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)

29 CFR 1921.10 - Appearances.

Science.gov (United States)

2010-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) RULES OF PRACTICE IN ENFORCEMENT PROCEEDINGS UNDER SECTION 41 OF THE LONGSHOREMEN'S AND HARBOR WORKERS' COMPENSATION ACT Hearing and Related Matters § 1921.10 Appearances. (a) Representation. The parties may appear...

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...

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 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)

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

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.

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.

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.

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

Directory of Open Access Journals (Sweden)

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

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.

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...

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.

[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.

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.

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.

Forensic DNA Phenotyping: Predicting human appearance from crime scene material for investigative purposes.

Science.gov (United States)

Kayser, Manfred

2015-09-01

Forensic DNA Phenotyping refers to the prediction of appearance traits of unknown sample donors, or unknown deceased (missing) persons, directly from biological materials found at the scene. "Biological witness" outcomes of Forensic DNA Phenotyping can provide investigative leads to trace unknown persons, who are unidentifiable with current comparative DNA profiling. This intelligence application of DNA marks a substantially different forensic use of genetic material rather than that of current DNA profiling presented in the courtroom. Currently, group-specific pigmentation traits are already predictable from DNA with reasonably high accuracies, while several other externally visible characteristics are under genetic investigation. Until individual-specific appearance becomes accurately predictable from DNA, conventional DNA profiling needs to be performed subsequent to appearance DNA prediction. Notably, and where Forensic DNA Phenotyping shows great promise, this is on a (much) smaller group of potential suspects, who match the appearance characteristics DNA-predicted from the crime scene stain or from the deceased person's remains. Provided sufficient funding being made available, future research to better understand the genetic basis of human appearance will expectedly lead to a substantially more detailed description of an unknown person's appearance from DNA, delivering increased value for police investigations in criminal and missing person cases involving unknowns. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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.

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

Effects of Display Gamma and Illuminant on the Appearance of Colours Viewed on LCD Monitors

Directory of Open Access Journals (Sweden)

Dragoljub Novakovic

2009-11-01

Full Text Available The CIECAM02 colour appearance model was developed to allow prediction of accurate colour appearance under various viewing conditions. In this study, a software module, based on mathematical transformations of the CIECAM02 model, was designed and implemented. Unlike the previous software modules, which were allowing use of only a limited choice of common standardized icc display profiles, the developed module also allows the use of optimized profiles created by the user. This paper presents prediction of the appearance of test images with assigned different display profiles after changing illuminant. The two used optimized profiles, created by software characterization of specific lcd display, have a different display gamma value (1.8 and 2.2.  It is observed that, after changing the initial cie D50 to a higher colour temperature illuminant (D65,  the colours of  images will be shifted to the blue hues, and, in the case of illuminant temperature less than D50 (A and F11,  to yellow hues. It is also observed that the intensity of colour shifts in the simulated images with associated profiles which have different gamma value will be significantly different, which implies that the icc display profile and display gamma value have the great impact on the prediction of the accurate colour appearance under various viewing conditions.

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.

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

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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.

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

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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.

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

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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.

基于色彩工学探究工程机械产品外观安全警示设计%Safety Design of the Engineering Machinery Product Appearance Based On the Color Engineering

Institute of Scientific and Technical Information of China (English)

曾智林

2012-01-01

运用色彩工学的原理,提出在工程机械产品外观设计中标准化、定量化进行色彩设计的依据。通过分析影响工程机械产品安全性的外部因素,以及当前色彩设计的现状,提出在进行产品外观色彩优化时要强化安全警示作用。从工程机械产品外观色彩结构、＂人—机—环境＂系统中色彩安全设计、暗视觉条件下加强色光安全设计等几方面强化安全设计理念。%By applying the principles of the color engineering, it put forward the standardization of color design about standardization, quantitation in engineering machinery products appearance. By analyzing the external factors about the safety, and the current situation of color design, it pointed out that the function of safety and caution must be emphasized in the product appearance colour optimization design process. From the colour structure of engineering machinery product appearance, the color safety design in the ＂man-machine-environment＂ system, it strengthened the color light safety design in dark vision, and safety design concept.

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.

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

Evolution of the electron temperature profile of ohmically heated plasmas in TFTR

International Nuclear Information System (INIS)

Taylor, G.; Efthimion, P.C.; Arunasalam, V.

1985-08-01

Blackbody electron cyclotron emission was used to ascertain and study the evolution and behavior of the electron temperature profile in ohmically heated plasmas in the Tokamak Fusion Test Reactor (TFTR). The emission was measured with absolutely calibrated millimeter wavelength radiometers. The temperature profile normalized to the central temperature and minor radius is observed to broaden substantially with decreasing limiter safety factor q/sub a/, and is insensitive to the plasma minor radius. Sawtooth activity was seen in the core of most TFTR discharges and appeared to be associated with a flattening of the electron temperature profile within the plasma core where q less than or equal to 1. Two types of sawtooth behavior were identified in large TFTR plasmas (minor radius, a less than or equal to 0.8 m) : a typically 35 to 40 msec period ''normal'' sawtooth, and a ''compound'' sawtooth with 70 to 80 msec period

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

Safety barriers and safety functions a comparison of different applications

International Nuclear Information System (INIS)

Harms-Ringdahl, L.

1998-01-01

A study is being made with the focus on different theories and applications concerning 'safety barriers' and 'safety functions'. One aim is to compare the characteristics of different kinds of safely functions, which can be purpose, efficiency, reliability, weak points etc. A further aim is to summarize how the combination of different barriers are described and evaluated. Of special interest are applications from nuclear and chemical process safety. The study is based on a literature review, interviews and discussions. Some preliminary conclusions are made. For example, it appears to exist a need for better tools to support the design and evaluation of procedures. There are a great number of theoretical models describing safety functions. However, it still appears to be an interest in further development of models, which might give the basis for improved practical tools. (author)

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

A study of chemical profiles and appearance of white crystals in Istrian dry-cured ham: effect of desalting

Directory of Open Access Journals (Sweden)

Helga Medić

2010-01-01

Full Text Available In order to find out the effect on physical-chemical profile of Istrian dry-cured ham with particular regard to the appearance of white crystals in the muscles, raw salted legs were desalted by soaking the legs in cold water for 24 hours. The 20 raw hams taken from 10 slaughtered hogs (Swedish Landrace breed and processed in the traditional Istrian manner were used. After salting and pressing, the raw hams were divided into two groups: 1 the 10 left legs of each hog were desalted (D; 2 the 10 right legs were not desalted (N. Following this, both groups of legs were subjected to continuous processing. Samples for chemical analysis and counting of white spots were taken from the 20 legs (10 N and 10 D from 10 hogs, each weighing 12 to 15 kg. Chemical analysis of muscle tissue showed a highly significant difference (P<0.0001 in the salt quantity in the N (6.85% and D (5.31% dry-cured hams, as expected. Desalting affected the level of calcium which was higher (P=0.0124 in the D hams (0.27 g than in the N hams (0.22 g. Desalting did not affect the free amino acid content, with the exception of methionine which was lower (P=0.0041 in D (0.14 g than in N hams (0.17 g. Desalting affected the level of two free fatty acids as follows: heptadecanoic acid was higher (P=0.0203 in N (0.18% than in D hams (0.24% and DPA was higher (P=0.0373 in N (0.49% than in D hams (0.39%. By counting the white precipitates, it was established that the regularity of appearance of the precipitate was noted on both the D and N hams, such that where there was no precipitate on the right N ham, nor was their any on the left D ham of the same hog. However, desalting only lead to a slight decrease in the appearance of precipitates (average of 0.7 points, but it is certain that desalting reduces the salt content in the legs, which affects some physical- chemical changes in the ham tissues during processing.

Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic.

Science.gov (United States)

Citrome, L

2011-02-01

To describe the efficacy and safety of lurasidone for the treatment of schizophrenia. The pivotal registration trials were accessed by querying the literature databases PubMed, EMBASE, ISI Web of Knowledge, as well as http://www.fda.gov and http://www.clinicaltrials.gov for the search term 'lurasidone'. Product labelling provided additional information. All available clinical reports of studies were identified. Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports, abstracts and posters. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Lurasidone is a second-generation antipsychotic approved for the treatment of schizophrenia at a recommended starting dose of 40 mg/day administered once daily with food (≥350 calories). The maximum recommended dose is 80 mg/day. Regulatory approval was based primarily on a clinical trial programme that included four 6-week randomised clinical trials demonstrating efficacy vs. placebo in acute patients with schizophrenia. One additional Phase II clinical trial was considered a failed study because neither lurasidone nor the active control, haloperidol, separated from placebo on the primary outcome measure. One additional Phase III study was completed after the new drug application was submitted to the US Food and Drug Administration. Efficacy outcomes appear consistently in favour of lurasidone 80 mg/day vs. placebo on multiple measures of psychopathology, however, at least two studies also demonstrated efficacy for the doses of 40 and 120 mg/day. NNT vs. placebo was 3-6 for response as defined by ≥20% reduction in psychopathological rating scale total scores from baseline, depending on the study and the dose. Response as defined by a ≥30% improvement yielded NNTs ranging from 7 to 13. The most common adverse events in the clinical trials were

Consideration of future safety consequences: a new predictor of employee safety.

Science.gov (United States)

Probst, Tahira M; Graso, Maja; Estrada, Armando X; Greer, Sarah

2013-06-01

Compliance with safety behaviors is often associated with longer term benefits, but may require some short-term sacrifices. This study examines the extent to which consideration of future safety consequences (CFSC) predicts employee safety outcomes. Two field studies were conducted to evaluate the reliability and validity of the newly developed Consideration of Future Safety Consequences (CFSC) scale. Surveys containing the CFSC scale and other measures of safety attitudes, behaviors, and outcomes were administered during working hours to a sample of 128 pulp and paper mill employees; after revising the CFSC scale based on these initial results, follow-up survey data were collected in a second sample of 212 copper miners. In Study I, CFSC was predictive of employee safety knowledge and motivation, compliance, safety citizenship behaviors, accident reporting attitudes and behaviors, and workplace injuries - even after accounting for conscientiousness and demographic variables. Moreover, the effects of CFSC on the variables generally appear to be direct, as opposed to mediated by safety knowledge or motivation. These findings were largely replicated in Study II. CFSC appears to be an important personality construct that may predict those individuals who are more likely to comply with safety rules and have more positive safety outcomes. Future research should examine the longitudinal stability of CFSC to determine the extent to which this construct is a stable trait, rather than a safety attitude amenable to change over time or following an intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

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.

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...

Stereotypes of physical appearance and labor market chances

OpenAIRE

Arai, Mahmood; Gartell, Marie; Rödin, Magnus; Özcan, Gülay

2016-01-01

Using an experimental setup involving 436 case workers at the Swedish Public Employment Service (SPES) as subjects and the profile photographs and recorded voices of 75 jobseekers as treatments, we report results indicating that male case workers tend to favor jobseekers perceived as having a stereotypical Swedish appearance when they select candidates to be recommended for labor market programs (LMP). This bias represents a roughly 50-percent greater chance of being selected if you compare t...

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

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

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.

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.

Owl's eye appearance: a case report

International Nuclear Information System (INIS)

Mathur, Mukul; Asha, P.

2010-01-01

Full text: Hyper-functioning thyroid nodule may present various scintigraphic appearances on thyroid scans. Autonomously hyper functioning thyroid nodules often show degenerative changes. These changes may give rise to peripheral photopenic areas on a thyroid scan. In this report we present a case of hyper functioning nodule showing appearance of an owl's eye. Although rare, such pattern can be seen in a variety of benign and malignant thyroid conditions. A 42-year-old man presented with a solitary thyroid nodule in the right lobe and weight loss for four months. The thyroid hormone profile confirmed hyperthyroidism. Thyroid function testing revealed T4=136.8 nmol/l (Normal = 66.0-181.0 nmol/L) and Thyroid Stimulating Hormone (TSH) = 0.283 (Normal =0.27- 4.2 μIU/ml). Antithyroglobulin antibodies and antimicrosmal antibodies were negative. The patient was referred for thyroid scan and uptake. A Thyroid scan was obtained after the intravenous injection of 5 mCi (185MBq) of 99m Tc pertechnetate. Anterior view obtained using a parallel hole collimator. The scan showed peripheral photopenic area with a central focal area of increased uptake giving the appearance of 'Owl's eye'. 99m Tc-pertechnetate uptake was increased. A scintigraphic 'Owl's eye' sign has been described in thyroid cyst, benign autonomous nodule and papillary carcinoma of the thyroid gland. This Owl's eye pattern appears to be caused by a focus of functioning tissue overlapping a large cold area in a nodule that has cystic,degenerative and necrotic changes in the middle of a benign and malignant pathology. Hyper functioning nodules may scintigraphically show Owl's eye pattern due to intra nodular degeneration, with residual hyper functioning tissue within or overlapping the degenerative area

Innovative safety ideas for fusion experimental machines

International Nuclear Information System (INIS)

Brereton, S.J.; Gouge, M.; Piet, S.J.; Merrill, B.J.; Holland, D.F.; Sze, D.K.

1990-01-01

Throughout the early stages of design of fusion experimental devices, such as ITER, safety experts have worked with designers to incorporate safety features into the design. Recent efforts have focused on passive safety features. Although designs of near-term fusion machines may appear consistent with expected regulatory requirements, the safety characteristics can potentially be more attractive. Here, a variety of suggestions that appear promising in terms of improving safety are given. These include new concepts, innovative technologies, further support of past concepts, and possible modification to operating scenarios. Some technical discussion on the feasibility of the proposals is provided. The ideas are generally conceptual at this stage and require further assessment and development work. However, each has the potential for enhancing the safety of experimental devices. 33 refs., 6 figs., 9 tabs

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...

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.

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 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

Road safety in developing countries.

NARCIS (Netherlands)

Schreuder, D.A.

1991-01-01

This paper presents a classification of countries (developing and developed alike), divided into two main categories: an economical and historical entry. When road safety problems are placed into the economical context, it then appears that, among other things: (1) The road safety problem in the

Nuclear power safety

International Nuclear Information System (INIS)

1988-01-01

The International Atomic Energy Agency, the organization concerned with worldwide nuclear safety has produced two international conventions to provide (1) prompt notification of nuclear accidents and (2) procedures to facilitate mutual assistance during an emergency. IAEA has also expanded operational safety review team missions, enhanced information exchange on operational safety events at nuclear power plants, and planned a review of its nuclear safety standards to ensure that they include the lessons learned from the Chernobyl nuclear plant accident. However, there appears to be a nearly unanimous belief among IAEA members that may attempt to impose international safety standards verified by an international inspection program would infringe on national sovereignty. Although several Western European countries have proposed establishing binding safety standards and inspections, no specific plant have been made; IAEA's member states are unlikely to adopt such standards and an inspection program

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

Usability of Calibrating Monitor for Soft Proof According to CIE CAM02 Colour Appearance Model

Directory of Open Access Journals (Sweden)

Dragoljub Novakovic

2010-06-01

Full Text Available Colour appearance models describe viewing conditions and enable simulating appearance of colours under different illuminants and illumination levels according to human perception. Since it is possible to predict how colour would look like when different illuminants are used, colour appearance models are incorporated in some monitor profiling software. Owing to these software, tone reproduction curve can be defined by taking into consideration viewing condition in which display is observed. In this work assessment of CIE CAM02 colour appearance model usage at calibrating LCD monitor for soft proof was tested in order to determine which tone reproduction curve enables better reproduction of colour. Luminance level was kept constant, whereas tone reproduction curves determined by gamma values and by parameters of CIE CAM02 model were varied. Testing was conducted in case where physical print reference is observed under illuminant which has colour temperature according to iso standard for soft-proofing (D50 and also for illuminants D65.  Based on the results of calibrations assessment, subjective and objective assessment of created profiles, as well as on the perceptual test carried out on human observers, differences in image display were defined and conclusions of the adequacy of CAM02 usage at monitor calibration for each of the viewing conditions reached.

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

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

The moderated relationship of appearance valence on appearance self consciousness: development and testing of new measures of appearance schema components.

Directory of Open Access Journals (Sweden)

Timothy P Moss

Full Text Available This paper describes the creation and psychometric properties of two independent measures of aspects of appearance schematicity--appearance salience and valence, assessed by the CARSAL and CARVAL, and their relation to appearance self-consciousness. Five hundred and ninety two participants provided data in a web based task. The results demonstrate the sound psychometric properties of both scales. This was demonstrated by good item total characteristics, good internal reliability of each scale, and the independence of the two scales shown through principal components analysis. Furthermore, the scales show independent and moderated relationships with valid measures of appearance related psychosocial distress. Negatively valenced appearance information was associated with increased appearance self-consciousness. More crucially, the impact of negative valence on appearance self-consciousness was exacerbated by the moderating effect increased salience of appearance.

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...

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.

LMFBR: safety aspects

International Nuclear Information System (INIS)

Natta, M.

