai Reprocessing Plant (TRP) is an activity to confirm the application of the safety activity implementation and to give effective additional measures for the facility safety and the improvement of its reliability. We implemented 4 items as follows; (1) evaluation of safety activity implementation, (2) evaluation of status of safety activities reflecting the latest technical knowledges, (3) technical evaluation about aging degradation, and (4) planning measures about a 10-years-plan that the operator shall implement in order to keep the facility condition. We summarized this report as the result of research and evaluation of above 4 items as the second periodic safety review at TRP. About (1), we researched about the 8 items that are QA activities, operation management, maintenance management, etc. We confirmed the result that we are adequately expanding its safety activities by preparing the necessary documents and schemes, and so on. About (2), we researched them in view point of safety research results and technology development results and confirmed that we reflect latest knowledges into our facility and make efforts for improvement of safety and reliability. About (3), we can keep the safety of the facilities important to safety and the sea discharge line, under assumption of the present maintenance till the next aging evaluation, because no 'focuses for aging degradation' exist which we cannot deny the gap between the initial prediction and actual condition, by measurements and technical view. About (4), by the technical results of aging degradation evaluation, we found no additional safety plans into maintenance strategies. (author)

Desonide: a review of formulations, efficacy and safety.

Science.gov (United States)

Kahanek, Nr; Gelbard, Cg; Hebert, Aa

2008-07-01

Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

Cardiovascular risk-benefit profile of sibutramine.

Science.gov (United States)

Scheen, A J

2010-01-01

Sibutramine is a combined norepinephrine and serotonin reuptake inhibitor used as an antiobesity agent to reduce appetite and promote weight loss in combination with diet and exercise. At a daily dose of 10-20 mg, it was initially considered to have a good safety profile, as it does not induce primary pulmonary hypertension or adverse effects on cardiac valves, in contrast to previous reports relating to some other antiobesity agents. However, it exerts disparate effects on cardiovascular risk factors. On the one hand, sibutramine may have antiatherogenic activities, as it improves insulin resistance, glucose metabolism, dyslipidemia, and inflammatory markers, with most of these effects resulting from weight loss rather than from an intrinsic effect of the drug. On the other hand, because of its specific mode of action, sibutramine exerts a peripheral sympathomimetic effect, which induces a moderate increase in heart rate and attenuates the reduction in BP attributable to weight loss or even slightly increases BP. It may also prolong the QT interval, an effect that could induce arrhythmias. Because of these complex effects, it is difficult to conclude what the final impact of sibutramine on cardiovascular outcomes might be. Sibutramine has been shown to exert favorable effects on some surrogate cardiovascular endpoints such as reduction of left ventricular hypertrophy and improvement of endothelial dysfunction. A good cardiovascular safety profile was demonstrated in numerous 1- to 2-year controlled trials, in both diabetic and nondiabetic well selected patients, as well as in several observational studies. However, since 2002, several cardiovascular adverse events (hypertension, tachycardia, arrhythmias, and myocardial infarction) have been reported in sibutramine-treated patients. This led to a contraindication of the use of this antiobesity agent in patients with established coronary heart disease, previous stroke, heart failure, or cardiac arrhythmias. SCOUT

2011 Annual Meeting of the Safety Pharmacology Society: an overview.

Science.gov (United States)

Cavero, Icilio

2012-03-01

The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization

Cytogenetically confirmed primary Ewing's sarcoma of the pancreas.

Science.gov (United States)

Golhar, Ankush; Ray, Samrat; Haugk, Beate; Singhvi, Suresh Kumar

2017-05-04

Ewing's sarcoma is a highly aggressive malignant tumour most commonly affecting long bones in children and adolescents. It is part of the Ewing's sarcoma family of tumours (ESFTs) that also include peripheral primitive neuroectodermal tumour and Askin's tumours. ESFTs share common cytogenetic aberrations, antigenic profiles and proto-oncogene expression with an overall similar clinical course. In 99% of ESFTs, genetic translocation with molecular fusion involves the EWSR1 gene on 22q12. Approximately 30% of ESFTs are extraosseous, most commonly occurring in the soft tissues of extremities, pelvis, retroperitoneum and chest wall. Primary presentation in solid organs is very rare but has been described in multiple sites including the pancreas. Accurate diagnosis of a Ewing's sarcoma in a solid organ is critical in facilitating correct treatment. We report the case of a 17-year-old girl with cytogenetically confirmed primary pancreatic Ewing's sarcoma and provide a brief review of the published literature. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Refractive outcomes of an advanced aspherically optimized profile for myopia corrections by LASIK: a retrospective comparison with the standard aspherically optimized profile

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Meyer B

2015-02-01

Full Text Available Bertram Meyer,1 Georg Sluyterman van Langeweyde,2 Matthias Wottke2 1Augencentrum Köln, Cologne, Germany; 2Carl Zeiss Meditec AG, Jena, Germany Purpose: A retrospective comparison of refractive outcomes of a new, aspherically optimized profile with an enhanced energy correction feature (Triple-A and the conventionally used aspherically optimized profile (ASA, or aberration smart ablation for correction of low-to-high myopia.Setting: Augen-OP-Centrum, Cologne, GermanyDesign: Retrospective nonrandomized comparative studyMethods: A central database at the Augen-OP-Centrum was used to gather retrospective data for low-to-high myopia (up to -10 D. One hundred and seven eyes (56 patients were treated with the ASA profile, and 79 eyes (46 patients were treated with the Triple-A profile. Postoperative outcomes were evaluated at 1 month, 3 months, 6 months, and 1 year follow-up time points.Results: The Triple-A profile showed better predictability indicated by a significantly lower standard deviation of residuals (0.32–0.34 vs 0.36–0.44, Triple-A vs ASA in the 6-month to 1-year period. The Triple-A group had better stability across all time intervals and achieved better postoperative astigmatism improvements with significantly lower scatter. This group achieved better safety at 1 year, with 100% of eyes showing no change or gain in Snellen lines, compared with 97% in the ASA group. A better safety index was observed for the Triple-A group at later time points. The Triple-A group had a better efficacy index and a higher percentage of eyes with an uncorrected Snellen visual acuity of 20/20 or greater at all investigated follow-up time points.Conclusion: The new aspherically optimized Triple-A profile can safely and effectively correct low-to-high myopia. It has demonstrated superiority over the ASA profile in most refractive outcomes. Keywords: Triple-A, wavefront measurements, corneal aberrations, corneal asphericity, ablation profile

Technique for unit testing of safety software verification and validation

International Nuclear Information System (INIS)

Li Duo; Zhang Liangju; Feng Junting

2008-01-01

The key issue arising from digitalization of the reactor protection system for nuclear power plant is how to carry out verification and validation (V and V), to demonstrate and confirm the software that performs reactor safety functions is safe and reliable. One of the most important processes for software V and V is unit testing, which verifies and validates the software coding based on concept design for consistency, correctness and completeness during software development. The paper shows a preliminary study on the technique for unit testing of safety software V and V, focusing on such aspects as how to confirm test completeness, how to establish test platform, how to develop test cases and how to carry out unit testing. The technique discussed here was successfully used in the work of unit testing on safety software of a digital reactor protection system. (authors)

Approach to uncertainty evaluation for safety analysis

International Nuclear Information System (INIS)

Ogura, Katsunori

2005-01-01

Nuclear power plant safety used to be verified and confirmed through accident simulations using computer codes generally because it is very difficult to perform integrated experiments or tests for the verification and validation of the plant safety due to radioactive consequence, cost, and scaling to the actual plant. Traditionally the plant safety had been secured owing to the sufficient safety margin through the conservative assumptions and models to be applied to those simulations. Meanwhile the best-estimate analysis based on the realistic assumptions and models in support of the accumulated insights could be performed recently, inducing the reduction of safety margin in the analysis results and the increase of necessity to evaluate the reliability or uncertainty of the analysis results. This paper introduces an approach to evaluate the uncertainty of accident simulation and its results. (Note: This research had been done not in the Japan Nuclear Energy Safety Organization but in the Tokyo Institute of Technology.) (author)

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads

Directory of Open Access Journals (Sweden)

Kirrilly Thompson

2015-07-01

Full Text Available Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52% reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1 identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles (2 harmonising laws regarding passing horses, (3 mandating personal protective equipment, (4 improving road signage, (5 comprehensive data collection, (6 developing mutual understanding amongst road-users, (7 safer road design and alternative riding spaces; and (8 increasing investment in horse-related safety initiatives.

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads.

Science.gov (United States)

Thompson, Kirrilly; Matthews, Chelsea

2015-07-22

Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles (2) harmonising laws regarding passing horses, (3) mandating personal protective equipment, (4) improving road signage, (5) comprehensive data collection, (6) developing mutual understanding amongst road-users, (7) safer road design and alternative riding spaces; and (8) increasing investment in horse-related safety initiatives.

Transarterial Chemoembolization for Hepatocellular Carcinoma with a New Generation of Beads: Clinical–Radiological Outcomes and Safety Profile

Energy Technology Data Exchange (ETDEWEB)

Spreafico, Carlo, E-mail: carlo.spreafico@istitutotumori.mi.it; Cascella, Tommaso, E-mail: tommaso.cascella@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Radiology (Italy); Facciorusso, Antonio, E-mail: antonio.facciorusso@istitutotumori.mi.it; Sposito, Carlo, E-mail: carlo.sposito@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Liver Surgery and Transplant (Italy); Rodolfo, Lanocita, E-mail: rodolfo.lanocita@istitutotumori.mi.it; Morosi, Carlo, E-mail: carlo.morosi@istitutotumori.mi.it; Civelli, Enrico M., E-mail: enrico.civelli@istitutotumori.mi.it; Vaiani, Marta, E-mail: marta.vaiani@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Radiology (Italy); Bhoori, Sherrie, E-mail: sherrie.bhoori@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Liver Surgery and Transplant (Italy); Pellegrinelli, Alessandro, E-mail: alessandro.pellegrinelli@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Pathology (Italy); Marchianò, Alfonso, E-mail: alfonso.marchiano@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Radiology (Italy); Mazzaferro, Vincenzo, E-mail: vincenzo.mazzaferro@istitutotumori.mi.it [Fondazione Istituto Tumori, Department of Liver Surgery and Transplant (Italy)

2015-02-15

PurposeTo evaluate the short-term safety and efficacy of the new generation of 70–150 µm drug-eluting beads (M1 DEB) in patients with hepatocellular carcinoma undergoing transarterial chemoembolization (TACE) as a primary therapy or as a bridge to liver transplantation (LT).MethodsForty-five consecutive patients underwent TACE with M1 DEB loaded with doxorubicin (DEBDOX/M1). Clinical data were recorded at 12, 24, and 48 h, 7 and 30 days after treatment. Response was assessed by computed tomographic scan according to the modified response evaluation criteria in solid tumors criteria, and a second DEBDOX/M1 TACE was scheduled within 6 weeks in case of a noncomplete response.ResultsAll patients had well-compensated cirrhosis (97.7 % Child A, 44.4 % hepatitis C virus, median age 61 years). Twenty patients (44.4 %) had Barcelona Clinic for Liver Cancer class B disease; the median number of nodules and their sum of diameters were 2 (range 1–6) and 43 mm (range 10–190), respectively. The mean number of TACE procedures per patient was 1.4. Objective response rate (complete + partial response) was 77.7 % with a median time to best response of 3 months (95 % confidence interval 2–4). In 13 patients, DEBDOX/M1 TACE served as a bridge/downstaging to LT/surgery. Pathology showed that more than 90 % necrosis was achieved in 10 of 28 nodules. DEBDOX/M1 TACE was well tolerated, and the grade 3/4 adverse event rate was low (1 of 65 procedures).ConclusionDEBDOX/M1 TACE is an effective procedure with a favorable safety profile and promising results in terms of objective response rate, tumor downstaging, and necrosis.

Reprogramming Methods Do Not Affect Gene Expression Profile of Human Induced Pluripotent Stem Cells.

Science.gov (United States)

Trevisan, Marta; Desole, Giovanna; Costanzi, Giulia; Lavezzo, Enrico; Palù, Giorgio; Barzon, Luisa

2017-01-20

Induced pluripotent stem cells (iPSCs) are pluripotent cells derived from adult somatic cells. After the pioneering work by Yamanaka, who first generated iPSCs by retroviral transduction of four reprogramming factors, several alternative methods to obtain iPSCs have been developed in order to increase the yield and safety of the process. However, the question remains open on whether the different reprogramming methods can influence the pluripotency features of the derived lines. In this study, three different strategies, based on retroviral vectors, episomal vectors, and Sendai virus vectors, were applied to derive iPSCs from human fibroblasts. The reprogramming efficiency of the methods based on episomal and Sendai virus vectors was higher than that of the retroviral vector-based approach. All human iPSC clones derived with the different methods showed the typical features of pluripotent stem cells, including the expression of alkaline phosphatase and stemness maker genes, and could give rise to the three germ layer derivatives upon embryoid bodies assay. Microarray analysis confirmed the presence of typical stem cell gene expression profiles in all iPSC clones and did not identify any significant difference among reprogramming methods. In conclusion, the use of different reprogramming methods is equivalent and does not affect gene expression profile of the derived human iPSCs.

Plutonian Moon confirmed

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In late February, two separate observations confirmed the 1978 discovery by U.S. Naval Observatory scientist James W. Christy of a moon orbiting the planet Pluto. According to the U.S. Naval Observatory, these two observations were needed before the International Astronomical Society (IAS) would officially recognize the discovery.Two types of observations of the moon, which was named Charon after the ferryman in Greek mythology who carried the dead to Pluto's realm, were needed for confirmation: a transit, in which the moon passes in front of Pluto, and an occultation, in which the moon passes behind the planet. These two phenomena occur only during an 8-year period every 124 years that had been calculated to take place during 1984-1985. Both events were observed in late February.

Algorithm Validation of the Current Profile Reconstruction of EAST Based on Polarimeter/Interferometer

International Nuclear Information System (INIS)

Qian Jinping; Ren Qilong; Wan Baonian; Liu Haiqin; Zeng Long; Luo Zhengping; Chen Dalong; Shi Tonghui; Sun Youwen; Shen Biao; Xiao Bingjia; Lao, L. L.; Hanada, K.

2015-01-01

The method of plasma current profile reconstruction using the polarimeter/interferometer (POINT) data from a simulated equilibrium is explored and validated. It is shown that the safety factor (q) profile can be generally reconstructed from the external magnetic and POINT data. The reconstructed q profile is found to reasonably agree with the initial equilibriums. Comparisons of reconstructed q and density profiles using the magnetic data and the POINT data with 3%, 5% and 10% random errors are investigated. The result shows that the POINT data could be used to a reasonably accurate determination of the q profile. (fusion engineering)

Contribution of operating feedback to probabilistic safety studies

International Nuclear Information System (INIS)

Guio, J.M. de; Lannoy, A.

1992-03-01

This paper presents the method used for PWR unit operation feedback analysis and its contribution to probabilistic safety studies. The targets were as follows: - use of failure data banks to assess reliability parameters, - use of event data banks to identify and quantify main system initiating events, - determination of a standard operating profile. These studies, performed in the context of nuclear power plant safety programs, prove useful not only to safety engineers but also to equipment experts, designers, operators and maintenance specialists. They constitute basic data for studies in all these areas or the departure point for new investigations. (authors). 3 figs., 3 tabs., 3 refs

Researches on nuclear criticality safety evaluation

Energy Technology Data Exchange (ETDEWEB)

Okuno, Hiroshi; Suyama, Kenya; Nomura, Yasushi [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

2003-10-01

For criticality safety evaluation of burnup fuel, the general-purpose burnup calculation code, SWAT, was revised, and its precision was confirmed through comparison with other results from OECD/NEA's burnup credit benchmarks. Effect by replacing the evaluated nuclear data from JENDL-3.2 to ENDF/B-VI and JEF-2.2 was also studied. Correction factors were derived for conservative evaluation of nuclide concentrations obtained with the simplified burnup code ORIGEN2.1. The critical masses of curium were calculated and evaluated for nuclear criticality safety management of minor actinides. (author)

Researches on nuclear criticality safety evaluation

International Nuclear Information System (INIS)

Okuno, Hiroshi; Suyama, Kenya; Nomura, Yasushi

2003-01-01

For criticality safety evaluation of burnup fuel, the general-purpose burnup calculation code, SWAT, was revised, and its precision was confirmed through comparison with other results from OECD/NEA's burnup credit benchmarks. Effect by replacing the evaluated nuclear data from JENDL-3.2 to ENDF/B-VI and JEF-2.2 was also studied. Correction factors were derived for conservative evaluation of nuclide concentrations obtained with the simplified burnup code ORIGEN2.1. The critical masses of curium were calculated and evaluated for nuclear criticality safety management of minor actinides. (author)

Safety assurance of cosmetics in Japan: current situation and future prospects.

Science.gov (United States)

Inomata, Shinji

2014-01-01

The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

Safety Culture Enhancement Project. Final Report. A Field Study on Approaches to Enhancement of Safety Culture

International Nuclear Information System (INIS)

Lowe, Andrew; Hayward, Brent

2006-08-01

Safety Culture Perceptions Questionnaire conducted with site managers to access their opinions about the adequacy of the local safety culture; - a framework of safety-related competencies for managers, representing desirable actions for leading and promoting a positive safety culture; - results of an evaluation survey completed by participants at the conclusion of the Management Workshops to assess the utility of this activity. Section 4 of the report, Recommendations for Future Action, highlights nine proposed activities that could be undertaken to build on the outcomes from this project, to support the enhancement of safety culture within the Swedish nuclear industry in the longer term. Specifically, these recommendations propose actions to: 1. Introduce formal processes to ensure the ongoing development of safety related competencies amongst industry managers. 2. Strengthen the resources, contribution, value and profile of Man Technology Organisation (MTO) expertise within nuclear industry sites, in order to promote a better understanding of human performance issues, enhance error management and accident prevention capabilities. 3. Identify ways to embed existing positive safety culture attributes, in an environment of considerable workforce changes resulting from increasing use of contractors and (expected) retirements amongst an ageing industry employee population. 4. Standardise and improve aspects of incident and accident investigation processes and analysis methodologies currently used, to improve information sharing and optimise learning. 5. Implement harmonised MTO / human factors awareness training programs at appropriate levels for all nuclear industry personnel. 6. Formalise the application of applied teamwork training (as per the principles of Crew Resource Management training in aviation) for NPP Control Room Operators, Maintenance workers and other employees working in safety-critical teams. 7. Increase the use of simulation training to enhance non

Safety culture evaluation and asset root cause analysis

International Nuclear Information System (INIS)

Okrent, D.; Xiong, Y.

1995-01-01

This paper examines the role of organizational and management factors in nuclear power plant safety through the use of operating experiences. The ASSET (Assessment of Safety Significant Events Team) reports of thirteen plants (total thirty events) have been analyzed in term of twenty organizational dimensions (factors) identified by Brookhaven National Laboratory and Pennsylvania State University. For three plants detailed results are reported in this paper. The results of thirteen plants are summarized in the form of a table. The study tends to confirm that organizational and management factors play an important role in plant safety. The twenty organizational dimensions and their definitions, in general, were adequate in this study. Formalization, Safety Culture, Technical Knowledge, Training, Roles-Responsibilities and Problem Identification appear to be key organizational factors which influence the safety of nuclear power plants studied

Completed suicide in an autopsy-confirmed case of early onset Alzheimer's disease.

Science.gov (United States)

Hartzell, Jennifer Wiener; Geary, Richard; Gyure, Kymberly; Chivukula, Venkata Ravi; Haut, Marc W

2018-04-01

We report a case of a 57-year-old male with clinically diagnosed and autopsy-confirmed early onset Alzheimer's disease who completed suicide by gunshot wound to the chest. This case has several unique aspects that have not been discussed in previous case reports of completed suicide in Alzheimer's disease. In particular, our patient's death was highly planned with successful compensation for his cognitive deficits. After all firearms had been removed from the home as a safety precaution, he obtained a new weapon, hid it and left himself cues to find and use it. The case is discussed in the context of literature differentiating the neural circuitry propagating impulsive versus planned suicidal acts.

Advanced Range Safety System for High Energy Vehicles

Science.gov (United States)

Claxton, Jeffrey S.; Linton, Donald F.

2002-01-01

The advanced range safety system project is a collaboration between the National Aeronautics and Space Administration and the United States Air Force to develop systems that would reduce costs and schedule for safety approval for new classes of unmanned high-energy vehicles. The mission-planning feature for this system would yield flight profiles that satisfy the mission requirements for the user while providing an increased quality of risk assessment, enhancing public safety. By improving the speed and accuracy of predicting risks to the public, mission planners would be able to expand flight envelopes significantly. Once in place, this system is expected to offer the flexibility of handling real-time risk management for the high-energy capabilities of hypersonic vehicles including autonomous return-from-orbit vehicles and extended flight profiles over land. Users of this system would include mission planners of Space Launch Initiative vehicles, space planes, and other high-energy vehicles. The real-time features of the system could make extended flight of a malfunctioning vehicle possible, in lieu of an immediate terminate decision. With this improved capability, the user would have more time for anomaly resolution and potential recovery of a malfunctioning vehicle.

Can we improve patient safety?

Science.gov (United States)

Corbally, Martin Thomas

2014-01-01

Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out World Health Organization (WHO), errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO Surgical Pause/Time Out aims to capture these errors and prevent them, but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical Pause and Time Out, perhaps to avoid additional stress. In addition, surgeons, like pilots, are subject to the phenomenon of "plan-continue-fail" with potentially disastrous outcomes. If we wish to improve patient safety during surgery and avoid wrong site errors then we must include parents in the Surgical Pause/Time Out. A recent pilot study has shown that neither staff nor parents found it added to their stress, but, moreover, 100% of parents considered that it should be a mandatory component of the Surgical Pause nor does it add to the stress of surgery. Surgeons should be required to confirm that the planned procedure is in keeping with the operative findings especially in extirpative surgery and this "step back" should be incorporated into the standard Surgical Pause. It is clear that we must improve patient safety further and these simple measures should add to that potential.

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire

Science.gov (United States)

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-01-01

Objective To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. Design A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). Setting 3 public hospitals and 27 health clinics. Participants 117 pharmacists. Main outcome measure(s) Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Results Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (psafety culture. As perceptions improved, the number of medication errors reported decreased. Group-specific interventions that target specific domains are necessary to improve the safety culture. PMID:26610761

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

Directory of Open Access Journals (Sweden)

Assia Boughaba

2014-06-01

Conclusion: The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

Science.gov (United States)

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

Development of safety analysis technology for integral reactor

Energy Technology Data Exchange (ETDEWEB)

Sim, Suk K.; Song, J. H.; Chung, Y. J. and others

1999-03-01

Inherent safety features and safety system characteristics of the SMART integral reactor are investigated in this study. Performance and safety of the SMART conceptual design have been evaluated and confirmed through the performance and safety analyses using safety analysis system codes as well as a preliminary performance and safety analysis methodology. SMART design base events and their acceptance criteria are identified to develop a preliminary PIRT for the SMART integral reactor. Using the preliminary PIRT, a set of experimental program for the thermal hydraulic separate effect tests and the integral effect tests was developed for the thermal hydraulic model development and the system code validation. Safety characteristics as well as the safety issues of the integral reactor has been identified during the study, which will be used to resolve the safety issues and guide the regulatory criteria for the integral reactor. The results of the performance and safety analyses performed during the study were used to feedback for the SMART conceptual design. The performance and safety analysis code systems as well as the preliminary safety analysis methodology developed in this study will be validated as the SMART design evolves. The performance and safety analysis technology developed during the study will be utilized for the SMART basic design development. (author)

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

International Nuclear Information System (INIS)

Song, Tae Young

2007-01-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

Energy Technology Data Exchange (ETDEWEB)

Song, Tae Young [Nuclear Engineering and Technology Institute, Daejeon (Korea, Republic of)

2007-07-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas.

Fatty Acid Profile and Physicochemical Properties of Landolphia ...

African Journals Online (AJOL)

Purpose: To elucidate lipid profile of Landolphia owariensis P. Beauv stringy seed oil, the bulk physicochemical properties of its neutral lipid (NL), and also to ascertain its nutritional properties, safety and industrial applications. Methods: The neutral lipid was recovered by macerating 500 g of L. owariensis stringy seed pulp ...

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

International Nuclear Information System (INIS)

Beyerle, Andrea; Nolte, Marc W.; Solomon, Cristina; Herzog, Eva; Dickneite, Gerhard

2014-01-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

Energy Technology Data Exchange (ETDEWEB)

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Nolte, Marc W. [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Solomon, Cristina [CSL Behring GmbH, Medical Affairs, Marburg (Germany); Department of Anaesthesiology, Perioperative Medicine and General Intensive Care, Paracelsus Medical University, Salzburg (Austria); Herzog, Eva; Dickneite, Gerhard [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany)

2014-10-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

Science.gov (United States)

Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2017-07-01

This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib.