1990-01-01

This presentation of LMFBR safety is limited at Super Phenix reactor. After a brief description of the reactor, some details on safety systems, in normal or accidental conditions, are given. The main functions studied are: chain reaction trip, residual power evacuation, reactor containment. In heavy accident the behaviour of Super Phenix is studied which its particular characteristics and the possibilities of operators reactions. The probability of appearance and the maximum consequences of heavy accidents are given [fr

Appearance of Keplerian discs orbiting Kerr superspinars

Energy Technology Data Exchange (ETDEWEB)

Stuchlik, Zdenek; Schee, Jan, E-mail: zdenek.stuchlik@fpf.slu.c, E-mail: jan.schee@fpf.slu.c [Institute of Physics, Faculty of Philosophy and Science, Silesian University in Opava, Bezrucovo nam. 13, Opava (Czech Republic)

2010-11-07

We study optical phenomena related to the appearance of Keplerian accretion discs orbiting Kerr superspinars predicted by string theory. The superspinar exterior is described by standard Kerr naked singularity geometry breaking the black hole limit on the internal angular momentum (spin). We construct local photon escape cones for a variety of orbiting sources that enable us to determine the superspinars silhouette in the case of distant observers. We show that the superspinar silhouette depends strongly on the assumed edge where the external Kerr spacetime is joined to the internal spacetime governed by string theory and significantly differs from the black hole silhouette. The appearance of the accretion disc is strongly dependent on the value of the superspinar spin in both their shape and frequency shift profile. Apparent extension of the disc grows significantly with the growing spin, while the frequency shift grows with the descending spin. This behaviour differs substantially from the appearance of discs orbiting black holes enabling thus, at least in principle, to distinguish clearly the Kerr superspinars and black holes. In vicinity of a Kerr superspinar the non-escaped photons have to be separated to those captured by the superspinar and those being trapped in its strong gravitational field leading to self-illumination of the disc that could even influence its structure and cause self-reflection effect of radiation of the disc. The amount of trapped photons grows with descending superspinar spin. We thus can expect significant self-illumination effects in the field of Kerr superspinars with near-extreme spin a {approx} 1.

Safety culture in transport

International Nuclear Information System (INIS)

Decobert, V.

1998-01-01

'Safety culture' is a wording that appeared first in 1986, during the evaluation of what happened during the Tchernobyl accident. Safety culture is defined in the IAEA 75-INSAG-4 document as the characteristics and attitude which, in organizations and in men behaviours, make that questions related to safety of nuclear power plants benefits, in priority, of the attention that they need in function of their importance. The INSAG-4 document identifies three different elements necessary to the development of the safety culture: commitment of the policy makers, commitment of the managers of the industry, and commitment of individuals. This paper gives examples to show how safety culture is existing in the way Transnucleaire performs the activities in the field of transport of nuclear materials. (author)

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

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...

Product Safety Culture: A New Variant of Safety Culture?

International Nuclear Information System (INIS)

Suhanyiova, L.; Flin, R.; Irwin, A.

2016-01-01

Product safety culture is a new research area which concerns user safety rather than worker or process safety. The concept appears to have emerged after the investigation into the Nimrod aircraft accident (Haddon-Cave, 2009) which echoed aspects of NASA’s Challenger and Columbia crashes. In these cases, through a blend of human and organizational failures, the culture deteriorated to the extent of damaging product integrity, resulting in user fatalities. Haddon-Cave noted that it was due to a failure in leadership and organizational safety culture that accidents such as the Nimrod happened, where the aircraft exploded due to several serious technical failures, preceded by deficiencies in the safety case. Now some organizations are starting to measure product safety culture. This is important in day-to-day life as well, where a product failure as a result of poor organizational safety culture, can cause user harm or death, as in the case of Takata airbags scandal in 2015. Eight people have lost their lives and many were injured. According to investigation reports this was due to the company’s safety malpractices of fixing faulty airbags and proceeding to install them in vehicles, as well as secretly conducting tests to assess the integrity of their product and then deleting the data and denying safety issues as a result of the company’s cost-cutting policies. As such, organizational culture, specifically the applications of safety culture, can have far-reaching consequences beyond the workplace of an organization.

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

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

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%.

The 5-CNL Front-of-Pack Nutrition Label Appears an Effective Tool to Achieve Food Substitutions towards Healthier Diets across Dietary Profiles.

Directory of Open Access Journals (Sweden)

Chantal Julia

Full Text Available Front-of-pack (FOP nutrition labels are considered helpful tools to help consumers making healthier food choices, thus improving their diet. In France, the implementation of a FOP nutrition label-the 5-Colour Nutrition Label (5-CNL-is currently under consideration. Our objective was to investigate dietary profiles in a French adult population using the 5-CNL, and to assess its potential impact in improving the diet through substitution of foods.Subjects included in the NutriNet-Santé cohort, who had completed three 24-h dietary records were included in this cross-sectional analysis. Mutually exclusive clusters of individuals were identified using the percentage of energy derived from foods of each of the 5-CNL colours as input variables. Three scenarios of substitution of foods for healthier alternative using the 5-CNL were tested. Food group and dietary intakes, socio-demographic and lifestyle data were compared across clusters using ANOVAs or Chi-square tests, as appropriate. We identified three mutually exclusive dietary profiles: 'Healthy' (N = 28 095, 29.3% of the sample, with high consumption of fruit, vegetables, whole cereals and fish; 'Western' (N = 33 386, 34.8%; with high consumption of sweetened beverages, breakfast cereal, cheese, fatty and sugary foods; 'Traditional' (N = 34 461, 35.1%, with high consumption of potatoes, bread, meat and dairy desserts. Overall, substitutions strategies led to an increase in the number of subjects reaching the recommended intakes in energy, macro and micronutrients. Increases were particularly high in the 'Western' pattern for lipids and saturates intakes: from 16.2% reaching the recommended amount for lipids (13.5% for saturates to 60.6% and 85.7% respectively.The use of the 5-CNL as an indicator of food choice meaningfully characterizes clusters of dietary habits and appears as an effective tool to help improving the nutritional quality of the diet.

The 5-CNL Front-of-Pack Nutrition Label Appears an Effective Tool to Achieve Food Substitutions towards Healthier Diets across Dietary Profiles.

Science.gov (United States)

Julia, Chantal; Méjean, Caroline; Péneau, Sandrine; Buscail, Camille; Alles, Benjamin; Fézeu, Léopold; Touvier, Mathilde; Hercberg, Serge; Kesse-Guyot, Emmanuelle

2016-01-01

Front-of-pack (FOP) nutrition labels are considered helpful tools to help consumers making healthier food choices, thus improving their diet. In France, the implementation of a FOP nutrition label-the 5-Colour Nutrition Label (5-CNL)-is currently under consideration. Our objective was to investigate dietary profiles in a French adult population using the 5-CNL, and to assess its potential impact in improving the diet through substitution of foods. Subjects included in the NutriNet-Santé cohort, who had completed three 24-h dietary records were included in this cross-sectional analysis. Mutually exclusive clusters of individuals were identified using the percentage of energy derived from foods of each of the 5-CNL colours as input variables. Three scenarios of substitution of foods for healthier alternative using the 5-CNL were tested. Food group and dietary intakes, socio-demographic and lifestyle data were compared across clusters using ANOVAs or Chi-square tests, as appropriate. We identified three mutually exclusive dietary profiles: 'Healthy' (N = 28 095, 29.3% of the sample), with high consumption of fruit, vegetables, whole cereals and fish; 'Western' (N = 33 386, 34.8%); with high consumption of sweetened beverages, breakfast cereal, cheese, fatty and sugary foods; 'Traditional' (N = 34 461, 35.1%), with high consumption of potatoes, bread, meat and dairy desserts. Overall, substitutions strategies led to an increase in the number of subjects reaching the recommended intakes in energy, macro and micronutrients. Increases were particularly high in the 'Western' pattern for lipids and saturates intakes: from 16.2% reaching the recommended amount for lipids (13.5% for saturates) to 60.6% and 85.7% respectively. The use of the 5-CNL as an indicator of food choice meaningfully characterizes clusters of dietary habits and appears as an effective tool to help improving the nutritional quality of the diet.

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

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.

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.

On Multiple Appearances

DEFF Research Database (Denmark)

Bork Petersen, Franziska

2012-01-01

reduction and epoché to focus on how dancing bodies appear in a stage context. To test these tools’ ability to explore dancing bodies from a third-person perspective, I analyse the Danish choreographer Kitt Johnson’s solo performance Drift (2011) - focussing on her shifting physical appearance. While...... phenomenology helps me to describe the multiple and radically different guises that Johnson assumes in her piece, my analysis, ultimately, does not aim to distil a truer, more real being from her appearances as is often the case in phenomenological philosophy. I complement my analytical approach...... with the Deleuzian notion of becoming animal and suggest that Johnson stages what could, in Judith Butler’s terms, be called a critical contingency of bodily appearance....

Correlation between safety climate and contractor safety assessment programs in construction.

Science.gov (United States)

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

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)

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

Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study.

Science.gov (United States)

Ascher, B; Hoffmann, K; Walker, P; Lippert, S; Wollina, U; Havlickova, B

2014-12-01

Unwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking. To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study. Patients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm(2) or placebo injected into their SMF for up to four treatments ~28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored. Compared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm(2) showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm(2) , P < 0.001 for ATX-101 2 mg/cm(2) vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area. ATX

The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature.

Science.gov (United States)

Derrick, Chase D; Shridharani, Sachin M; Broyles, Justin M

2015-09-01

In the past decade, the practice of body contouring using cryolipolysis has increased tremendously. While numerous anecdotal reports extol the efficacy of this product, the majority of these studies are small, retrospective case-series that lack control groups. The authors aim to systematically review available literature to better illustrate the efficacy and safety of this new procedure. A systematic literature review performed using MEDLINE, Embase, PubMed, and Cochrane databases identified all published studies evaluating cryolipolysis for body contouring. A total of 34 articles up to February 2015 were identified. Nineteen articles matched the selection criteria and were included in the analysis. Sixteen were evaluated in the final analysis. A total of 1445 patients had reportable data for analysis of the safety profile. Twelve patients (0.82%) reported complications with the most common being diminished sensation lasting greater than 4 weeks. An aggregate total of 295 patients had objective data for evaluation of tissue reduction. The mean time from procedure to objective outcome evaluation was 3.83 months. The mean reduction of subcutaneous tissue was 19.55% with respect to a designated control site. Selective cryolipolysis appears, at short-term follow-up, to reliably decrease subcutaneous tissue deposits. Reported complications are uncommon and appear to resolve without intervention. Future studies should aim to optimize patient selection and treatment characteristics while obtaining long-term follow-up data. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Geographic profiling survey : a preliminary examination of geographic profilers' views and experiences

NARCIS (Netherlands)

Emeno, Karla; Bennell, Craig; Snook, Brent; Taylor, Paul Jonathon

Geographic profiling (GP) is an investigative technique that involves predicting a serial offender?s home location (or some other anchor point) based on where he or she committed a crime. Although the use of GP in police investigations appears to be on the rise, little is known about the procedure

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...

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.

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.

SAFETY PLATFORM OF POLISH TRANSPORT

Directory of Open Access Journals (Sweden)

Katarzyna CHRUZIK

2016-03-01

Full Text Available Analyzing the level of Polish transport safety culture can be seen that it is now dependent on the culture of safety management within the organization and the requirements and recommendations of law in this field for different modes of transport (air, rail, road, water. Of the four basic types of transport requirements are widely developed in the aviation, rail, and water – the sea. In order to harmonize the requirements for transport safety so it appears advisable to develop a platform for exchange of safety information for different modes of transport, and the development of good practices multimodal offering the possibility of improving Polish transport safety. Described in the publication of the proposal in addition to the alignment platform experience and knowledge in the field of transport safety in all its kinds, it can also be a tool for perfecting new operators of public transport.

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....

Safety and environment

International Nuclear Information System (INIS)

Cogne, F.

1975-01-01

The author analyses the papers presented by C. Starr and M. Muntzing at the Paris Conference on the maturity of nuclear energy. The main problems raised in the matter of safety (safety of the plants, plutonium toxicity, the possibilities of theft or sabotage, treatment and storage of the waste) are analyzed and it is pointed out that the hazards arising from the use of nuclear power are contained within reasonable limits. The experts should take the initiative of informing the general public on these matters as the mass media circulate too much inaccurate information in this field. As concerns the environment, it is the choice of sites and the harmonizing of the rules and procedures which appear to be the most important problems for the authorities charged with safety measures [fr

Traffic safety in the U.S.: re-examining major opportunities.

Science.gov (United States)

Sivak, Michael; Luoma, Juha; Flannagan, Michael J; Bingham, C Raymond; Eby, David W; Shope, Jean T

2007-01-01

This article examines five major road-safety risk factors: exceeding posted speed limits, not using safety belts, driving while intoxicated, nighttime driving, and young drivers. The importance of each of these factors is documented, known effective countermeasures (both policy and technology based) are discussed, and impediments to the implementation of these countermeasures in the United States are examined. Based on current understanding of the five major risk factors, and of the available countermeasures, there appear to be a variety of opportunities to make substantial gains in road safety using existing knowledge. The limited implementation of a variety of known countermeasures therefore appears to be inconsistent with high-level, strategic goals to improve road safety. Consequently, a recommendation is made to comprehensively re-examine the balance between the countermeasures discussed in this article and economic, mobility, and privacy concerns. IMPACT ON PUBLIC SAFETY: Such a re-examination is likely to result in broad support for these countermeasures, with a consequent major improvement in road safety.

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)

Managing Safety and Operations: The Effect of Joint Management System Practices on Safety and Operational Outcomes.

Science.gov (United States)

Tompa, Emile; Robson, Lynda; Sarnocinska-Hart, Anna; Klassen, Robert; Shevchenko, Anton; Sharma, Sharvani; Hogg-Johnson, Sheilah; Amick, Benjamin C; Johnston, David A; Veltri, Anthony; Pagell, Mark

2016-03-01

The aim of this study was to determine whether management system practices directed at both occupational health and safety (OHS) and operations (joint management system [JMS] practices) result in better outcomes in both areas than in alternative practices. Separate regressions were estimated for OHS and operational outcomes using data from a survey along with administrative records on injuries and illnesses. Organizations with JMS practices had better operational and safety outcomes than organizations without these practices. They had similar OHS outcomes as those with operations-weak practices, and in some cases, better outcomes than organizations with safety-weak practices. They had similar operational outcomes as those with safety-weak practices, and better outcomes than those with operations-weak practices. Safety and operations appear complementary in organizations with JMS practices in that there is no penalty for either safety or operational outcomes.

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.

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

Directory of Open Access Journals (Sweden)

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

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.

Petechiae/purpura in well-appearing infants.

Science.gov (United States)

Lee, Melissa Huilin; Barnett, Peter L J

2012-06-01

Well infants with petechiae and/or purpura can present to emergency departments, and their management can be difficult. Many will have extensive investigations and treatment that may not be necessary. This was a retrospective and descriptive audit investigating well infants (purpura in the absence of fever to a pediatric emergency department over a 9½-year period. All presenting problems of petechiae or purpura were reviewed. Patients were excluded if they appeared unwell, were febrile or have a history of fever, or had eccyhmoses on presentation. Thirty-six babies were identified. The average age was 3.8 months (range, 1-7 months). The majority of the infants had localized purpura/petechiae to the lower limbs (92%) with two thirds of these patients having bilateral signs. None had generalized signs. Most infants had a full blood count (94%), coagulation profile (59%) and C-reactive protein (59%), and blood cultures (59%), with all being normal (except for mild elevation in platelets). Nine patients were admitted for observation, with only 1 patient having progression of signs. This patient had a diagnosis of acute hemorrhagic edema of infancy. The rest of the patients were thought to have either a mechanical reason for their petechiae/purpura (tourniquet phenomena) or a formal diagnosis was not specified. Well infants with localized purpura and/or petechiae with an absence of fever are more likely to have a benign etiology. Further study is required to determine if a full blood count and coagulation profile is necessary, or a period of observation (4 hours) is all that is required. If there is no progression of signs, it is likely that they can be safely discharged. The likely cause may be due to a tourniquet phenomenon (eg, diaper).

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)

Natural gas annual 1992: Supplement: Company profiles

Energy Technology Data Exchange (ETDEWEB)

1994-01-01

The data for the Natural Gas Annual 1991 Supplement : Company Profiles are taken from Form EIA-176, (open quotes) Annual Report of Natural and Supplemental Gas Supply and Disposition (close quotes). Other sources include industry literature and corporate annual reports to shareholders. The companies appearing in this report are major interstate natural gas pipeline companies, large distribution companies, or combination companies with both pipeline and distribution operations. The report contains profiles of 45 corporate families. The profiles describe briefly each company, where it operates, and any important issues that the company faces. The purpose of this report is to show the movement of natural gas through the various States served by the 45 large companies profiled.

Assuring nuclear safety competence into the 21. century a swedish perspective

International Nuclear Information System (INIS)

Lowenhielm, G.; Svensson, G.; Tiren, IN

2000-01-01

Many initiatives have been taken and are being considered to maintain and develop competence in the nuclear field in Sweden. The number of qualified nuclear engineering staff at the plants and at the regulatory bodies appears to be rather small for all important tasks to be carried out. Nevertheless, the current programmes indicate that one can look at future recruitment and competence with some confidence-in spite of the age profile of qualified staff with many approaching retirement. The Swedish Nuclear Power Inspectorate, (SKI), the academic community, and the Industry are conducting several research projects that support the optimistic view expressed above. Examples include: Safety research at SKI and universities: Since many years, SKI is sponsoring research in safety analysis within the framework of its Research Programme. In this programme the regulator supports two professors, one in Nuclear Power Safety at KTH and the other in the Interaction of Man, Technology and Organisation at the University of Stockholm. Swedish Centre of Nuclear Technology: A main activity of the Centre is to support PhD candidates (with scientific advice and economy) in topics related to nuclear technology. The Industry also makes great efforts to support recruitment by various initiatives: Design reconstitution projects: Each one of the older operating plants was subject to a design review that engaged a large number of young staff at the utilities and the vendors. 'Young Generation': It constitutes a communication network among young engineers at European nuclear plants, regulators, and other organisations. (authors)

Recurrent and multiple bladder tumors show conserved expression profiles

International Nuclear Information System (INIS)

Lindgren, David; Fioretos, Thoas; Månsson, Wiking; Höglund, Mattias; Gudjonsson, Sigurdur; Jee, Kowan Ja; Liedberg, Fredrik; Aits, Sonja; Andersson, Anna; Chebil, Gunilla; Borg, Åke; Knuutila, Sakari

2008-01-01

Urothelial carcinomas originate from the epithelial cells of the inner lining of the bladder and may appear as single or as multiple synchronous tumors. Patients with urothelial carcinomas frequently show recurrences after treatment making follow-up necessary. The leading hypothesis explaining the origin of meta- and synchronous tumors assumes a monoclonal origin. However, the genetic relationship among consecutive tumors has been shown to be complex in as much as the genetic evolution does not adhere to the chronological appearance of the metachronous tumors. Consequently, genetically less evolved tumors may appear chronologically later than genetically related but more evolved tumors. Forty-nine meta- or synchronous urothelial tumors from 22 patients were analyzed using expression profiling, conventional CGH, LOH, and mutation analyses. We show by CGH that partial chromosomal losses in the initial tumors may not be present in the recurring tumors, by LOH that different haplotypes may be lost and that detected regions of LOH may be smaller in recurring tumors, and that mutations present in the initial tumor may not be present in the recurring ones. In contrast we show that despite apparent genomic differences, the recurrent and multiple bladder tumors from the same patients display remarkably similar expression profiles. Our findings show that even though the vast majority of the analyzed meta- and synchronous tumors from the same patients are not likely to have originated directly from the preceding tumor they still show remarkably similar expressions profiles. The presented data suggests that an expression profile is established early in tumor development and that this profile is stable and maintained in recurring tumors

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

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.

Body Image and the Appearance Culture Among Adolescent Girls and Boys: An Examination of Friend Conversations, Peer Criticism, Appearance Magazines, and the Internalization of Appearance Ideals

Science.gov (United States)

Jones, Diane Carlson; Vigfusdottir, Thorbjorg Helga; Lee, Yoonsun

2004-01-01

This research evaluates the contributions of three dimensions of appearance culture (appearance magazine exposure, appearance conversations with friends, and peer appearance criticism) and body mass index (BMI) to internalization of appearance ideals and body image dissatisfaction. Four hundred thirty-three girls and 347 boys in Grades 7 through…

To improve the safety of treatments in radiotherapy by developing a safety culture

International Nuclear Information System (INIS)

2008-01-01

Following the radiotherapy accidents between 2004 and 2006, the I.R.S.N. deemed necessary to lead a study on the safety of treatments in radiotherapy and on the use and the adaptation to the medical domain of safety analysis approach developed for the nuclear installations. Of this study, six mains lines of investigation appear: Endow the radiotherapy services with real referential of safety, reinforce the robustness of the organization of radiotherapy services, improve the safety of the equipment and software at the design and operating stages, improve the management of the expertise and reinforce the operating feed back on incidents and accidents. The main learning from this study is the benefit that could be gained by fitting the safety analysis concepts and methods to the specificities of radiotherapy considering the organization of it collective work, the cooperation between actors stemming from different jobs as well as the interactions between actors and technical systems in the process of the treatments, when they are put into service and during their periodic checks. (author)

Safety culture in the nuclear field

International Nuclear Information System (INIS)

2005-09-01

The council of IAEA governors ratified twelve elemental principles of physical protection of nuclear matters and installations. These principles will be included in the future updating of the international convention on the physical protection. The F basic principle proposes a definition of the safety culture and recommends that its implementation and its perenniality to be a reality in the concerned organisms.It appears as necessary to precise the concept of safety culture. The twelve principles are as follow: A State liability, B liability during international transports, C legislative and regulatory framework, D competent authority, E operators liability, F safety culture, G threats, H graduated approach, I deep defence, J assurance of the quality, K emergency plan, L confidentiality. The present document is complementary of INSAG-4, 1991 (safety series number 75, INSAG-4 safety culture, a report by the international nuclear safety advisory group, IAEA, 1991) that presents a concept of safety culture. It proposes also, in a particular chapter, the comparisons( common points and specificities) between safety culture and security culture. (N.C.)

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

Safety activities in small businesses

Science.gov (United States)

Sinclair, Raymond C.; Cunningham, Thomas R.

2015-01-01

Background Workplace injuries occur at higher rates in smaller firms than in larger firms, and the number of workplace safety activities appear to be inversely associated with those rates. Predictors of safety activities are rarely studied. Methods This study uses data from a national random survey of firms (n = 722) with less than 250 employees conducted in 2002. Results We found that, regardless of firm size or industry, safety activities were more common in 2002 than they were in a similar 1983 study. Having had an OSHA inspection in the last five years and firm size were stronger predictors of safety activities than industry hazardousness and manager’s perceptions of hazardousness. All four variables were significant predictors (β range .19 to .28; R2 = .27). Conclusions Further progress in the prevention of injuries in small firms will require attention to factors likely subsumed within the firm size variable, especially the relative lack of slack resources that might be devoted to safety activities. PMID:26339124

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

Directory of Open Access Journals (Sweden)

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.

THE PHOTOMETRIC AND KINEMATIC STRUCTURE OF FACE-ON DISK GALAXIES. II. INTEGRATED LINE PROFILE CHARACTERIZATION AND THE ORIGIN OF LINE PROFILE ASYMMETRY

International Nuclear Information System (INIS)

Andersen, David R.; Bershady, Matthew A.

2009-01-01

We perform a moments analysis of H I and H II global line profiles for 33 nearly face-on disk galaxies for the threefold purpose of rationalizing and interpreting line profile indices in the literature, presenting robust moment definitions with analytic error functions calibrated against Monte Carlo simulation, and probing the physical origin of line profile asymmetries. The first four profile moments serve as viable surrogates for the recession velocity, line width, asymmetry, and profile shape, respectively. The first three moments are superior, by a factor of ∼2 in precision, to related quantities defined in the literature. First and third profile moments are related; skew can be used to calculate more accurate recession velocities from global profiles. Second and fourth profile moments are linked, corresponding to the known trend that narrow (but well resolved) line widths tend to be more Gaussian. Hα kurtosis also appears correlated with the spatially resolved line width of the ionized gas. No systematics appear between various measures of line width and true rotation speed other than the wide range of normalizations, which we calibrate. This conclusion and calibration, however, is highly sample dependent. The ratio of H II to H I widths is consistent with unity, even at low projected line width. There may be a trend toward a decrease in the ratio of H II to H I widths consistent with previous studies, but we also observe greater scatter. While there is good agreement between H I and H II first, second, and fourth moments, we find no positive correlation between skew measured from H I and H II profiles. Detailed analysis of the spatially resolved Hα distribution demonstrates that H II global profile asymmetries are dominated by differences in the gas distribution, not kinematic asymmetries.

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.

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

Safety policy in the production of electricity

International Nuclear Information System (INIS)

Siddall, E.

1982-01-01

When safety is properly understood, defined and quantified, it can be seen that the development of our present industrial civilization has resulted in a progressive improvement in human safety. Increased safety has come with increased wealth in such close association that a high degree of cause-and-effect relationship must be considered. The quantitative relationship between wealth production and safety improvement is derived from different sources of evidence. When this is applied to the wealth production from electricity generation in a standard module of population in an advanced society, a safety benefit is indicated which exceeds the assessed direct risk associated with the electricity generation by orders of magnitude. It appears that a goal or policy intended to confer the greatest safety benefit to the population would result in attitudes and actions diametrically opposite to those which are conventional at the moment

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 ...

Building safety and human behaviour in fire: A literature review

NARCIS (Netherlands)

Kobes, M.; Helsloot, I.; de Vries, B.; Post, J.

2010-01-01

The most crucial aspect of a building's safety in the face of fire is the possibility of safe escape. An important precondition is that its fire safety facilities enable independent and adequate fire response performances by the building's occupants. In practice, it appears that the measures

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.

Design an optimum safety policy for personnel safety management - A system dynamic approach

International Nuclear Information System (INIS)

Balaji, P.

2014-01-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making

Design an optimum safety policy for personnel safety management - A system dynamic approach

Energy Technology Data Exchange (ETDEWEB)

Balaji, P. [The Glocal University, Mirzapur Pole, Delhi- Yamuntori Highway, Saharanpur 2470001 (India)

2014-10-06

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

Design an optimum safety policy for personnel safety management - A system dynamic approach

Science.gov (United States)

Balaji, P.

2014-10-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

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.

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

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

Safety policy in the production of electricity

International Nuclear Information System (INIS)

Siddall, E.

1983-01-01

When safety is properly understood, defined and quantified, it can be seen that the development of our present industrial civilization has resulted in a progressive and great improvement in human safety which is still continuing. Increased safety has come with increased wealth in such close association that a high degree of cause-and-effect relationship must be considered. The quantitative relationship between wealth production and safety improvement is derived from different sources of evidence. When this is applied to the wealth production from electricity generation in a standard module of population in an advanced society, a safety benefit is indicated which exceeds the assessed direct risk associated with the electricity generation by orders of magnitude. It appears that a goal or policy intended to confer the greatest safety benefit to the population would result in attitudes and actions diametrically opposite to those which are conventional at the moment

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

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

Directory of Open Access Journals (Sweden)

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

FDA drug safety communications: a narrative review and clinical considerations for older adults.

Science.gov (United States)

Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

2012-08-01

The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

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.

Evolution, Appearance, and Occupational Success

Directory of Open Access Journals (Sweden)

Anthony C. Little

2012-12-01

Full Text Available Visual characteristics, including facial appearance, are thought to play an important role in a variety of judgments and decisions that have real occupational outcomes in many settings. Indeed, there is growing evidence suggesting that appearance influences hiring decisions and even election results. For example, attractive individuals are more likely to be hired, taller men earn more, and the facial appearance of candidates has been linked to real election outcomes. In this article, we review evidence linking physical appearance to occupational success and evaluate the hypothesis that appearance based biases are consistent with predictions based on evolutionary theories of coalition formation and leadership choice. We discuss why appearance based effects are so pervasive, addressing ideas about a “kernel of truth” in attributions and about coalitional psychology. We additionally highlight that appearance may be differently related to success at work according to the types of job or task involved. For example, leaders may be chosen because the characteristics they possess are seen as best suited to lead in particular situations. During a time of war, a dominant-appearing leader may inspire confidence and intimidate enemies while during peace-time, when negotiation and diplomacy are needed, interpersonal skills may outweigh the value of a dominant leader. In line with these ideas, masculine-faced leaders are favored in war-time scenarios while feminine-faced leaders are favored in peace-time scenarios. We suggest that such environment or task specific competencies may be prevalent during selection processes, whereby individuals whose appearance best matches perceived task competences are most likely selected, and propose the general term “task-congruent selection” to describe these effects. Overall, our review highlights how potentially adaptive biases could influence choices in the work place. With respect to certain biases

National Needs for Appearance Metrology

Science.gov (United States)

Nadal, Maria E.

2003-04-01

Appearance greatly influences a customer's judgement of the quality and acceptability of manufactured products, as yearly there is approximately $700 billion worth of shipped goods for which overall appearance is critical to their sale. For example, appearance is reported to be a major factor in about half of automobile purchases. The appearance of an object is the result of a complex interaction of the light field incident upon the object, the scattering and absorption properties of the object, and human perception. The measurable attributes of appearance are divided into color (hue, saturation, and lightness) and geometry (gloss, haze). The nature of the global economy has increased international competition and the need to improve the quality of many manufactured products. Since the manufacturing and marketing of these products is international in scope, the lack of national appearance standard artifacts and measurement protocols results in a direct loss to the supplier. One of the primary missions of the National Institute of Standards and Technology (NIST) is to strengthen the U.S. economy by working with industry to develop and apply technology, measurements and standards. The NIST Physics Laboratory has established an appearance metrology laboratory. This new laboratory provides calibration services for 0^o/45^o color standards and 20^o°, 60^o°, and 85^o° specular gloss, and research in the colorimetric characterization of gonioapparent including a new Standard Reference Material for metallic coatings (SRM 2017) and measurement protocols for pearlescent coatings. These services are NIST's first appearance metrology efforts in many years; a response to needs articulated by industry. These services are designed to meet demands for improved measurements and standards to enhance the acceptability of final products since appearance often plays a major role in their acceptability.

Satisfaction with facial profile aesthetics: are norms overrated?

Science.gov (United States)

Manevska, I; Pavlic, A; Katic, V; Trinajstic Zrinski, M; Drevensek, M; Spalj, S

2018-01-01

This study aimed to explore to what extent adults perceive deviations from the norm of a balanced profile with normal occlusion as reducing satisfaction with facial appearance and having a psychosocial impact. This cross-sectional study included 225 Caucasian subjects (64% women) aged 18-42 years. Their facial profiles were analyzed photogrammetrically and they were classified into three categories: within, below, or above the standard range for the Croatian population with a normal occlusion. Psychosocial issues were assessed by self-reported satisfaction with facial appearance and domains from the Orthognathic Quality of Life Questionnaire: social aspects of dentofacial aesthetics (SA), facial aesthetics concern (FA), and awareness of dentofacial aesthetics (AW). Men with a concave profile were less satisfied with their faces than those with a flat or convex profile (P<0.05). A reduced upper lip height in men resulted in a lower level of satisfaction and increased FA score, when compared to men with a normal or increased upper lip height (P<0.05). In women, a reduced middle third of the face increased AW (P=0.045). Deviations from a well-balanced facial profile, as well as the morphology of the nose and lip, do not increase psychosocial issues to a great extent. The range of acceptable facial characteristics is evidently much broader than the norms. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

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)

The impact of the European health and safety directives on engineering in higher education

Science.gov (United States)

Crisp, Alan Roy

This thesis examines the effect that six sets of Health and Safety legislation introduced in 1993 have had on working practices at the University, particularly within the Engineering Departments. The legislation, collectively known colloquially as "the six pack", had much in common with extant United Kingdom (UK) law but, because it emanated from the European Union (EU), it appears to be viewed in the UK as unduly restrictive and time consuming. Much of the thesis is therefore devoted to examining this suspicion in which the EU and its legislation is held by UK employers and employees. The thesis begins by examining the general background and recent history of the EU, before going on to look in greater detail at the development of Health and Safety legislation in particular. The area of interest is then further narrowed to look at the impact of this legislation on Higher Education Institutions by comparing recent accident statistics with those for industry and commerce. The main outcome of this section is that Higher Education has a similar accident profile by 'type' to industry and commerce and therefore would act in a similar manner when implementing the legislation. It is argued that industry and commerce can benefit from this similarity by emulating two case studies at the University where legislation is applied to some engineering equipment and procedures. These are described in detail and the point is made that safety is an approach that pervades all stages of an engineering process, commencing with the design or ordering of equipment. This is reinforced with the results of a primary survey of purchasing at similar institutions with regards to observance of current safety practices. It is concluded that suspicion of the "six pack" legislation is largely the result of overloading of those people responsible for safety by the arrival of a plethora of legislation all at once. Ironically this overloading appears to have influenced safety officers to pay attention

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

Safety of MR liver specific contrast media

Energy Technology Data Exchange (ETDEWEB)

Bellin, Marie-France [Hopital Paul Brousse, Universite Paris 11, Villejuif Cedex (France); Webb, Judith A.W. [St. Bartholomew' s Hospital, Department of Diagnostic Imaging, London (United Kingdom); Molen, Aart J. van der [Leiden University Medical Centre, Department of Radiology, Leiden (Netherlands); Thomsen, Henrik S. [Copenhagen University Hospital at Herlev, Department of Diagnostic Radiology 54E2, Herlev (Denmark); Morcos, Sameh K. [Northern General Hospital, Sheffield Teaching Hospitals NHS Trust, Department of Diagnostic Imaging, Sheffield (United Kingdom)

2005-08-01

Over the past few years a number of magnetic resonance (MR) liver specific contrast agents have been introduced. In this report the safety issues of these agents are addressed. A literature search was carried out. Based on the available information, simple guidelines on the safety issue of liver specific contrast agents have been produced by the Contrast Media Safety Committee of the European Society of Urogenital Radiology. The report and guidelines were discussed at the 11th European Symposium on Urogenital Radiology in Santiago de Compostela. Liver specific contrast agents appear in general to be safe and well tolerated. However, the incidence of adverse reactions with iron oxides and the intravenous manganese based agent seems to be slightly higher than with gadolinium based agents. However, no safety information from comparative clinical trials has been published. Guidelines on the safety aspects are presented. (orig.)

Safety of MR liver specific contrast media

International Nuclear Information System (INIS)

Bellin, Marie-France; Webb, Judith A.W.; Molen, Aart J. van der; Thomsen, Henrik S.; Morcos, Sameh K.

2005-01-01

Over the past few years a number of magnetic resonance (MR) liver specific contrast agents have been introduced. In this report the safety issues of these agents are addressed. A literature search was carried out. Based on the available information, simple guidelines on the safety issue of liver specific contrast agents have been produced by the Contrast Media Safety Committee of the European Society of Urogenital Radiology. The report and guidelines were discussed at the 11th European Symposium on Urogenital Radiology in Santiago de Compostela. Liver specific contrast agents appear in general to be safe and well tolerated. However, the incidence of adverse reactions with iron oxides and the intravenous manganese based agent seems to be slightly higher than with gadolinium based agents. However, no safety information from comparative clinical trials has been published. Guidelines on the safety aspects are presented. (orig.)

Program nuclear safety research: report 2000

International Nuclear Information System (INIS)

Muehl, B.

2001-09-01

The reactor safety R and D work of forschungszentrum karlsruhe (FZK) had been part of the nuclear safety research project (PSF) since 1990. In 2000, a new organisational structure was introduced and the Nuclear Safety Research Project was transferred into the nuclear safety research programme (NUKLEAR). In addition to the three traditional main topics - Light Water Reactor safety, Innovative systems, Studies related to the transmutation of actinides -, the new Programme NUKLEAR also covers Safety research related to final waste storage and Immobilisation of HAW. These new topics, however, will only be dealt with in the next annual report. Some tasks related to the traditional topics have been concluded and do no longer appear in the annual report; other tasks are new and are described for the first time. Numerous institutes of the research centre contribute to the work programme, as well as several external partners. The tasks are coordinated in agreement with internal and external working groups. The contributions to this report, which are either written in German or in English, correspond to the status of early/mid 2001. (orig.)