Science.gov (United States)

Curtis, Jeffrey R; Zhang, Richard; Krishnaswami, Sriram; Anisfeld, Andrew; Chen, Yan; Strengholt, Sander; Chen, Connie; Geier, Jamie

2017-03-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To characterise the relative safety profile of tofacitinib to biologic disease-modifying antirheumatic drugs (bDMARDs), the accrued patient-years (pt-yrs) of exposure needed in an RA clinical trial programme to detect a potential increase in risk of specific adverse events (AEs) was determined. This case study/framework was constructed on the pt-yrs' accrual within pooled phase (P)1, P2 and P3, as well as long-term extension, studies of tofacitinib in RA (March 2015 data-cut) and published AE incidence rates for bDMARDs. Sample size calculations were based on a Poisson distribution to estimate pt-yrs' exposure required for 90 % probability that the lower bound of the 95 % confidence interval for tofacitinib/bDMARD would be >1, assuming that tofacitinib rates were 1.2×/1.5×/2.0× greater than comparator rates. AE rates for bDMARDs were derived from sources intended to optimise similarity with the tofacitinib database in terms of baseline characteristics, study duration and follow-up. Based on the tofacitinib exposure accrued (19,406 pt-yrs), data were sufficient (90 % probability) to detect potential differences over external bDMARD comparator rates in serious infections (≥1.2×), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, major adverse cardiovascular events (MACE) and lymphoma (each ≥1.5×), as well as opportunistic infections and gastrointestinal perforations (≥2×), should they exist. This risk characterisation approach can support the comparative safety of new RA medications. To date, tofacitinib safety appears similar to approved published data from bDMARDs with respect to serious infections, malignancies (excluding NMSC), NMSC, MACE, lymphoma, opportunistic infections and gastrointestinal perforations.

tRNA modification profiles of the fast-proliferating cancer cells

Energy Technology Data Exchange (ETDEWEB)

Dong, Chao; Niu, Leilei; Song, Wei [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China); Xiong, Xin; Zhang, Xianhua [Departmentof Pharmacy, Peking University Third Hospital, Peking University, Beijing 100191 (China); Zhang, Zhenxi; Yang, Yi; Yi, Fan [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China); Zhan, Jun; Zhang, Hongquan [Department of Anatomy, Histology and Embryology, Laboratory of Molecular Cell Biology and Tumor Biology, Peking University, Beijing 100191 (China); Yang, Zhenjun; Zhang, Li-He [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China); Zhai, Suodi [Departmentof Pharmacy, Peking University Third Hospital, Peking University, Beijing 100191 (China); Li, Hua, E-mail: huali88@sina.com [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China); Ye, Min, E-mail: yemin@bjmu.edu.cn [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China); Du, Quan, E-mail: quan.du@pku.edu.cn [State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Department of Obstetrics and Gynecology, Peking University Third Hospital, Peking University, Beijing 100191 (China)

2016-08-05

Despite the recent progress in RNA modification study, a comprehensive modification profile is still lacking for mammalian cells. Using a quantitative HPLC/MS/MS assay, we present here a study where RNA modifications are examined in term of the major RNA species. With paired slow- and fast-proliferating cell lines, distinct RNA modification profiles are first revealed for diverse RNA species. Compared to mRNAs, increased ribose and nucleobase modifications are shown for the highly-structured tRNAs and rRNAs, lending support to their contribution to the formation of high-order structures. This study also reveals a dynamic tRNA modification profile in the fast-proliferating cells. In addition to cultured cells, this unique tRNA profile has been further confirmed with endometrial cancers and their adjacent normal tissues. Taken together, the results indicate that tRNA is a actively regulated RNA species in the fast-proliferating cancer cells, and suggest that they may play a more active role in biological process than expected. -- Highlights: •RNA modifications were first examined in term of the major RNA species. •A dynamic tRNA modifications was characterized for the fast-proliferating cells. •The unique tRNA profile was confirmed with endometrial cancers and their adjacent normal tissues. •tRNA was predicted as an actively regulated RNA species in the fast-proliferating cancer cells.

tRNA modification profiles of the fast-proliferating cancer cells

International Nuclear Information System (INIS)

Dong, Chao; Niu, Leilei; Song, Wei; Xiong, Xin; Zhang, Xianhua; Zhang, Zhenxi; Yang, Yi; Yi, Fan; Zhan, Jun; Zhang, Hongquan; Yang, Zhenjun; Zhang, Li-He; Zhai, Suodi; Li, Hua; Ye, Min; Du, Quan

2016-01-01

Despite the recent progress in RNA modification study, a comprehensive modification profile is still lacking for mammalian cells. Using a quantitative HPLC/MS/MS assay, we present here a study where RNA modifications are examined in term of the major RNA species. With paired slow- and fast-proliferating cell lines, distinct RNA modification profiles are first revealed for diverse RNA species. Compared to mRNAs, increased ribose and nucleobase modifications are shown for the highly-structured tRNAs and rRNAs, lending support to their contribution to the formation of high-order structures. This study also reveals a dynamic tRNA modification profile in the fast-proliferating cells. In addition to cultured cells, this unique tRNA profile has been further confirmed with endometrial cancers and their adjacent normal tissues. Taken together, the results indicate that tRNA is a actively regulated RNA species in the fast-proliferating cancer cells, and suggest that they may play a more active role in biological process than expected. -- Highlights: •RNA modifications were first examined in term of the major RNA species. •A dynamic tRNA modifications was characterized for the fast-proliferating cells. •The unique tRNA profile was confirmed with endometrial cancers and their adjacent normal tissues. •tRNA was predicted as an actively regulated RNA species in the fast-proliferating cancer cells.

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

Energy Technology Data Exchange (ETDEWEB)

Ryan, Patricia C., E-mail: ryanp@medimmune.com [MedImmune, LLC, Gaithersburg, MD (United States); Sleeman, Matthew A. [MedImmune, LLC, Cambridge (United Kingdom); Rebelatto, Marlon [MedImmune, LLC, Gaithersburg, MD (United States); Wang, Bing; Lu, Hong [MedImmune, LLC, Moutain View, CA (United States); Chen, Xiaomin [Novartis, East Hanover, NJ (United States); Wu, Chi-Yuan [MedImmune, LLC, Moutain View, CA (United States); Hinrichs, Mary Jane; Roskos, Lorin [MedImmune, LLC, Gaithersburg, MD (United States); Towers, Heidi [MedImmune, LLC, Cambridge (United Kingdom); McKeever, Kathleen; Dixit, Rakesh [MedImmune, LLC, Gaithersburg, MD (United States)

2014-09-01

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters other than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. �

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

International Nuclear Information System (INIS)

Ryan, Patricia C.; Sleeman, Matthew A.; Rebelatto, Marlon; Wang, Bing; Lu, Hong; Chen, Xiaomin; Wu, Chi-Yuan; Hinrichs, Mary Jane; Roskos, Lorin; Towers, Heidi; McKeever, Kathleen; Dixit, Rakesh

2014-01-01

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters other than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. �

A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.

Science.gov (United States)

Hadjigeorgiou, G M; Doxani, C; Miligkos, M; Ziakas, P; Bakalos, G; Papadimitriou, D; Mprotsis, T; Grigoriadis, N; Zintzaras, E

2013-12-01

The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'. Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2)) using direct and indirect analyses. The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences. This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments. © 2013 John Wiley & Sons Ltd.

Long-term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis.

NARCIS (Netherlands)

Kerkhof, P.C.M. van de; Berth-Jones, J.; Griffiths, C.E.; Harrison, P.V.; Honigsmann, H.; Marks, R.; Roelandts, R.; Schopf, E.; Trompke, C.

2002-01-01

BACKGROUND: As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. OBJECTIVES: The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 microg g(-1)) ointment

Safety options for the 1300 MWe program

International Nuclear Information System (INIS)

Cayol, A.; Dupuis, M.C.; Fourest, B.; Oury, J.M.

1980-04-01

Standardization of the nuclear plants built in France implies an examination of the main technical safety options to be taken for a given type of reactor. By this procedure the subjects for which detailed studies will be needed to confirm the decisions made for the project can be defined in advance. In this context the technical safety option analysis for the 1300 MWe plants was conducted from the end of 1975 to the middle of 1978 according to usual regulation examination practice. The main conclusions are presented on the following subjects: safety methods; technical options concerning the containment vessel, primary fluid activity, fuel elements, steam generators; general organization of the lay-out [fr

The relationship between patient safety climate and occupational safety climate in healthcare - A multi-level investigation.

Science.gov (United States)

Pousette, Anders; Larsman, Pernilla; Eklöf, Mats; Törner, Marianne

2017-06-01

Patient safety climate/culture is attracting increasing research interest, but there is little research on its relation with organizational climates regarding other target domains. The aim of this study was to investigate the relationship between patient safety climate and occupational safety climate in healthcare. The climates were assessed using two questionnaires: Hospital Survey on Patient Safety Culture and Nordic Occupational Safety Climate Questionnaire. The final sample consisted of 1154 nurses, 886 assistant nurses, and 324 physicians, organized in 150 work units, within hospitals (117units), primary healthcare (5units) and elderly care (28units) in western Sweden, which represented 56% of the original sample contacted. Within each type of safety climate, two global dimensions were confirmed in a higher order factor analysis; one with an external focus relative the own unit, and one with an internal focus. Two methods were used to estimate the covariation between the global climate dimensions, in order to minimize the influence of bias from common method variance. First multilevel analysis was used for partitioning variances and covariances in a within unit part (individual level) and a between unit part (unit level). Second, a split sample technique was used to calculate unit level correlations based on aggregated observations from different respondents. Both methods showed associations similar in strength between the patient safety climate and the occupational safety climate domains. The results indicated that patient safety climate and occupational safety climate are strongly positively related at the unit level, and that the same organizational processes may be important for the development of both types of organizational climate. Safety improvement interventions should not be separated in different organizational processes, but be planned so that both patient safety and staff safety are considered concomitantly. Copyright © 2017 National Safety

10 April 2014: Safety Day at CERN

CERN Multimedia

Antonella Del Rosso

2014-01-01

A wide variety of chemicals is used every day in the different laboratories and workshops around CERN. Potentially toxic, corrosive, polluting or hazardous in other ways, these chemicals all have to be handled carefully, as we will be reminded by the Safety Day campaign to be held by the HSE Unit on 10 April to mark World Day for Safety and Health at Work.   The use of chemicals at CERN is regulated by "Safety Regulation SR-C, Chemical Agents", which defines the minimum health and safety protection requirements for people exposed to the potentially hazardous effects of dangerous chemicals. This regulation is complemented by other Safety guides. Regretfully, despite strict procedures and regular inspections, accidents caused by the improper use of chemicals do occur every year. "Unfortunately, each year we see a small number of accidents related to the handling of chemicals," confirms chemicals expert Jonathan Gulley, who is a member of the Prevention and Sa...

Calibration and Confirmation in Geophysical Models

Science.gov (United States)

Werndl, Charlotte

2016-04-01

For policy decisions the best geophysical models are needed. To evaluate geophysical models, it is essential that the best available methods for confirmation are used. A hotly debated issue on confirmation in climate science (as well as in philosophy) is the requirement of use-novelty (i.e. that data can only confirm models if they have not already been used before. This talk investigates the issue of use-novelty and double-counting for geophysical models. We will see that the conclusions depend on the framework of confirmation and that it is not clear that use-novelty is a valid requirement and that double-counting is illegitimate.

Optimized profiles for improved confinement and stability in the Dill-D tokamak

International Nuclear Information System (INIS)

Taylor, T.S.; St John, H.; Turnbull, A.D.

1994-01-01

Simultaneous achievement of high energy confinement, τ E , and high plasma beta, β, leads to an economically attractive compact tokamak fusion reactor. High confinement enhancement, H τ E /τ E -ITER89P 4, and high normalized beta β N β/(I/aB) = 6%-m-T/MA. have been obtained in DIII-D experimental discharges. These improved confinement and/or improved stability limits are observed in several DIII-D high performance operational regimes: VH-mode, high l i H-mode, second stable core, and high beta poloidal. We have identified several important features of the improved performance in these discharges: details of the plasma shape, toroidal rotation or ExB flow profile, q profile and current density profile, and pressure profile. From our improved physics understanding of these enhanced performance regimes, we have developed operational scenarios which maintain the essential features of the improved confinement and which increase the stability limits using localized current profile control. The stability limit is increased by modifying the interior safety factor profile to be nonmonotonic with high central q, while maintaining the edge current density consistent with the improved transport regimes and the high edge bootstrap current. We have calculated high beta equilibria with β N 6.5, stable to ideal n=1 kinks and stable to ideal ballooning modes. The safety factor at the 95% flux surface is 6, the central q value is 3.9 and the minimum in q is 2.6. The current density profile is maintained by the natural profile of the bootstrap current, and a modest amount of electron cyclotron current drive. (Author)

Optimized profiles for improved confinement and stability in the DIII-D tokamak

International Nuclear Information System (INIS)

Taylor, T.S.; St. John, H.; Turnbull, A.D.

1995-02-01

Simultaneous achievement of high energy confinement, τ E , and high plasma beta, β, leads to an economically attractive compact tokamak fusion reactor. High confinement enhancement, H = τ E /τ E-ITER89P = 4, and high normalized beta β N = β/(I/aB) = 6%-m-T/MA, have been obtained in DIII-D experimental discharges. These improved confinement and/or improved stability limits are observed in several DIII-D high performance operational regimes: VH-mode, high ell i H-mode, second stable core, and high beta poloidal. The authors have identified several important features of the improved performance in these discharges: details of the plasma shape, toroidal rotation or ExB flow profile, q profile and current density profile, and pressure profile. From the improved physics understanding of these enhanced performance regimes, they have developed operational scenarios which maintain the essential features of the improved confinement and which increase the stability limits using localized current profile control. The stability limit is increased by modifying the interior safety factor profile to be nonmonotonic with high central q, while maintaining the edge current density consistent with the improved transport regimes and the high edge bootstrap current. They have calculated high beta equilibria with β N = 6.5, stable to ideal n = 1 kinks and stable to ideal ballooning modes. The safety factor at the 95% flux surface is 6, the central q value is 3.9 and the minimum in q is 2.6. The current density profile is maintained by the natural profile of the bootstrap current, and a modest amount of electron cyclotron current drive

EFFICACY AND SAFETY OF THE INFLUENZA VACCINE AMONG CHILDREN WITH DIFFERENT HEALTH CONDITIONS

OpenAIRE

M.G. Galitskaya

2007-01-01

Efficacy and safety of vaccine «Grippol» among children with different health status was analyzed. The most efficacy of the influenza vaccine revealed in the group of children with compromised health status, as well as in the group of allergic children. The safety of influenza vaccination was confirmed in children with different health conditions.Key words: children, vaccination, influenza, efficacy, safety.

Mucosal Barrier Injury Laboratory-Confirmed Bloodstream Infections (MBI-LCBI): Descriptive Analysis of Data Reported to National Healthcare Safety Network (NHSN), 2013.

Science.gov (United States)

Epstein, Lauren; See, Isaac; Edwards, Jonathan R; Magill, Shelley S; Thompson, Nicola D

2016-01-01

OBJECTIVES To determine the impact of mucosal barrier injury laboratory-confirmed bloodstream infections (MBI-LCBIs) on central-line-associated bloodstream infection (CLABSI) rates during the first year of MBI-LCBI reporting to the National Healthcare Safety Network (NHSN) DESIGN Descriptive analysis of 2013 NHSN data SETTING Selected inpatient locations in acute care hospitals METHODS A descriptive analysis of MBI-LCBI cases was performed. CLABSI rates per 1,000 central-line days were calculated with and without the inclusion of MBI-LCBIs in the subset of locations reporting ≥1 MBI-LCBI, and in all locations (regardless of MBI-LCBI reporting) to determine rate differences overall and by location type. RESULTS From 418 locations in 252 acute care hospitals reporting ≥1 MBI-LCBIs, 3,162 CLABSIs were reported; 1,415 (44.7%) met the MBI-LCBI definition. Among these locations, removing MBI-LCBI from the CLABSI rate determination produced the greatest CLABSI rate decreases in oncology (49%) and ward locations (45%). Among all locations reporting CLABSI data, including those reporting no MBI-LCBIs, removing MBI-LCBI reduced rates by 8%. Here, the greatest decrease was in oncology locations (38% decrease); decreases in other locations ranged from 1.2% to 4.2%. CONCLUSIONS An understanding of the potential impact of removing MBI-LCBIs from CLABSI data is needed to accurately interpret CLABSI trends over time and to inform changes to state and federal reporting programs. Whereas the MBI-LCBI definition may have a large impact on CLABSI rates in locations where patients with certain clinical conditions are cared for, the impact of MBI-LCBIs on overall CLABSI rates across inpatient locations appears to be more modest. Infect. Control Hosp. Epidemiol. 2015;37(1):2-7.

Safety Analysis for Enlargement of Allowance Band of Main Steam Safety Valve Opening Setpoint of Wolsong Unit 1

Energy Technology Data Exchange (ETDEWEB)

Kim, Sungmin [Korea Hydro and Nuclear Power Co., Ltd., Daejeon (Korea, Republic of); Kim, Jonghyun; Cho, Cheonhwey [Atomic Creative Technology Co., Ltd., Daejeon (Korea, Republic of)

2013-05-15

The target events were selected to be the two most secondary system pressurization events - Loss of Class IV Power (LOCL4) and Loss of Condenser Vacuum (LOCV). In the actual analysis, an uncertainty of 1% was added to be conservative, so an allowance band of ±4% was used. A safety analysis was performed with CATHENA code to evaluate the safety of increasing the opening setpoint allowance band of MSSVs in WSNPP-1 The analysis results for both LOCL4 and LOCV confirm that the enlarged allowance would bring no harm to the safety of the plant from the viewpoint of fuel integrity and pressure boundary integrity. Therefore, the new allowance band of MSSVs will be incorporated into the Technical Specifications of WSNPP-1.

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

Science.gov (United States)

Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

2017-04-01

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada ® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits

Research oil guidelines for safety review of category 2 waste disposal

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

Safety confirmation items and monitoring items for engineered barriers were compiled, considering the current technical status and monitoring plan for the simulated subsurface disposal and its test facilities. In order to develop the guidelines of the safety review for the disposal of LLW generated from RI facilities and research facilities, technical issues relating toxic substances were surveyed. (author)

US nuclear safety. Review and experience

International Nuclear Information System (INIS)

Hanauer, S.H.

1977-01-01

The paper deals with the evolution of reactor safety principles, design bases, regulatory requirements, and experience in the United States. Safety concerns have evolved over the years, from reactivity transients and shut-down systems, to blowdowns and containment, to severe design basis accidents and mitigating systems, to the performance of actual materials, systems and humans. The primary safety concerns of one epoch have been superseded in considerable measure by those of later times. Successive plateaus of technical understanding are achieved by solutions being found to earlier problems. Design studies, research, operating experience and regulatory imperatives all contribute to the increased understanding and thus to the safety improvements adopted and accepted. The improvement of safety with time, and the ability of existing reactors to operate safely in the face of new concerns, has confirmed the correctness and usefulness of the defence-in-depth approach and safety margins used in safety design in the United States of America. A regulatory programme such as the one in the United States justifies its great cost by its important contributions to safety. Yet only the designers, constructors and operators of nuclear power plants can actually achieve public safety. The regulatory programme audits, assesses and spot-checks the actual work. Since neither materials nor human beings are flawless, mistakes will be made; that is why defence-in-depth and safety margins are provided. The regulatory programme should enhance safety by decreasing the frequency of uncorrected mistakes. Maintenance of public safety also requires technical and managerial competence and attention in the organizations responsible for nuclear plants as well as regulatory organizations. (author)

CONFIRMATION OF THE COMPACTNESS OF A z = 1.91 QUIESCENT GALAXY WITH HUBBLE SPACE TELESCOPE'S WIDE FIELD CAMERA 3

International Nuclear Information System (INIS)

Szomoru, Daniel; Franx, Marijn; Bouwens, Rychard J.; Van Dokkum, Pieter G.; Trenti, Michele; Illingworth, Garth D.; Labbe, Ivo; Oesch, Pascal A.; Carollo, C. Marcella

2010-01-01

We present very deep Wide Field Camera 3 (WFC3) photometry of a massive, compact galaxy located in the Hubble Ultra Deep Field. This quiescent galaxy has a spectroscopic redshift z = 1.91 and has been identified as an extremely compact galaxy by Daddi et al. We use new H F160W imaging data obtained with Hubble Space Telescope/WFC3 to measure the deconvolved surface brightness profile to H ∼ 28 mag arcsec -2 . We find that the surface brightness profile is well approximated by an n = 3.7 Sersic profile. Our deconvolved profile is constructed by a new technique which corrects the best-fit Sersic profile with the residual of the fit to the observed image. This allows for galaxy profiles which deviate from a Sersic profile. We determine the effective radius of this galaxy: r e = 0.42 ± 0.14 kpc in the observed H F160W band. We show that this result is robust to deviations from the Sersic model used in the fit. We test the sensitivity of our analysis to faint 'wings' in the profile using simulated galaxy images consisting of a bright compact component and a faint extended component. We find that due to the combination of the WFC3 imaging depth and our method's sensitivity to extended faint emission we can accurately trace the intrinsic surface brightness profile, and that we can therefore confidently rule out the existence of a faint extended envelope around the observed galaxy down to our surface brightness limit. These results confirm that the galaxy lies a factor ∼10 off from the local mass-size relation.

Complementary safety assessments - Report by the French Nuclear Safety Authority

International Nuclear Information System (INIS)

2011-12-01

As an immediate consequence of the Fukushima accident, the French Authority of Nuclear Safety (ASN) launched a campaign of on-site inspections and asked operators (mainly EDF, AREVA and CEA) to make complementary assessments of the safety of the nuclear facilities they manage. The approach defined by ASN for the complementary safety assessments (CSA) is to study the behaviour of nuclear facilities in severe accidents situations caused by an off-site natural hazard according to accident scenarios exceeding the current baseline safety requirements. This approach can be broken into 2 phases: first conformity to current design and secondly an approach to the beyond design-basis scenarios built around the principle of defence in depth. 38 inspections were performed on issues linked to the causes of the Fukushima crisis. It appears that some sites have to reinforce the robustness of the heat sink. The CSA confirmed that the processes put into place at EDF to detect non-conformities were satisfactory. The complementary safety assessments demonstrated that the current seismic margins on the EDF nuclear reactors are satisfactory. With regard to flooding, the complementary safety assessments show that the complete reassessment carried out following the flooding of the Le Blayais nuclear power plant in 1999 offers the installations a high level of protection against the risk of flooding. Concerning the loss of electrical power supplies and the loss of cooling systems, the analysis of EDF's CSA reports showed that certain heat sink and electrical power supply loss scenarios can, if nothing is done, lead to core melt in just a few hours in the most unfavourable circumstances. As for nuclear facilities that are not power or experimental reactors, some difficulties have appeared to implement the CSA approach that was initially devised for reactors. Generally speaking, ASN considers that the safety of nuclear facilities must be made more robust to improbable risks which are not

An Analytical Method for the Abel Inversion of Asymmetrical Gaussian Profiles

International Nuclear Information System (INIS)

Xu Guosheng; Wan Baonian

2007-01-01

An analytical algorithm for fast calculation of the Abel inversion for density profile measurement in tokamak is developed. Based upon the assumptions that the particle source is negligibly small in the plasma core region, density profiles can be approximated by an asymmetrical Gaussian distribution controlled only by one parameter V 0 /D and V 0 /D is constant along the radial direction, the analytical algorithm is presented and examined against a testing profile. The validity is confirmed by benchmark with the standard Abel inversion method and the theoretical profile. The scope of application as well as the error analysis is also discussed in detail

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire.

Science.gov (United States)

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-11-26

To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). 3 public hospitals and 27 health clinics. 117 pharmacists. Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (pculture. As perceptions improved, the number of medication errors reported decreased. Group-specific interventions that target specific domains are necessary to improve the safety culture. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

Science.gov (United States)

Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2018-03-12

We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

The Public Safety Impact of Community Notification Laws: Rearrest of Convicted Sex Offenders

Science.gov (United States)

Freeman, Naomi J.

2012-01-01

Sex offender management is one of the highest-profile issues in public safety today. Although states have enacted community notification laws as a means to protect communities from sexual offending, limited research has been conducted to examine the impact of these laws on public safety. As such, this study used a quasi-experimental design to…

Impact of biomarker development on drug safety assessment

International Nuclear Information System (INIS)

Marrer, Estelle; Dieterle, Frank

2010-01-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

External Port Tissue Expansion in the Pediatric Population: Confirming Its Safety and Efficacy.

Science.gov (United States)

Azadgoli, Beina; Fahradyan, Artur; Wolfswinkel, Erik M; Tsuha, Michaela; Magee, William; Hammoudeh, Jeffrey A; Urata, Mark M; Howell, Lori K

2018-06-01

External filling ports in tissue expander-based reconstruction have the advantages of being associated with less pain and emotional distress. However, among practicing surgeons using tissue expansion, a theoretical concern remains regarding higher risk of infection. The authors' goal was to evaluate external port safety in the pediatric population by looking at the complications and overall success rate of reconstruction. A retrospective review of all patients undergoing tissue expansion using external ports at Children's Hospital Los Angeles between January of 2008 and June of 2016 was conducted. Patient demographic and perioperative data were collected and analyzed. Two hundred forty-one expanders were placed in 100 pediatric patients, resulting in 123 procedures for congenital and acquired conditions, with an average age at the time of surgery of 7.1 years (range, 1 month to 19.9 years) and average follow-up length of 2.5 years (range, 2.8 months to 8.8 years). The overall complication rate was 29.9 percent, and the infection rate was 17 percent. The majority of these cases were treated conservatively without additional need for surgery. Of 123 cases, 25 required premature expander removal because of complications. Despite early intervention, 21 of these cases underwent successful completion of their reconstruction according to the preoperative plan, resulting in an overall 96.7 percent success rate of tissue expander reconstruction. In children, who are often less tolerant of the pain and distress associated with internal port expansion, the authors encourage the use of external ports. This study found a high success rate in terms of successful reconstruction, with the majority of complications being treated conservatively. Therapeutic, IV.