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.

Q-profile requirements for electro ITB formation

Energy Technology Data Exchange (ETDEWEB)

Goodman, T. P.; Coda, S.; Henderson, M. A.; Sauter, O.; Behn, R.; Bottino, A.; Fable, E.; Martynov, A.; Nikkola, P.; Zucca, C.

2005-07-01

The formation requirements of ITBs on numerous tokamaks have been correlated with either a power threshold, appearance of a low order rational surface near q{sub m}in or q{sub 9}5, weak or negative shear, etc. On TCV, electron ITBs (eITBs) can be formed during a gradual evolution from a centrally peaked to hollow current profile while all external actuators are held constant. The formation occurs rapidly (<{tau}{sub e}E) and locally and, according to ASTRA modeling, is correlated with the appearance of a local minimum in the q-profile. There is no clear evidence that the minimum in q appears at a low order rational. These eITBs are sustained by non-inductively driven current (ECCD and bootstrap current) while the current in the tokamak transformer is beld constant. Thus, they are not inherently transient but can exist for several current redistribution times; limited only by the pulse length of the gyrotrons. After the barrier is formed, the gransformer coil can be used as a counter (or co-) current source with negligible accompanying input power. The eITB performance can be enhanced (degraded) by altering solely the current or q-profile: when negative (positive) inductive current is driven, the on-axis current density decreases (increases) resulting in a stronger (weaker) reversed shear as both the ECCD and bootstrap currents are peaked off-axis. These experiments provide a unique realm of eITB formation and performance characteristics that can be used to isolate the physics criteria governing the eITB. (Author)

Ovarian metastases: Computed tomographic appearances

International Nuclear Information System (INIS)

Megibow, A.J.; Hulnick, D.H.; Bosniak, M.A.; Balthazar, E.J.

1985-01-01

Computed tomographic scans of 34 patients with ovarian metastases were reviewed to assess the radiographic appearances and to correlate these with the primary neoplasms. Primary neoplasms were located in the colon (20 patients), breast (six), stomach (five), small bowel (one), bladder (one), and Wilms tumor of the kidney (one). The radiographic appearance of the metastatic lesions could be described as predominantly cystic (14 lesions), mixed (12 lesions), or solid (seven lesions). The cystic and mixed lesions tended to be larger in overall diameter than the solid. The metastases from gastric carcinoma appeared solid in four of five cases. The metastases from the other neoplasms had variable appearances simulating primary ovarian carcinoma

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 climate and firefighting: Focus group results.

Science.gov (United States)

DeJoy, David M; Smith, Todd D; Dyal, Mari-Amanda

2017-09-01

Firefighting is a hazardous occupation and there have been numerous calls for fundamental changes in how fire service organizations approach safety and balance safety with other operational priorities. These calls, however, have yielded little systematic research. As part of a larger project to develop and test a model of safety climate for the fire service, focus groups were used to identify potentially important dimensions of safety climate pertinent to firefighting. Analyses revealed nine overarching themes. Competency/professionalism, physical/psychological readiness, and that positive traits sometimes produce negative consequences were themes at the individual level; cohesion and supervisor leadership/support at the workgroup level; and politics/bureaucracy, resources, leadership, and hiring/promotion at the organizational level. A multi-level perspective seems appropriate for examining safety climate in firefighting. Safety climate in firefighting appears to be multi-dimensional and some dimensions prominent in the general safety climate literature also seem relevant to firefighting. These results also suggest that the fire service may be undergoing transitions encompassing mission, personnel, and its fundamental approach to safety and risk. These results help point the way to the development of safety climate measures specific to firefighting and to interventions for improving safety performance. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Occupational Safety and Health Practices: An Alarming Call to Action

Science.gov (United States)

Threeton, Mark D.; Evanoski, Danielle C.

2014-01-01

In an effort to provide additional insight on providing a secure teaching and learning environment within schools, this study sought to: (1) explore the safety and health practices within Career and Technical Education (CTE); and (2) identify the perceived obstacles which appear to hinder implementation of health and safety programs. While it…

The role of appearance schematicity in the internalization of media appearance ideals: A panel study of preadolescents.

Science.gov (United States)

Rousseau, Ann; Gamble, Hilary; Eggermont, Steven

2017-10-01

Individuals who are more strongly invested in their appearance, appearance schematics, have a tendency to engage in appearance-related comparison. Appearance schematicity consists of two components. The self-evaluative component concerns the degree to which appearance is central to self-worth, referred to as dysfunctional appearance beliefs. Motivational salience refers to the engagement in behaviors designed to enhance appearance, such as body surveillance. Based on a three-wave panel survey of 973 Flemish preadolescents (M age  = 11.15, SD = 1.13) we found that the motivational and self-evaluative components had a different impact on media internalization. For preadolescents who engaged in more body surveillance, watching television resulted in more media internalization. For preadolescents who had fewer dysfunctional appearance beliefs, watching television resulted in more media internalization. These findings suggest that appearance schematicity is an important susceptibility variable in the relationship between TV-exposure and media internalization, and emphasize the importance of investigating individual dispositions beyond gender differences. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Nuclear health and safety

International Nuclear Information System (INIS)

1991-08-01

This paper is a review of environmental and safety programs at facilities in the Naval Reactors Program which shows no basis for allegations that unsafe conditions exist there or that the environment is being harmed by activities conducted there. The prototype reactor design provides safety measures that are consistent with commercial nuclear power plants. Minor incidents affecting safety and the environment have occurred, however, and dents affecting safety and the environment have occurred, however, and as with other nuclear facilities, past activities have caused environmental problems that require ongoing monitoring and vigilance. While the program has historically been exempt from most oversight, some federal and state environmental oversight agencies have recently been permitted access to Naval Reactors facilities for oversight purposes. The program voluntarily cooperates with the Nuclear Regulatory Commission regarding reactor modifications, safety improvements, and component reliability. In addition, the program and its contractors have established an extensive internal oversight program that is geared toward reporting the slightest deviations from requirements or procedures. Given the program's classification policies and requirements, it does not appear that the program routinely overclassifies information to prevent its release to the public or to avoid embarrassment. However, GAO did not some instances in which documents were improperly classified

ADTT safety aspects

International Nuclear Information System (INIS)

Thedeen, T.

1997-01-01

Beside the technical problems of ADTT which remain to be solved it is crucial for the ADTT progress that safety and economical aspects are considered already during the research and planning phases. Safety here stands for the converse of risk, negative consequences for human life and health and the environment together with the corresponding probabilities. The system to be considered includes all phases of an ADTT plant, a life cycle analysis (LCA). The risk analysis is useful for two purposes: comparison with other ways of handling nuclear waste, e.g. geological repository and for valuation of different construction designs. Due to lack of precise plans and adequate data the analysis will be more of a qualitative than quantitative type. The main risks appear in connection with repair and replacement work. 2 refs., 1 fig

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 ...

Safety and tolerability of repetitive transcranial magnetic stimulation in patients with pathologic positive sensory phenomena: a review of literature

Science.gov (United States)

Muller, Paul A; Pascual-Leone, Alvaro; Rotenberg, Alexander

2013-01-01

BACKGROUND Repetitive transcranial magnetic stimulation (rTMS) is emerging as a valuable therapeutic and diagnostic tool. rTMS appears particularly promising for disorders characterized by positive sensory phenomena attributable to alterations in sensory cortex excitability. Among these are tinnitus, auditory and visual hallucinations, and pain syndromes. OBJECTIVE Despite studies addressing rTMS efficacy in suppression of positive sensory symptoms, the safety of stimulation of potentially hyperexcitable cortex has not been fully addressed. We performed a systematic literature review and metanalysis to describe the rTMS safety profile in these disorders. METHODS Using the PubMed database, we performed an English-language literature search from January 1985 to April 2011 to review all pertinent publications. Per study, we noted and listed pertinent details. From these data we also calculated a crude per-subject risk for each adverse event. RESULTS 106 publications (n = 1815 subjects) were identified with patients undergoing rTMS for pathologic positive sensory phenomena. Adverse events associated with rTMS were generally mild and occurred in 16.7% of subjects. Seizure was the most serious adverse event, and occurred in three patients with a 0.16% crude per-subject risk. The second most severe adverse event involved aggravation of sensory phenomena, occurring in 1.54%. CONCLUSIONS The published data suggest rTMS for the treatment or diagnosis of pathologic positive sensory phenomena appears to be a relatively safe and well-tolerated procedure. However, published data are lacking in systematic reporting of adverse events, and safety risks of rTMS in these patient populations will have to be addressed in future prospective trials. PMID:22322098

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.

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. �

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

Safety evaluation of synthetic β-carotene

NARCIS (Netherlands)

Woutersen, R.A.; Wolterbeek, A.P.M.; Appel, M.J.; Berg, H. van den; Goldbohm, R.A.; Feron, V.J.

1999-01-01

The safety of β-carotene was reassessed by evaluating the relevant literature on the beneficial and adverse effects of β-carotene on cancer and, in particular, by evaluating the results of toxicity studies. β- Carotene appeared neither genotoxic nor reprotoxic or teratogenic, and no signs of organ

Relationship between body image and somatotype profile in young women

Directory of Open Access Journals (Sweden)

Marcela Rodrigues Castro

2017-11-01

Full Text Available This study aimed to investigate associations among body dissatisfaction, behaviors, feelings, and beliefs related to the body - and somatotypical profile. The sample included 142 undergraduate female students (21.81 ± 3 years who underwent to assessment of Body Mass Index and somatotype, according to the World Health Organization and Heath-Carter protocols, respectively. To assess body image the following instruments were applied: Body Shape Questionnaire, Body Attitudes Questionnaire, Body Image Avoidance Questionnaire, Sociocultural Attitudes Towards Appearance Scale, Self-Subject Silhouettes To the analysis data we proceeded to multivariate analysis of variance (MANOVA one-way. As the main result, we find that body dissatisfaction, body avoidance and negative attitudes about appearance components are linked to each other and they are influenced by body profiles with mesomorphic and endomorphic predominance. We conclude that the somatotype profile can be an important predictor of changes in body image and is indicated for tracking risk groups.

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

The RIASEC Profile of Foreign Language Teachers

Science.gov (United States)

Swanson, Peter B.

2008-01-01

Vocational choice appears to crystallize during adolescence and one's career aspirations begin to take shape later. Over 40 years ago Holland studied incoming freshman to match vocational aspirations to vocational preference profiles. Individuals seeking to become foreign language teachers were assigned a Social, Artistic, Enterprising vocational…

Effects of gender and physical attractiveness on visual attention to Facebook profiles.

Science.gov (United States)

Seidman, Gwendolyn; Miller, Olivia S

2013-01-01

The current study examined viewers' gaze while observing Facebook profiles of strangers varying in gender and physical attractiveness. Fifty-one participants viewed four Facebook profiles, a physically attractive and unattractive individual of each gender. Participants' eye movements were tracked as they viewed each profile for 60 seconds. Results showed that participants paid more attention to the physical appearance (main profile photograph) of female than of male profile owners and to the personal information (likes and interests) of male than to female profile owners. Participants spent more time focusing on information that was irrelevant to forming an impression of the profile owner (advertisements) when viewing the profiles of unattractive than attractive individuals, suggesting that they made a greater effort to learn about these individuals.

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

Breaking the circle: challenging Western sociocultural norms for appearance influences young women's attention to appearance-related media.

Science.gov (United States)

Mischner, Isabelle H S; van Schie, Hein T; Engels, Rutger C M E

2013-06-01

Paying attention to thin media models may negatively affect women's self-evaluation. This study aimed to reduce the amount of attention that young women give to appearance-related information by challenging the sociocultural norms for appearance, and studied the moderating role of self-esteem. Seventy-one college women either received norm-confirming, norm-challenging, or no information regarding the sociocultural norms for appearance. Subsequently, participants' visual attention to appearance-related and neutral advertisements was measured using an eye-tracker. The results demonstrate that when no information or norm-confirming information was received, women with lower self-esteem paid more attention to the appearance-related advertisements than women with higher self-esteem. Importantly however, when norm-challenging information was received, women with lower self-esteem paid significantly less attention to the appearance-related ads than women with lower self-esteem who did not receive this manipulation. These findings indicate that challenging the sociocultural norms for appearance can attenuate the amount of attention women give to appearance-related media. Copyright © 2013 Elsevier Ltd. All rights reserved.

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)

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

Science.gov (United States)

Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

2015-12-01

Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher

Safety issues for superconducting fusion magnets

International Nuclear Information System (INIS)

Hsieh, S.Y.; Reich, M.; Powell, J.R.

1978-01-01

Safety issues for future superconducting fusion magnet systems are examined. It is found that safety and failure experience with existing superconducting magnets is not very applicable to predictions as to the safety and reliability of fusion magnets. Such predictions will have to depend on analysis and judgement for many years to come, rather than on accumulated experience. A number of generic potential structural, thermal-hydraulic, and electrical safety problems are identified and analyzed. Prevention of quenches and non-uniform temperature distributions, if quenches should occur, is of great importance, since such events can trigger processes which lead to magnet damage or failure. Engineered safety features will be necessary for fusion magnets. Two of these, an energy dispersion system and external coil containment, appear capable of reducing the probability of coil disruption to very low levels. However, they do not prevent loss of function accidents which are of economic concern. Elaborate detector, temperature equalization, and energy removal systems will be required to minimize the chances of loss of function accidents

Early Botulinum Toxin Injections in Infants With Musculoskeletal Disorders: A Systematic Review of Safety and Effectiveness.

Science.gov (United States)

Bourseul, Jean-Sébastien; Molina, Anais; Lintanf, Mael; Houx, Laetitia; Chaléat-Valayer, Emmanuelle; Pons, Christelle; Brochard, Sylvain

2018-06-01

To report current evidence regarding the safety of intramuscular botulinum toxin injection (BTI) in children with orthopedic- and neurologic-related musculoskeletal disorders >2 years of age. PubMed, Cochrane Library, and ScienceDirect, Google Scholar, and Web of Science. Two reviewers independently selected studies based on predetermined inclusion criteria. Data relating to the aim were extracted. Methodologic quality was graded independently by 2 reviewers using the Physiotherapy Evidence Database scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs. Level of evidence was determined using the modified Sackett scale. Data of 473 infants were analyzed. Fifty-five infants had cerebral palsy, 112 had obstetric brachial plexus palsy, 257 had clubfoot, and 44 had congenital torticollis. No studies reported any severe adverse event that could be attributed to the BTI. The rate of mild to moderate adverse events reported varied from 5% to 25%. Results regarding efficacy were preliminary, dependent on the pathology, and limited by the small number of studies and their low levels of evidence. BTI is already widely used as an early treatment for this age group. The safety profile of BTI in infants appears similar to that of older children and risks appear more related to the severity of the pathology and the location of the injections than to the toxin itself. Regarding effectiveness, other studies with higher levels of evidence should be carried out for each specific pathology. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Audiologist-patient communication profiles in hearing rehabilitation appointments.

Science.gov (United States)

Meyer, Carly; Barr, Caitlin; Khan, Asaduzzaman; Hickson, Louise

2017-08-01

To profile the communication between audiologists and patients in initial appointments on a biomedical-psychosocial continuum; and explore the associations between these profiles and 1) characteristics of the appointment and 2) patients' decisions to pursue hearing aids. Sixty-three initial hearing assessment appointments were filmed and audiologist-patient communication was coded using the Roter Interaction Analysis System. A hierarchical cluster analysis was conducted to profile audiologist-patient communication, after which regression modelling and Chi-squared analyses were conducted. Two distinct audiologist-patient communication profiles were identified during both the history taking phase (46=biopsychosocial profile, 15=psychosocial profile) and diagnosis and management planning phase (45=expanded biomedical profile, 11=narrowly biomedical profile). Longer appointments were significantly more likely to be associated with an expanded biomedical interaction during the diagnosis and management planning phase. No significant associations were found between audiologist-patient communication profile and patients' decisions to pursue hearing aids. Initial audiology consultations appear to remain clinician-centred. Three quarters of appointments began with a biopsychosocial interaction; however, 80% ended with an expanded biomedical interaction. Findings suggest that audiologists could consider modifying their communication in initial appointments to more holistically address the needs of patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Immunogenicity, safety and tolerability of inactivated trivalent influenza vaccine in overweight and obese children.

Science.gov (United States)

Esposito, Susanna; Giavoli, Claudia; Trombetta, Claudia; Bianchini, Sonia; Montinaro, Valentina; Spada, Anna; Montomoli, Emanuele; Principi, Nicola

2016-01-02

Obesity may be a risk factor for increased hospitalization and deaths from infections due to respiratory pathogens. Additionally, obese patients appear to have impaired immunity after some vaccinations. To evaluate the immunogenicity, safety and tolerability of an inactivated trivalent influenza vaccine (TIV) in overweight and obese children, 28 overweight/obese pediatric patients and 23 healthy normal weight controls aged 3-14 years received a dose of TIV. Four weeks after vaccine administration, significantly higher seroprotection rates against the A/H1N1 strain were observed among overweight/obese children compared with normal weight controls (pvaccination, similar or slightly higher seroconversion and seroprotection rates against the A/H1N1 and A/H3N2 strains were detected in overweight/obese than in normal weight children, whereas significantly higher rates of seroconversion and seroprotection against the B strain were found in overweight/obese patients than in normal weight controls (pvaccine administration (pchildren, antibody response to TIV administration is similar or slightly higher than that evidenced in normal weight subjects of similar age and this situation persists for at least 4 months after vaccine administration in the presence of a favorable safety profile. Copyright © 2015 Elsevier Ltd. All rights reserved.

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 IAEA programme on research reactor safety

International Nuclear Information System (INIS)

Abou Yehia, H.

2007-01-01

According to the research reactor database of IAEA (RRDB), 250 reactors are operating worldwide, 248 have been shut down and 170 have been decommissioned. Among the 248 reactors that do not run, some will resume their activities, others will be dismantled and the rest do not face a clear future. The analysis of reported incidents shows that the ageing process is a major cause of failures, more than two thirds of operating reactors are over 30 years old. It also appears that the lack of adequate regulations or safety standards for research reactors is an important issue concerning reactor safety particularly when reactors are facing re-starting or upgrading or modifications. The IAEA has launched a 4-axis program: 1) to set basic safety regulations and standards for research reactors, 2) to provide IAEA members with an efficient help for the application of these safety regulations to their reactors, 3) to foster international exchange of information on research reactor safety, and 4) to provide IAEA members with a help concerning safety issues linked to malicious acts or sabotage on research reactors

Ways of improving safety for future PWRs in France

International Nuclear Information System (INIS)

Gros, G.; Jalouneix, J.; Manesse, D.; Mattei, J.M.

1994-01-01

For the design of a new generation of nuclear power plants which could be ordered in France at the end of the nineties, there is a broad consensus on the choice of the evolutionary way, in view of the significant progress in the field of safety which appears possible with this approach, due to feedback of operating experience from a large number of reactors, results of extended safety research and development projects, general technical progress and findings from detailed probabilistic safety studies performed. This paper presents results of thinkings and studies, conducted within the Institute for Nuclear Safety and Protection (IPSN) in the various fields mentioned, in view of the definition of safety objectives and principles for future PWRs. These results contributed to the preparation of a common safety approach for future plants in France and Germany. (authors). 1 tab., 3 refs

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.

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.

Towards an occupational safety and health culture

NARCIS (Netherlands)

Zwetsloot, G.I.J.M.; Steijger, N.

2014-01-01

Occupational safety and health (OSH) is a highly regulated area that appears to be based on rational planning and logical management approaches, e.g. OSM Management Systems: employers and employees of organisations should be aware of OSH risks, assess these risks systematically, provide the

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

Multi-band Modelling of Appearance

DEFF Research Database (Denmark)

Stegmann, Mikkel Bille; Larsen, Rasmus

2003-01-01

the appearance of both derived feature bands and an intensity band. As a special case of feature-band augmented appearance modelling we propose a dedicated representation with applications to face segmentation. The representation addresses a major problem within face recognition by lowering the sensitivity...

Multi-band Modelling of Appearance

DEFF Research Database (Denmark)

Stegmann, Mikkel Bille; Larsen, Rasmus

2002-01-01

the appearance of both derived feature bands and an intensity band. As a special case of feature-band augmented appearance modelling we propose a dedicated representation with applications to face segmentation. The representation addresses a major problem within face recognition by lowering the sensitivity...

Supplement report to the Nuclear Criticality Safety Handbook of Japan

International Nuclear Information System (INIS)

Okuno, Hiroshi; Komuro, Yuichi; Nakajima, Ken

1995-10-01

Supplementing works to 'The Nuclear Criticality Safety Handbook' of Japan have been continued since 1988, the year the handbook edited by the Science and Technology Agency first appeared. This report publishes the fruits obtained in the supplementing works. Substantial improvements are made in the chapters of 'Modelling the evaluation object' and 'Methodology for analytical safety assessment', and newly added are chapters of 'Criticality safety of chemical processes', 'Criticality accidents and their evaluation methods' and 'Basic principles on design and installation of criticality alarm system'. (author)

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.

Profile of aclidinium bromide in the treatment of chronic obstructive pulmonary disease

Directory of Open Access Journals (Sweden)

Sims MW

2011-09-01

Full Text Available Michael W Sims, Reynold A Panettieri, Jr. Pulmonary, Allergy, and Critical Care Division, Airways Biology Initiative, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA Abstract: Bronchodilators provide the mainstay of pharmacologic therapy for chronic obstructive pulmonary disease (COPD, and anticholinergic bronchodilators, in particular, appear to be the most effective. There are currently two anticholinergic agents available in the US for the treatment of COPD (ipratropium bromide and tiotropium bromide, but several others are in various stages of development. Aclidinium bromide, a novel, long-acting, anticholinergic bronchodilator, is currently in Phase III trials for the management of COPD. Available evidence suggests that aclidinium is a safe and well tolerated drug with a relatively rapid onset and a sufficient duration of action to provide once-daily dosing. This article will provide a pharmacologic profile of aclidinium bromide and review the preclinical and clinical studies evaluating its safety and efficacy in the treatment of COPD. Keywords: aclidinium bromide, bronchodilators, pulmonary disease, chronic obstructive, muscarinic antagonists, pharmacokinetics, pharmacology

Spatial profiling of ion and neutral excitation in noble gas electron cyclotron resonance plasmas

International Nuclear Information System (INIS)

Rhoades, R.L.; Gorbatkin, S.M.

1994-01-01

Optical emission from neutrals and ions of several noble gases has been profiled in an electron cyclotron resonance plasma system. In argon plasmas with a net microwave power of 750 W, the neutral (696.5-nm) and ion (488-nm) emission profiles are slightly center peaked at 0.32 mTorr and gradually shift to a hollow appearance at 2.5 mTorr. Neon profiles show a similar trend from 2.5 to 10.0 mTorr. For the noble gases, transition pressure scales with the ionization potential of the gas, which is consistent with neutral depletion. Studies of noble gas mixtures, however, indicate that neutral depletion is not always dominant in the formation of hollow profiles. For Kr/Ar, Ar/Ne, and Ne/He plasmas, the majority gas tends to set the overall shape of the profile at any given pressure. For the conditions of the current system, plasma density appears to be more dominant than electron temperature in the formation of hollow profiles. The general method described is also a straightforward, inexpensive technique for measuring the spatial distribution of power deposited in plasmas, particularly where absolute scale can be calibrated by some other means

General principles of nuclear safety management related to research reactor decommissioning

International Nuclear Information System (INIS)

Banciu, Ortenzia; Vladescu, Gabriela

2003-01-01

The paper contents the general principles applicable to the decommissioning of research reactors to ensure a proper nuclear safety management, during both decommissioning activities and post decommissioning period. The main objective of decommissioning is to ensure the protection of workers, population and environment against all radiological and non-radiological hazards that could result after a reactor shutdown and dismantling. In the same time, it is necessary, by some proper provisions, to limit the effect of decommissioning for the future generation, according to the new Romanian, IAEA and EU Norms and Regulations. Assurance of nuclear safety during decommissioning process involves, in the first step, to establish of some safety principles and requirements to be taken into account during whole process. In the same time, it is necessary to perform a series of analyses to ensure that the whole process is conducted in a planned and safe manner. The general principles proposed for a proper management of safety during research reactor decommissioning are as follows: - Set-up of all operations included in a Decommissioning Plan; - Set-up and qualitative evaluation of safety problems, which could appear during normal decommissioning process, both radiological and nonradiological risks for workers and public; - Set-up of accident list related to decommissioning process the events that could appear both due to some abnormal working conditions and to some on-site and off-site events like fires, explosions, flooding, earthquake, etc.); - Development and qualitative/ quantitative evaluation of scenarios for each incidents; - Development (and evaluation) of safety indicator system. The safety indicators are the most important tools used to assess the level of nuclear safety during decommissioning process, to discover the weak points and to establish safety measures. The paper contains also, a safety case evaluation (description of facility according to the decommissioning

Appearance questions can be misleading

DEFF Research Database (Denmark)

Hansen, Mikkel; Markman, Ellen M.

2005-01-01

Preschoolers' success on the appearance-reality task is a milestone in theory-of-mind development. On the standard task children see a deceptive object, such as a sponge that looks like a rock, and are asked, "What is this really?" and "What does this look like?" Children below 4 1/2 years of age...... fail saying that the object not only is a sponge but also looks like a sponge. We propose that young children's difficulty stems from ambiguity in the meaning of "looks like." This locution can refer to outward appearance ("Peter looks like Paul") but in fact often refers to likely reality ("That looks...... like Jim"). We propose that "looks like" is taken to refer to likely reality unless the reality is already part of the common ground of the conversation. Because this joint knowledge is unclear to young children on the appearance-reality task, they mistakenly think the appearance question is about...

THE CONDITION AND THE DYNAMICS OF CHANGES OF REGIONAL ENERGETIC SAFETY LEVEL

Directory of Open Access Journals (Sweden)

A.L. Myzin

2006-12-01

Full Text Available On the basis of indicative analysis method use, the dynamic processes of changes of energetic safety condition of federal districts and subjects of Russian Federation for last 5 years are investigated. The results of diagnosing safety levels for separate indicators, their blocks and the results of situation evaluation as a whole are discussed. The comparison of regions’ energetic safety condition is given, the causes of crisis situations appearance are discovered, and on this basis the suggestions for regions’ safety levels increasing are formulated.

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

78 FR 76628 - Draft Risk Profile on Pathogens and Filth in Spices: Availability; Extension of Comment Period

Science.gov (United States)

2013-12-18

...] Draft Risk Profile on Pathogens and Filth in Spices: Availability; Extension of Comment Period AGENCY... Profile on Pathogens and Filth in Spices: Availability'' that appeared in the Federal Register of November... Risk Profile on Pathogens and Filth in Spices: Availability.'' The notice provided a 60-day comment...

Wedgelet Enhanced Appearance Models

DEFF Research Database (Denmark)

Darkner, Sune; Larsen, Rasmus; Stegmann, Mikkel Bille

2004-01-01

Statistical region-based segmentation methods such as the Active Appearance Model (AAM) are used for establishing dense correspondences in images based on learning the variation in shape and pixel intensities in a training set. For low resolution 2D images correspondences can be recovered reliably....... The wedgelet regression trees employed are based on triangular domains and estimated using cross validation. The wedgelet regression trees are functional descriptions of the intensity information and serve to 1) reduce noise and 2) produce a compact textural description. The wedgelet enhanced appearance model...

Fast Newton active appearance models

NARCIS (Netherlands)

Kossaifi, Jean; Tzimiropoulos, Georgios; Pantic, Maja

2014-01-01

Active Appearance Models (AAMs) are statistical models of shape and appearance widely used in computer vision to detect landmarks on objects like faces. Fitting an AAM to a new image can be formulated as a non-linear least-squares problem which is typically solved using iterative methods. Owing to

Some safety considerations in laser-controlled thermonuclear reactors. Final report

International Nuclear Information System (INIS)

Botts, T.E.; Breton, D.; Chan, C.K.; Levy, S.I.; Sehnert, M.; Ullman, A.Z.

1978-07-01

A major objective of this study was to identify potential safety questions for laser controlled thermonuclear reactors. From the safety viewpoint, it does not appear that the actual laser controlled thermonuclear reactor conceptual designs present hazards very different than those of magnetically confined fusion reactors. Some aspects seem beneficial, such as small lithium inventories, and the absence of cryogenic devices, while other aspects are new, for example the explosion of pressure vessels and laser hazards themselves. Major aspects considered in this report include: (a) general safety considerations, (b) tritium inventories, (c) system behavior during loss of flow accidents, and (d) safety considerations of laser related penetrations

Alternate approaches to nuclear safety

International Nuclear Information System (INIS)

Crane, A.T.

1985-01-01

For the US nuclear power industry to expand, a greatly increased portion of the public must come to share the industry's confidence in reactor safety. Major obstacles to establishing this confidence are frequent incidents with potential safety implications and a lack of incontrovertible proof that the risk of a major accident is very low. The most important step toward overcoming these obstacles would be for each utility to operate, maintain, and evaluate its reactors according to far higher standards. With improvements in reliability and safety margins, existing plants would be a stimulus for building new ones rather than an impediment. If changes to the operation of existing plants and improvements to the design of future ones were inadequate, the only hope for a revival of the nuclear industry would be an alternative reactor so obviously safe that risk would no longer be an issue. Three possible concepts are the modular high-temperature gas reactor, the process inherent ultimate safety reactor, and the liquid-metal fast reactor. All three have inherent safety features that should make a meltdown essentially impossible. They cannot know just how great the advantage of these alternate reactors would be, but the benefits of developing one or more of the concepts appear great

Mammographic appearances of male breast disease.

Science.gov (United States)

Appelbaum, A H; Evans, G F; Levy, K R; Amirkhan, R H; Schumpert, T D

1999-01-01

Various male breast diseases have characteristic mammographic appearances that can be correlated with their pathologic diagnoses. Male breast cancer is usually subareolar and eccentric to the nipple. Margins of the lesions are more frequently well defined, and calcifications are rarer and coarser than those occurring in female breast cancer. Gynecomastia usually appears as a fan-shaped density emanating from the nipple, gradually blending into surrounding fat. It may have prominent extensions into surrounding fat and, in some cases, an appearance similar to that of a heterogeneously dense female breast. Although there are characteristic mammographic features that allow breast cancer in men to be recognized, there is substantial overlap between these features and the mammographic appearance of benign nodular lesions. The mammographic appearance of gynecomastia is not similar to that of male breast cancer, but in rare cases, it can mask malignancy. Gynecomastia can be mimicked by chronic inflammation. All mammographically lucent lesions of the male breast appear to be benign, similar to such lesions in the female breast.

Exact analytical density profiles and surface tension

Indian Academy of Sciences (India)

journal of. May 2005 physics pp. 785–801. Classical charged fluids at equilibrium near ... is provided by the excess surface tension for an air–water interface, which is determined ... the potential drop created by the electric layer which appears as soon as the fluid has ...... radii, by symmetry, the charge density profile is flat,.

Nasolabial appearance after two palatoplasty types in cleft lip and palate.

Science.gov (United States)

Brudnicki, A; Bronkhorst, E M; Nada, R; Dudkiewicz, Z; Kaminek, M; Katsaros, C; Fudalej, P S

2014-05-01

Facial appearance is important for normal psychosocial development in children with cleft lip and palate (CLP). There is conflicting evidence on how deficient maxillary growth may affect nasolabial esthetics. We retrospectively investigated nasolabial appearance in two groups, the Langenback (35 children; mean age 11.1 years; range: 7.9-13.6) and Vomerplasty (58 children; mean age 10.8 years; range: 7.8-14), who received unilateral CLP surgery by the same surgeon. The hard palate repair technique differed between the two groups. In the Langenback group, palatal bone on the non-cleft side only was left denuded, inducing scar formation and inhibiting maxillary growth. In the Vomerplasty group, a vomerplasty with tight closure of the soft tissues on the palate was applied. Thirteen lay judges rated nasolabial esthetics on photographs using a modified Asher-McDade's index. Nasolabial esthetics in both groups was comparable (p > 0.1 for each nasolabial component). Inferior view was judged as the least esthetic component and demonstrated mean scores 3.18 (SD = 0.63) and 3.13 (SD = 0.47) in the Langenback and Vomerplasty groups, respectively. Mean scores for other components were from 2.52 (SD = 0.63) to 2.81 (SD = 0.62). Regression analysis showed that vomerplasty is related with slight improvement in the nasal profile only (coefficient B = -0.287; p = 0.043; R(2 ) = 0.096). This study demonstrates that the use of vomerplasty instead of the Langenbeck technique is weakly associated with the nasolabial appearance among pre-adolescent patients with UCLP. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Blood transfusion safety: a new philosophy.

Science.gov (United States)

Franklin, I M

2012-12-01

Blood transfusion safety has had a chequered history, and there are current and future challenges. Internationally, there is no clear consensus for many aspects of the provision of safe blood, although pan-national legislation does provide a baseline framework in the European Union. Costs are rising, and new safety measures can appear expensive, especially when tested against some other medical interventions, such as cancer treatment and vaccination programmes. In this article, it is proposed that a comprehensive approach is taken to the issue of blood transfusion safety that considers all aspects of the process rather than considering only new measures. The need for an agreed level of safety for specified and unknown risks is also suggested. The importance of providing care and support for those inadvertently injured as a result of transfusion problems is also made. Given that the current blood safety decision process often uses a utilitarian principle for decision making--through the calculation of Quality Adjusted Life Years--an alternative philosophy is proposed. A social contract for blood safety, based on the principles of 'justice as fairness' developed by John Rawls, is recommended as a means of providing an agreed level of safety, containing costs and providing support for any adverse outcomes. © 2012 The Author. Transfusion Medicine © 2012 British Blood Transfusion Society.

National Profiles in Technical and Vocational Education in Asia and the Pacific: Bangladesh.

Science.gov (United States)

United Nations Educational, Scientific and Cultural Organization, Bangkok (Thailand). Principal Regional Office for Asia and the Pacific.

This technical and vocational education (TVE) profile on Bangladesh is one in a series of profiles of UNESCO member countries. It is intended to be a handy reference on TVE systems, staff development, technical cooperation, and information networking. An overview of the report appears first. Part I provides general information on the physical…

Natural safety indicators and their application to repository safety cases

International Nuclear Information System (INIS)

Miller, B.

2002-01-01

Radiological dose and risk are the standard end-points calculated in all performance assessments. Their calculation requires, however, assumptions to be made for future human behaviour. To complement dose and risk, other safety indicators have been suggested which do not require such assumptions to be made. One proposed set of safety indicators are the concentrations and fluxes of naturally-occurring chemical species in the environment which may be compared with the performance assessment predictions of repository releases. Such comparisons can be valid because both the natural and repository species would occur in the same system and their transport behaviour would be controlled by exactly the same processes at the same rates. Although simple in concept, there is currently no consensus on the most appropriate comparisons to make or on the interpretation of such comparisons. A number of national and international research projects are evaluating this proposed approach, including an IAEA Co-ordinated Research Programme. These projects suggest that that the approach appears to be workable and that it may be a valuable component of a safety case, complementing the dose and risk presentations. Further work is, however, necessary to develop the approach to a level where it may be confidently applied in further performance assessments in a consistent and methodical manner. (author)

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 ...

Safety, pharmacokinetics, and antitumor activity of AMG 386, a selective angiopoietin inhibitor, in adult patients with advanced solid tumors.