Towards a Competency-based Vision for Construction Safety Education

Science.gov (United States)

Pedro, Akeem; Hai Chien, Pham; Park, Chan Sik

2018-04-01

Accidents still prevail in the construction industry, resulting in injuries and fatalities all over the world. Educational programs in construction should deliver safety knowledge and skills to students who will become responsible for ensuring safe construction work environments in the future. However, there is a gap between the competencies current pedagogical approaches target, and those required for safety in practice. This study contributes to addressing this issue in three steps. Firstly, a vision for competency-based construction safety education is conceived. Building upon this, a research scheme to achieve the vision is developed, and the first step of the scheme is initiated in this study. The critical competencies required for safety education are investigated through analyses of literature, and confirmed through surveys with construction and safety management professionals. Results from the study would be useful in establishing and orienting education programs towards current industry safety needs and requirements

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism

Directory of Open Access Journals (Sweden)

Ran Gao

2016-11-01

Full Text Available The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA and the remaining data were submitted to structural equation modeling (SEM. Top management commitment (TMC and supervisors’ expectation (SE were identified as factors to represent organizational safety climate (OSC and supervisor safety climate (SSC, respectively, and coworkers’ caring and communication (CCC and coworkers’ role models (CRM were identified as factors to denote coworker safety climate (CSC. SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry.

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism.

Science.gov (United States)

Gao, Ran; Chan, Albert P C; Utama, Wahyudi P; Zahoor, Hafiz

2016-11-08

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors' expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers' caring and communication (CCC) and coworkers' role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry.

Offset-electrode profile acquisition strategy for electrical resistivity tomography

Science.gov (United States)

Robbins, Austin R.; Plattner, Alain

2018-04-01

We present an electrode layout strategy that allows electrical resistivity profiles to image the third dimension close to the profile plane. This "offset-electrode profile" approach involves laterally displacing electrodes away from the profile line in an alternating fashion and then inverting the resulting data using three-dimensional electrical resistivity tomography software. In our synthetic and field surveys, the offset-electrode method succeeds in revealing three-dimensional structures in the vicinity of the profile plane, which we could not achieve using three-dimensional inversions of linear profiles. We confirm and explain the limits of linear electrode profiles through a discussion of the three-dimensional sensitivity patterns: For a homogeneous starting model together with a linear electrode layout, all sensitivities remain symmetric with respect to the profile plane through each inversion step. This limitation can be overcome with offset-electrode layouts by breaking the symmetry pattern among the sensitivities. Thanks to freely available powerful three-dimensional resistivity tomography software and cheap modern computing power, the requirement for full three-dimensional calculations does not create a significant burden and renders the offset-electrode approach a cost-effective method. By offsetting the electrodes in an alternating pattern, as opposed to laying the profile out in a U-shape, we minimize shortening the profile length.

Performance Confirmation for the Engineered Barrier System. Report of a Workshop

International Nuclear Information System (INIS)

Bennett, David G.

2004-08-01

As part of preparations for review of future license applications, the Swedish Nuclear Power Inspectorate (SKI) organised a workshop on the engineered barrier system for the KBS-3 concept, focused on Performance Confirmation (PC). The workshop was held during 12 - 14 May, 2004 at Oskarshamn. The main purpose of the workshop was to identify key issues relating to the demonstration of long-term safety using a system of engineered barriers. The workshop began with introductory presentations on Performance Confirmation, on monitoring, and on long-term experiments in underground research laboratories. Working groups were then convened to discuss these topics and identify questions to put to the Swedish Nuclear Fuel and Waste Management Company (SKB) the following day. On the second day, SKB made several presentations, mainly on long-term experiments conducted at the Aespoe underground research laboratory. These presentations were followed by an informal session during which the questions identified by the working groups on the first day were discussed with SKB and its representatives. This report includes the questions identified by the working groups and a summary of the workshop discussions. Extended abstracts for the introductory presentations are included in an appendix. The conclusions and viewpoints presented in this report are those of one or several workshop participants. They do not necessarily coincide with those of SKI

Evaluating the U.S. Food Safety Modernization Act Produce Safety Rule Standard for Microbial Quality of Agricultural Water for Growing Produce

NARCIS (Netherlands)

Havelaar, Arie H; Vazquez, Kathleen M; Topalcengiz, Zeynal; Muñoz-Carpena, Rafael; Danyluk, Michelle D

2017-01-01

The U.S. Food and Drug Administration (FDA) has defined standards for the microbial quality of agricultural surface water used for irrigation. According to the FDA produce safety rule (PSR), a microbial water quality profile requires analysis of a minimum of 20 samples for Escherichia coli over 2 to

Reprogramming Methods Do Not Affect Gene Expression Profile of Human Induced Pluripotent Stem Cells

Directory of Open Access Journals (Sweden)

Marta Trevisan

2017-01-01

Full Text Available Induced pluripotent stem cells (iPSCs are pluripotent cells derived from adult somatic cells. After the pioneering work by Yamanaka, who first generated iPSCs by retroviral transduction of four reprogramming factors, several alternative methods to obtain iPSCs have been developed in order to increase the yield and safety of the process. However, the question remains open on whether the different reprogramming methods can influence the pluripotency features of the derived lines. In this study, three different strategies, based on retroviral vectors, episomal vectors, and Sendai virus vectors, were applied to derive iPSCs from human fibroblasts. The reprogramming efficiency of the methods based on episomal and Sendai virus vectors was higher than that of the retroviral vector-based approach. All human iPSC clones derived with the different methods showed the typical features of pluripotent stem cells, including the expression of alkaline phosphatase and stemness maker genes, and could give rise to the three germ layer derivatives upon embryoid bodies assay. Microarray analysis confirmed the presence of typical stem cell gene expression profiles in all iPSC clones and did not identify any significant difference among reprogramming methods. In conclusion, the use of different reprogramming methods is equivalent and does not affect gene expression profile of the derived human iPSCs.

Resistance and cross-resistance profile of the diaryltriazine NNRTI and candidate microbicide UAMC01398.

Science.gov (United States)

Ariën, Kevin K; Venkatraj, Muthusamy; Michiels, Johan; Joossens, Jurgen; Vereecken, Katleen; Van der Veken, Pieter; Heeres, Jan; De Winter, Hans; Heyndrickx, Leo; Augustyns, Koen; Vanham, Guido

2016-05-01

The resistance development, cross-resistance to other NNRTIs and the impact of resistance on viral replicative fitness were studied for the new and potent NNRTI UAMC01398. Resistance was selected by dose escalation and by single high-dose selection against a comprehensive panel of NNRTIs used as therapeutics and NNRTIs under investigation for pre-exposure prophylaxis of sexual HIV transmission. A panel of 27 site-directed mutants with single mutations or combinations of mutations involved in reverse transcriptase (RT) inhibitor-mediated resistance was developed and used to confirm resistance to UAMC01398. Cross-resistance to other NNRTIs was assessed, as well as susceptibility of UAMC01398-resistant HIV to diarylpyrimidine-resistant viruses. Finally, the impact of UAMC01398 resistance on HIV replicative fitness was studied. We showed that UAMC01398 has potent activity against dapivirine-resistant HIV, that at least four mutations in the RT are required in concert for resistance and that the resistance profile is similar to rilpivirine, both genotypically and phenotypically. Resistance development to UAMC01398 is associated with a severe fitness cost. These data, together with the enhanced safety profile and good solubility in aqueous gels, make UAMC01398 an excellent candidate for HIV topical prevention. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Safety analysis for research reactors

International Nuclear Information System (INIS)

2008-01-01

The aim of safety analysis for research reactors is to establish and confirm the design basis for items important to safety using appropriate analytical tools. The design, manufacture, construction and commissioning should be integrated with the safety analysis to ensure that the design intent has been incorporated into the as-built reactor. Safety analysis assesses the performance of the reactor against a broad range of operating conditions, postulated initiating events and other circumstances, in order to obtain a complete understanding of how the reactor is expected to perform in these situations. Safety analysis demonstrates that the reactor can be kept within the safety operating regimes established by the designer and approved by the regulatory body. This analysis can also be used as appropriate in the development of operating procedures, periodic testing and inspection programmes, proposals for modifications and experiments and emergency planning. The IAEA Safety Requirements publication on the Safety of Research Reactors states that the scope of safety analysis is required to include analysis of event sequences and evaluation of the consequences of the postulated initiating events and comparison of the results of the analysis with radiological acceptance criteria and design limits. This Safety Report elaborates on the requirements established in IAEA Safety Standards Series No. NS-R-4 on the Safety of Research Reactors, and the guidance given in IAEA Safety Series No. 35-G1, Safety Assessment of Research Reactors and Preparation of the Safety Analysis Report, providing detailed discussion and examples of related topics. Guidance is given in this report for carrying out safety analyses of research reactors, based on current international good practices. The report covers all the various steps required for a safety analysis; that is, selection of initiating events and acceptance criteria, rules and conventions, types of safety analysis, selection of

Child and youth care workers: Profile, nutrition knowledge and food ...

African Journals Online (AJOL)

CCWs (N = 40) employed permanently or part-time were included. Convenience purposive sampling of the CCWs was undertaken. A structured self-administered questionnaire, developed and tested for this purpose, was used to gather information on the profile, nutrition knowledge, food safety and hygiene practices.

Risk Profiles for Endometriosis in Japanese Women: Results From a Repeated Survey of Self-Reports

Science.gov (United States)

Yasui, Toshiyuki; Hayashi, Kunihiko; Nagai, Kazue; Mizunuma, Hideki; Kubota, Toshiro; Lee, Jung-Su; Suzuki, Shosuke

2015-01-01

Background The prevalence and risk factors for endometriosis may differ according to diagnosis methodologies, such as study populations and diagnostic accuracy. We examined risk profiles in imaging-diagnosed endometriosis with and without surgical confirmation in a large population of Japanese women, as well as the differences in risk profiles of endometriosis based on history of infertility. Methods Questionnaires that included items on sites of endometriosis determined by imaging techniques and surgical procedure were mailed to 1025 women who self-reported endometriosis in a baseline survey of the Japan Nurses’ Health Study (n = 15 019). Results Two hundred and ten women had surgically confirmed endometriosis (Group A), 120 had imaging-diagnosed endometriosis without a surgical procedure (Group B), and 264 had adenomyosis (Group C). A short menstrual cycle at 18–22 years of age and cigarette smoking at 30 years of age were associated with significantly increased risk of endometriosis (Group A plus Group B), while older age was associated with risk of adenomyosis (Group C). In women with a history of infertility, a short menstrual cycle was associated with a significantly increased risk of endometriosis in both Group A and Group B, but risk profiles of endometriosis were different between Group A and Group B in women without a history of infertility. Conclusions Women with surgically confirmed endometriosis and those with imaging-diagnosed endometriosis without surgery have basically common risk profiles, but these risk profiles are different from those with adenomyosis. The presence of a history of infertility should be taken into consideration for evaluation of risk profiles. PMID:25716280

Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers.

Directory of Open Access Journals (Sweden)

Jose Muñoz

2018-01-01

Full Text Available Ivermectin is a pivotal drug for the control of onchocerciasis and lymphatic filariasis, which is increasingly identified as a useful drug for the control of other Neglected Tropical Diseases. Its role in the treatment of soil transmitted helminthiasis through improved efficacy against Trichuris trichiura in combination with other anthelmintics might accelerate the progress towards breaking transmission. Ivermectin is a derivative of Avermectin B1, and consists of an 80:20 mixture of the equipotent homologous 22,23 dehydro B1a and B1b. Pharmacokinetic characteristics and safety profile of ivermectin allow to explore innovative uses to further expand its utilization through mass drug administration campaigns to improve coverage rates. We conducted a phase I clinical trial with 54 healthy adult volunteers who sequentially received 2 experimental treatments using a new 18 mg ivermectin tablet in a fixed-dose strategy of 18 and 36 mg single dose regimens, compared to the standard, weight based 150–200 μg/kg, regimen. Volunteers were recruited in 3 groups based on body weight. Plasma concentrations of ivermectin were measured through HPLC up to 168 hours post treatment. Safety data showed no significant differences between groups and no serious adverse events: headache was the most frequent adverse event in all treatment groups, none of them severe. Pharmacokinetic parameters showed a half-life between 81 and 91 h in the different treatment groups. When comparing the systemic bioavailability (AUC0t and Cmax of the reference product (WA-ref with the other two study groups using fixed doses, we observed an overall increase in AUC0t and Cmax for the two experimental treatments of 18 mg and 36 mg. Body mass index (BMI and weight were associated with t1/2 and V/F, probably reflecting the high liposolubility of IVM with longer retention times proportional to the presence of more adipose tissue. Systemic exposure to ivermectin (AUC0t or Cmax was not

Profiling hydrogen in materials using ion beams

International Nuclear Information System (INIS)

Ziegler, J.F.; Wu, C.P.; Williams, P.

1977-01-01

Over the last few years many ion beam techniques have been reported for the profiling of hydrogen in materials. Nine of these were evaluated using similar samples of hydrogen ion-implanted into silicon. When possible the samples were analyzed using two or more techniques to confirm the ion-implanted accuracy. The results of this analysis which has produced a consensus profile of H in silicon which is useful as a calibration standard are reported. The analytical techniques used have capabilities ranging from very high depth resolution (approximately 50 A) and high sensitivity (less than 1 ppM) to deep probes for hydrogen which can sample throughout thin sheets

A search profile for dwellings with elevated radon levels

DEFF Research Database (Denmark)

Damkjær, A.; Andersen, C.E.; Majborn, B.

1996-01-01

A search profile for dwellings with elevated radon levels has been employed to investigate possibly radon-prone areas in Denmark and to find houses suitable for radon mitigation studies. The profile is defined as dwellings which are single-family houses with slab-on-grade foundation or partly...... basement/slab-on-grade foundation built on either fractured granitic basement rocks, or fractured limestone. Clayey till areas were also included in the profile in order to confirm earlier findings. Three areas representing these surface geologies were selected for indoor radon measurements with CR-39...... track detectors, and a total of 200 houses matching the profile underwent radon measurements during the winter 1994-95. The distribution of the measured radon concentrations were found in most cases to comply with log-normal distributions. Measurements in the living rooms of houses in each of the three...

Using the profile method for evaluationthe beer quality

Directory of Open Access Journals (Sweden)

O. Bocharova

2017-04-01

Full Text Available The expediency of using the profile method of analysis for assessing the influence of technological factors on the quality of beer has been established. The characteristics for the evaluation of beer quality by the profile method are chosen. The results obtained using the profile method give a more complete picture of the properties of beer than the results of the scoring method. Each of the samples was analyzed and studied. The results of analysis of such criteria as aroma, flavor, appearance and physicochemical parameters are demonstrated on profilograms. Estimation of flavor is the most difficult, since this concept includes a complex sensation of taste, aroma and consistency, determined in the oral cavity. To confirm the organoleptic properties of the «body» of the best sort of beer, rheological analysis data were presented. Such an integrated approach will allow fully studying the properties of a low-alcohol beverage and clearly demonstrating the advantages of a profile method of analysis.

Influence of workplace demands on nurses' perception of patient safety.

Science.gov (United States)

Ramanujam, Rangaraj; Abrahamson, Kathleen; Anderson, James G

2008-06-01

Patient safety is an ongoing challenge in the design and delivery of health-care services. As registered nurses play an integral role in patient safety, further examination of the link between nursing work and patient safety is warranted. The present study examines the relationship between nurses' perceptions of job demands and nurses' perceptions of patient safety. Structural equation modeling is used to analyze the data collected from a survey of 430 registered nurses at two community hospitals in the USA. As hypothesized, nurses' perception of patient safety decreases as the job demands increase. The level of personal control over practice directly affects nurses' perception of the ability to assure patient well-being. Nurses who work full-time and are highly educated have a decreased perception of patient safety, as well. The significant relationship between job demands and patient safety confirms that nurses make a connection between their working conditions and the ability to deliver safe care.

Current density profile inside q=1 on Tore Supra

International Nuclear Information System (INIS)

Joffrin, E.; Desgranges, C.; Sabot, R.; Dubois, M.A.

1995-01-01

The Tore Supra polarimeter used to measure the poloidal field distribution is described. The current density profiles are computed in two different ways using the interferometric and polarimetric data in conjunction with the magnetic data and the location of the inversion radius determined by the soft X-ray camera. The current density inside the q=1 surface is investigated for normal and monster sawteeth. Its variation are also measured by the polarimeter and compared with that predicted by the current diffusion equation assuming complete reconnection. Finally, the safety factor profile is compared with that obtained with the striation data of the pellet ablation. The results of the evolution of the q profile during sawteeth are in good agreement with those obtained in other devices. (author) 9 refs.; 4 figs

Oil characteristics and fatty acid profile of seeds from three varieties ...

African Journals Online (AJOL)

Oil characteristics and fatty acid profile of seeds from three varieties of date palm ... of oils, as indicators of the quality and safety, and oxidative status of edible oils, ... industry, these data suggest that the potential applications of date seed oil for ...

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

Science.gov (United States)

Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

2017-03-28

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

Safety evaluation of Tokai reprocessing plant (TRP). Report of safety evaluation of Tokai reprocessing plant

International Nuclear Information System (INIS)

Yamauchi, Takamichi; Maki, Akira; Nojiri, Ichiro

1999-02-01

The fire and explosion incident of the bituminization facility happened in March 1997 although JNC had taken enough care of the safety of TRP. JNC reflected on it and decided to evaluate the safety of TRP voluntarily. This evaluation has included five activities, that is, (1) confirmation of the structure and organization of TRP, (2) research of the data for operation, radiation and maintenance of TRP, (3) research of reflection of the accidents and troubles which have happened at the past, (4) evaluation on the prevention system, (5) evaluation on the mitigation system. We publish this report to contribute to inheritance of accumulated knowledge and techniques from generation to generation, and remind us of lesson from the fire and explosion incident of the bituminization. (author)

Comparison of the Safety of Seven Iodinated Contrast Media

Science.gov (United States)

Seong, Jong-Mi; Choi, Nam-Kyong; Lee, Joongyub; Chang, Yoosoo; Kim, Ye-Jee; Yang, Bo Ram; Jin, Xue-Mei; Kim, Ju-Young

2013-01-01

We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety. PMID:24339697

Important matter by confirmation of administrative office regarding repair of enriched uranium dissolution tanks in reprocessing plant of Power Reactor and Nuclear Fuel Development Corp

International Nuclear Information System (INIS)

1985-01-01

The Nuclear Safety Commission acknowledged the policy of handling this matter by Science and Technology Agency after having received a report from the Committee on Examination of Nuclear Fuel Safety on April 11, 1985, and carried out the deliberation. The investigation and deliberation of this matter were instructed by the NSC to the Committee on January 24, 1985. It was confirmed that the repair welding applied to the place of leak of the dissolution tanks would not hinder the expected test dissolution, and if the leak occurs, the measures to detect it properly have been taken. In order to confirm the soundness of the repair welding, the Power Reactor and Nuclear Fuel Development Corp. is to carry out the test dissolution for about 400 hours per one tank dividing into three runs, and the observation of appearance is to be made after every run. The time of test dissolution, the items and contents of inspection were confirmed to be adequate. Moreover, the immersion corrosion test of test pieces and the long term corrosion test in a laboratory are to be carried out. (Kako, I.)

Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids

Directory of Open Access Journals (Sweden)

Mark A Ware

2005-01-01

Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.

American National Standard: for safety in conducting subcritical neutron-multiplication measurements in-situ

International Nuclear Information System (INIS)

1983-01-01

This standard provides safety guidance for conducting subcritical neutron-multiplication measurements where physical protection of personnel against the consequences of a criticality accident is not provided. The objectives of in-situ measurements are either to confirm an adequate safety margin or to improve an estimate of such a margin. The first objective may constitute a test of the criticality safety of a design that is based on calculations. The second may effect improved operating conditions by reducing the uncertainty of safety margins and providing guidance to new designs

The need for detailed gender-specific occupational safety analysis.

Science.gov (United States)

Cruz Rios, Fernanda; Chong, Wai K; Grau, David

2017-09-01

The female work in population is growing in the United States, therefore the occupational health and safety entities must start to analyze gender-specific data related to every industry, especially to nontraditional occupations. Women working in nontraditional jobs are often exposed to extreme workplace hazards. These women have their safety and health threatened because there are no adequate policies to mitigate gender-specific risks such as discrimination and harassment. Employers tend to aggravate this situation because they often fail to provide proper reporting infrastructure and support. According to past studies, women suffered from workplace injuries and illnesses that were less prominent among men. Statistics also confirmed that men and women faced different levels of risks in distinct work environments. For example, the rates of workplace violence and murders by personal acquaintances were significantly higher among women. In this paper, the authors analyze prior public data on fatal and nonfatal injuries to understand why we need to differentiate genders when analyzing occupational safety and health issues. The analyses confirmed that women dealt with unique workplace hazards compared to men. It is urgent that public agencies, such as the U.S. Department of Labor, record gender-specific data in details and by occupations and industries. The reader will become aware of the current lack - and need - of data and knowledge about injuries and illnesses separated by gender and industry. Finally, safety and health researchers are encouraged to investigate the gender-specific data in all industries and occupations, as soon as they become available. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Efficacy and safety of adalimumab in ankylosing spondylitis

Directory of Open Access Journals (Sweden)

Mounach A

2014-08-01

Full Text Available Aziza Mounach, Abdellah El MaghraouiRheumatology Department, Military Hospital Mohammed V, Rabat, MoroccoAbstract: Ankylosing spondylitis (AS is the most common and most severe subtype of spondyloarthritis. It also may be an outcome of any of the other spondyloarthritis subtypes. AS preferentially affects the sacroiliac joints and the tip of the column, with a tendency to later ankylosis. Peripheral joints, enthesis, and other extra-articular involvement may be observed. Tumor necrosis factor (TNF inhibitors are now well-established, effective drugs in the treatment of AS symptoms. Adalimumab, which is a fully human monoclonal antibody that binds to and neutralizes TNF, has demonstrated efficacy in treating AS symptoms, including axial involvement, peripheral arthritis, enthesitis, uveitis, gut involvement, and psoriasis. Furthermore, adalimumab has showed an overall acceptable safety profile. In this paper, we review the efficacy and safety profile of adalimumab in the treatment of AS, and discuss its differences from the other anti-TNF drugs reported in the literature.Keywords: ankylosing spondylitis, spondyloarthritis, adalimumab, tumor necrosis factor-α

A methodology for a quantitative assessment of safety culture in NPPs based on Bayesian networks

International Nuclear Information System (INIS)

Kim, Young Gab; Lee, Seung Min; Seong, Poong Hyun

2017-01-01

Highlights: • A safety culture framework and a quantitative methodology to assess safety culture were proposed. • The relation among Norm system, Safety Management System and worker's awareness was established. • Safety culture probability at NPPs was updated by collecting actual organizational data. • Vulnerable areas and the relationship between safety culture and human error were confirmed. - Abstract: For a long time, safety has been recognized as a top priority in high-reliability industries such as aviation and nuclear power plants (NPPs). Establishing a safety culture requires a number of actions to enhance safety, one of which is changing the safety culture awareness of workers. The concept of safety culture in the nuclear power domain was established in the International Atomic Energy Agency (IAEA) safety series, wherein the importance of employee attitudes for maintaining organizational safety was emphasized. Safety culture assessment is a critical step in the process of enhancing safety culture. In this respect, assessment is focused on measuring the level of safety culture in an organization, and improving any weakness in the organization. However, many continue to think that the concept of safety culture is abstract and unclear. In addition, the results of safety culture assessments are mostly subjective and qualitative. Given the current situation, this paper suggests a quantitative methodology for safety culture assessments based on a Bayesian network. A proposed safety culture framework for NPPs would include the following: (1) a norm system, (2) a safety management system, (3) safety culture awareness of worker, and (4) Worker behavior. The level of safety culture awareness of workers at NPPs was reasoned through the proposed methodology. Then, areas of the organization that were vulnerable in terms of safety culture were derived by analyzing observational evidence. We also confirmed that the frequency of events involving human error

Profile control simulations and experiments on TCV : A controller test environment and results using a model-based predictive controller

NARCIS (Netherlands)

Maljaars, E.; Felici, F.; Blanken, T.C.; Galperti, C.; Sauter, O.; de Baar, M.R.; Carpanese, F.; Goodman, T.P.; Kim, D.; Kim, S.H.; Kong, M.G.; Mavkov, B.; Merle, A.; Moret, J.M.; Nouailletas, R.; Scheffer, M.; Teplukhina, A.A.; Vu, N.M.T.