Science.gov (United States)

Herbst, Roy S; Hong, David; Chap, Linnea; Kurzrock, Razelle; Jackson, Edward; Silverman, Jeffrey M; Rasmussen, Erik; Sun, Yu-Nien; Zhong, Don; Hwang, Yuying C; Evelhoch, Jeffrey L; Oliner, Jonathan D; Le, Ngocdiep; Rosen, Lee S

2009-07-20

PURPOSE AMG 386 is an investigational peptide-Fc fusion protein (ie, peptibody) that inhibits angiogenesis by preventing the interaction of angiopoietin-1 and angiopoietin-2 with their receptor, Tie2. This first-in-human study evaluated the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of AMG 386 in adults with advanced solid tumors. PATIENTS AND METHODS Patients in sequential cohorts received weekly intravenous AMG 386 doses of 0.3, 1, 3, 10, or 30 mg/kg. Results Thirty-two patients were enrolled on the study and received AMG 386. One occurrence of dose-limiting toxicity was seen at 30 mg/kg: respiratory arrest, which likely was caused by tumor burden that was possibly related to AMG 386. The most common toxicities were fatigue and peripheral edema. Proteinuria (n = 11) was observed without clinical sequelae. Only four patients (12%) experienced treatment-related toxicities greater than grade 1. A maximum-tolerated dose was not reached. PK was dose-linear and the mean terminal-phase elimination half-life values ranged from 3.1 to 6.3 days. Serum AMG 386 levels appeared to reach steady-state after four weekly doses, and there was minimal accumulation. No anti-AMG 386 neutralizing antibodies were detected. Reductions in volume transfer constant (K(trans); measured by dynamic contrast-enhanced magnetic resonance imaging) were observed in 10 patients (13 lesions) 48 hours to 8 weeks after treatment. One patient with refractory ovarian cancer achieved a confirmed partial response (ie, 32.5% reduction by Response Evaluation Criteria in Solid Tumors) and withdrew from the study with a partial response after 156 weeks of treatment; four patients experienced stable disease for at least 16 weeks. CONCLUSION Weekly AMG 386 appeared well tolerated, and its safety profile appeared distinct from that of vascular endothelial growth factor-axis inhibitors. AMG 386 also appeared to impact tumor vascularity and showed antitumor activity in this patient

Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

Directory of Open Access Journals (Sweden)

Bander Balkhi

2018-02-01

Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

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

Resonance line-profiles in galactic disk UV-bright stars

International Nuclear Information System (INIS)

Carrasco, L.; Costero, R.

1987-01-01

We have made a comparative analysis of UV resonance line-profiles in O-type stars members of young clusters and OB associations, with those of hot stars located away from sites of recent star formation (including ''runaway'' stars). The resonance line-profiles are found to be generally dominated by stellar winds that appear to depend mainly on the surface gravity and temperature of the star, and not on its mass. We also present the C IV, Si IV and N V resonance line-profiles for eleven stars not published in the previous two papers. The use of only the largest stellar wind velocity detectable in the resonance lines as a stellar population indicator, is disputed. (author)

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.

Advanced reactor concepts and safety

International Nuclear Information System (INIS)

Lipsett, J.J.

1988-06-01

The need for some consistency in the terms used to describe the evolution of methods for ensuring the safety of nuclear reactors has been identified by the IAEA. This is timely since there appears to be a danger that the precision of many valuable words is being diluted and that a new jargon may appear that will confuse rather than aid the communication of important but possibly diverse philosophies and concepts. Among the difficulties faced by the nuclear industry is promoting and gaining a widespread understanding of the risks actually posed by nuclear reactors. In view of the importance of communication to both the public and to the technical community generally, the starting point for the definition of terms must be with dictionary meanings and common technical usage. The nuclear engineering community should use such words in conformance with the whole technical world. This paper addresses many of the issues suggested in the invitation to meet and also poses some additional issues for consideration. Some examples are the role of the operator in either enhancing or degrading safety and how the meaning or interpretation of the word 'safety' can be expected to change during the next few decades. It is advantageous to use criteria against which technologies and ongoing operating performance can be judged provided that the criteria are generic and not specific to particular reactor concepts. Some thoughts are offered on the need to frame the criteria carefully so that innovative solutions and concepts are fostered, not stifled

A study of microbial profile modification

Energy Technology Data Exchange (ETDEWEB)

Bae, J.H.; Lee, H.O.

1995-12-31

A microbial profile modification method using spores was investigated. A halotolerant, spore-forming, biopolymer-producing mesophile was used in Berea cores with a specifically formulated nutrient package to reduce the permeability of the rock. The degree of permeability reduction varied widely depending on the stimulation protocols used. The incubation period had a significant impact on permeability reduction, and there appeared to be an optimum incubation time for maximum permeability reduction. The reduction persisted for many PV of brine injection and appeared very stable. For our microbes used in this study, the permeability reduction was about the same when the NaCl concentration was above 2 wt% in the range from 0 wt% to 10 wt%.

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

Observation of electron temperature profile in HL-1M tokamak

International Nuclear Information System (INIS)

Cao Jianyong; Xu Deming; Ding Xuantong

2000-01-01

The principle and method of the electron temperature measurement by means of electron cyclotron emission (ECE) have been described. Several results under different conditions on HL-1M tokamak have been given. The hollow profile of electron temperature appears in some stages, such as current rising, pellet injection and impurity concentration in the plasma centre. When the bias voltage is applied, the electron temperature profile become steeper. All of the phenomena are related with the transport in plasma centre

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

The condition and the dynamics of changes of regional energetic safety level

OpenAIRE

Anatoliy Myzin; Aleksey Kalina; Andrey Kozitsyn; Pavel Pykhov

2006-01-01

On the basis of indicative analysis method use, the dynamic processes of changes of energetic safety condition of federal districts and subjects of Russian Federation for last 5 years are investigated. The results of diagnosing safety levels for separate indicators, their blocks and the results of situation evaluation as a whole are discussed. The comparison of regions’ energetic safety condition is given, the causes of crisis situations appearance are discovered, and on this basis the sugg...

Safety targets and public risk perceptions in the nuclear field - technical treadmill or institutional responses?

International Nuclear Information System (INIS)

Wynne, B.

1989-01-01

The context of our treatment of risk perceptions and safety targets is the apparently wide gap between expert judgements of 'objective risks' and public perceptions of those risks. In the nuclear field the latter appear to so multiply the objective risks as seen by the experts, as to make safety targets vastly too strict (whether for routine discharges or for large accidents), thus design extravagantly expensive on any 'rational' criteria. In recent years the nuclear industry has come to terms more with the public perceptions problem, and has accepted that it is legitimate to exercise different, more severe and costly safety standards in the nuclear field if that is what society wants, as it appears to do. Whilst retaining the conviction that this is scientifically unwarranted, the industry has therefore reconciled itself somewhat to more stringent technical safety targets. (author)

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)

Safety and Efficacy of Intrapleural Tissue Plasminogen Activator and DNase during Extended Use in Complicated Pleural Space Infections

Directory of Open Access Journals (Sweden)

Jason R. McClune

2016-01-01

Full Text Available The use of intrapleural therapy with tissue plasminogen activator and DNase improves outcomes in patients with complicated pleural space infections. However, little data exists for the use of combination intrapleural therapy after the initial dosing period of six doses. We sought to describe the safety profile and outcomes of intrapleural therapy beyond this standard dosing. A retrospective review of patients receiving intrapleural therapy with tissue plasminogen activator and DNase was performed at two institutions. We identified 101 patients from January 2013 to August 2015 receiving intrapleural therapy for complicated pleural space infection. The extended use of intrapleural tissue plasminogen activator and DNase therapy beyond six doses was utilized in 20% (20/101 of patients. The mean number of doses in those undergoing extended dosing was 9.8 (range of 7–16. Within the population studied there appears to be no statistically significant increased risk of complications, need for surgical referral, or outcome differences when comparing those receiving standard or extended dosing intrapleural therapy. Future prospective study of intrapleural therapy as an alternative option for patients who fail initial pleural drainage and are unable to tolerate/accept a surgical intervention appears a potential area of study.

Ways of ensuring short/long term safety

International Nuclear Information System (INIS)

Boeck, B. de; Baltes, B.; Besnus, F.

2006-01-01

Various strategies have been adopted among countries to manage radioactive waste. The present publication gives to this respect a broad overview of the policies and strategies adopted by Germany, Belgium and France. It appears that these may show remarkable differences, but motivated mainly by political and societal considerations. With regard to safety, practices for waste management are consistent and reflect the broad international consensus that has been progressively established. As an illustration, safety practices and possible specificities for the storage and geological disposal of spent fuel and high level radioactive waste from reprocessing are shortly described. (authors)

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.

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.

Exploring the relationship between appearance-contingent self-worth and self-esteem: The roles of self-objectification and appearance anxiety.

Science.gov (United States)

Adams, Katherine E; Tyler, James M; Calogero, Rachel; Lee, Jenifer

2017-12-01

Previous work has shown that both an appearance-contingent self-worth (i.e., staking one's overall self-evaluation on one's physical appearance) and self-objectification are associated with higher appearance anxiety and lower self-esteem among women. Although prior evidence separately links both appearance-contingent self-worth and self-objectification to these negative outcomes, no work has examined the mediating processes that may underlie this relationship. With the current project, we examined the relationship between appearance-contingent self-worth and self-objectification, and the degree to which this relationship is associated with higher appearance anxiety and lower overall self-esteem. We hypothesized that appearance-contingent self-worth would be positively associated with self-objectification; in turn, we expected self-objectification to be related to higher appearance anxiety, and ultimately, lower self-esteem. Across two studies, one cross-sectional (N=208) and one short-term longitudinal (N=191), we found compelling support for this hypothesis. These findings have practical and theoretical significance for both the self-objectification and contingent self-worth literatures. Published by Elsevier Ltd.

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.

Metabolic Profiling Reveals Differences in Plasma Concentrations of Arabinose and Xylose after Consumption of Fiber-Rich Pasta and Wheat Bread with Differential Rates of Systemic Appearance of Exogenous Glucose in Healthy Men.

Science.gov (United States)

Pantophlet, Andre J; Wopereis, Suzan; Eelderink, Coby; Vonk, Roel J; Stroeve, Johanna H; Bijlsma, Sabina; van Stee, Leo; Bobeldijk, Ivana; Priebe, Marion G

2017-02-01

The consumption of products rich in cereal fiber and with a low glycemic index is implicated in a lower risk of metabolic diseases. Previously, we showed that the consumption of fiber-rich pasta compared with bread resulted in a lower rate of appearance of exogenous glucose and a lower glucose clearance rate quantified with a dual-isotope technique, which was in accordance with a lower insulin and glucose-dependent insulinotropic polypeptide response. To gain more insight into the acute metabolic consequences of the consumption of products resulting in differential glucose kinetics, postprandial metabolic profiles were determined. In a crossover study, 9 healthy men [mean ± SEM age: 21 ± 0.5 y; mean ± SEM body mass index (kg/m 2 ): 22 ± 0.5] consumed wheat bread (132 g) and fresh pasta (119 g uncooked) enriched with wheat bran (10%) meals. A total of 134 different metabolites in postprandial plasma samples (at -5, 30, 60, 90, 120, and 180 min) were quantified by using a gas chromatography-mass spectrometry-based metabolomics approach (secondary outcomes). Two-factor ANOVA and advanced multivariate statistical analysis (partial least squares) were applied to detect differences between both food products. Forty-two different postprandial metabolite profiles were identified, primarily representing pathways related to protein and energy metabolism, which were on average 8% and 7% lower after the men consumed pasta rather than bread, whereas concentrations of arabinose and xylose were 58% and 53% higher, respectively. Arabinose and xylose are derived from arabinoxylans, which are important components of wheat bran. The higher bioavailability of arabinose and xylose after pasta intake coincided with a lower rate of appearance of glucose and amino acids. We speculate that this higher bioavailability is due to higher degradation of arabinoxylans by small intestinal microbiota, facilitated by the higher viscosity of arabinoxylans after pasta intake than after bread

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.

Appearance-change instruction effects on eyewitness lineup identification accuracy are not moderated by amount of appearance change.

Science.gov (United States)

Molinaro, Peter F; Arndorfer, Andrea; Charman, Steve D

2013-12-01

Instructing witnesses that a criminal may have changed appearance prior to showing them a lineup has been shown to increase false identifications without increasing correct identifications (S. D. Charman & G. L. Wells, 2007, Is the appearance-change instruction a good idea? Law and Human Behavior, Vol. 31, pp. 3-22). However, the generalizability of the effects of this appearance-change instruction (ACI) is unknown, and there are reasons to believe that the instruction's effects may be moderated by the amount of appearance change the criminal has actually undergone. The current study tested this hypothesis. Undergraduate students (N = 315) were exposed to a series of target faces and lineups, some of which contained the target and some of which did not, and made identification decisions. Half of the participants received a standard ACI prior to each lineup; the other half did not. The targets varied with respect to the amount to which their appearance had changed. Results indicated that the ACI inflated false identifications without inflating correct identifications, and that these effects did not depend on the amount of appearance change the target had undergone. Current recommendations to administer the ACI seem to be unfounded and may be harmful to the reliability of identification evidence. (c) 2013 APA, all rights reserved

The CT appearance of intraoral chewing gum

Energy Technology Data Exchange (ETDEWEB)

Towbin, Alexander J. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States)

2008-12-15

When imaged, intraoral chewing gum has the potential to be misdiagnosed. Chewing gum has a characteristic appearance on CT: it is ovoid in shape, hyperdense, and has small internal locules of air. Reports have described the appearance of gum on radiographs and abdominal CT images; however, no reports could be found detailing its appearance within the mouth. This report describes the appearance of intraoral chewing gum as well as the properties of the gum that lead to this appearance. Because of the potential for misdiagnosis, screening for intraoral foreign bodies should be considered prior to imaging. (orig.)

The CT appearance of intraoral chewing gum

International Nuclear Information System (INIS)

Towbin, Alexander J.

2008-01-01

When imaged, intraoral chewing gum has the potential to be misdiagnosed. Chewing gum has a characteristic appearance on CT: it is ovoid in shape, hyperdense, and has small internal locules of air. Reports have described the appearance of gum on radiographs and abdominal CT images; however, no reports could be found detailing its appearance within the mouth. This report describes the appearance of intraoral chewing gum as well as the properties of the gum that lead to this appearance. Because of the potential for misdiagnosis, screening for intraoral foreign bodies should be considered prior to imaging. (orig.)

Improving patient safety in radiation oncology

International Nuclear Information System (INIS)

Hendee, William R.; Herman, Michael G.

2011-01-01

Beginning in the 1990s, and emphasized in 2000 with the release of an Institute of Medicine report, healthcare providers and institutions have dedicated time and resources to reducing errors that impact the safety and well-being of patients. But in January 2010 the first of a series of articles appeared in the New York Times that described errors in radiation oncology that grievously impacted patients. In response, the American Association of Physicists in Medicine and the American Society of Radiation Oncology sponsored a working meeting entitled ''Safety in Radiation Therapy: A Call to Action''. The meeting attracted 400 attendees, including medical physicists, radiation oncologists, medical dosimetrists, radiation therapists, hospital administrators, regulators, and representatives of equipment manufacturers. The meeting was cohosted by 14 organizations in the United States and Canada. The meeting yielded 20 recommendations that provide a pathway to reducing errors and improving patient safety in radiation therapy facilities everywhere.

Control of Industrial Safety Based on Dynamic Characteristics of a Safety Budget-Industrial Accident Rate Model in Republic of Korea.

Science.gov (United States)

Choi, Gi Heung; Loh, Byoung Gook

2017-06-01

Despite the recent efforts to prevent industrial accidents in the Republic of Korea, the industrial accident rate has not improved much. Industrial safety policies and safety management are also known to be inefficient. This study focused on dynamic characteristics of industrial safety systems and their effects on safety performance in the Republic of Korea. Such dynamic characteristics are particularly important for restructuring of the industrial safety system. The effects of damping and elastic characteristics of the industrial safety system model on safety performance were examined and feedback control performance was explained in view of cost and benefit. The implications on safety policies of restructuring the industrial safety system were also explored. A strong correlation between the safety budget and the industrial accident rate enabled modeling of an industrial safety system with these variables as the input and the output, respectively. A more effective and efficient industrial safety system could be realized by having weaker elastic characteristics and stronger damping characteristics in it. A substantial decrease in total social cost is expected as the industrial safety system is restructured accordingly. A simple feedback control with proportional-integral action is effective in prevention of industrial accidents. Securing a lower level of elastic industrial accident-driving energy appears to have dominant effects on the control performance compared with the damping effort to dissipate such energy. More attention needs to be directed towards physical and social feedbacks that have prolonged cumulative effects. Suggestions for further improvement of the safety system including physical and social feedbacks are also made.

Atypical imaging appearances of intracranial meningiomas

Energy Technology Data Exchange (ETDEWEB)

O' Leary, S. [Radiology Department, Derriford Hospital, Plymouth (United Kingdom); Adams, W.M. [Radiology Department, Derriford Hospital, Plymouth (United Kingdom); Parrish, R.W. [Radiology Department, Derriford Hospital, Plymouth (United Kingdom); Mukonoweshuro, W. [Radiology Department, Derriford Hospital, Plymouth (United Kingdom)]. E-mail: William.mukonoweshuro@phnt.swest.nhs.uk

2007-01-15

Meningiomas are the commonest primary, non-glial intracranial tumours. The diagnosis is often correctly predicted from characteristic imaging appearances. This paper presents some examples of atypical imaging appearances that may cause diagnostic confusion.

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.