2017-01-01

The successful performance of a model predictive profile controller is demonstrated in simulations and experiments on the TCV tokamak, employing a profile controller test environment. Stable high-performance tokamak operation in hybrid and advanced plasma scenarios requires control over the safety

Profile control simulations and experiments on TCV: a controller test environment and results using a model-based predictive controller

NARCIS (Netherlands)

Maljaars, B.; Felici, F.; Blanken, T. C.; Galperti, C.; Sauter, O.; de Baar, M. R.; Carpanese, F.; Goodman, T. P.; Kim, D.; Kim, S. H.; Kong, M.; Mavkov, B.; Merle, A.; Moret, J.; Nouailletas, R.; Scheffer, M.; Teplukhina, A.; Vu, T.

2017-01-01

The successful performance of a model predictive profile controller is demonstrated in simulations and experiments on the TCV tokamak, employing a profile controller test environment. Stable high-performance tokamak operation in hybrid and advanced plasma scenarios requires control over the safety

Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme

Science.gov (United States)

Angelo, Maria-Genalin; David, Marie-Pierre; Zima, Julia; Baril, Laurence; Dubin, Gary; Arellano, Felix; Struyf, Frank

2014-01-01

Purpose The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies. Methods Unsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies. Results Thirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0–113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups. Conclusions Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and

Confirming competence of operators - A regulatory approach to fuel cycle facilities

International Nuclear Information System (INIS)

Vesely, M.; Sigetich, J.

2013-01-01

For the past 40 years the Canadian Nuclear Safety Commission (CNSC), formerly the Atomic Energy Control Board, has certified workers in nuclear facilities. The requirement for certified personnel has ensured that workers assigned to positions that have a direct impact on the safe operation of the facility are fully qualified to perform their duties. This certification regime is defined in the regulatory framework under which the CNSC operates. Traditionally, this certification regime has been applied to Reactor Operators, Shift Supervisors and Health Physicists in Nuclear Power Plants and research reactors as well as to Exposure Device Operators who use nuclear substances for the purposes of industrial radiography. Stemming from progress made in implementing risk-informed regulatory oversight activities as well as a formal suggestion from the International Atomic Energy Agency - International Regulatory Review Service (IRRS) conducted on the CNSC in 2009, a regulatory approach to confirming the competence of Operators at Fuel Cycle Facilities has been initiated by CNSC staff. In the first stage of the implementation of this new regulatory approach, the CNSC had Cameco Corporation implement a formal internal qualification programme for the UF6 Operators at its Port Hope Conversion Facility (PHCF) in Port Hope, Ontario. In the future, following a review of the results of the qualification programme at the PHCF, the CNSC staff will evaluate the need for the application of a similar regulatory approach to confirm the competence of the Operators at other Fuel Cycle Facilities in Canada. (authors)

Safety Assessment for transient event occurred during the ASTS test of Hanbit Unit 2

International Nuclear Information System (INIS)

Yang, Changkeun; Kim, Yohan; Ha, Sangjun

2014-01-01

Safety Injection has been actuated during the ASTS (Automatic Seismic Trip System) test of Hanbit Unit 2 on Feb. 28, 2014. It could be bad effect on system integrity. KHNP has been performed safety assessment of system for effect of Safety Injection (SI) actuation occurred during the ASTS test of hanbit Unit 2. Stable state of nuclear power plant system has been confirmed according to Safety Injection and reactor trip event occurred during the ASTS test of hanbit Unit 2. In the result of system safety assessment, major variables of nuclear power plant are located in optimal range and not exceed safety limit. It remains nuclear fuel and the integrity of the power plant is in a safe condition were conformed. After ASTS action, thermal elimination has been processed throughout the turbine until turbine signal occurrence because ASTS is connected to M-G set in the present hanbit Unit 2. Therefore, Safety Injection signal has been actuated by rapid reduction of Steam Generator pressure. In this paper, it is concluded that consideration of equipment and setpoint is needed for that Safety Injection has been not occurred under the unnecessary situation. Stable state of nuclear power plant system has been confirmed for Safety Injection and reactor trip event occurred during the ASTS test of hanbit Unit 2. In the result of system safety assessment, major variables of nuclear power plant are located in optimal range and not exceed safety limit. It remains nuclear fuel and the integrity of the plant is in a safe condition were conformed. It is concluded that consideration of equipment and setpoint is needed for that Safety Injection has been not occurred under the unnecessary situation

Plutonium, americium, and uranium concentrations in Nevada Test Site soil profiles

International Nuclear Information System (INIS)

Essington, E.H.; Gilbert, R.O.; Eberhardt, L.L.; Fowler, E.B.

1975-01-01

Many soil profile samples were collected by the Nevada Applied Ecology Group from five nuclear safety test sites on the Nevada Test Site and Tonopah Test Range in Nevada, U.S.A. The profile samples were analyzed for 239 Pu, 240 Pu, 241 Am, and in some cases 235 U and 238 U, in order to estimate the depth of radionuclide penetration and level of contamination at specific sampling depths after an extended period of time since deposition on the surface. Nearly 70 individual profiles were examined. About one-half of the profiles exhibited a smooth leaching pattern with more than 95 percent of the plutonium in the top 5 cm. Other profile patterns are discussed relative to mechanical disturbance of the profile after the initial deposition, accumulation of plutonium in specific zones within the soil profile, and occurrence of large amounts of plutonium in the deepest parts of the soil profile. The implications of these observations are discussed with respect to redistribution of radioactivity by wind, water, and burrowing animals, ingestion by burrowing and grazing animals, uptake by vegetation, and cleanup operations. (auth)

CERN confirms LHC schedule

CERN Document Server

2003-01-01

The CERN Council held its 125th session on 20 June. Highlights of the meeting included confirmation that the LHC is on schedule for a 2007 start-up, and the announcement of a new organizational structure in 2004.

Safety related experience in FFTF startup and operation

International Nuclear Information System (INIS)

Peterson, R.E.; Halverson, T.G.; Daughtry, J.W.

1982-06-01

The Fast Flux Test Facility (FFTF) is a 400 MW(t) sodium cooled fast reactor operating at the Hanford Engineering Development Laboratory, Richland, Washington, to conduct fuels and materials testing in support of the US LMFBR program. Startup and initial power ascension testing of the facility involved a comprehensive series of readiness reviews and acceptance tests, many of which relate to the inherent safety of the plant. Included are physics measurements, natural circulation, integrated containment leakage, shielding effectiveness, fuel failure detection, and plant protection system tests. Described are the measurements taken to confirm the design safety margins upon which the operating authorization of the plant was based. These measurements demonstrate that large margins of safety are available in the FFTF design

The directive establishing a community framework for the nuclear safety of nuclear installations: the European Union approach to nuclear safety

International Nuclear Information System (INIS)

Garribba, M.; Chirtes, A.; Nauduzaite, M.

2009-01-01

This article aims at explaining the evolution leading to the adoption of the recent Council Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations adopted with the consent of all 27 members states following the overwhelming support of the European Parliament, that creates for the first time, a binding legal framework that brings legal certainty to European Union citizens and reinforces the role and independence of national regulators. The paper is divided into three sections. The first section addresses the competence of the European Atomic energy Community to legislate in the area of nuclear safety. It focuses on the 2002 landmark ruling of the European Court of justice that confirmed this competence by recognizing the intrinsic link between radiation protection and nuclear safety. The second part describes the history of the Nuclear safety directive from the initial 2003 European Commission proposal to today 's text in force. The third part is dedicated to a description of the content of the Directive and its implications on the further development of nuclear safety in the European Union. (N.C.)

Safety culture and networks of influence

International Nuclear Information System (INIS)

Pereira, Carlos Henrique V.; Barroso, Antonio C.O.; Vieira Neto, Antonio S.

2011-01-01

This paper analyzes the social networks that influence the formation and maintenance of the safety culture within the Institute of Energy and Nuclear Research (IPEN-CNEN/SP). From the mapping and analysis of social networks, actors with a significant degree of influence were identified. Later using a questionnaire, the beliefs of the population sample were mapped. Thus, the importance of key actors in the network analysis could be confirmed statistically. Therefore, based on the mentioned methods we could demonstrate our hypothesis, that there are some social networks that are important in the formation of safety culture, as well as the fact that the influence of some distinguished actors plays an essential role in this amalgam. (author)

Safety culture and networks of influence

Energy Technology Data Exchange (ETDEWEB)

Pereira, Carlos Henrique V.; Barroso, Antonio C.O.; Vieira Neto, Antonio S., E-mail: carloshvp@usp.br, E-mail: barroso@ipen.br, E-mail: asvneto@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

2011-07-01

This paper analyzes the social networks that influence the formation and maintenance of the safety culture within the Institute of Energy and Nuclear Research (IPEN-CNEN/SP). From the mapping and analysis of social networks, actors with a significant degree of influence were identified. Later using a questionnaire, the beliefs of the population sample were mapped. Thus, the importance of key actors in the network analysis could be confirmed statistically. Therefore, based on the mentioned methods we could demonstrate our hypothesis, that there are some social networks that are important in the formation of safety culture, as well as the fact that the influence of some distinguished actors plays an essential role in this amalgam. (author)

Experimental Confirmation of Stable, Small-Debye-Length, Pure-Electron-Plasma Equilibria in a Stellarator

International Nuclear Information System (INIS)

Kremer, J. P.; Pedersen, T. Sunn; Lefrancois, R. G.; Marksteiner, Q.

2006-01-01

The creation of the first small-Debye length, low temperature pure electron plasmas in a stellarator is reported. A confinement time of 20 ms has been measured. The long confinement time implies the existence of macroscopically stable equilibria and that the single particle orbits are well confined despite the lack of quasisymmetry in the device, the Columbia non-neutral torus. This confirms the beneficial confinement effects of strong electric fields and the resulting rapid ExB rotation of the electrons. The particle confinement time is presently limited by the presence of bulk insulating materials in the plasma, rather than any intrinsic plasma transport processes. A nearly flat temperature profile is seen in the inner part of the plasma

Experimental confirmation of stable, small-debye-length, pure-electron-plasma equilibria in a stellarator.

Science.gov (United States)

Kremer, J P; Pedersen, T Sunn; Lefrancois, R G; Marksteiner, Q

2006-09-01

The creation of the first small-Debye length, low temperature pure electron plasmas in a stellarator is reported. A confinement time of 20 ms has been measured. The long confinement time implies the existence of macroscopically stable equilibria and that the single particle orbits are well confined despite the lack of quasisymmetry in the device, the Columbia non-neutral torus. This confirms the beneficial confinement effects of strong electric fields and the resulting rapid E x B rotation of the electrons. The particle confinement time is presently limited by the presence of bulk insulating materials in the plasma, rather than any intrinsic plasma transport processes. A nearly flat temperature profile is seen in the inner part of the plasma.

Evaluation of Patient Safety Culture and Organizational Culture as a Step in Patient Safety Improvement in a Hospital in Jakarta, Indonesia

Directory of Open Access Journals (Sweden)

Afrisya Iriviranty

2016-07-01

Full Text Available Introduction: Establishment of patient safety culture is the first step in the improvement of patient safety. As such, assessment of patient safety culture in hospitals is of paramount importance. Patient safety culture is an inherent component of organizational culture, so that the study of organizational culture is required in developing patient safety. This study aimed to evaluate patient safety culture among the clinical staff of a hospital in Jakarta, Indonesia and identify organizational culture profile. Materials and Methods: This cross-sectional, descriptive, qualitative study was conducted in a hospital in Jakarta, Indonesia in 2014. Sample population consisted of nurses, midwives, physicians, pediatricians, obstetrics and gynecology specialists, laboratory personnel, and pharmacy staff (n=152. Data were collected using the Hospital Survey on Patient Safety Culture developed by the Agency for Healthcare Research and Quality (AHRQ and Organizational Culture Assessment Instrument (OCAI. Results: Teamwork within units” was the strongest dimension of patient safety culture (91.7%, while “staffing” and “non-punitive response to error” were the weakest dimensions (22.7%. Moreover, clan culture was the most dominant type of organizational culture in the studied hospital. This culture serves as a guide for the changes in the healthcare organization, especially in the development of patient safety culture. Conclusion: According to the results of this study, healthcare providers were positively inclined toward the patient safety culture within the organization. As such, the action plan was designed through consensus decision-making and deemed effective in articulating patient safety in the vision and mission of the organization.

External evaluation on Monju Core Confirmation Test in FY 2010 (the Technical Committee on Monju Research Utilization)

International Nuclear Information System (INIS)

2011-06-01

This report describes the review made by the 'Technical Committee on Monju Research Utilization' on the results of Core Confirmation Test conducted from May to July in 2010. The committee consists of technical specialists in the relevant engineering domains from various Japanese industries and universities. The Committee was convened twice in 2010, in August and December, where the each item of the Core Confirmation Test was explained by individual personnel in charge, and the outline and the detailed analysis were discussed, respectively. Evaluations were made by the Committee after the questions and answers. Main points of the evaluations are listed below: After the 14 year stand-by, the Core Confirmation Test has been successfully completed within a brief duration of 3 months, with provision of precious technical data for future development and commercialization of FBRs. Safety has been confirmed and valuable data for analysis code validation have been acquired on an FBR core containing 1.5%wt of Am-241. It is significant that the newly released nuclear data library, JENDL-4.0 has been validated based on studies of capture cross section of Am-241 and of fission cross section of Pu-239. Finally, the chief examiner of the Committee stated his expectation for advancement of Japanese FBR technologies with the JAEA's leadership based of achievements on Monju, to be reflected on subsequent FBR developments. (author)

Aliskiren: a clinical profile

Directory of Open Access Journals (Sweden)

Roland E Schmieder

2006-06-01

Full Text Available Aliskiren is a novel oral antihypertensive agent, and the first in the new class of direct renin inhibitors. Here we review the key criteria that a new antihypertensive drug should possess, notably effective blood pressure lowering as monotherapy and combination therapy, 24-hour blood pressure control, safety and tolerability, end-organ protective effects, minimal drug interaction and efficacy during long-term use.Aliskiren fulfils key criteria for a new antihypertensive agent.The drug demonstrates effective blood lowering in a number of studies as monotherapy and in combination with a thiazide diuretic (hydrochlorothiazide, an angiotensin-converting enzyme inhibitor (ramipril and a calcium channel blocker (amlodipine. Other studies applying ambulatory blood pressure monitoring show that aliskiren maintains blood pressure control for more than 24 hours. Aliskiren, 150 mg and 300 mg have demonstrated a placebo-like safety and tolerability profile, with no interactions with a wide range of commonly used drugs. Three studies (AVOID, ALOFT and ALLAY are ongoing properties. with aliskiren to assess end-organ protective properties.

Fuel safety research 2001

Energy Technology Data Exchange (ETDEWEB)

Uetsuka, Hiroshi (ed.) [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

2002-11-01

The Fuel Safety Research Laboratory is in charge of research activity which covers almost research items related to fuel safety of water reactor in JAERI. Various types of experimental and analytical researches are being conducted by using some unique facilities such as the Nuclear Safety Research Reactor (NSRR), the Japan Material Testing Reactor (JMTR), the Japan Research Reactor 3 (JRR-3) and the Reactor Fuel Examination Facility (RFEF) of JAERI. The research to confirm the safety of high burn-up fuel and MOX fuel under accident conditions is the most important item among them. The laboratory consists of following five research groups corresponding to each research fields; Research group of fuel behavior under the reactivity initiated accident conditions (RIA group). Research group of fuel behavior under the loss-of-coolant accident conditions (LOCA group). Research group of fuel behavior under the normal operation conditions (JMTR/BOCA group). Research group of fuel behavior analysis (FEMAXI group). Research group of radionuclides release and transport behavior from irradiated fuel under severe accident conditions (VEGA group). The research conducted in the year 2001 produced many important data and information. They are, for example, the fuel behavior data under BWR power oscillation conditions in the NSRR, the data on failure-bearing capability of hydrided cladding under LOCA conditions and the FP release data at very high temperature in steam which simulate the reactor core condition during severe accidents. This report summarizes the outline of research activities and major outcomes of the research executed in 2001 in the Fuel Safety Research Laboratory. (author)

Nuclear criticality safety aspects of gaseous uranium hexafluoride (UF6) in the diffusion cascade

International Nuclear Information System (INIS)

Huffer, J.E.

1997-04-01

This paper determines the nuclear safety of gaseous UF 6 in the current Gaseous Diffusion Cascade and auxiliary systems. The actual plant safety system settings for pressure trip points are used to determine the maximum amount of HF moderation in the process gas, as well as the corresponding atomic number densities. These inputs are used in KENO V.a criticality safety models which are sized to the actual plant equipment. The ENO V.a calculation results confirm nuclear safety of gaseous UF 6 in plant operations

The Consumer Motivation Scale: A detailed review of item generation, exploration, confirmation, and validation procedures

Directory of Open Access Journals (Sweden)

I. Barbopoulos

2017-08-01

Full Text Available This data article offers a detailed description of analyses pertaining to the development of the Consumer Motivation Scale (CMS, from item generation and the extraction of factors, to confirmation of the factor structure and validation of the emergent dimensions. The established goal structure – consisting of the sub-goals Value for Money, Quality, Safety, Stimulation, Comfort, Ethics, and Social Acceptance – is shown to be related to a variety of consumption behaviors in different contexts and for different products, and should thereby prove useful in standard marketing research, as well as in the development of tailored marketing strategies, and the segmentation of consumer groups, settings, brands, and products.

The Consumer Motivation Scale: A detailed review of item generation, exploration, confirmation, and validation procedures.

Science.gov (United States)

Barbopoulos, I; Johansson, L-O

2017-08-01

This data article offers a detailed description of analyses pertaining to the development of the Consumer Motivation Scale (CMS), from item generation and the extraction of factors, to confirmation of the factor structure and validation of the emergent dimensions. The established goal structure - consisting of the sub-goals Value for Money, Quality, Safety, Stimulation, Comfort, Ethics, and Social Acceptance - is shown to be related to a variety of consumption behaviors in different contexts and for different products, and should thereby prove useful in standard marketing research, as well as in the development of tailored marketing strategies, and the segmentation of consumer groups, settings, brands, and products.

Independent assessment for new nuclear reactor safety

Directory of Open Access Journals (Sweden)

D'Auria Francesco

2017-01-01

Full Text Available A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On the one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs. Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry. The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty approach.

Independent assessment for new nuclear reactor safety

International Nuclear Information System (INIS)

D'Auria, F.; Glaeser, H.; Debrecin, N.

2017-01-01

A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs). Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry). The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty (BEPU) approach. (authors)

Requirements on the provisional safety analyses and technical comparison of safety measures

International Nuclear Information System (INIS)

2010-04-01

The concept of a Geological Underground Repository (SGT) was adopted by the Swiss Federal Council on April 2 nd , 2008. It fixes the goals and the safety technical criteria as well as the procedures for the choice of the site for an underground repository. Those responsible for waste management evaluate possible site regions according to the present status of geological knowledge and based on the safety criteria defined in SGT as well as on technical feasibility. In a first step, they propose geological repository sites for high level (HAA) and for low and intermediate level (SMA) radioactive wastes and justify their choice in a report delivered to the Swiss Federal Office of Energy. The Swiss Federal Council reviews the choices presented and, in the case of positive evaluation, approves them and considers them as an initial orientation. In a second step, based on the possible sites according to step 1, the waste management institution responsible has to reduce the repositories chosen for HAA and SMA by taking into account safety aspects, technical feasibility as well as space planning and socio-economical aspects. In making this choice, safety aspects have the highest priority. The criteria used for the evaluation in the first step have to be defined using provisional quantitative safety analyses. On the basis of the whole appraisal, including space planning and socio-economical aspects, those responsible for waste management propose at least two repository sites for HAA- and SMA-waste. Their selection is then reviewed by the authorities and, in the case of a positive assesment, the selection is taken as an intermediate result. The remaining sites are further studied to examine site choice and the delivery of a request for a design license. If necessary, the requested geological knowledge has to be confirmed by new investigations. Based on the results of the choosing process and a positive evaluation by the safety authorities, the Swiss Federal Council has to

The In Vitro-In Vivo Safety Confirmation of PEG-40 Hydrogenated Castor Oil as a Surfactant for Oral Nanoemulsion Formulation.

Science.gov (United States)

Rachmawati, Heni; Novel, Miranti Anggraeni; Ayu, Sri; Berlian, Guntur; Tandrasasmita, Olivia Mayasari; Tjandrawinata, Raymond Rubianto; Anggadiredja, Kusnandar

2017-03-31

Evaluation on the safety use of high concentration of polyoxyl 40 (PEG-40) hydrogenated castor oil as a surfactant for oral nanoemulsion was performed in Webster mice. As previously reported, nearly 20% of PEG-40 hydrogenated castor oil was used to emulsify the glyceryl monooleate (GMO) as an oil to the aqueous phase. Thermodynamically stable and spontaneous nanoemulsion was formed by the presence of co-surfactant polyethylene glycol 400 (PEG-400). Standard parameters were analyzed for nanoemulsion including particle size and particle size distribution, the surface charge of nanoemulsion, and morphology. To ensure the safety of this nanoemulsion, several cell lines were used for cytotoxicity study. In addition, 5000 mg/kg body weight (BW) of the blank nanoemulsion was given orally to Webster mice once a day for 14 days. Several parameters such as gross anatomy, body weight, and main organs histopathology were observed. In particular, by considering the in vivo data, it is suggested that nanoemulsion composed with a high amount of PEG-40 hydrogenated castor oil is acceptable for oral delivery of active compounds.

An intelligent safety system concept for future CANDU reactors

International Nuclear Information System (INIS)

Hinds, H.W.

1980-01-01

A review of the current Regional Over-power Trip (ROPT) system employed on the Bruce NGS-A reactors confirmed the belief that future reactors should have an improved ROPT system. We are developing such an 'intelligent' safety system. It uses more of the available information on reactor status and employs modern computer technology. Fast triplicated safety computers compute maps of fuel channel power, based on readings from prompt-responding flux detectors. The coefficients for this calculation are downloaded periodically from a fourth supervisor computer. These coefficients are based on a detailed 3-D flux shape derived from physics data and other plant information. A demonstration of one of three safety channels of such a system is planned. (auth)

Safety considerations of PWR's

International Nuclear Information System (INIS)

Arnold, W.H. Jr.

1977-01-01

The safety of the central station pressurized water reactor is well established and substantiated by its excellent operating record. Operating data from 55 reactors of this type have established a record of safe operating history unparalleled by any modern large scale industry. The 186 plants under construction require a continuing commitment to maintain this outstanding record. The safety of the PWR has been further verified by the recently completed Reactor Safety Study (''Rasmussen'' Report). Not only has this study confirmed the exceptionally low risk associated with PWR operation, it has also introduced a valuable new tool in the decision making process. PWR designs, utilizing the philosophy of defense in depth, provide the bases for evaluating margins of safety. The design of the reactor coolant system, the containment system, emergency core cooling system and other related systems and components provide substantial margins of safety under both normal and postulated accident conditions even considering simultaneous effects of earthquakes and other environmental phenomena. Margins of safety in the assessment of various postulated accident conditions, with emphasis on the postulated loss of reactor coolant accident (LOCA), have been evaluated in depth as exemplified by the comprehensive ECCS rulemaking hearings followed by imposition of very conservative Nuclear Regulatory Commission requirements. When evaluated on an engineering best estimate approach, the significant margins to safety for a LOCA become more apparent. Extensive test programs have also substantiated margins to safety limits. These programs have included both separate effects and systems tests. Component testing has also been performed to substantiate performance levels under adverse combinations of environmental stress. The importance of utilizing past experience and of optimizing the deployment of incremental resources is self evident. Recent safety concerns have included specific areas such

Stationary density profiles in the Alcator C-mod tokamak

International Nuclear Information System (INIS)

Kesner, J.; Ernst, D.; Hughes, J.; Mumgaard, R.; Shiraiwa, S.; Whyte, D.; Scott, S.

2012-01-01

In the absence of an internal particle source, plasma turbulence will impose an intrinsic relationship between an inwards pinch and an outwards diffusion resulting in a stationary density profile. The Alcator C-mod tokamak utilizes RF heating and current drive so that fueling only occurs in the vicinity of the separatrix. Discharges that transition from L-mode to I-mode are seen to maintain a self-similar stationary density profile as measured by Thomson scattering. For discharges with negative magnetic shear, an observed rise of the safety factor in the vicinity of the magnetic axis appears to be accompanied by a decrease of electron density, qualitatively consistent with the theoretical expectations.

Observational Pharmacoepidemiology in the Drug Safety and Effectiveness Evaluation

Directory of Open Access Journals (Sweden)

José Cabrita

2017-04-01

Full Text Available Observational epidemiological studies have been used in the medicines context for more than 40 years, contributing to characterize drug use patterns and safety, efficacy and effectiveness profiles. Its use has been increased in recognition of the clinical trials limitations to assess the therapeutic and iatrogenic potential of the medicines after its commercialization. The evolution of the regulatory framework for pharmacovigilance, requiring post-marketing studies, post-authorization safety studies (PASS and the post-authorization efficacy studies (PAES to approve certain drugs, reinforced the importance of observational pharmacoepidemiology for the characterization of the medicines safety and effectiveness profiles. Pharmacoepidemiological research can be carried out from field studies designed to obtain the necessary information or in databases with health records of population samples that already contain the information. This 2nd option is more efficient and more and more frequent. Although, observational research from field studies continues to have its space, the increasing availability of databases allowed a new development to observational pharmacoepidemiology. Indeed, access to automated records databases with up-to-date information on medical prescriptions and global health care to representative population samples with long follow-up periods is a valuable tool for the study of drug use patterns and therapeutic and iatrogenic potential in routine clinical practice. In this context, observational pharmacoepidemiology reinforces its role as a scientific area particularly suitable for evaluating the safety and the effectiveness of the medicines in the “real world”, making a relevant contribution to overcome the gap in translating the evidence from the clinical trials for clinical practice.

Intensity profiles behind a five-stage neutron interferometer

International Nuclear Information System (INIS)

Kischko, U.

1983-01-01

By means of the quantitative photography intensity profiles behind a five-stage ideal-crystal neutron interferometer at the thermal channel H25 of the high-flux reactor at the institute Laue-Langevin in Grenoble/France were dermined and compared with theoretical profiles. Contravily to X-rays by neutrons the hole Borrmann range is excited. This leads in the interference picture to superposition of several wave field components. It was shown that the spherical wave theory, as it was developed by W. Bauspiess, U. Bonse, and W. Graeff for the absorption-free neutron interferometer, describes well quantitatively the experimental intensity profiles. Expecially for the t-2t-t geometry the theoretically predicted focusing was confirmed. For the H-beam the intensity profile is symmetric and spatially limited; the O-beam is asymetric with intensities decreasing slowly up to the boundary. Geometrical differences within single stages lead to unique changes in the intensity profile. The pigtail pattern leading in the past to some puzzle guessing could be explained by the influence of geometrical defocusings on the phase shift. Important conclusions for the geometrical tolerances, which have to be regarded in the construction of neutron interferometers, could be obtained. (orig.) [de

Construction of Earthquake - Proof Safety Evaluaiton Methods for Pipes with Wall Thinning

International Nuclear Information System (INIS)

Miyano, H.; Sekimura, N.; Takizawa, M.; Mastumoto, M.

2012-01-01

Since the Fukushima Dai-ichi accident, the importance of 'system safety' has been recognized anew. Particularly, system safety assessment of plants in operation from the various degradation perspectives, specifically, transition of time is very important. Accordingly, assessment on degradation will focus on the degradation of functions with passing of time, combined with the changes in the safety standards and concept of safety. Reliability assessment will be made on the consolidation of important functions, and not on individual components. The boundary function of the system will be one of the focus of this study. For the purpose of reliability assessment on the system by evaluating and quantifying the damage (or rupture) risk of piping - method for confirming the integrity of the system through the assessment on the damage (rupture) risk of the system when an external force caused by an earthquake is applied (the system is sound if the damage (rupture) risk is small) was examined on the basis of the prediction results for each of the parts in pipe wall thinning. In the next phase, the prediction results will be verified by tests, whereby, the improvement in reliability will be confirmed, and a combined assessment will be made in relation to the degradation factors of other systems. 'System safety' assessment method of plants in operation will be developed in a manner where a comprehensive assessment on the safety of the entire plant can be made. Specifically, the changes in the conditions, such as material degradations that degrade performance will be assessed on the entire system. Whereby, the risk caused by functional failure (damage) due to degradation will be regarded as the total of risk in the assessment. A framework on safety assessment will be structured, where the degree of safety will be measured by functional degradation, taking into consideration the changes made in the safety standards up to present. (author)

NASA's Software Safety Standard

Science.gov (United States)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those

Role of lifestyle variables on the lipid profile of selected South Indian subjects

Directory of Open Access Journals (Sweden)

Uma Chitra

2012-01-01

Conclusion: Our results confirm that diet and exercise routines significantly affect the serum lipid profile. Obesity and overweight constitute a risk factor for the development of hypercholesterolaemia and hypertriglyceridaemia.

Safety design guides for environmental qualification for CANDU 9

International Nuclear Information System (INIS)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young; A. C. D. Wright

1996-03-01

This safety design guide describes the safety philosophy and requirements for the environmental qualification of safety related systems and components for CANDU 9. The environmental qualification program identifies the equipments to be qualified and conditions to be used for qualification and provides comprehensive set of documentation to ensure that the qualification is complete and can be maintained for the life of the plant. A summary of the system, components and structures requiring environmental qualification is provided in the table for the guidance of the system design, and this table will be subject to change or confirmation by the environmental qualification program. Also, plant ares subject to harsh environment is provided in the figure. The change status of the regulatory requirements, code and standards should be traced and this safety design guide shall be updated accordingly. 1 tab., 5 figs. (Author) .new

A comparative safety review between GLP-1 receptor agonists and SGLT2 inhibitors for diabetes treatment.

Science.gov (United States)

Consoli, Agostino; Formoso, Gloria; Baldassarre, Maria Pompea Antonia; Febo, Fabrizio

2018-03-01

Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it is more and more important to gather and discuss information about their safety profile. Area Covered: adverse events and the safety concerns most often emerged in trials with GLP-1RA namely, exenatide long acting release (LAR), dulaglutide, liraglutide, semaglutide, lixisenatide or SGLT2i, namely empagliflozin, dapagliflozin, canagliflozin and SGLT2i with an attempt at comparing the safety profiles of molecules of these two classes. Expert opinion: GLP-1RA and SGLT2i, although each associated with different specific side effects, share a 'similar' safety profile and are both drugs relatively easy to handle. The potentially complementary mechanisms of action, the cardio and nephroprotective effects demonstrated by molecules of both classes, make these drugs potentially useful even in add on to each other.

Krsko periodic safety review project prioritization process

International Nuclear Information System (INIS)

Basic, I.; Vrbanic, I.; Spiler, J.; Lambright, J.

2004-01-01

Definition of a Krsko Periodic Safety Review (PSR) project is a comprehensive safety review of a plant after last ten years of operation. The objective is a verification by means of a comprehensive review using current methods that Krsko NPP remains safety when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. This objective encompasses the three main criteria or goals: confirmation that the plant is as safe as originally intended, determination if there are any structures, systems or components that could limit the life of the plant in the foreseeable future, and comparison the plant against modern safety standards and to identify where improvements would be beneficial at justifiable cost. Krsko PSR project is structured in the three phases: Phase 1: Preparation of Detailed 10-years PSR Program, Phase 2: Performing of 10-years PSR Program and preparing of associated documents (2001-2003), and Phase 3: Implementation of the prioritized compensatory measures and modifications (development of associated EEAR, DMP, etc.) after agreement with the SNSA on the design, procedures and time-scales (2004-2008). This paper presents the NEK PSR results of work performed under Phase 2 focused on the ranking of safety issues and prioritization of corrective measures needed for establishing an efficient action plan. Safety issues were identified in Phase 2 during the following review processes: Periodic Safety Review (PSR) task; Krsko NPP Regulatory Compliance Program (RCP) review; Westinghouse Owner Group (WOG) catalog items screening/review; SNSA recommendations (including IAEA RAMP mission suggestions/recommendations).(author)

Preparation of the PRACLAY demonstration and confirmation experiments: construction of the PRACLAY gallery

International Nuclear Information System (INIS)

Bastiaens, W.

2009-01-01

The PRACLAY demonstration and confirmation experiments contribute to the Belgian research, development and demonstration programme to assess the safety and feasibility of geological disposal of radioactive waste in Boom Clay. Within this programme, the large scale PRACLAY heater experiment aims to verify that Boom Clay is suitable to host heat emitting radioactive waste. A 35 m long section of an experimental gallery in the underground research facility HADES (at 225 m depth) will be heated up to 95 degrees Celsius during ten years. The heater experiment focuses on the response of the host rock to the thermal load. The figure below shows the experimental lay-out. In 2007, an important milestone was reached with the realisation of the PRACLAY gallery (45 m long, external diameter 2.5 m)

Leading and lagging indicators of occupational health and safety: The moderating role of safety leadership.

Science.gov (United States)

Sheehan, Cathy; Donohue, Ross; Shea, Tracey; Cooper, Brian; Cieri, Helen De

2016-07-01

In response to the call for empirical evidence of a connection between leading and lagging indicators of occupational health and safety (OHS), the first aim of the current research is to consider the association between leading and lagging indicators of OHS. Our second aim is to investigate the moderating effect of safety leadership on the association between leading and lagging indicators. Data were collected from 3578 employees nested within 66 workplaces. Multi-level modelling was used to test the two hypotheses. The results confirm an association between leading and lagging indicators of OHS as well as the moderating impact of middle management safety leadership on the direct association. The association between leading and lagging indicators provides OHS practitioners with useful information to substantiate efforts within organisations to move away from a traditional focus on lagging indicators towards a preventative focus on leading indicators. The research also highlights the important role played by middle managers and the value of OHS leadership development and investment at the middle management level. Copyright © 2016 Elsevier Ltd. All rights reserved.

Toroidal equilibrium and radial profiles from magnetic measurements in Extrap T1

International Nuclear Information System (INIS)

Brunsell, Per; Jin Li; Tennfors, Einar

1991-01-01

The toroidal equilibrium position in the Extrap T1 toroidal Z-pinch is studied by measuring the currents induced in the external octupole field rings. Radial profiles are obtained by an internal magnetic coil array. From the magnetic field, profiles of current density, plasma pressure, safety factor, resistivity and input power density are deduced. A polynomial model is developed to simulate the measured profiles. The classical ion heat conduction losses in Extrap discharges are calculated using this model and compared to the power input. for polynomials matched to magnetic field profiles measured in present experiments, these losses are small. By varying the coefficients of the polynomials, a region is found where the power input can balance the classical heat conduction losses at higher values of Θ and β o . (Author)

Protectionism or Legitimate Regulations: What can Trade Partners Expect from the New US Food Safety Regime?

OpenAIRE

Nakuja, T.; Kerr, William A.

2013-01-01

In January 2011, the US passed the Food Safety Modernization Act (FSMA) which represents a major legislative initiative to revise and strengthen the regulatory regime pertaining to foodborne illness and contamination. The tightening of the regulatory regime was justified on the basis of a number of high-profile foodborne disease incidents, which are claimed to have undermined public confidence in the US food safety system. While tightening food safety regulations inevitably increase barriers ...

Advances in Predictive Toxicology for Discovery Safety through High Content Screening.

Science.gov (United States)

Persson, Mikael; Hornberg, Jorrit J

2016-12-19

High content screening enables parallel acquisition of multiple molecular and cellular readouts. In particular the predictive toxicology field has progressed from the advances in high content screening, as more refined end points that report on cellular health can be studied in combination, at the single cell level, and in relatively high throughput. Here, we discuss how high content screening has become an essential tool for Discovery Safety, the discipline that integrates safety and toxicology in the drug discovery process to identify and mitigate safety concerns with the aim to design drug candidates with a superior safety profile. In addition to customized mechanistic assays to evaluate target safety, routine screening assays can be applied to identify risk factors for frequently occurring organ toxicities. We discuss the current state of high content screening assays for hepatotoxicity, cardiotoxicity, neurotoxicity, nephrotoxicity, and genotoxicity, including recent developments and current advances.

Estimation of left-turning vehicle maneuvers for the assessment of pedestrian safety at intersections

Directory of Open Access Journals (Sweden)

Wael K.M. Alhajyaseen

2012-07-01

Full Text Available Improving pedestrian safety at intersections remains a critical issue. Although several types of safety countermeasures, such as reforming intersection layouts, have been implemented, methods have not yet been established to quantitatively evaluate the effects of these countermeasures before installation. One of the main issues in pedestrian safety is conflicts with turning vehicles. This study aims to develop an integrated model to represent the variations in the maneuvers of left-turners (left-hand traffic at signalized intersections that dynamically considers the vehicle reaction to intersection geometry and crossing pedestrians. The proposed method consists of four empirically developed stochastic sub-models, including a path model, free-flow speed profile model, lag/gap acceptance model, and stopping/clearing speed profile model. Since safety assessment is the main objective driving the development of the proposed model, this study uses post-encroachment time (PET and vehicle speed at the crosswalk as validation parameters. Preliminary validation results obtained by Monte Carlo simulation show that the proposed integrated model can realistically represent the variations in vehicle maneuvers as well as the distribution of PET and vehicle speeds at the crosswalk.

Earth-mass haloes and the emergence of NFW density profiles

Science.gov (United States)

Angulo, Raul E.; Hahn, Oliver; Ludlow, Aaron D.; Bonoli, Silvia

2017-11-01

We simulate neutralino dark matter (χDM) haloes from their initial collapse, at ˜ earth mass, up to a few percent solar. Our results confirm that the density profiles of the first haloes are described by a ˜r-1.5 power law. As haloes grow in mass, their density profiles evolve significantly. In the central regions, they become shallower and reach on average ˜r-1, the asymptotic form of an NFW profile. Using non-cosmological controlled simulations, we observe that temporal variations in the gravitational potential caused by major mergers lead to a shallowing of the inner profile. This transformation is more significant for shallower initial profiles and for a higher number of merging systems. Depending on the merger details, the resulting profiles can be shallower or steeper than NFW in their inner regions. Interestingly, mergers have a much weaker effect when the profile is given by a broken power law with an inner slope of -1 (such as NFW or Hernquist profiles). This offers an explanation for the emergence of NFW-like profiles: after their initial collapse, r-1.5 χDM haloes suffer copious major mergers, which progressively shallows the profile. Once an NFW-like profile is established, subsequent merging does not change the profile anymore. This suggests that halo profiles are not universal but rather a combination of (1) the physics of the formation of the microhaloes and (2) their early merger history - both set by the properties of the dark matter particle - as well as (3) the resilience of NFW-like profiles to perturbations.

Profiling high-frequency accident locations using association rules

OpenAIRE

GEURTS, Karolien; WETS, Geert; BRIJS, Tom; VANHOOF, Koen

2003-01-01

In Belgium, traffic safety is currently one of the government's highest priorities. Identifying and profiling black spots and black zones in terms of accident related data and location characteristics must provide new insights into the complexity and causes of road accidents, which, in ram, provide valuable input for government actions. In this paper, association rules are used to identify accident circumstances that frequently occur together at high frequency accident locations. Furthermore...

A case for safety leadership team training of hospital managers.

Science.gov (United States)

Singer, Sara J; Hayes, Jennifer; Cooper, Jeffrey B; Vogt, Jay W; Sales, Michael; Aristidou, Angela; Gray, Garry C; Kiang, Mathew V; Meyer, Gregg S

2011-01-01

Delivering safe patient care remains an elusive goal. Resolving problems in complex organizations like hospitals requires managers to work together. Safety leadership training that encourages managers to exercise learning-oriented, team-based leadership behaviors could promote systemic problem solving and enhance patient safety. Despite the need for such training, few programs teach multidisciplinary groups of managers about specific behaviors that can enhance their role as leadership teams in the realm of patient safety. The aims of this study were to describe a learning-oriented, team-based, safety leadership training program composed of reinforcing exercises and to provide evidence confirming the need for such training and demonstrating behavior change among management groups after training. Twelve groups of managers from an academic medical center based in the Northeast United States were randomly selected to participate in the program and exposed to its customized, experience-based, integrated, multimodal curriculum. We extracted data from transcripts of four training sessions over 15 months with groups of managers about the need for the training in these groups and change in participants' awareness, professional behaviors, and group activity. Training transcripts confirmed the need for safety leadership team training and provided evidence of the potential for training to increase targeted behaviors. The training increased awareness and use of leadership behaviors among many managers and led to new routines and coordinated effort among most management groups. Enhanced learning-oriented leadership often helped promote a learning orientation in managers' work areas. Team-based training that promotes specific learning-oriented leader behaviors can promote behavioral change among multidisciplinary groups of hospital managers.

Safety of nifedipine GITS in stable angina: The ACTION trial

NARCIS (Netherlands)

P. Poole-Wilson (Philip); B.A. Kirwan (Bridget Anne); Z. Vokó (Zoltán); S. de Brouwer (Sophie); F.J. van Dalen (Frederik); J. Lubsen (Jacob)

2006-01-01

textabstractAim: We describe the safety profile of nifedipine GITS as assessed from adverse events reported in the ACTION trial in which 7,665 patients with stable, symptomatic coronary artery disease were randomly assigned nifedipine GITS or placebo and followed for a mean of 4.9 years. Methods:

Students' Perceptions of Safety at School after Sandy Hook

Science.gov (United States)

Fisher, Benjamin W.; Nation, Maury; Nixon, Carol T.; McIlroy, Sarah

2017-01-01

High profile school shootings have served as pivotal events for developing policies to promote student safety. Although previous studies indicate that exposure to violence is associated with feeling unsafe at school and poorer academic and psychosocial outcomes, research on the relationship between widely publicized acts of school violence and…

High safety in the mining industry

Energy Technology Data Exchange (ETDEWEB)

1987-08-01

Presents an interview in question and answer format with the deputy chairman of Gosgortekhnadzor (Committee for Supervision of Industrial Work Safety and Mining Supervision) in which he discusses two recent fatal accidents in the Yasinovskaya-Glubokaya and Chaikino coal mines and identifies areas where safety needs to be improved (more automation, protective devices, ventilation etc.). Discusses the particular problems involved with deep mining (20% of mines are now deeper than 700 m and 27 mines are deeper than 1000 m), such as fires, dust, methane, rock falls, insufficient maintenance and strata control and poor ventilation. Confirms that a large number of accidents is due to poor organization and stresses the fact the coal industry must be subjected to perestroika (restructuring) as much as other areas of society.

Inherent safety characteristics of innovative reactors

International Nuclear Information System (INIS)

Heil, J.A.

1995-11-01

The added safety value of innovative or third generation reactor designs has been evaluated in order to determine the most suitable candidate for Dutch government funded research and development support. To this end, four innovative reactor concepts, viz. PIUS (Process Inherent Ultimate Safety), PRISM (Power Reactor Innovative Small), HTR-M (High Temperature Reactor Module) and MHTGR (Modular High Temperature Gas-cooled Reactor), have been studied and their passive and inherent safety characteristics have been outlined. Also the outlook for further technological and industrial development has been considered. The results of the study confirm the perspective of the innovative reactors for reduced dependence on active safety provisions and for a further reduced vulnerability to technical failures and human errors. The accident responses to generic accident initiators, viz. reactivity and cooling accidents, and also to reactor specific accidents show that neither active safety systems nor short term operator actions are required for maintaining the reactor core in a controlled and coolable condition. Whether this gives rise to a higher total safety of the innovative reactor designs, compared to evolutionary or advanced reactors, cannot be concluded. Supplementary experimental and analytical analyses of reactor specific accidents are required to be able to assess the safety of these innovative designs in a more quantitative manner. It is believed that the safety case of innovative reactors, which are less dependent on active safety systems, can be communicated with the general public in a more transparent way. Considering the perspective for further technological and industrial development it is not expected that any of the considered innovative reactor concepts will become commercially available within the next one to two decades. However, they could be made available earlier if they would receive sufficient financial backing. Considering the added safety perspectives

Safety of treatment options for spondyloarthritis: a narrative review.

Science.gov (United States)

D'Angelo, Salvatore; Carriero, Antonio; Gilio, Michele; Ursini, Francesco; Leccese, Pietro; Palazzi, Carlo

2018-05-01

Spondyloarthritis (SpA) are chronic inflammatory diseases with overlapping pathogenic mechanisms and clinical features. Treatment armamentarium against SpA includes non-steroidal anti-inflammatory drugs, glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs, including sulfasalazine, methotrexate, leflunomide, cyclosporine), targeted synthetic DMARDs (apremilast) and biological DMARDs (TNF inhibitors, anti-IL 12/23 and anti-IL-17 agents). Areas covered: A narrative review of published literature on safety profile of available SpA treatment options was performed. Readers will be provided with a comprehensive overview on frequent and rare adverse events associated with each drug listed in current SpA treatment recommendations. Expert opinion: The overall safety profile of such molecules is good and serious adverse events are rare but need to be promptly recognized and treated. However, the monitoring of adverse events is a major challenge for clinicians because it is not adequately addressed by current treatment recommendations. A tailored treatment is crucial and rheumatologists must accurately select patients in order to identify those more susceptible to develop adverse events.

Bacteriologically confirmed tuberculosis in children

International Nuclear Information System (INIS)

Ozere, I.; Sele, A.; Ozolina, A.

2005-01-01

Tuberculosis in children and adults is a growing problem with important public health implications. In Latvia the incidence of tuberculosis (TB) in children up to age 14 has increased from 7,1 per 100000 in 1992 to 28,8 per 100000 in 2003. The diagnosis of TB is confirmed by isolation and identification of M. tuberculosis (MT) from clinical specimen. Confirmation of the disease, however, is difficult in children due to poor bacilli excretion and even under the best circumstances only about 30-40% of pediatric TB cases are proved bacteriologically. Of the 370 pediatric TB cases diagnosed between January 1, 2001 and December 1, 2003 in Latvia, 53 (14,3%) were confirmed bacteriologically. The clinical, radiological, immunological and anamnestic features of confirmed TB can serve as cornerstones for diagnosing of TB, when culture is not available. Objective To evaluate the sensitivity of diagnostic criteria of TB, clinical and radiological manifestation of TB and drug susceptibility of MT isolated also. Methods All consecutive children (53 in total) up to age 14 diagnosed with bacteriologically confirmed TB during 01.01.2001. -01.12.2003. were prospectively evaluated for reasons mentioned above. Results Of the 53 children identified all but one had respiratory tract TB. 17(32,1 %) children were under 4 years of age, 9 (17%) children were 5-9 years old, but 27 (50,9%) patients were 10-14 years old. During evaluation data on TB source case were found in addition in 13 children and total TB contact history was positive in 37 (69,8%) patients. All clinical and radiographical forms of respiratory tract TB were diagnosed. The most common encountered forms were intrathoracic adenopathy in 10 (18,9%) cases and TB pneumonia in 6 (11,3%) cases in children aged 10-14 years. lnthrathoracic adenopathy associated with segmental parenchymal lesion was the most common form in children under 4 years of age -7 (13,2%) cases respectively. Conclusions 1. The clinical and radiological

Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru.

Science.gov (United States)

Lanata, Claudio F; Andrade, Teresa; Gil, Ana I; Terrones, Cynthia; Valladolid, Omar; Zambrano, Betzana; Saville, Melanie; Crevat, Denis

2012-09-07

In a randomized, placebo-controlled, monocenter, observer blinded study conducted in an area where dengue is endemic, we assessed the safety and immunogenicity of a recombinant, live, attenuated, tetravalent dengue vaccine candidate (CYD-TDV) in 2-11 year-olds with varying levels of pre-existing yellow-fever immunity due to vaccination 1-7 years previously. 199 children received 3 injections of CYD-TDV (months 0, 6 and 12) and 99 received placebo (months 0 and 6) or pneumococcal polysaccharide vaccine (month 12). One month after the third dengue vaccination, serotype specific neutralizing antibody GMTs were in the range of 178-190 (1/dil) (versus 16.7-38.1 in the control group), a 10-20 fold-increase from baseline, and 94% of vaccines were seropositive to all four serotypes (versus 39% in the control group). There were no vaccine-related SAEs. The observed reactogenicity profile was consistent with phase I studies, with severity grade 1-2 injection site pain, headache, malaise and fever most frequently reported and no increase after subsequent vaccinations. Virologically confirmed dengue cases were seen after completion of the 3 doses: 1 in the CYD-TDV group (N=199), and 3 in the control group (N=99). A 3-dose regimen of CYD-TDV had a good safety profile in 2-11 year olds with a history of YF vaccination and elicited robust antibody responses that were balanced against the four serotypes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review

Science.gov (United States)

Solmi, Marco; Murru, Andrea; Pacchiarotti, Isabella; Undurraga, Juan; Veronese, Nicola; Fornaro, Michele; Stubbs, Brendon; Monaco, Francesco; Vieta, Eduard; Seeman, Mary V; Correll, Christoph U; Carvalho, André F

2017-01-01

Since the discovery of chlorpromazine (CPZ) in 1952, first-generation antipsychotics (FGAs) have revolutionized psychiatric care in terms of facilitating discharge from hospital and enabling large numbers of patients with severe mental illness (SMI) to be treated in the community. Second-generation antipsychotics (SGAs) ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders (DSM) categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed

PERFORMANCE CONFIRMATION IN-SITU INSTRUMENTATION

International Nuclear Information System (INIS)

N.T. Raczka

2000-01-01

The purpose of this document is to identify and analyze the types of in-situ instruments and methods that could be used in support of the data acquisition portion of the Performance Confirmation (PC) program at the potential nuclear waste repository at Yucca Mountain. The PC program will require geomechanical , geophysical, thermal, and hydrologic instrumentation of several kinds. This analysis is being prepared to document the technical issues associated with each type of measurement during the PC period. This analysis utilizes the ''Performance Confirmation Input Criteria'' (CRWMS M andO 1999a) as its starting point. The scope of this analysis is primarily on the period after the start of waste package emplacement and before permanent closure of the repository, a period lasting between 15 and 300 years after last package emplacement (Stroupe 2000, Attachment 1, p. 1). The primary objectives of this analysis are to: (1) Review the design criteria as presented in the ''Performance Confirmation Input Criteria'' (CRWMS M andO 1999a). The scope of this analysis will be limited to the instrumentation related to parameters that require continuous monitoring of the conditions underground. (2) Preliminary identification and listing of the data requirements and parameters as related to the current repository layout in support of PC monitoring. (3) Preliminary identification of methods and instrumentation for the acquisition of the required data. Although the ''Performance Confirmation Input Criteria'' (CRWMS M andO 1999a) defines a broad range of data that must be obtained from a variety of methods, the focus of this analysis is on instrumentation related to the performance of the rock mass and the formation of water in the repository environment, that is obtainable from in-situ observation, testing, and monitoring

Safety issue resolution strategy plan for inactive miscellaneous underground storage tanks

International Nuclear Information System (INIS)

Wang, O.S.; Powers, T.B.