Color appearance in stereoscopy

Science.gov (United States)

Gadia, Davide; Rizzi, Alessandro; Bonanomi, Cristian; Marini, Daniele; Galmonte, Alessandra; Agostini, Tiziano

2011-03-01

The relationship between color and lightness appearance and the perception of depth has been studied since a while in the field of perceptual psychology and psycho-physiology. It has been found that depth perception affects the final object color and lightness appearance. In the stereoscopy research field, many studies have been proposed on human physiological effects, considering e.g. geometry, motion sickness, etc., but few has been done considering lightness and color information. Goal of this paper is to realize some preliminar experiments in Virtual Reality in order to determine the effects of depth perception on object color and lightness appearance. We have created a virtual test scene with a simple 3D simultaneous contrast configuration. We have created three different versions of this scene, each with different choices of relative positions and apparent size of the objects. We have collected the perceptual responses of several users after the observation of the test scene in the Virtual Theater of the University of Milan, a VR immersive installation characterized by a semi-cylindrical screen that covers 120° of horizontal field of view from an observation distance of 3.5 m. We present a description of the experiments setup and procedure, and we discuss the obtained results.

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.

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

A Guide to Laser Safety

Energy Technology Data Exchange (ETDEWEB)

Davies, W M

1998-09-01

In one of the few volumes dedicated to laser safety to appear since the 'bible' of Sliney and Wolbarsht, Roy Henderson sets out to provide the reader with a practical account of both the philosophy and practice across contemporary application of lasers. The book is split into three sections. The first section is essentially a non-mathematical review of lasers, optical hazards and laser safety. It is intended as an easily digestible introduction to the subject, conveying the primary concepts of laser safety without the camouflage of equations. This piece of text is manifestly readable by all who have interest in the topic. The second section introduces more meat onto the bones introduced in the first section and some of the practical mathematics necessary to determine optical irradiance in simple laser beams. The book is not intended as a scientific treatise and rigorous treatment of laser physics is left (for the better) to other texts. Laser hazard assessment and safety management are covered in sufficient detail to allow the reader to understand what precautions are necessary to mitigate the risks of laser use. The final section takes a brief look at laser safety in a number of specific industrial applications. These include industrial processing, medicine, telecommunications and entertainment. These should be taken in the context of the second section and are not stand-alone text. With few typographical errors, and packed with practical hints, this book serves as an excellent text for any educational course on laser safety and provides a quick and easy reference for laser safety officers. (book review: A Roy Henderson - ISBN: 0 412 72940 7)

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.

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)

Criminal psychological profiling of serial arson crimes.

Science.gov (United States)

Kocsis, Richard N; Cooksey, Ray W

2002-12-01

The practice of criminal psychological profiling is frequently cited as being applicable to serial arson crimes. Despite this claim, there does not appear to be any empirical research that examines serial arson offence behaviors in the context of profiling. This study seeks to develop an empirical model of serial arsonist behaviors that can be systematically associated with probable offender characteristics. Analysis has produced a model of offence behaviors that identify four discrete behavior patterns, all of which share a constellation of common nondiscriminatory behaviors. The inherent behavioral themes of each of these patterns are explored with discussion of their broader implications for our understanding of serial arson and directions for future research.

Genital Appearance Dissatisfaction: Implications for Women's Genital Image Self-Consciousness, Sexual Esteem, Sexual Satisfaction, and Sexual Risk.

Science.gov (United States)

Schick, Vanessa R; Calabrese, Sarah K; Rima, Brandi N; Zucker, Alyssa N

2010-09-01

Findings regarding the link between body image and sexuality have been equivocal, possibly because of the insensitivity of many of body image measures to potential variability across sensory aspects of the body (e.g., appearance versus odor), individual body parts (e.g., genitalia versus thighs), and social settings (e.g., public versus intimate). The current study refined existing methods of evaluating women's body image in the context of sexuality by focusing upon two highly specified dimensions: satisfaction with the visual appearance of the genitalia and self-consciousness about the genitalia during a sexual encounter. Genital appearance dissatisfaction, genital image self-consciousness, and multiple facets of sexuality were examined with a sample of 217 undergraduate women using an online survey. Path analysis revealed that greater dissatisfaction with genital appearance was associated with higher genital image self-consciousness during physical intimacy, which, in turn, was associated with lower sexual esteem, sexual satisfaction, and motivation to avoid risky sexual behavior. These findings underscore the detrimental impact of negative genital perceptions on young women's sexual wellbeing, which is of particular concern given their vulnerability at this stage of sexual development as well as the high rates of sexually transmitted infections within this age group. Interventions that enhance satisfaction with the natural appearance of their genitalia could facilitate the development of a healthy sexual self-concept and provide long-term benefits in terms of sexual safety and satisfaction.

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 ...

Semantic attributes for people's appearance description: an appearance modality for video surveillance applications

Science.gov (United States)

Frikha, Mayssa; Fendri, Emna; Hammami, Mohamed

2017-09-01

Using semantic attributes such as gender, clothes, and accessories to describe people's appearance is an appealing modeling method for video surveillance applications. We proposed a midlevel appearance signature based on extracting a list of nameable semantic attributes describing the body in uncontrolled acquisition conditions. Conventional approaches extract the same set of low-level features to learn the semantic classifiers uniformly. Their critical limitation is the inability to capture the dominant visual characteristics for each trait separately. The proposed approach consists of extracting low-level features in an attribute-adaptive way by automatically selecting the most relevant features for each attribute separately. Furthermore, relying on a small training-dataset would easily lead to poor performance due to the large intraclass and interclass variations. We annotated large scale people images collected from different person reidentification benchmarks covering a large attribute sample and reflecting the challenges of uncontrolled acquisition conditions. These annotations were gathered into an appearance semantic attribute dataset that contains 3590 images annotated with 14 attributes. Various experiments prove that carefully designed features for learning the visual characteristics for an attribute provide an improvement of the correct classification accuracy and a reduction of both spatial and temporal complexities against state-of-the-art approaches.

Struma ovarii. MR and CT appearance

International Nuclear Information System (INIS)

Joja, Ikuo; Mitsumori, Akihito; Hiraki, Yoshio; Kudo, Takafumi; Nakagawa, Tomio; Asakawa, Toru; Ando, Masaaki; Akamatsu, Nobuo.

1997-01-01

The purpose of this study was to examine the appearance of struma ovarii on MR and CT images. All 13 patients showed both cystic and solid components with a multilobulated surface and thickened septa. Various signal intensities were seen on both T1WI and T2WI. The cystic component, which showed low signal intensity on T2WI, showed high density on CT images. The characteristic MR and CT appearance of struma ovarii appears to be that of multicystic tumor indicating the presence of viscid materials containing iodine. (author)

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.

Faces On Facebook Associated Factors In Choosing The Facebook Profile Picture By Young Adults In SLIATE

Directory of Open Access Journals (Sweden)

N. D. Gunasekara

2015-08-01

Full Text Available This is a preliminary study which focuses on Facebook profile picture from two different perspectives selection and substitution. It attempt to identify amp evaluate the related variables that has an impact on profile picture selection. Participants include 309 male and female Facebook users between the ages of 18 to 34 who are enrolled in a higher education institute in Sri Lanka. The analysis finds that profile picture categories differ according to gender. Majority of the males prefer to use their own close up photo while female equally like to use their own close up photo or a photo of a celebrity. Profile picture category did not significantly vary by age perhaps because of less variation in the age group considered. But it depends on the appearance Facebook user is trying to convey through the profile picture. The individuals who post their own close up photos believe that they appear attractive. The individuals who feel that they look happy are uploading photos with their friends mostly. Most of the individuals change their profile picture when they find a better picture. Reason for changing the profile picture vary according to the age. The males believe they can build an impression about themselves through the profile picture whilst the females respond is neutral. Implications of these findings as well as suggestions for future research are discussed.

Patent ductus arteriosus occlusion in small dogs utilizing a low profile Amplatz® canine duct occluder prototype.

Science.gov (United States)

Stauthammer, Christopher D; Olson, Janet; Leeder, Damon; Hohnadel, Kristin; Hanson, Melissa; Tobias, Anthony H

2015-09-01

To develop procedural methodology and assess the safety, utility and effectiveness of a low profile Amplatz(®) canine duct occluder (ACDO) prototype in dogs deemed too small to undergo ductal occlusion with the commercially-available ACDO device. Twenty-one dogs with left-to-right shunting patent ductus arteriosus (PDA). Dogs were ≥1.5 kg but considered too small to accommodate a 6 Fr catheter or 4 Fr sheath within the femoral artery. Prospective canine study using a low profile ACDO prototype delivered through a 4 Fr catheter via a femoral arterial approach. Procedural methods, fluoroscopy time, perioperative complications, and residual ductal flow were evaluated, and angiographic ductal morphology and dimensions were tabulated. All 21 dogs underwent successful ductal occlusion using the prototype device, 4 Fr catheter, and right femoral artery approach. No perioperative complications or device embolization occurred. The median minimal ductal diameter was 1.9 mm (range, 0.4-3.4), and the median device size deployed was 4 mm (range, 3-6). Complete ductal occlusion was noted in 17 dogs (81%) on post-deployment angiography. Twenty dogs (95%) had no residual flow on echocardiography performed the following day. In the 17 dogs (81%) that returned for a long-term (≥3months) follow-up evaluation, all had complete ductal occlusion based on echocardiography. The low profile ACDO prototype is a safe and effective method of PDA occlusion in the small dog. The deployment procedure appears of similar technical difficulty to the commercially available ACDO. Copyright © 2015 Elsevier B.V. All rights reserved.

Element bow profiles from new and irradiated CANDU fuel bundles

International Nuclear Information System (INIS)

Dennier, D.; Manzer, A.M.; Ryz, M.A.

1996-01-01

Improved methods of measuring element profiles on new CANDU fuel bundles were developed at the Sheridan Park Engineering Laboratory, and have now been applied in the hot cells at Whiteshell Laboratories. For the first time, the outer element profiles have been compared between new, out-reactor tested, and irradiated fuel elements. The comparison shows that irradiated element deformation is similar to that observed on elements in out-reactor tested bundles. In addition to the restraints applied to the element via appendages, the element profile appears to be strongly influenced by gravity and the end loads applied by local deformation of the endplate. Irradiation creep in the direction of gravity also tends to be a dominant factor. (author)

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...

Nuclear fuels with high burnup: safety requirements

International Nuclear Information System (INIS)

Phuc Tran Dai

2016-01-01

Vietnam authorities foresees to build 3 reactors from Russian design (VVER AES 2006) by 2030. In order to prepare the preliminary report on safety analysis the Vietnamese Agency for Radioprotection and Safety has launched an investigation on the behaviour of nuclear fuels at high burnups (up to 60 GWj/tU) that will be those of the new plants. This study deals mainly with the behaviour of the fuel assemblies in case of loss of coolant (LOCA). It appears that for an average burnup of 50 GWj/tU and for the advanced design of the fuel assembly (cladding and materials) safety requirements are fulfilled. For an average burnup of 60 GWj/tU, a list of issues remains to be assessed, among which the impact of clad bursting or the hydrogen embrittlement of the advanced zirconium alloys. (A.C.)

Quantitative Appearance Inspection for Film Coated Tablets.

Science.gov (United States)

Yoshino, Hiroyuki; Yamashita, Kazunari; Iwao, Yasunori; Noguchi, Shuji; Itai, Shigeru

2016-01-01

The decision criteria for the physical appearance of pharmaceutical products are subjective and qualitative means of evaluation that are based entirely on human interpretation. In this study, we have developed a comprehensive method for the quantitative analysis of the physical appearance of film coated tablets. Three different kinds of film coated tablets with considerable differences in their physical appearances were manufactured as models, and their surface roughness, contact angle, color measurements and physicochemical properties were investigated as potential characteristics for the quantitative analysis of their physical appearance. All of these characteristics were useful for the quantitative evaluation of the physical appearances of the tablets, and could potentially be used to establish decision criteria to assess the quality of tablets. In particular, the analysis of the surface roughness and film coating properties of the tablets by terahertz spectroscopy allowed for an effective evaluation of the tablets' properties. These results indicated the possibility of inspecting the appearance of tablets during the film coating process.

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 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…

Chemical plant innovative safety investments decision-support methodology.

Science.gov (United States)

Reniers, G L L; Audenaert, A

2009-01-01

This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

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.

Persuasive appeals in road safety communication campaigns: Theoretical frameworks and practical implications from the analysis of a decade of road safety campaign materials.

Science.gov (United States)

Guttman, Nurit

2015-11-01

Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

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

Mother-child conversations about safety: implications for socializing safety values in children.

Science.gov (United States)

O'Neal, Elizabeth E; Plumert, Jodie M

2014-05-01

This study examined how mothers socialize their children about safety through conversations about potentially unsafe activities. Mothers and their 8- and 10-year-old children discussed and rated the safety of 12 photographs depicting another same-gender child engaged in potentially dangerous activities. Conversations usually unfolded with children giving the first rating or rationale, followed by additional discussion between the mother and child. Mothers and children relied on 2 main types of rationales to justify their ratings: potential outcomes of the activity and specific features of the situation (dangerous and nondangerous). Mothers (but not children) used dangerous feature rationales more often than dangerous outcome rationales. When disagreements arose, mothers typically guided children to adopt their own rating rather than the child's rating. Additionally, children who used more nondangerous feature and outcome rationales had experienced more injuries requiring medical attention. Mothers' focus on dangerous features appears to reflect their efforts to help children make causal connections between dangerous elements of the situation and adverse outcomes that might result.

Object Knowledge Modulates Colour Appearance

Directory of Open Access Journals (Sweden)

Christoph Witzel

2011-01-01

Full Text Available We investigated the memory colour effect for colour diagnostic artificial objects. Since knowledge about these objects and their colours has been learned in everyday life, these stimuli allow the investigation of the influence of acquired object knowledge on colour appearance. These investigations are relevant for questions about how object and colour information in high-level vision interact as well as for research about the influence of learning and experience on perception in general. In order to identify suitable artificial objects, we developed a reaction time paradigm that measures (subjective colour diagnosticity. In the main experiment, participants adjusted sixteen such objects to their typical colour as well as to grey. If the achromatic object appears in its typical colour, then participants should adjust it to the opponent colour in order to subjectively perceive it as grey. We found that knowledge about the typical colour influences the colour appearance of artificial objects. This effect was particularly strong along the daylight axis.

Object knowledge modulates colour appearance

Science.gov (United States)

Witzel, Christoph; Valkova, Hanna; Hansen, Thorsten; Gegenfurtner, Karl R

2011-01-01

We investigated the memory colour effect for colour diagnostic artificial objects. Since knowledge about these objects and their colours has been learned in everyday life, these stimuli allow the investigation of the influence of acquired object knowledge on colour appearance. These investigations are relevant for questions about how object and colour information in high-level vision interact as well as for research about the influence of learning and experience on perception in general. In order to identify suitable artificial objects, we developed a reaction time paradigm that measures (subjective) colour diagnosticity. In the main experiment, participants adjusted sixteen such objects to their typical colour as well as to grey. If the achromatic object appears in its typical colour, then participants should adjust it to the opponent colour in order to subjectively perceive it as grey. We found that knowledge about the typical colour influences the colour appearance of artificial objects. This effect was particularly strong along the daylight axis. PMID:23145224

Safety upgrading of the PAKS Nuclear Plant

International Nuclear Information System (INIS)

Vamos, G.; Vigassy, J.

1993-01-01

In the last several years the net electricity from the Paks NPP represents almost half of the Hungarian total. The 4 units of Paks belong to the latest generation of the VVER-440 units, the small-sized Russian designed PWRs. Reviewing the main design features of them, the safety merits and safety concerns are summarized. Due to the conservative design and the extensive operating experience the safety merits appear to be more significant than generally believed. The VVER-440 type has two models, the 230 and 213, which have a large number of distinctive safety features. These are highlighted in the section comparisons. A quality assurance program was initiated in Paks very early. A long-term safety upgrading program was also initiated, originating from vendor recommendations, regulatory decisions, in-house operating experience and safety concerns, and independent reviews. The main areas and some examples of the measures are described. This program, like all other activities related to nuclear safety, has been under regulatory control. The specific features of the Hungarian regulatory system are described. For advanced, general and new evaluation of the safety of the units in Paks in accordance with the internationally recommended criteria of the 90's, the project AGNES has been launched with international participation. The scope of this project is summarized. International efforts as the IAEA Regional Project on safety assessment of VVER-440/213 and VVER-440/230 units are underway. Since safety is not only a question of design, but it can be significantly influenced by operations and maintenance practices, the Paks NPP has invited LAEA's OSART and ASSET missions, WANO's Pilot Peer Review

Safety of Abiraterone Acetate in Castration-resistant Prostate Cancer Patients With Concomitant Cardiovascular Risk Factors.

Science.gov (United States)

Procopio, Giuseppe; Grassi, Paolo; Testa, Isabella; Verzoni, Elena; Torri, Valter; Salvioni, Roberto; Valdagni, Riccardo; de Braud, Filippo

2015-10-01

The aim of this study was to evaluate the safety profile of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) men with cardiovascular comorbidity, as little conclusive safety data are available in this patient subset. A retrospective analysis of mCRPC patients with controlled cardiovascular comorbidities, receiving AA 1000 mg administered orally once daily and prednisone 5 mg twice daily, between April 2011 and July 2012, was performed. All clinical and instrumental variables and toxicity data were analyzed by descriptive statistics: mean, standard deviation, minimum and maximum values for continuous variables, and absolute and relative frequencies for categorical variables. A total of 51 mCRPC patients were evaluated. Metastatic sites included the bone (74%), lungs, and liver (26%). All patients were previously treated with at least 2 lines of hormone and 1 docetaxel-based chemotherapy. Preexisting cardiac risk factors included hypertension (41%), cardiac ischemia (12%), arrhythmias (6%), dislipidemia (18%), and hyperglycemia (30%). No grade 3-4 adverse events were observed. Grade 1-2 adverse events included fluid retention (18%), asthenia (15%), and hypertension (16%). Median progression-free survival was 5.1 months (95% confidence interval, 0.5-12). Prostate specific antigen assessment revealed a good overall disease control rate (64%). AA appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases.