1994-09-01

The purpose of this strategy plan is to identify, confirm, and resolve safely issues associated with inactive miscellaneous underground storage tanks (MUSTs) using a risk-based priority approach. Assumptions and processes to assess potential risks and operational concerns are documented in this report. Safety issue priorities are ranked based on a number of considerations including risk ranking and cost effectiveness. This plan specifies work scope and recommends schedules for activities related to resolving safety issues, such as collecting historical data, searching for authorization documents, performing Unreviewed Safety Question (USQ) screening and evaluation, identifying safety issues, imposing operational controls and monitoring, characterizing waste contents, mitigating and resolving safety issues, and fulfilling other remediation requirements consistent with the overall Tank Waste Remediation System strategy. Recommendations for characterization and remediation are also recommended according to the order of importance and practical programmatic consideration

[Profile of silodosin].

Science.gov (United States)

Montorsi, Francesco

2013-01-01

Silodosin is a highly selective alpha1A-adrenoceptor antagonist approved for the treatment of the signs and symptoms of benign prostatic hyperplasia. Its clinical pharmacology profile offers a number of advantages, including uroselectivity, once-daily (QD) dosing, a standard dose of 8 mg QD that does not need to be adjusted according to age, and the feasibility of concomitant treatment with phosphodiesterase type 5 (PDE5) inhibitors and antihypertensive agents. Three phase 3 double-blind, randomised trials using the dosage regimen of 8 mg QD in > 800 patients have shown that silodosin is significantly more effective than placebo (p nocturia (p = 0.03). Safety data collected in 1581 patients exposed to chronic treatment with silodosin 8 mg QD have shown that the drug is safe and well tolerated. As was to be expected with a uroselective compound, cardiovascular effects have been minimal. The most common adverse reaction is "retrograde ejaculation" (anejaculation), which led to treatment discontinuation in only 3.9% of patients. The rare, drug class-related safety issue of intraocular floppy iris syndrome can be satisfactorily managed by warning patients simply to inform their ophthalmologist that they are or were on treatment with an alpha1-adrenoceptor blocker.

Insights from the U.S. department of Energy plant safety evaluation program of VVER and RBMK reactors

International Nuclear Information System (INIS)

Petri, M.C.; Binder, J.L.; Pasedag, W.F.

2001-01-01

Throughout the years 1990 the U.S. Department of Energy has worked build capability in countries of the former Soviet Union to assess the safety of their VVER and RBMK reactors. Through this Plant Safety Evaluation Program, deterministic and probabilistic analyses have been used to provide a documented plant risk profile to support safe plant operation and to set priorities for safety upgrades. Work has been sponsored at thirteen nuclear power plant sites in eight countries. The Plant Safety Evaluation Program has resulted in immediate and long-term safety benefits for the Soviet-designed nuclear plants. (author)

Culture confirmation of tuberculosis cases in Birmingham, UK.

Science.gov (United States)

Hayer, Kalbir S; Sitch, Alice J; Dedicoat, Martin; Wood, Annette L

2013-10-01

The proportion of culture-confirmed tuberculosis (TB) cases in Birmingham had gradually decreased to less than 65% in 2008. Reasons for this were unclear, therefore this study assessed diagnostic methods used for confirming TB and reviewed factors involved in positive culture. A cross-sectional study was carried out. A list of notified TB cases for Birmingham in those aged 16 y and over in 2009 was collated. Where no positive culture was recorded, further data were collected from hospital databases and case notes. Of 449 TB cases, 419 (93%) had samples taken for culture testing. Of all cases, 309 (69%) were confirmed by culture testing; of those receiving culture testing, 73% were confirmed. Pulmonary TB was identified as a predictor of positive culture in both the unadjusted and adjusted analyses: odds ratio (OR) 2.05, 95% confidence interval (CI) 1.32-3.19, and OR 2.32, 95% CI 1.29-4.17, respectively. Gender, age, ethnicity, UK born, and treatment delay were not significantly associated with positive culture. Of 140 cases not confirmed by culture, 129 (92%) had their diagnosis supported by at least one other test. The vast majority of TB cases had microbiological specimens taken to help confirm the disease. Furthermore, culture confirmation rates in Birmingham were meeting national targets in 2009. However culture confirmation rates were significantly lower in extrapulmonary TB, therefore further work is suggested in this group. The role of other investigations (e.g. interferon-gamma release assay (IGRA), Mantoux) is unclear. Further collaboration between clinicians, histopathologists, and microbiologists is advised to ensure samples are sent appropriately and culture confirmation is optimized.

Performance Confirmation Data Acquisition System

International Nuclear Information System (INIS)

D.W. Markman

2000-01-01

The purpose of this analysis is to identify and analyze concepts for the acquisition of data in support of the Performance Confirmation (PC) program at the potential subsurface nuclear waste repository at Yucca Mountain. The scope and primary objectives of this analysis are to: (1) Review the criteria for design as presented in the Performance Confirmation Data Acquisition/Monitoring System Description Document, by way of the Input Transmittal, Performance Confirmation Input Criteria (CRWMS M and O 1999c). (2) Identify and describe existing and potential new trends in data acquisition system software and hardware that would support the PC plan. The data acquisition software and hardware will support the field instruments and equipment that will be installed for the observation and perimeter drift borehole monitoring, and in-situ monitoring within the emplacement drifts. The exhaust air monitoring requirements will be supported by a data communication network interface with the ventilation monitoring system database. (3) Identify the concepts and features that a data acquisition system should have in order to support the PC process and its activities. (4) Based on PC monitoring needs and available technologies, further develop concepts of a potential data acquisition system network in support of the PC program and the Site Recommendation and License Application

A New Way to Confirm Planet Candidates

Science.gov (United States)

Kohler, Susanna

2016-05-01

What was the big deal behind the Kepler news conference yesterday? Its not just that the number of confirmed planets found by Kepler has more than doubled (though thats certainly exciting news!). Whats especially interesting is the way in which these new planets were confirmed.Number of planet discoveries by year since 1995, including previous non-Kepler discoveries (blue), previous Kepler discoveries (light blue) and the newly validated Kepler planets (orange). [NASA Ames/W. Stenzel; Princeton University/T. Morton]No Need for Follow-UpBefore Kepler, the way we confirmed planet candidates was with follow-up observations. The candidate could be validated either by directly imaging (which is rare) or obtaining a large number radial-velocity measurements of the wobble of the planets host star due to the planets orbit. But once Kepler started producing planet candidates, these approaches to validation became less feasible. A lot of Kepler candidates are small and orbit faint stars, making follow-up observations difficult or impossible.This problem is what inspired the development of whats known as probabilistic validation, an analysis technique that involves assessing the likelihood that the candidates signal is caused by various false-positive scenarios. Using this technique allows astronomers to estimate the likelihood of a candidate signal being a true planet detection; if that likelihood is high enough, the planet candidate can be confirmed without the need for follow-up observations.A breakdown of the catalog of Kepler Objects of Interest. Just over half had previously been identified as false positives or confirmed as candidates. 1284 are newly validated, and another 455 have FPP of1090%. [Morton et al. 2016]Probabilistic validation has been used in the past to confirm individual planet candidates in Kepler data, but now Timothy Morton (Princeton University) and collaborators have taken this to a new level: they developed the first code thats designed to do fully

Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US

Directory of Open Access Journals (Sweden)

Jara M

2013-03-01

Full Text Available Michele Jara,1 Graham Barker,2 Herbert R Henney 3rd1 1Acorda Therapeutics, Inc, Ardsley, NY, USA; 2Biogen Idec, Inc, Maidenhead, Berkshire, UK Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine in some countries were approved in the US to improve walking in patients with multiple sclerosis, as demonstrated by improvement in walking speed. Postmarketing safety experience is available from exposure of approximately 46,000 patients in the US from product approval through March 2011. Objective: To provide a descriptive analysis of all spontaneously reported postmarketing adverse events (AEs for dalfampridine-ER since product launch. Methods: AE data were extracted from the safety database from product launch through March 31, 2011; AEs were classified using the Medical Dictionary for Regulatory Activities. Seizure cases were reviewed for patient demographics, time to event from treatment onset, and presence of additional risk factors. Results: The most frequently reported postmarketing AEs were similar to those reported during clinical development: dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, asthenia, and back pain (all included in US product labeling. New clinically significant findings are related to lack of efficacy and inappropriate dosing. Of the approximately 46,000 patients exposed, 85 seizures were reported (~5.4/1000 patient-years, of which 82 were reported or confirmed by a health care practitioner (~5.2/1000 patient-years. Beyond the intrinsic multiple sclerosis-related seizure risk, more than half of the 85 cases (62% had an additional potential risk factor for seizure including a previous history of convulsions, renal impairment, incorrect dosing, or use of concurrent medications with a labeled seizure risk. Duration of treatment prior to the seizure ranged from one dose to 365 days; 26/85 (31% patients suffered a seizure

Analysis of tank safety with propane-butane on LPG distribution station

Directory of Open Access Journals (Sweden)

Krzysiak Zbigniew

2017-12-01

Full Text Available An analysis of the risk of failure in the safety valve – tank with propane-butane (LPG system has been conducted. An uncontrolled outflow of liquid LPG, caused by a failure of the above mentioned system has been considered as a threat. The main research goal of the study is the hazardous analysis of propane-butane gas outflow for the safety valve – LPG tank system. The additional goal is the development of an useful method to fast identify the hazard of a mismatched safety valve. The results of the research analysis have confirmed that safety valves are basic protection of the installation (tank against failures that can lead to loss of life, material damage and further undesired costs of their unreliability. That is why a new, professional computer program has been created that allows for the selection of safety valves or for the verification of a safety valve selection in installations where any technical or technological changes have been made.

Nuclear critical safety analysis for UX-30 transport of freight package

International Nuclear Information System (INIS)

Quan Yanhui; Zhou Qi; Yin Shenggui

2014-01-01

The nuclear critical safety analysis and evaluation for UX-30 transport freight package in the natural condition and accident condition were carried out with MONK-9A code and MCNP code. Firstly, the critical benchmark experiment data of public in international were selected, and the deflection and subcritical limiting value with MONK-9A code and MCNP code in calculating same material form were validated and confirmed. Secondly, the neutron efficiency multiplication factors in the natural condition and accident condition were calculated and analyzed, and the safety in transport process was evaluated by taking conservative suppose of nuclear critical safety. The calculation results show that the max value of k eff for UX-30 transport freight package is less than the subcritical limiting value, and the UX-30 transport freight package is in the state of subcritical safety. Moreover, the critical safety index (CSI) for UX-30 package can define zero based on the definition of critical safety index. (authors)

Nuclear criticality safety aspects of gaseous uranium hexafluoride (UF{sub 6}) in the diffusion cascade

Energy Technology Data Exchange (ETDEWEB)

Huffer, J.E. [Parallax, Inc., Atlanta, GA (United States)

1997-04-01

This paper determines the nuclear safety of gaseous UF{sub 6} in the current Gaseous Diffusion Cascade and auxiliary systems. The actual plant safety system settings for pressure trip points are used to determine the maximum amount of HF moderation in the process gas, as well as the corresponding atomic number densities. These inputs are used in KENO V.a criticality safety models which are sized to the actual plant equipment. The ENO V.a calculation results confirm nuclear safety of gaseous UF{sub 6} in plant operations..

Modern diaper performance: construction, materials, and safety review.

Science.gov (United States)

Dey, Swatee; Kenneally, Dianna; Odio, Mauricio; Hatzopoulos, Ioannis

2016-07-01

A review of the literature on diapers and diaper rash reveals that many clinicians are unfamiliar with modern diaper construction and materials as well as diaper safety testing methods. Typical modern diapers do not contain ingredients of concern such as latex and disperse dyes, but use ingredients such as spandex and pigments with a favorable safety profile. Today's disposable diaper is a high performance product whose carefully designed layers and liners provide optimal urine and feces absorption and an ever more clothing-like and comfortable fit. This is possible due to a variety of specialized polymer materials that provide optimal absorption of urine and feces, thereby minimizing skin exposure. © 2016 The International Society of Dermatology.

Risk perception, safety goals and regulatory decision-making

International Nuclear Information System (INIS)

Hoegberg, Lars

1998-01-01

Deciding on 'how safe is safe enough?' includes value judgements with implications of an ethical and political nature. As regulators are accountable to governments, parliaments and the general public, regulatory decision-making should be characterized by transparency with respect to how such value judgements are reflected in risk assessments and regulatory decisions. Some approaches in this respect are discussed in the paper, based on more than fifteen years of experience in nuclear regulatory decision-making. Issues discussed include: (1) risk profiles and safety goals associated with severe reactor accidents--individual health risks, societal risks and risk of losing investments; (2) risk profile-based licensing of the Swedish SFR final disposal facility for low and intermediate level radioactive waste

Facilitating improved road safety based on increased knowledge about driving behaviour and profiling sub-groups of drivers

DEFF Research Database (Denmark)

Martinussen, Laila Marianne

The aim of the Ph.D. study presented in this thesis was to facilitate improved road safety through increased understanding of methods used to measure driving behaviour, and through increased knowledge about driving behaviour in sub-groups of drivers. More specifically, the usefulness of the Driver...... with underlying mechanisms of lack of focus, emotional stress, recklessness and confusion, and hence it is highly important to further explore means to making drivers become more focused or attentive when driving, and to deal with emotional responses in traffic like impatience and frustration (Article 1). 2......, indicating that the problem lies in the drivers’ attitudes towards safety (Article 3). 6. It is indicated that rather than viewing safety and risk as two ends of a continuum, safety and risk should be understood as two separate constructs, with different underlying motives. Therefore it is suggested...

Domestic Regulation for Periodic Safety Review of Nuclear Power Plants

International Nuclear Information System (INIS)

Kim, Daesik; Ahn, Seunghoon; Auh, Geunsun; Lee, Jonghyeok

2015-01-01

The so-called Periodic Safety Review (PSR) has been carried out such safety assessment throughout its life, on a periodic basis. In January 2001, the Atomic Energy Act and related regulations were amended to adopt the PSR institutional scheme from IAEA Nuclear Safety Guide 50-SG-O12. At that time the safety assessment was made to review the plant safety on 10 safety factors, such as aging management and emergency planning, where the safety factor indicates the important aspects of safety of an operating NPP to be addressed in the PSR. According to this legislation, the domestic utility, the KHNP has conducted the PSR for the operating NPP of 10 years coming up from operating license date, starting since May 2000. Some revisions in the PSR rule were made to include the additional safety factors last year. This paper introduces the current status of the PSR review and regulation, in particular new safety factors and updated technical regulation. Comprehensive safety assessment for Korea Nuclear Power Plants have performed a reflecting design and procedure changes and considering the latest technology every 10 years. This paper also examined the PSR system changes in Korea. As of July 2015, reviews for PSR of 18 units have been completed, with 229 nuclear safety improvement items. And implementation have been completed for 165 of them. PSR system has been confirmed that it has contributed to improvement of plant safety. In addition, this paper examined the PSR system change in Korea

Profiling high frequency accident locations using associations rules

OpenAIRE

GEURTS, Karolien; WETS, Geert; BRIJS, Tom; VANHOOF, Koen

2002-01-01

In Belgium, traffic safety is currently one of the government’s highest priorities. Identifying and profiling black spots and black zones in terms of accident related data and location characteristics must provide new insights into the complexity and causes of road accidents which, in turn, provide valuable input for government actions. In this paper, association rules are used to identify accident circumstances that frequently occur together at high frequency accident locations. Furthermore,...

ELEMENTS OF SAFETY IN PARAGLIDING

Directory of Open Access Journals (Sweden)

Janez Mekinc

2016-06-01

Full Text Available Paragliding is an opportunity for tourism development, depending on what position the sport has place in the local community, the restrictions for paragliders and the safety components of the region. The paper explores the phenomenon of paragliding and safety elements in the Upper Soča region, one of ten best paragliding sites in the world (Placestoseeinyourlifetime, 2015. The purpose of the research is to analyse the safety elements, the development and the risk of paragliding.The goals of the research are to propose solutions in order to improve the safety conditions for paragliding and to make suggestions on the further development of paragliding within the framework of tourism in the Upper Soča destination. According to the interviewees, paragliding is becoming safer from year to year. This is also supported with the ever-growing numbers of pilots, and on the other hand, the number of accidents that do not follow the same trend. The identified causes for the accidents are human errors or weather conditions. The statistical data confirmed the paragliding in the Upper Soča region, with its unique geographical location, has a positive impact on local tourism and its development. The results of the study are useful for paragliders, local tourism stakeholders, researchers of sport tourism, as well to municipalities in the Upper Soča region.

Unraveling the organizational mechanism at the root of safety compliance in an Italian manufacturing firm.

Science.gov (United States)

Avanzi, Lorenzo; Savadori, Lucia; Fraccaroli, Franco

2018-03-01

Safety performance is recognized as the more proximal and effective precursor of safety outcomes. In particular, safety compliance significantly reduces workplace accidents and injuries. However, it is not entirely clear what role organizational factors play in determining workers' safety. The present study contributes to defining which organizational factors increase safety compliance by testing a mediational model in which supervisor support is related to safety climate, which in turn is related to organizational identification that finally is related to safety compliance. We tested our hypotheses in a sample of 186 production workers of an Italian manufacturing firm using a cross-sectional design. Findings confirm our hypotheses. Management should consider these organizational factors in order to implement primary prevention practices against work accidents.

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

Science.gov (United States)

McKenney, James; Bays, Harold; Gleim, Gilbert; Mitchel, Yale; Kuznetsova, Olga; Sapre, Aditi; Sirah, Waheeda; Maccubbin, Darbie

2015-01-01

The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets. We examined the safety profile of ERN-LRPT vs the comparators ERN alone and statins in the ERN-LRPT development program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to ERN or LRPT. Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) ERN-LRPT; (2) ERN-NSP (ERN, Merck & Co, Inc or Niaspan [NSP], Abbott Laboratories); and (3) statin-PBO (statin or PBO). The safety profiles of ERN-LRPT and ERN-NSP were similar, except for less flushing with ERN-LRPT. Nonflushing AEs reported more frequently with ERN-LRPT or ERN-NSP than with statin-PBO were mostly nonserious and typical of niacin (nausea, diarrhea, and increased blood glucose). There was no evidence for an increased risk of serious AEs related to diabetes, muscle, infection, or bleeding. Pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of ERN-LRPT was similar to that of ERN-NSP; LRPT did not appear to adversely affect the side-effect profile of ERN. The inability to replicate the unexpected AE findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

OpenAIRE

Kim, Seung Won; Kim, Bae-Hwan

2016-01-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a d...

Safety insights from forensics evaluations at Daiichi

Directory of Open Access Journals (Sweden)

J. Rempe

2017-01-01

Information obtained from Daiichi is required to inform Decontamination and Decommissioning activities, improving the ability of the Tokyo Electric Power Company (TEPCO to characterize potential hazards and to ensure the safety of workers involved with cleanup activities. This paper reports initial results from the US Forensics Effort to utilize examination information obtained by TEPCO to enhance the safety of existing and future nuclear power plant designs. In this paper, three examples are presented in which examination information, such as visual images, dose surveys, sample evaluations, and muon tomography examinations, along with data from plant instrumentation, are used to obtain significant safety insights in the areas of component performance, fission product release and transport, debris end-state location, and combustible gas generation and transport. In addition to reducing uncertainties related to severe accident modeling progression, these insights confirm actions, such as the importance of water addition and containment venting, that are emphasized in updated guidance for severe accident prevention, mitigation, and emergency planning.

Scrapping of student bursaries confirmed.

Science.gov (United States)

Longhurst, Chris

2016-07-27

Student bursaries for nurses will be scrapped from next year, the government has confirmed. Undergraduate nursing and midwifery students in England will now face tuition fees and student loans from August 2017.

Differential proteomic profiling of primary and recurrent chordomas.

Science.gov (United States)

Chen, Su; Xu, Wei; Jiao, Jian; Jiang, Dongjie; Liu, Jian; Chen, Tenghui; Wan, Zongmiao; Xu, Leqin; Zhou, Zhenhua; Xiao, Jianru

2015-05-01

Chordomas are locally destructive tumors with high rates of recurrence and a poor prognosis. The mechanisms involved in chordoma recurrence remain largely unknown. In the present study, we examined the proteomic profile of a chordoma primary tumor (CSO) and a recurrent tumor (CSR) through mass spectrum in a chordoma patient who underwent surgery. Bioinformatic analysis of the profile showed that 359 proteins had a significant expression difference and 21 pathways had a striking alteration between the CSO and the CSR. The CSR showed a significant increase in carbohydrate metabolism. Immunohistochemistry (IHC) confirmed that the cancer stem cell marker activated leukocyte cell adhesion molecule (ALCAM or CD166) expression level was higher in the recurrent than that in the primary tumor. The present study analyzed the proteomic profile change between CSO and CSR and identified a new biomarker ALCAM in recurrent chordomas. This finding sheds light on unraveling the pathophysiology of chordoma recurrence and on exploring more effective prognostic biomarkers and targeted therapies against this devastating disease.

Effects of various tool pin profiles on mechanical and metallurgical properties of friction stir welded joints of cryorolled AA2219 aluminium alloy

Science.gov (United States)

Kamal Babu, Karupannan; Panneerselvam, Kavan; Sathiya, Paulraj; Noorul Haq, Abdul Haq; Sundarrajan, Srinivasan; Mastanaiah, Potta; Srinivasa Murthy, Chunduri Venkata

2018-02-01

Friction stir welding (FSW) process was conducted on cryorolled (CR) AA2219 plate using different tool pin profiles such as cylindrical pin, threaded cylindrical pin, square pin and hexagonal pin profiles. The FSW was carried out with pairs of 6 mm thick CR aluminium plates with different tool pin profiles. The different tool pin profile weld portions' behaviors like mechanical (tensile strength, impact and hardness) and metallurgical characteristics were analyzed. The results of the mechanical analysis revealed that the joint made by the hexagonal pin tool had good strength compared to other pin profiles. This was due to the pulsating action and material flow of the tool resulting in dynamic recrystallization in the weld zone. This was confirmed by the ultra fine grain structure formation in Weld Nugget (WN) of hexagonal pin tool joint with a higher percentage of precipitate dissolution. The fractograph of the hexagonal tool pin weld portion confirmed the finer dimple structure morphology without having any interior defect compared to other tool pin profiles. The lowest weld joint strength was obtained from cylindrical pin profile weld joint due to insufficient material flow during welding. The Transmission Electron Microscope and EDX analysis showed the dissolution of the metastable θ″, θ' (Al2Cu) partial precipitates in the WN and proved the influence of metastable precipitates on enhancement of mechanical behavior of weld. The XRD results also confirmed the Al2Cu precipitation dissolution in the weld zone.

Gas reactor in-pile safety test project (GRIST-2)

International Nuclear Information System (INIS)

Kelley, A.P. Jr.; Arbtin, E.; St Pierre, R.

1979-01-01

Although out-of-pile tests may be expected to confirm individual phenomena models in core disruptive accident analysis codes, only in-pile tests are capable of verifying the extremely complex integrated model effects within the appropriate time phase for these accidents. For this reason, the GRIST-2 project, the purpose of which is to design and construct an in-pile helium loop capable of transient safety testing in the TREAT facility in Idaho, forms a cornerstone of the US GCFR safety program. The project organization, experiment program, facility, helium system design, and schedule which have been selected to meet the objectives are described

Fatal pulmonary embolism in hospitalized patients. Clinical diagnosis versus pathological confirmation

Directory of Open Access Journals (Sweden)

Cláudio Tinoco Mesquita

1999-09-01

Full Text Available OBJECTIVE - To assess the incidence of fatal pulmonary embolism (FPE, the accuracy of clinical diagnosis, and the profile of patients who suffered an FPE in a tertiary University Hospital. METHODS - Analysis of the records of 3,890 autopsies performed at the Department of General Pathology from January 1980 to December 1990. RESULTS - Among the 3,980 autopsies, 109 were cases of clinically suspected FPE; of these, 28 cases of FPE were confirmed. FPE accounted for 114 deaths, with clinical suspicion in 28 cases. The incidence of FPE was 2.86%. No difference in sex distribution was noted. Patients in the 6th decade of life were most affected. The following conditions were more commonly related to FPE: neoplasias (20% and heart failure (18.5%. The conditions most commonly misdiagnosed as FPE were pulmonary edema (16%, pneumonia (15% and myocardial infarction (10%. The clinical diagnosis of FPE showed a sensitivity of 25.6%, a specificity of 97.9%, and an accuracy of 95.6%. CONCLUSION - The diagnosis of pulmonary embolism made on clinical grounds still has considerable limitations.

The safety of available and emerging options for emergency contraception.

Science.gov (United States)

Lee, Jessica K; Schwarz, Eleanor Bimla

2017-10-01

Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regarding the safety of EC as well as directions for further study. PubMed was searched for all relevant studies published prior to June 2017. Expertopinion: All available methods of EC (i.e., ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown. The copper IUD has the highest efficacy of EC methods. Given the excellent safety profiles of mifepristone and the levonorgestrel IUD, research is ongoing related to use of these products for EC.

Oral active vitamin d therapy as a potential chemoprevention against post-transplant malignancy

Directory of Open Access Journals (Sweden)

Yoshitsugu Obi

2012-06-01

Our results suggest a novel potential strategy to prevent PTM by using a normal dose of AVDs with a well-known safety profile. A randomized controlled trial should be performed to confirm our findings.

Issues in the management of acute agitation: how much current guidelines consider safety?

Directory of Open Access Journals (Sweden)

Bruno ePacciardi

2013-05-01

Full Text Available Agitated behavior constitutes up to 10% of emergency psychiatric interventions. Pharmacological tranquilization is often used as a valid treatment for agitation but a strong evidence base does not underpin it. Available literature shows different recommendations, supported by research data, theoretical considerations or clinical experience. Rapid tranquilization is mainly based on parenteral drug treatment and the few existing guidelines on this topic, when suggesting the use of first generation antipsychotics and benzodiazepines, include drugs with questionable tolerability profile such as chlorpromazine, haloperidol, midazolam and lorazepam. In order to systematically evaluate safety concerns related to the adoption of such guidelines, we reviewed them independently from principal diagnosis while examining tolerability data for suggested treatments. There is a growing evidence about safety profile of second generation antipsychotics for rapid tranquilization but further controlled studies providing definitive data in this area are urgently needed.

RETRAN safety analyses of the nuclear-powered ship Mutsu

International Nuclear Information System (INIS)

Yoshinori, N.; Ishida, T.; Tanaka, Y.; Yoshiaki, F.

1983-01-01

A number of operational transient analyses of the nuclear-powered ship Mutsu have been performed in response to Japanese nuclear safety regulatory concerns. The RETRAN and COBRA-IV computer codes were used to provide a quantitative basis for the safety evaluation of the plant. This evaluation includes a complete loss of load without reactor scram, an excessive load increase incident, and an accidental depressurization of the primary system. The minimum departure from nucleate boiling ratio remained in excess of 1.53 for these three transients. Hence, the integrity of the core was shown to be maintained during these transients. Comparing the transient behaviors with those of land-based pressurized water reactors, the characteristic features of the Mutsu reactor were presented and the safety of the plant under the operational transient conditions was confirmed

Safety Profile of Meswak Root Extract on Liver, Kidney, Sexual Hormones and Hematological Parameters of Rats

Directory of Open Access Journals (Sweden)

Abeer Y. IBRAHIM

2012-02-01

Full Text Available This study was conducted to investigate the safety profile of Salvadora persica (Salvadoraceae aqueous alcoholic root extract by carrying out acute and sub-chronic toxicity assessment in order to find out any side effect of the traditionally using of these root sticks. Regarding to acute toxicity test, mice were administered the extract up to 5 g kg-1, intraperitoneally. Animals were then observed for behavioural changes; signs of toxicity, and mortality within 24 h. Surviving mice were monitored for 7 days for signs of delayed toxicity. In the sub-chronic toxicity test, rats were daily treated with the extract at a dose of 400 mg kg-1 intraperitoneally, for 30 days. At the end of the test period, hematological and biochemical parameters were determined in blood and serum samples with determination of vital organs weights. In the acute toxicity test, the extract was practically non-toxic showing no mortality and visible signs of delayed toxicity. The LD50, given intraperitoneally, was estimated to be 4 g kg-1. Administration of extract (at a dose of 400 mg Kg-1 b.wt. to male and female rats for 30 days did not produce any significant (P < 0.05 effect on hematological and most biochemical parameters also vital organs weights. The root extract showed adverse effects on sexual hormones, by increasing estrogen secretion and reducing testosterone level in male rats. At the same time, the extract reduces progesterone level in female satellite group. Overall, Meswak aqueous extract is safe concerning liver and kidney functions and hematological assessments; however, it induces reversal effect on sexual hormones levels determined in sera.

Can we Improve Patient Safety?

Directory of Open Access Journals (Sweden)

Martin Thomas Corbally

2014-09-01

Full Text Available Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out (WHO,errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO surgical pause / Time Out aims to capture these errors and prevent them but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical pause and Time Out perhaps to avoid additional stress. In addition surgeons, like pilots, are subject to the phenomenon of plan continue fail with potentially disastrous outcomes.

Nonclinical safety strategies for stem cell therapies

Energy Technology Data Exchange (ETDEWEB)

Sharpe, Michaela E., E-mail: michaela_sharpe@yahoo.com [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom); Morton, Daniel [Exploratory Drug Safety, Drug Safety Research and Development, Pfizer Inc, Cambridge, 02140 (United States); Rossi, Annamaria [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom)

2012-08-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Nonclinical safety strategies for stem cell therapies

International Nuclear Information System (INIS)

Sharpe, Michaela E.; Morton, Daniel; Rossi, Annamaria

2012-01-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability

Directory of Open Access Journals (Sweden)

Pan CY

2013-05-01

Full Text Available CY Pan,1 XL Wang21Chinese PLA General Hospital, Beijing, People's Republic of China; 2Medical Affairs Department, Beijing Novartis Pharma Co, Ltd, Beijing, People's Republic of ChinaAbstract: Vildagliptin is a selective and potent dipeptidyl peptidase-4 inhibitor that improves glycemic control by inhibiting the degradation of both endogenous glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. This article is a comprehensive review of the safety and efficacy of vildagliptin in patients with type 2 diabetes. Clinical evidence has proven that it effectively decreases hemoglobin A1c with a low risk of hypoglycemia and is weight neutral. The addition of vildagliptin to metformin improves glucose control and significantly reduces gastrointestinal adverse events, particularly in patients inadequately controlled with metformin monotherapy. Its long-term advantages include preservation of β-cell function, reduction in total cholesterol, decrease in fasting lipolysis in adipose tissue, and triglyceride storage in non-fat tissues. Vildagliptin is well tolerated with a low incidence of AEs, and it does not increase the risk of cardiovascular/cerebrovascular (CCV events. It can be taken before or after meals, and has little drug interaction, thus it will be well accepted.Keywords: dipeptidyl peptidase-4, incretin hormones, vildagliptin, efficacy, safety, patient acceptability

EC6 safety design improvements

Energy Technology Data Exchange (ETDEWEB)

Yu, S.; Lee, A.G.; Soulard, M. [Candu Energy Inc., Mississauga, ON (Canada)

2014-07-01

The Enhanced CANDU 6 (EC6) builds on the proven high performance design such as the Qinshan CANDU 6 reactor, and has made improvements to safety, operational performance, and has incorporated extensive operational feedback. Completion of all three phases of the pre-licensing design review by the Canadian Regulator - the Canadian Nuclear Safety Commission has provided a higher level of assurance that the EC6 reference design has taken modern regulatory requirements and expectations into account and further confirmed that there are no fundamental barriers to licensing the EC6 design in Canada. The EC6 design is based on the defence-in-depth principles in INSAG-10 and provides further safety features that address the lessons learned from Fukushima. With these safety features, the EC6 design has strengthened accident prevention as the first priority in the defence-in-depth strategy, as outlined in INSAG-10. As well, the EC6 design has incorporated further mitigation measures to provide additional protection of the public and the environment if the preventive measures fail. The EC6 design has an appropriate combination of inherent, passive safety characteristics, engineered features and administrative safety measures to effectively prevent and mitigate severe accident progressions. A strong contributor to the robustness and redundancy of CANDU design is the two-group separation philosophy. This ensures a high degree of independence between safety systems as well as physical separation and functional independence in how fundamental safety functions are provided. This paper will describe the following safety features based on the application of defence-in-depth and design approach to prevent beyond design basis events progressing to severe accidents and to mitigate the consequences if it occurs: Improved steam generator heat sink via a more reliable emergency heat removal system; Increased time before manual field actions are required via enhanced capacity of

Evaluation of Sexual Dimorphism in the Efficacy and Safety of Simvastatin/Atorvastatin Therapy in a Southern Brazilian Cohort

Energy Technology Data Exchange (ETDEWEB)

Smiderle, Lisiane [Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS (Brazil); Lima, Luciana O.; Hutz, Mara Helena [Universidade Federal do Rio Grande do Sul, Porto Alegre, RS (Brazil); Sand, Cézar Roberto Van der; Sand, Luiz Carlos Van der; Ferreira, Maria Elvira Wagner; Pires, Renan Canibal [Centro de Diagnóstico Cardiológico, Porto Alegre, RS (Brazil); Almeida, Silvana; Fiegenbaum, Marilu [Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS (Brazil)

2014-07-15

Dyslipidemia is the primary risk factor for cardiovascular disease, and statins have been effective in controlling lipid levels. Sex differences in the pharmacokinetics and pharmacodynamics of statins contribute to interindividual variations in drug efficacy and toxicity. To evaluate the presence of sexual dimorphism in the efficacy and safety of simvastatin/atorvastatin treatment. Lipid levels of 495 patients (331 women and 164 men) were measured at baseline and after 6 ± 3 months of simvastatin/atorvastatin treatment to assess the efficacy and safety profiles of both drugs. Women had higher baseline levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared with men (p < 0.0001). After treatment, women exhibited a greater decrease in plasma TC and LDL-C levels compared with men. After adjustment for covariates, baseline levels of TC and LDL-C influenced more than 30% of the efficacy of lipid-lowering therapy (p < 0.001), regardless of sex. Myalgia [with or without changes in creatine phosphokinase (CPK) levels] occurred more frequently in women (25.9%; p = 0.002), whereas an increase in CPK and/or abnormal liver function was more frequent in in men (17.9%; p = 0.017). Our results show that baseline TC and LDL-C levels are the main predictors of simvastatin/atorvastatin therapy efficacy, regardless of sex. In addition, they suggest the presence of sexual dimorphism in the safety of simvastatin/atorvastatin. The effect of sex differences on receptors, transporter proteins, and gene expression pathways needs to be better evaluated and characterized to confirm these observations.

Evaluation of Sexual Dimorphism in the Efficacy and Safety of Simvastatin/Atorvastatin Therapy in a Southern Brazilian Cohort

International Nuclear Information System (INIS)

Smiderle, Lisiane; Lima, Luciana O.; Hutz, Mara Helena; Sand, Cézar Roberto Van der; Sand, Luiz Carlos Van der; Ferreira, Maria Elvira Wagner; Pires, Renan Canibal; Almeida, Silvana; Fiegenbaum, Marilu

2014-01-01

Dyslipidemia is the primary risk factor for cardiovascular disease, and statins have been effective in controlling lipid levels. Sex differences in the pharmacokinetics and pharmacodynamics of statins contribute to interindividual variations in drug efficacy and toxicity. To evaluate the presence of sexual dimorphism in the efficacy and safety of simvastatin/atorvastatin treatment. Lipid levels of 495 patients (331 women and 164 men) were measured at baseline and after 6 ± 3 months of simvastatin/atorvastatin treatment to assess the efficacy and safety profiles of both drugs. Women had higher baseline levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared with men (p < 0.0001). After treatment, women exhibited a greater decrease in plasma TC and LDL-C levels compared with men. After adjustment for covariates, baseline levels of TC and LDL-C influenced more than 30% of the efficacy of lipid-lowering therapy (p < 0.001), regardless of sex. Myalgia [with or without changes in creatine phosphokinase (CPK) levels] occurred more frequently in women (25.9%; p = 0.002), whereas an increase in CPK and/or abnormal liver function was more frequent in in men (17.9%; p = 0.017). Our results show that baseline TC and LDL-C levels are the main predictors of simvastatin/atorvastatin therapy efficacy, regardless of sex. In addition, they suggest the presence of sexual dimorphism in the safety of simvastatin/atorvastatin. The effect of sex differences on receptors, transporter proteins, and gene expression pathways needs to be better evaluated and characterized to confirm these observations

1D profiling using highly dispersive guided waves

International Nuclear Information System (INIS)

Volker, Arno; Zon, Tim van; Enthoven, Daniel; Verburg, Wesley

2015-01-01

Corrosion is one of the industries major issues regarding the integrity of assets. Currently inspections are conducted at regular intervals to ensure a sufficient integrity level of these assets. Cost reduction while maintaining a high level of reliability and safety of installations is a major challenge. There are many situations where the actual defect location is not accessible, e.g., a pipe support or a partially buried pipe. Guided wave tomography has been developed to reconstruct the wall thickness. In case of bottom of the line corrosion, i.e., a single corrosion pit, a simpler approach may be followed. Data is collected in a pit-catch configuration at the 12 o'clock position using highly dispersive guided waves. The phase spectrum is used to invert for a wall thickness profile in the circumferential direction, assuming a Gaussian defect profile. An EMAT sensor design has been made to measure at the 12 o'clock position of a pipe. The concept is evaluated on measured data, showing good sizing capabilities on a variety simple defect profiles

t(6;11) renal cell carcinoma (RCC): expanded immunohistochemical profile emphasizing novel RCC markers and report of 10 new genetically confirmed cases.

Science.gov (United States)

Smith, Nathaniel E; Illei, Peter B; Allaf, Mohamed; Gonzalez, Nilda; Morris, Kerry; Hicks, Jessica; Demarzo, Angelo; Reuter, Victor E; Amin, Mahul B; Epstein, Jonathan I; Netto, George J; Argani, Pedram

2014-05-01

Renal cell carcinomas (RCCs) harboring the t(6;11)(p21;q12) translocation were first described in 2001 and recently recognized by the 2013 International Society of Urological Pathology Vancouver Classification of Renal Neoplasia. Although these RCCs are known to label for melanocytic markers HMB45 and Melan A and the cysteine protease cathepsin K by immunohistochemistry (IHC), a comprehensive IHC profile has not been reported. We report 10 new t(6;11) RCCs, all confirmed by break-apart TFEB fluorescence in situ hybridization. A tissue microarray containing 6 of these cases and 7 other previously reported t(6;11) RCCs was constructed and immunolabeled for 21 different antigens. Additional whole sections of t(6;11) RCC were labeled with selected IHC markers. t(6;11) RCC labeled diffusely and consistently for cathepsin K and Melan A (13 of 13 cases) and almost always at least focally for HMB45 (12 of 13 cases). They labeled frequently for PAX8 (14 of 23 cases), CD117 (10 of 14 cases), and vimentin (9 of 13 cases). A majority of cases labeled at least focally for cytokeratin Cam5.2 (8 of 13 cases) and CD10 and RCC marker antigen (10 of 14 cases each). In contrast to a prior study's findings, only a minority of cases labeled for Ksp-cadherin (3 of 19 cases). The median H score (product of intensity score and percentage labeling) for phosphorylated S6, a marker of mTOR pathway activation, was 101, which is high relative to most other RCC subtypes. In summary, IHC labeling for PAX8, Cam5.2, CD10, and RCC marker antigen supports classification of the t(6;11) RCC as carcinomas despite frequent negativity for broad-spectrum cytokeratins and EMA. Labeling for PAX8 distinguishes the t(6;11) RCC from epithelioid angiomyolipoma, which otherwise shares a similar immunoprofile. CD117 labeling is more frequent in the t(6;11) RCC compared with the related Xp11 translocation RCC. Increased pS6 expression suggests a possible molecular target for the uncommon t(6;11) RCCs that

t(6;11) Renal Cell Carcinoma (RCC) Expanded Immunohistochemical Profile Emphasizing Novel RCC Markers and Report of 10 New Genetically Confirmed Cases

Science.gov (United States)

Smith, Nathaniel E.; Illei, Peter B.; Allaf, Mohamed; Gonzalez, Nilda; Morris, Kerry; Hicks, Jessica; DeMarzo, Angelo; Reuter, Victor E.; Amin, Mahul B.; Epstein, Jonathan I.; Netto, George J.; Argani, Pedram

2015-01-01

Renal cell carcinomas (RCCs) harboring the t(6;11)(p21;q12) translocation were first described in 2001 and recently recognized by the 2013 International Society of Uro-logical Pathology Vancouver Classification of Renal Neoplasia. Although these RCCs are known to label for melanocytic markers HMB45 and Melan A and the cysteine protease cath-epsin K by immunohistochemistry (IHC), a comprehensive IHC profile has not been reported. We report 10 new t(6;11) RCCs, all confirmed by break-apart TFEB fluorescence in situ hybridization. A tissue microarray containing 6 of these cases and 7 other previously reported t(6;11) RCCs was constructed and immunolabeled for 21 different antigens. Additional whole sections of t(6;11) RCC were labeled with selected IHC markers. t(6;11) RCC labeled diffusely and consistently for cathepsin K and Melan A (13 of 13 cases) and almost always at least focally for HMB45 (12 of 13 cases). They labeled frequently for PAX8 (14 of 23 cases), CD117 (10 of 14 cases), and vimentin (9 of 13 cases). A majority of cases labeled at least focally for cytokeratin Cam5.2 (8 of 13 cases) and CD10 and RCC marker antigen (10 of 14 cases each). In contrast to a prior study's findings, only a minority of cases labeled for Ksp-cadherin (3 of 19 cases). The median H score (product of intensity score and percentage labeling) for phosphorylated S6, a marker of mTOR pathway activation, was 101, which is high relative to most other RCC subtypes. In summary, IHC labeling for PAX8, Cam5.2, CD10, and RCC marker antigen supports classification of the t(6;11) RCC as carcinomas despite frequent negativity for broad-spectrum cytokeratins and EMA. Labeling for PAX8 distinguishes the t(6;11) RCC from epithelioid angiomyolipoma, which otherwise shares a similar immunoprofile. CD117 labeling is more frequent in the t(6;11) RCC compared with the related Xp11 translocation RCC. Increased pS6 expression suggests a possible molecular target for the uncommon t(6;11) RCCs that

Patient safety: Safety culture and patient safety ethics

DEFF Research Database (Denmark)

Madsen, Marlene Dyrløv

2006-01-01

,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...

Gene expression profiling for food safety assessment: examples in potato and maize

CSIR Research Space (South Africa)

Van Dijk, JP

2010-01-01

Full Text Available Northumberlan Brummeria GMO Food safety Food specifi can of samplin input system, but also different cultivars of the same crop species, including genetically modified ones. A n tool e in th larger blotting at a particular position is a measure... of transcriptomics, proteomics and metabolomics for the detection of undesirable side effects of genetically modifying plants (Cellini et al., 2004); http://www.entransfood.nl/RTDprojects/GMO- CARE/GMOCARE.html; http...

Supplementary safety system 1/4 scale testing

Energy Technology Data Exchange (ETDEWEB)

Garrett, R.L.; Paik, I.K.

1993-09-01

During the course of updating the K-Reactor Safety Analysis Report Chapter 15 in 1990, it was identified that the current Supplementary Safety System (SSS) may not be adequate in protecting the reactor during the process water pump coastdown initiated by a loss of AC power when the safety rods are assumed to fail. A SSS modification project was initiated to add an additional ink injection pathway near the pump suction. In addition, the Department of Energy raised a question on the thermal buoyancy effects on moderator flow pattern and ink dispersion in the moderator space. The development and documentation of a two-dimensional code called MODFLOW was undertaken to describe the problem. This report discusses the results of the moderator flow and ink (Gadolinium Poison Solution - GPS) dispersion tests designed to provide qualified data for validation and benchmarking of the MODFLOW computer code with the secondary objectives being the development of concentration profiles and video footage of simulated GPS dispersion under steady-state and transient flow conditions.

Selective enrichment of volatiles confirmed

Science.gov (United States)

de Pater, Imke

2018-05-01

Hydrogen sulfide gas is detected above Uranus's main cloud deck, confirming the prevalence of H2S ice particles as the main cloud component and a strongly unbalanced nitrogen/sulfur ratio in the planet's deep atmosphere.

Regulation for delivery of subsidies for public relations and safety

International Nuclear Information System (INIS)

1984-01-01

The regulations provide for subsidies for the public relations activities and safety operations carried out by a local government for the local inhabitants in the vicinity of a nuclear power generation, etc. facility. This type of activity includes the dissemination of information on nuclear power, studies on securing the safety of the inhabitants and communication concerning the facility safety. The contents are as follows: limits of the subsidies, terms of subsidy allocations, the application for subsidies, determination of subsidy allocations, withdrawal of applications, the conditions to the allocations, a report on the work proceedings, a report on the results, confirmation on the sum of subsidies, withdrawal of the decision for subsidies, limitations for disposal of the properties, etc. (Mori, K.)

The reevaluation of seismic safety of existing nuclear power plant

International Nuclear Information System (INIS)

Kitagawa, Hiroshi; Tominaga, Shohei; Kumagai, Chiyoshi; Koshiba, Koremutsu; Kono, Tomonori; Agawa, Kazuyoshi; Kuwata, Kenichiro

2003-01-01

We have carried out additional geological surveys in order to enrich our database on geological faults in the vicinity of Shimane Nuclear Power Plant (NPP). Prior to additional geological surveys, given the social importance of nuclear power plants, we hypothetically assumed that almost the whole length of an area covered by surveys would be an active fault that must be considered in seismic design, and tried to reevaluate the seismic safety of the NPP by applying an input earthquake ground motion larger than the level at the design stage. As a result, we have confirmed that seismic safety of the NPP can be maintained. This paper describes the method that we employed to reevaluate the seismic safety of Shimane NPP. (author)

Regulation for delivery of subsidies for public relations and safety

International Nuclear Information System (INIS)

1985-01-01

The regulations provide for subsidies for the public relations activities and safety operations carried out by a local government for the local inhabitants in the vicinity of a nuclear power generation, etc. facility. This type of activity includes the dissemination of information on nuclear power, studies on securing the safety of the inhabitants and communication concerning the facility safety. The contents are as follows : limits of the subsidies, terms of subsidy allocations, the application for subsidies, determination of subsidy allocations, withdrawal of applications, the conditions to the allocations, a report on the work proceedings, a report on the results, confirmation on the sum of subsidies, withdrawal of the decision for subsidies, limitations for disposal of the properties, etc. (Kubozono, M.)

On results of aseismatic safety examination for atomic energy facilities based on Southern Hyogo Prefecture Earthquake in 1995

International Nuclear Information System (INIS)

1996-01-01

The Nuclear Safety Commission received the report on the results of examination from the ad hoc examination committee. There was no particular effect to atomic energy facilities in the Southern Hyogo Prefecture Earthquake, however, from the viewpoint of perfecting the safety confirmation for atomic energy facilities, the Nuclear Safety Commission set up the aseismatic safety examination committee to investigate the validity of the guidelines related to aseismatic design used for safety examination. The basic plan of the investigation, the outline of the guidelines related to aseismatic design, the state of Southern Hyogo Prefecture Earthquake and the obtained knowledge and the investigation of the validity of the guidelines related to aseismatic design based on the state of Southern Hyogo Prefecture Earthquake are reported. The extraction of the items to be investigated, the evaluation of earthquakes and earthquake motion, vertical earthquake force and active faults, and the way of thinking on right under type earthquakes in the guideline for aseismatic design examination are reported. It was confirmed that the validity of guidelines is not impaired by the earthquake. (K.I.)

An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with glibenclamide as adjunctive therapy in patients with type 2 diabetes poorly controlled on metformin

DEFF Research Database (Denmark)

Barnett, AH; Dreyer, M; Lange, Peter

2006-01-01

OBJECTIVE: To compare the efficacy and safety profile of adding inhaled human insulin (INH) (Exubera) or glibenclamide to metformin monotherapy in patients with poorly controlled type 2 diabetes. RESEARCH DESIGN AND METHODS: We conducted an open-label, parallel, 24-week multicenter trial. Patients...... associated clinical manifestations. CONCLUSIONS: In patients with type 2 diabetes poorly controlled on metformin, adding INH or glibenclamide was similarly effective in improving glycemic control, and both were well tolerated. A predefined subgroup with very high A1C (>9.5%) was more effectively treated...

Fire probability safety analysis in France for 900 MWe nuclear power plants

International Nuclear Information System (INIS)

Bertrand, R.; Bonneval, F.; Mattei, J.M.

2000-01-01

This paper describes the methodology implemented by the Institute for Nuclear Safety and Protection (IPSN) to carry out the Fire Probabilistic Safety Assessment (Fire PSA) for French 900 MWe pressurised water reactors. The initial results obtained are presented. Additional research and development activities are indicated which IPSN carried out or decided to perform in order to reduce the amount of uncertainty associated with the data or to confirm hypotheses that can impact significantly the study results. (orig.) [de

Nonclinical Profile of BLZ-100, a Tumor-Targeting Fluorescent Imaging Agent.

Science.gov (United States)

Parrish-Novak, Julia; Byrnes-Blake, Kelly; Lalayeva, Narine; Burleson, Stefanie; Fidel, Janean; Gilmore, Rhonda; Gayheart-Walsten, Pamela; Bricker, Gregory A; Crumb, William J; Tarlo, K S; Hansen, Stacey; Wiss, Valorie; Malta, Errol; Dernell, William S; Olson, James M; Miller, Dennis M

BLZ-100 is a single intravenous use, fluorescent imaging agent that labels tumor tissue to enable more complete and precise surgical resection. It is composed of a chlorotoxin peptide covalently bound to the near-infrared fluorophore indocyanine green. BLZ-100 is in clinical development for intraoperative visualization of human tumors. The nonclinical safety and pharmacokinetic (PK) profile of BLZ-100 was evaluated in mice, rats, canines, and nonhuman primates (NHP). Single bolus intravenous administration of BLZ-100 was well tolerated, and no adverse changes were observed in cardiovascular safety pharmacology, PK, and toxicology studies in rats and NHP. The single-dose no-observed-adverse-effect-levels (NOAELs) were 7 mg (28 mg/kg) in rats and 60 mg (20 mg/kg) in NHP, corresponding to peak concentration values of 89 400 and 436 000 ng/mL and area-under-the-curve exposure values of 130 000 and 1 240 000 h·ng/mL, respectively. Based on a human imaging dose of 3 mg, dose safety margins are >100 for rat and monkey. BLZ-100 produced hypersensitivity reactions in canine imaging studies (lethargy, pruritus, swollen muzzle, etc). The severity of the reactions was not dose related. In a follow-up study in dogs, plasma histamine concentrations were increased 5 to 60 minutes after BLZ-100 injection; this coincided with signs of hypersensitivity, supporting the conclusion that the reactions were histamine based. Hypersensitivity reactions were not observed in other species or in BLZ-100 human clinical studies conducted to date. The combined imaging, safety pharmacology, PK, and toxicology studies contributed to an extensive initial nonclinical profile for BLZ-100, supporting first-in-human clinical trials.

Psychosocial safety climate moderates the job demand-resource interaction in predicting workgroup distress.

Science.gov (United States)

Dollard, Maureen F; Tuckey, Michelle R; Dormann, Christian

2012-03-01

Psychosocial safety climate (PSC) arises from workplace policies, practices, and procedures for the protection of worker psychological health and safety that are largely driven by management. Many work stress theories are based on the fundamental interaction hypothesis - that a high level of job demands (D) will lead to psychological distress and that this relationship will be offset when there are high job resources (R). However we proposed that this interaction really depends on the organizational context; in particular high levels of psychosocial safety climate will enable the safe utilization of resources to reduce demands. The study sample consisted of police constables from 23 police units (stations) with longitudinal survey responses at two time points separated by 14 months (Time 1, N=319, Time 2, N=139). We used hierarchical linear modeling to assess the effect of the proposed three-way interaction term (PSC×D×R) on change in workgroup distress variance over time. Specifically we confirmed the interaction between emotional demands and emotional resources (assessed at the individual level), in the context of unit psychosocial safety climate (aggregated individual data). As predicted, high emotional resources moderated the positive relationship between emotional demands and change in workgroup distress but only when there were high levels of unit psychosocial safety climate. Results were confirmed using a split-sample analysis. Results support psychosocial safety climate as a property of the organization and a target for higher order controls for reducing work stress. The 'right' climate enables resources to do their job. Copyright © 2011 Elsevier Ltd. All rights reserved.

Criticality safety analysis for plutonium dissolver using silver mediated electrolytic oxidation method

International Nuclear Information System (INIS)

Umeda, Miki; Sugikawa, Susumu; Nakamura, Kazuhito; Egashira, Tetsurou

1998-08-01

Design and construction of a plutonium dissolver using silver mediated electrolytic oxidation method are promoted in NUCEF. Criticality safety analysis for the plutonium dissolver is described in this report. The electrolytic plutonium dissolver consists of connection pipes and three pots for MOX powder supply, circulation and electrolysis. The criticality control for the dissolver is made by geometrically safe shape with mass limitation. Monte Carlo code KENO-IV using MGCL-137 library based on ENDF/B-IV was used for the criticality safety analysis for the plutonium dissolver. Considering the required size for construction and criticality safety, diameter of pot and distance between two pots were determined. On this condition, the criticality safety analysis for the plutonium dissolver with connection pipes was carried out. As the result of the criticality safety analysis, an effective neutron multiplication factor keff of 0.91 was obtained and the criticality safety of the plutonium dissolver was confirmed on the basis of criteria of ≤0.95. (author)

A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients

Directory of Open Access Journals (Sweden)

Yu Sue

2008-09-01

Full Text Available Abstract Background Lumiracoxib is a selective cyclooxygenase-2 inhibitor effective in the treatment of osteoarthritis (OA with a superior gastrointestinal (GI safety profile as compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs, ibuprofen and naproxen. This safety study compared the GI tolerability, the blood pressure (BP profile and the incidence of oedema with lumiracoxib and rofecoxib in the treatment of OA. Rofecoxib was withdrawn worldwide due to an associated increased risk of CV events and lumiracoxib has been withdrawn from Australia, Canada, Europe and a few other countries following reports of suspected adverse liver reactions. Methods This randomised, double-blind study enrolled 309 patients (aged greater than or equal to 50 years with primary OA across 51 centres in Europe. Patients were randomly allocated to receive either lumiracoxib 400 mg od (four times the recommended dose in OA (n = 154 or rofecoxib 25 mg od (n = 155. The study was conducted for 6 weeks and assessments were performed at Weeks 3 and 6. The primary safety measures were the incidence of predefined GI adverse events (AEs and peripheral oedema. The secondary safety measures included effect of treatment on the mean sitting systolic and diastolic blood pressure (msSBP and msDBP. Tolerability of lumiracoxib 400 mg was assessed by the incidence of AEs. Results Lumiracoxib and rofecoxib displayed similar GI safety profiles with no statistically significant difference in predefined GI AEs between the two groups (43.5% vs. 37.4%, respectively. The incidence and severity of individual predefined GI AEs was comparable between the two groups. The incidence of peripheral oedema was low and identical in both the groups (n = 9, 5.8%. Only one patient in the lumiracoxib group and three patients in the rofecoxib group had a moderate or severe event. At Week 6 there was a significantly lower msSBP and msDBP in the lumiracoxib group compared to the rofecoxib

A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project.

Science.gov (United States)

Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M; Corripio, Iluminada; Aguilar, Eduardo J; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J; Bernardo, Miguel

2016-04-01

The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, Psecurity issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Risø 1978: Further Investigations into the Effects of Local Terrain Irregularties on Tower-Measured Wind Profiles

DEFF Research Database (Denmark)

Peterson, E. W.; Taylor, P. A.; Højstrup, Jørgen

1980-01-01

Observations of flow over complex terrain taken at Risø during June–July 1978 and numerical studies confirm earlier findings that small variations in surface elevation have significant effects on mean wind profiles. Measured shear stresses in the nonequilibrium region of the flow are consistent w...... with theory but quite different from those obtained assuming simple flux-profile relationships. These findings imply that flux-profile relationships can be quite complicated over other than simple homogeneous terrain....

Safety Analysis for Key Design Features of KALIMER-600 Design Concept

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Bum; Kwon, Y. M.; Kim, E. K.; Suk, S. D.; Chang, W. P.; Jeong, H. Y.; Ha, K. S

2007-02-15

This report contains the safety analyses of the KALIMER-600 conceptual design which KAERI has been developing under the Long-term Nuclear R and D Program. The analyses have been performed reflecting the design developments during the second year of the 4th design phase in the program. The specific presentations are the key design features with the safety principles for achieving the safety objectives, the event categorization and safety criteria, and results on the safety analyses for the DBAs and ATWS events, the containment performance, and the channel blockages. The safety analyses for both the DBAs and ATWS events have been performed using SSC-K version 1.3., and the results have shown the fulfillment of the safety criteria for DBAs with conservative assumptions. The safety margins as well as the inherent safety also have been confirmed for the ATWS events. For the containment performance analysis, ORIGEN-2.1 and CONTAIN-LMR have been used. In results, the structural integrity has been acceptable and the evaluated exposure dose rate has been complied with 10 CFR 100 and PAG limits. The analysis results for flow blockages of 6-subchannels, 24-subchannels, and 54- subchannels with the MATRA-LMR-FB code, have assured the integrity of subassemblies.

Research and development on reduced-moderation light water reactor with passive safety features (Contract research)

International Nuclear Information System (INIS)

Iwamura, Takamichi; Okubo, Tsutomu; Akie, Hiroshi; Kugo, Teruhiko; Yonomoto, Taisuke; Kureta, Masatoshi; Ishikawa, Nobuyuki; Nagaya, Yasunobu; Araya, Fumimasa; Okajima, Shigeaki; Okumura, Keisuke; Suzuki, Motoe; Mineo, Hideaki; Nakatsuka, Toru

2004-06-01

relation to the cooling limit of the core, sufficient coolability of the core was confirmed by experiments. Investigating the effect of system pressure on the stability limits of flow dynamics, rational start-up procedure has been proposed. As for the effects of the flow channel gap, the effects on boiling heat transfer coefficient and friction multiplier of two-phase flow were clarified from the preliminary experiments. As for the stability analysis, the stability of RMWR core is confirmed through the time domain analysis. As the neutronics feasibility study, the calculation accuracy was evaluated using the critical experiments' data of simulative RMWR core. As the fuel safety, the fuel behavior of MOX fuel irradiated in RMWR in normal condition was confirmed using MOX fuel safety analysis code. As the fuel cycle study, the economical reprocessing technology was selected for RMWR fuel reprocessing. The feasibility of the RMWR with passive safety features has been confirmed by the present project. (author)

Safety and efficacy of elbasvir and grazoprevir for treatment of hepatitis C.

Science.gov (United States)

Carrion, Andres F; Martin, Paul

2016-06-01

The combination of elbasvir and grazoprevir in a single co-formulated tablet is highly effective for treatment of hepatitis C virus (HCV) infection. This regimen affords profound inhibition of NS3/4A protease and NS5A activity, resulting in potent activity against HCV genotypes 1, 4, and 6 with high rates of sustained virological response. This review covers the mechanism of action, pharmacokinetics, clinical applications, efficacy and safety profile of elbasvir/grazoprevir including special populations such as individuals with compensated and decompensated cirrhosis, HCV/HIV co-infection, advanced chronic kidney disease, and those that previously failed antiviral therapy. Elbasvir/grazoprevir is an effective antiviral regimen for treatment of genotypes 1 and 4 and has a very favorable safety profile based on extensive data from several pre-licensure clinical trials that included patient subgroups at increased risk of toxicity. This regimen is currently the only one licensed for use in individuals with advanced chronic kidney disease requiring hemodialysis.

Gas-cooled breeder reactor safety

Energy Technology Data Exchange (ETDEWEB)

Chermanne, J.; Burgsmueller, P. [Societe Belge pour l' Industrie Nucleaire, Brussels

1981-01-15

The European Association for the Gas-cooled Breeder Reactor (G B R A), set-up in 1969 prepared between 1972 and 1974 a 1200 MWe Gas-cooled Breeder Reactor (G B R) commercial reference design G B R 4. It was then found necessary that a sound and neutral appraisal of the G B R licenseability be carried out. The Commission of the European Communities (C E C) accepted to sponsor this exercise. At the beginning of 1974, the C E C convened a group of experts to examine on a Community level, the safety documents prepared by the G B R A. A working party was set-up for that purpose. The experts examined a ''Preliminary Safety Working Document'' on which written questions and comments were presented. A ''Supplement'' containing the answers to all the questions plus a detailed fault tree and reliability analysis was then prepared. After a final study of this document and a last series of discussions with G B R A representatives, the experts concluded that on the basis of the evidence presented to the Working Party, no fundamental reasons were identified which would prevent a Gas-cooled Breeder Reactor of the kind proposed by the G B R A achieving a satisfactory safety status. Further work carried out on ultimate accident have confirmed this conclusion. One can therefore claim that the overall safety risk associated with G B R s compares favourably with that of any other reactor system.

Consumer satisfaction and confirmation of habits of comprehension

DEFF Research Database (Denmark)

Sørensen, Bent; Andersen, Christian; Andersen, Morten Purup

2014-01-01

the formation of consumer satisfaction; the perspective is that of the confirmation paradigm within advertisement research. Inductive advertisements support cognitive habit formation through confirmation, and the confirmation paradigm explains exactly consumer satisfaction with reference to confirmation. Hence......The purpose of this article is twofold: First, within a Peircean framework it shall be demonstrated how there is a relation between the compositional structure of certain types of print advertisements and their bringing about inductive comprehension, and how the consumer can be understood...... as a bundle of habits. It is the assumption that advertising that supports an inductive effect particularly appeals to the cognitive tendency of habit formation in the consumer. Second, it is asked whether advertisements that predominantly invite inductive processes of comprehension also influence...

New safety concept for geological disposal in Japan - -16339

International Nuclear Information System (INIS)

Kitayama, Kazumi

2009-01-01

This paper describes a new safety concept for the Japanese geological disposal program, which is a development of the conventional multi-barrier system concept. The Japanese government established the 'Nuclear Waste Management Organization of Japan' (NUMO) as an implementation body in 2000 based on the 'Final disposal act' following the publication of the 'H-12 Report', which confirmed the scientific and engineering feasibility of HLW geological disposal in Japan. Since then, NUMO has undertaken further technical developments aimed at achieving safe and efficient implementation of final disposal. The safety concept developed in the 'H-12 Report' provides sufficient safety on the basis of site-generic considerations. However, it is considered to be over-conservative and therefore does not represent the most probable performance of the engineered or natural barriers. Recently, concrete measures have been proposed requiring the safety case to be presented in terms of a realistic assessment of the most probable performance. This approach takes into account the safety functions of both engineered and natural barriers as well as the long-term static geochemical equilibrium. In particular, the evolution of the safety performance of engineered and natural barriers can be efficiently augmented by the realistic long-term geochemical equilibrium. (author)

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

Science.gov (United States)

Kim, Seung Won; Kim, Bae-Hwan

2016-07-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

Defining safety culture and the nexus between safety goals and safety culture. 4. Enhancing Safety Culture Through the Establishment of Safety Goals

International Nuclear Information System (INIS)

Tateiwa, Kenji; Miyata, Koichi; Yahagi, Kimitoshi

2001-01-01

Safety culture is the perception of each individual and organization of a nuclear power plant that safety is the first priority, and at Tokyo Electric Power Company (TEPCO), we have been practicing it in everyday activities. On the other hand, with the demand for competitiveness of nuclear power becoming even more intense these days, we need to pursue efficient management while maintaining the safety level at the same time. Below, we discuss how to achieve compatibility between safety culture and efficient management as well as enhance safety culture. Discussion at Tepco: safety culture-nurturing activities such as the following are being implemented: 1. informing the employees of the 'Declaration of Safety Promotion' by handing out brochures and posting it on the intranet home page; 2. publishing safety culture reports covering stories on safety culture of other industry sectors, recent movements on safety culture, etc.; 3. conducting periodic questionnaires to employees to grasp how deeply safety culture is being established; 4. carrying out educational programs to learn from past cases inside and outside the nuclear industry; 5. committing to common ownership of information with the public. The current status of safety culture in Japan sometimes seems to be biased to the quest of ultimate safety; rephrasing it, there have been few discussions regarding the sufficiency of the quantitative safety level in conjunction with the safety culture. Safety culture is one of the most crucial foundations guaranteeing the plant's safety, and for example, the plant safety level evaluated by probabilistic safety assessment (PSA) could be said to be valid only on the ground that a sound and sufficient safety culture exists. Although there is no doubt that the safety culture is a fundamental and important attitude of an individual and organization that keeps safety the first priority, the safety culture in itself should not be considered an obstruction to efforts to implement

Translating Health Services Research into Practice in the Safety Net.

Science.gov (United States)

Moore, Susan L; Fischer, Ilana; Havranek, Edward P

2016-02-01

To summarize research relating to health services research translation in the safety net through analysis of the literature and case study of a safety net system. Literature review and key informant interviews at an integrated safety net hospital. This paper describes the results of a comprehensive literature review of translational science literature as applied to health care paired with qualitative analysis of five key informant interviews conducted with senior-level management at Denver Health and Hospital Authority. Results from the literature suggest that implementing innovation may be more difficult in the safety net due to multiple factors, including financial and organizational constraints. Results from key informant interviews confirmed the reality of financial barriers to innovation implementation but also implied that factors, including institutional respect for data, organizational attitudes, and leadership support, could compensate for disadvantages. Translating research into practice is of critical importance to safety net providers, which are under increased pressure to improve patient care and satisfaction. Results suggest that translational research done in the safety net can better illuminate the special challenges of this setting; more such research is needed. © Health Research and Educational Trust.

Establishment of Management System for Korea Institute of Nuclear Safety

Energy Technology Data Exchange (ETDEWEB)

Han, Soon-Kyoo; Ha, Jong-Tae; Chung, Ku-Young; Lee, Je-Hang; Kim, Kyung-Im [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2015-05-15

In order to optimize of nuclear safety regulation in the rapidly changing nuclear safety environment, Korea government determined that the existing safety standards needed to be reviewed from Integrated Regulatory Review Service(IRRS) team of International Atomic Energy Agency(IAEA). For optimizations of nuclear safety regulation, the reviews were performed by IAEA IRRS team from July 10-22, 2011. In the results of 2011 IRRS mission, 12 suggestion and 10 recommendation were found. To confirm follow-up measures, IRRS follow-up mission would be also performed by IRRS team 18-24 months later after the mission was over. In order to prepare the IRRS follow-up mission, the establishment of MS of Korea Institute of Nuclear Safety(KINS) had been initiated by reflecting the 4 found supplement items in module 4 and IAEA GS-R-3 requirements. As a result of the initiation, MS of KINS was established. To introduce the MS of KINS and gather another suggestions for its enhancement, the MS was considered as a theme.

Surface glycosylation profiles of urine extracellular vesicles.

Directory of Open Access Journals (Sweden)

Jared Q Gerlach

Full Text Available Urinary extracellular vesicles (uEVs are released by cells throughout the nephron and contain biomolecules from their cells of origin. Although uEV-associated proteins and RNA have been studied in detail, little information exists regarding uEV glycosylation characteristics. Surface glycosylation profiling by flow cytometry and lectin microarray was applied to uEVs enriched from urine of healthy adults by ultracentrifugation and centrifugal filtration. The carbohydrate specificity of lectin microarray profiles was confirmed by competitive sugar inhibition and carbohydrate-specific enzyme hydrolysis. Glycosylation profiles of uEVs and purified Tamm Horsfall protein were compared. In both flow cytometry and lectin microarray assays, uEVs demonstrated surface binding, at low to moderate intensities, of a broad range of lectins whether prepared by ultracentrifugation or centrifugal filtration. In general, ultracentrifugation-prepared uEVs demonstrated higher lectin binding intensities than centrifugal filtration-prepared uEVs consistent with lesser amounts of co-purified non-vesicular proteins. The surface glycosylation profiles of uEVs showed little inter-individual variation and were distinct from those of Tamm Horsfall protein, which bound a limited number of lectins. In a pilot study, lectin microarray was used to compare uEVs from individuals with autosomal dominant polycystic kidney disease to those of age-matched controls. The lectin microarray profiles of polycystic kidney disease and healthy uEVs showed differences in binding intensity of 6/43 lectins. Our results reveal a complex surface glycosylation profile of uEVs that is accessible to lectin-based analysis following multiple uEV enrichment techniques, is distinct from co-purified Tamm Horsfall protein and may demonstrate disease-specific modifications.

Confirmation of Essure placement using transvaginal ultrasound.

Science.gov (United States)

Veersema, Sebastiaan; Vleugels, Michel; Koks, Caroline; Thurkow, Andreas; van der Vaart, Huub; Brölmann, Hans

2011-01-01

To evaluate the protocol for confirmation of satisfactory Essure placement using transvaginal ultrasound. Prospective multicenter cohort study (Canadian Task Force classification II-2). Outpatient departments of 4 teaching hospitals in the Netherlands. Eleven hundred forty-five women who underwent hysteroscopic sterilization using the Essure device between March 2005 and December 2007. Transvaginal ultrasound examination 12 weeks after uncomplicated successful bilateral placement or as indicated according to the transvaginal ultrasound protocol after 4 weeks, and hysterosalpingography (HSG) at 12 weeks to confirm correct placement of the device after 3 months. The rate of successful placement was 88.4% initially. In 164 women (15%), successful placement was confirmed at HSG according the protocol. In 9 patients (0.84%), incorrect position of the device was observed at HSG. The cumulative pregnancy rate after 18 months was 3.85 per thousand women. Transvaginal ultrasound should be the first diagnostic test used to confirm the adequacy of hysteroscopic Essure sterilization because it is minimally invasive, averts ionizing radiation, and does not decrease the effectiveness of the Essure procedure. Copyright © 2011 AAGL. Published by Elsevier Inc. All rights reserved.

Evaluation model for safety capacity of chemical industrial park based on acceptable regional risk

Institute of Scientific and Technical Information of China (English)

Guohua Chen; Shukun Wang; Xiaoqun Tan

2015-01-01

The paper defines the Safety Capacity of Chemical Industrial Park (SCCIP) from the perspective of acceptable regional risk. For the purpose of exploring the evaluation model for the SCCIP, a method based on quantitative risk assessment was adopted for evaluating transport risk and to confirm reasonable safety transport capacity of chemical industrial park, and then by combining with the safety storage capacity, a SCCIP evaluation model was put forward. The SCCIP was decided by the smaller one between the largest safety storage capacity and the maximum safety transport capacity, or else, the regional risk of the park will exceed the acceptable level. The developed method was applied to a chemical industrial park in Guangdong province to obtain the maximum safety transport capacity and the SCCIP. The results can be realized in the regional risk control of the park effectively.

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

Science.gov (United States)

Haslberger, Alexander G

2006-05-03

information. An integrated assessment might help to focus and save capacities in highly technical areas such as molecular characterization or profiling, which are often necessary for both assessments. In the area of establishing international standards for traded foods, such as for the newly created Standards in Trade and Development Facility (STDF), an integrated assessment might help in the consideration of important environmental aspects involved in health and food safety. Furthermore, an established integrated view on GMOs may create greater consumer confidence in the technology.

Safety in conducting subcritical neutron-multiplication measurements in situ (Revision of N16.3-1969) - approved 1975

International Nuclear Information System (INIS)

Anon.

1977-01-01

The standard provides safety guidance for conducting subcritical neutron-multiplication measurements where physical protection of personnel against the consequences of a criticality accident is not provided. The objectives of in situ measurements are either to confirm an adequate safety margin or to improve an estimate of such a margin. The first objective may constitute a test of the criticality safety of a design that is based on calculations. The second may effect improved operating conditions by reducing the uncertainty of safety margins and providing guidance to new designs

Opinion dynamics with confirmation bias.

Directory of Open Access Journals (Sweden)

Armen E Allahverdyan

Full Text Available Confirmation bias is the tendency to acquire or evaluate new information in a way that is consistent with one's preexisting beliefs. It is omnipresent in psychology, economics, and even scientific practices. Prior theoretical research of this phenomenon has mainly focused on its economic implications possibly missing its potential connections with broader notions of cognitive science.We formulate a (non-Bayesian model for revising subjective probabilistic opinion of a confirmationally-biased agent in the light of a persuasive opinion. The revision rule ensures that the agent does not react to persuasion that is either far from his current opinion or coincides with it. We demonstrate that the model accounts for the basic phenomenology of the social judgment theory, and allows to study various phenomena such as cognitive dissonance and boomerang effect. The model also displays the order of presentation effect-when consecutively exposed to two opinions, the preference is given to the last opinion (recency or the first opinion (primacy -and relates recency to confirmation bias. Finally, we study the model in the case of repeated persuasion and analyze its convergence properties.The standard Bayesian approach to probabilistic opinion revision is inadequate for describing the observed phenomenology of persuasion process. The simple non-Bayesian model proposed here does agree with this phenomenology and is capable of reproducing a spectrum of effects observed in psychology: primacy-recency phenomenon, boomerang effect and cognitive dissonance. We point out several limitations of the model that should motivate its future development.

Modeling of passengers' safety perception for buses on mountainous roads.

Science.gov (United States)

Khoo, Hooi Ling; Ahmed, Muaid

2018-04-01

This study had developed a passenger safety perception model specifically for buses taking into consideration the various factors, namely driver characteristics, environmental conditions, and bus characteristics using Bayesian Network. The behaviour of bus driver is observed through the bus motion profile, measured in longitudinal, lateral, and vertical accelerations. The road geometry is recorded using GPS and is computed with the aid of the Google map while the perceived bus safety is rated by the passengers in the bus in real time. A total of 13 variables were derived and used in the model development. The developed Bayesian Network model shows that the type of bus and the experience of the driver on the investigated route could have an influence on passenger's perception of their safety on buses. Road geometry is an indirect influencing factor through the driver's behavior. The findings of this model are useful for the authorities to structure an effective strategy to improve the level of perceived bus safety. A high level of bus safety will definitely boost passenger usage confidence which will subsequently increase ridership. Copyright © 2018 Elsevier Ltd. All rights reserved.

Spent fuel packaging and its safety analysis

International Nuclear Information System (INIS)

Takada, Kimitaka; Nakaoki, Kozo; Tamamura, Tadao; Matsuda, Fumio; Fukudome, Kazuyuki

1983-01-01

An all stainless steel B(U) type packaging is proposed to transport spent fuels discharged from research reactors and other radioactive materials. The package is used dry and provided with surface fins to absorb drop shock and to dissipate decay heat. Safety was analyzed for structural, thermal, containment shielding and criticality factors, and the integrity of the package was confirmed with the MARC-CDC, TRUMP, ORIGEN, QAD, ANISN, and KENO computer codes. (author)