[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.

How many employees receive safety training during their first year of a new job?

Science.gov (United States)

Smith, Peter M; Mustard, Cameron A

2007-02-01

To describe the provision of safety training to Canadian employees, specifically those in their first year of employment with a new employer. Three repeated national Canadian cross-sectional surveys. 59 159 respondents from Statistics Canada's Workplace and Employee Surveys (1999, 2001 and 2003), 5671 who were in their first year of employment. Receiving occupational health and safety training, orientation training or office or non-office equipment training in either a classroom or on-the-job in the previous 12 months. Only 12% of women and 16% of men reported receiving safety training in the previous 12 months. Employees in their first 12 months of employment were more likely to receive safety training than employees with >5 years of job tenure. However, still only one in five new employees had received any safety training while with their current employer. In a fully adjusted regression model, employees who had access to family and support programs, women in medium-sized workplaces and in manufacturing, and men in large workplaces and in part-time employment all had an increased probability of receiving safety training. No increased likelihood of safety training was found in younger workers or those in jobs with higher physical demands, both of which are associated with increased injury risk. From our results, it would appear that only one in five Canadian employees in their first year of a new job received safety training. Further, the provision of safety training does not appear to be more prevalent among workers or in occupations with increased risk of injuries.

Interactive Appearance Prediction for Cloudy Beverages

DEFF Research Database (Denmark)

Dal Corso, Alessandro; Frisvad, Jeppe Revall; Kjeldsen, Thomas Kim

2016-01-01

Juice appearance is important to consumers, so digital juice with a slider that varies a production parameter or changes juice content is useful. It is however challenging to render juice with scattering particles quickly and accurately. As a case study, we create an appearance model that provide...

Inner body and outward appearance: The relationships among appearance orientation, eating disorder symptoms, and internal body awareness

NARCIS (Netherlands)

Spoor, S.T.P.; Bekker, M.H.J.; Heck, G.L. van; Croon, M.A.; Strien, T. van

2005-01-01

This study investigated the associations of appearance orientation and eating disorder symptoms with internal body awareness in an eating-disordered group of women and a general sample of women. In the eating-disordered group, appearance orientation was positively associated with internal body

Radiological appearances of papillary breast lesions

International Nuclear Information System (INIS)

Brookes, M.J.; Bourke, A.G.

2008-01-01

This review illustrates the varied appearances of benign and malignant papillary breast tumours, as identified by a breast cancer-screening programme. The commonest mammographic appearance of a papillary tumour is as a soft-tissue mass, with calcification present in less than half of cases. When calcification is present the pattern is variable, but clusters of pleomorphic calcification can occur, sometimes resembling the mammographic appearance of invasive ductal carcinoma. Ultrasonography of papillary lesions typically shows a solid, oval, intraductal mass, often associated with duct dilatation. A cystic component is also commonly seen, and lesions may appear hypervascular on colour Doppler ultrasound. Magnetic resonance imaging (MRI) has a high sensitivity, but low specificity for detecting papillary tumours, and is useful in establishing the extent and distribution of lesions in patients with multiple papillomatosis. Despite a benign histology on core biopsy, an argument exists for complete surgical excision of all papillary tumours, as a significant proportion of papillomas will contain foci of atypia or overt malignant change

Radiological appearances of papillary breast lesions

Energy Technology Data Exchange (ETDEWEB)

Brookes, M.J. [Sir Charles Gairdner Hospital, Nedlands, Perth, Western Australia (Australia)], E-mail: mattbrookes@doctors.org.uk; Bourke, A.G. [Sir Charles Gairdner Hospital, Nedlands, Perth, Western Australia (Australia)

2008-11-15

This review illustrates the varied appearances of benign and malignant papillary breast tumours, as identified by a breast cancer-screening programme. The commonest mammographic appearance of a papillary tumour is as a soft-tissue mass, with calcification present in less than half of cases. When calcification is present the pattern is variable, but clusters of pleomorphic calcification can occur, sometimes resembling the mammographic appearance of invasive ductal carcinoma. Ultrasonography of papillary lesions typically shows a solid, oval, intraductal mass, often associated with duct dilatation. A cystic component is also commonly seen, and lesions may appear hypervascular on colour Doppler ultrasound. Magnetic resonance imaging (MRI) has a high sensitivity, but low specificity for detecting papillary tumours, and is useful in establishing the extent and distribution of lesions in patients with multiple papillomatosis. Despite a benign histology on core biopsy, an argument exists for complete surgical excision of all papillary tumours, as a significant proportion of papillomas will contain foci of atypia or overt malignant change.

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)

Appearance, discrimination, and reaction qualifications

OpenAIRE

Mason, Andrew

2016-01-01

When are selectors for advantaged social positions morally justified in giving weight to the appearance of the candidates? In order to address this issue adequately, we need to know when a person’s appearance can be a legitimate qualification for a position. Some of the hardest cases are jobs that involve interacting with clients or customers who prefer to deal with good-looking employees or who respond more favourably to them. But there is also a wide range of difficult cases in which an unc...

Breaking the circle: Challenging Western sociocultural norms for appearance influences young women's attention to appearance-related media

NARCIS (Netherlands)

Mischner, I.H.S.; Schie, H.T. van; Engels, R.C.M.E.

2013-01-01

Paying attention to thin media models may negatively affect women's self-evaluation. This study aimed to reduce the amount of attention that young women give to appearance-related information by challenging the sociocultural norms for appearance, and studied the moderating role of self-esteem.

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...

CT appearance of splenosis

Energy Technology Data Exchange (ETDEWEB)

Mendelson, D.S.; Cohen, B.A.; Armas, R.R.

1982-12-01

Splenosis is an unusual complication of splenic trauma. The computed tomographic (CT) appearance of splenosis is described. One should consider this diagnosis when faced with a history of splenic trauma and multiple round or oval masses at CT.

CT appearance of splenosis

International Nuclear Information System (INIS)

Mendelson, D.S.; Cohen, B.A.; Armas, R.R.

1982-01-01

Splenosis is an unusual complication of splenic trauma. The computed tomographic (CT) appearance of splenosis is described. One should consider this diagnosis when faced with a history of splenic trauma and multiple round or oval masses at CT

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,...

List of reports in reactor safety research by BMFT, EPRI, JSTA, and USNRC

International Nuclear Information System (INIS)

1981-05-01

This list reviews reports from the Federal Republic of Germany, from the United States of America and from Japan concerning special problems in the field of reactor safety research. The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Program of BMFT, reporting organisation. The list of reports appears quarterly. (orig./HP) [de

Appearance is a function of the face.

Science.gov (United States)

Borah, Gregory L; Rankin, Marlene K

2010-03-01

Increasingly, third-party insurers deny coverage to patients with posttraumatic and congenital facial deformities because these are not seen as "functional." Recent facial transplants have demonstrated that severely deformed patients are willing to undergo potentially life-threatening surgery in search of a normal physiognomy. Scant quantitative research exists that objectively documents appearance as a primary "function" of the face. This study was designed to establish a population-based definition of the functions of the human face, rank importance of the face among various anatomical areas, and determine the risk value the average person places on a normal appearance. Voluntary adult subjects (n = 210) in three states aged 18 to 75 years were recruited using a quota sampling technique. Subjects completed study questionnaires of demography and bias using the Gamble Chance of Death Questionnaire and the Rosenberg Self-Esteem Scale. The face ranked as the most important anatomical area for functional reconstruction. Appearance was the fifth most important function of the face, after breathing, sight, speech, and eating. Normal facial appearance was rated as very important for one to be a functioning member of American society (p = 0.01) by 49 percent. One in seven subjects (13 percent) would accept a 30 to 45 percent risk of death to obtain a "normal" face. Normal appearance is a primary function of the face, based on a large, culturally diverse population sample across the lifespan. Normal appearance ranks above smell and expression as a function. Restoration of facial appearance is ranked the most important anatomical area for repair. Normal facial appearance is very important for one to be a functional member of American society.

The practical implementation of safety culture

Energy Technology Data Exchange (ETDEWEB)

Touzet, Rodolfo [Comision Nacional de Energia Atomica, Buenos Aires. (Argentina)

2008-07-01

When, during the review of the Chernobyl accident, the INSAG Committee introduced the term 'Safety Culture', it spread very quickly. Later on, as a result of activities sponsored by the IAEA, the original Safety Culture concept was extended to include a large number of issues that are typical requirements of Quality Assurance Unfortunately, the way in which certain organizations approached this subject has not helped to find the right way for it to be implemented. Safety Culture is not mentioned at all in ICRP-60 and in the new recommendations of 2005 it does not even appear in the principal body and only a minor reference exists. The IAEA's Basic Safety Standards deal with the requirements for Safety Culture and for Quality Assurance as absolutely individual issues; however, Safety Culture should be considered as a part of the Quality System. Very recently the situation was strongly improved by the release of the new standard 'The Management System for Facilities and Activities' Safety Requirements GS-R-3. The EURATOM 97/43 Directive, used in the European Community for the preparation of regulations for medical practice, which, while inspired by ICRP-73, does not even mention Safety Culture. Increasing personnel training is not enough if, at the same time, there are no activities aimed at improving their attitude towards quality and safety. To achieve a change in Culture in the organization or to implant the new concept, there must be a suitable supporting Methodology to allow it to be put into practice. If not, the Safety Culture will only be a simple expression of wishes without any chance of success. Criteria, methodology and effective practical tools must be available. Two basic principles for the management system (GSR-3): a) All the tasks may be considered as 'a system of interactive processes'; b) All persons must take part in order to achieve safety and quality. These two principles are the basis of the strategy for the development of a Safety Culture

The practical implementation of safety culture

International Nuclear Information System (INIS)

Touzet, Rodolfo

2008-01-01

When, during the review of the Chernobyl accident, the INSAG Committee introduced the term 'Safety Culture', it spread very quickly. Later on, as a result of activities sponsored by the IAEA, the original Safety Culture concept was extended to include a large number of issues that are typical requirements of Quality Assurance Unfortunately, the way in which certain organizations approached this subject has not helped to find the right way for it to be implemented. Safety Culture is not mentioned at all in ICRP-60 and in the new recommendations of 2005 it does not even appear in the principal body and only a minor reference exists. The IAEA's Basic Safety Standards deal with the requirements for Safety Culture and for Quality Assurance as absolutely individual issues; however, Safety Culture should be considered as a part of the Quality System. Very recently the situation was strongly improved by the release of the new standard 'The Management System for Facilities and Activities' Safety Requirements GS-R-3. The EURATOM 97/43 Directive, used in the European Community for the preparation of regulations for medical practice, which, while inspired by ICRP-73, does not even mention Safety Culture. Increasing personnel training is not enough if, at the same time, there are no activities aimed at improving their attitude towards quality and safety. To achieve a change in Culture in the organization or to implant the new concept, there must be a suitable supporting Methodology to allow it to be put into practice. If not, the Safety Culture will only be a simple expression of wishes without any chance of success. Criteria, methodology and effective practical tools must be available. Two basic principles for the management system (GSR-3): a) All the tasks may be considered as 'a system of interactive processes'; b) All persons must take part in order to achieve safety and quality. These two principles are the basis of the strategy for the development of a Safety Culture

Long-Term Safety and Effectiveness of the “OptEase” Vena Cava Filter

International Nuclear Information System (INIS)

Kalva, Sanjeeva P.; Marentis, Theodore C.; Yeddula, Kalpana; Somarouthu, Bhanusupriya; Wicky, Stephan; Stecker, Michael S.

2011-01-01

Purpose: To assess the long-term safety and effectiveness of the OptEase inferior vena cava (IVC) filter. Materials and Methods: In this Institutional Review Board-approved, retrospective study, we reviewed data of 71 patients who received an OptEase filter at our institution from 2002 to 2007. Thirty-nine (55%) patients had symptoms of venous thromboembolism before filter placement. The indications for filter included contraindication to anticoagulation in 31 (44%) patients, prophylaxis against pulmonary embolism (PE) in 29 (41%) patients, and failure of anticoagulation in 11 (15%) patients. Procedure-related complications, such as symptomatic post-filter PE, deep venous thrombosis (DVT), IVC occlusion, and incidental imaging-evident filter-related complications, were recorded. Safety was assessed by the occurrence of filter-related complications during placement and follow-up. Effectiveness was assessed by the occurrence of post-filter PE. Results: Sixty-five (92%) filters were placed under fluoroscopy, and 6 (8%) were placed using intravascular ultrasound guidance. Seventy (99%) filters were placed successfully. Seven (10%) filters were placed in the suprarenal cava. Retrieval was attempted in 14 (20%) patients, and 12 filters were successfully retrieved. Clinical follow-up was available for 20 ± 21 months. Symptoms of postfilter PE and DVT occurred in 15% (n = 11) and 10% (n = 7) patients, respectively. None of these patients had computed tomography (CT)-proven PE, and only one had ultrasound-proven new DVT. One patient had symptomatic IVC occlusion. Follow-up abdominal CT in 20 patients showed thrombus in the filter in two of them. There were no instances of filter migration, filter tilt, or caval wall penetration. Conclusion: The OptEase filter appears to have an acceptable long-term safety profile. The filter was effective against PE.

The imaging appearance of crayons

International Nuclear Information System (INIS)

McAllister, Aaron S.; Jones, Blaise V.; Lall, Neil U.; Tawfik, Kareem O.

2017-01-01

A crayon fragment was determined to be the source of a foreign body inflammatory process in the masticator space of a 15-month-old boy. The appearance of the crayon on CT and MR imaging was unexpected, leading to a further analysis of the imaging features of crayons. To investigate and characterize the imaging appearance of crayons at CT and MRI. The authors obtained CT and MR images of 22 crayons from three manufacturers and three non-pigmented crayons cast by the authors. CT attenuation of the crayons and diameter of the MRI susceptibility signal dropout were plotted versus brand and color. All crayons demonstrated a longitudinal central hypo-attenuating tract. Crayon attenuation varied by brand and color. All of the crayons demonstrated a signal void on T1 and T2 imaging and signal dropout on susceptibility-weighted imaging, the diameter of which varied by brand and color. Understanding the imaging appearance of crayons could help in the correct identification of a crayon as a foreign body on imaging studies, even when it is located in unusual places. (orig.)

The imaging appearance of crayons

Energy Technology Data Exchange (ETDEWEB)

McAllister, Aaron S.; Jones, Blaise V. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Lall, Neil U. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Ochsner Health System, Department of Radiology, New Orleans, LA (United States); Tawfik, Kareem O. [University of Cincinnati College of Medicine, Department of Otolaryngology-Head and Neck Surgery, Cincinnati, OH (United States)

2017-05-15

A crayon fragment was determined to be the source of a foreign body inflammatory process in the masticator space of a 15-month-old boy. The appearance of the crayon on CT and MR imaging was unexpected, leading to a further analysis of the imaging features of crayons. To investigate and characterize the imaging appearance of crayons at CT and MRI. The authors obtained CT and MR images of 22 crayons from three manufacturers and three non-pigmented crayons cast by the authors. CT attenuation of the crayons and diameter of the MRI susceptibility signal dropout were plotted versus brand and color. All crayons demonstrated a longitudinal central hypo-attenuating tract. Crayon attenuation varied by brand and color. All of the crayons demonstrated a signal void on T1 and T2 imaging and signal dropout on susceptibility-weighted imaging, the diameter of which varied by brand and color. Understanding the imaging appearance of crayons could help in the correct identification of a crayon as a foreign body on imaging studies, even when it is located in unusual places. (orig.)

Focus on safety : a comparative analysis of pipeline safety performance 2000-2002

International Nuclear Information System (INIS)

2004-01-01

Canada's National Energy Board (NEB) is responsible for the promotion of safety, environmental protection and economic efficiency in the Canadian public interest in regulating the design, construction, operation and abandonment of interprovincial and international pipelines within Canada. This second annual report provides a review of the safety performance of oil and gas pipeline companies that are regulated by the NEB. The data used to prepare this report originates from two sources: incident reports submitted under the Onshore Pipeline Regulations, 1999, and from information voluntarily provided by pipeline companies under the Safety Performance Indicators (SPI) initiative. Data comparisons with external reference organizations were included. Six key indicators have been identified to provide comprehensive measures of safety performance for pipeline companies: fatalities, ruptures, injury frequencies, liquid releases, gas releases, and unauthorized activities on the right of way. The safety performance of the federally regulated pipeline industry within Canada was satisfactory during this reporting period (2000-2002). The contractor injury frequency rates reported in 2002 were lower than those reported in 2001, and exhibited more consistency with the levels reported in 2000. The NEB is of the opinion that the elevated number of liquid hydrocarbon spills reported in 2000 were a result of elevated construction levels. No fatalities were reported. There was an increase to three from two in the number of ruptures, due in large part to metal loss (corrosion) and cracking, and external interference (third party damage). The number of spills increased to 76 in 2002 from 55 in 2001, which appears to be more in line with industry averages. The volume of hydrocarbon liquid released in 2002 represented one third the volume released in 2001. refs., 5 tabs., 14 figs

Safety lessons from aviation.

Science.gov (United States)

Higton, Phil

2005-07-01

Thirty years ago the world of Commercial Aviation provided a challenging environment. In my early flying days, aircraft accidents were not unusual, flying was seen as a risky business and those who took part, either as a provider or passenger, appeared grudgingly willing to accept the hazards involved. A reduction in the level of risk was sought in technological advances, greater knowledge of physics and science, and access to higher levels of skill through simulation, practice and experience. While these measures did have an impact, the expected safety dividend was not realized. The most experienced, technically competent individuals with the best equipment featured far too regularly in the accident statistics. We had to look at the human element, the impact of flaws or characteristics of the human condition. We call this area Human Factors. My paper describes the concept of Human Factors, its establishment as a key safety tool in aviation and the impact of this on my working life.

Profile analysis of microparticles

International Nuclear Information System (INIS)

Konarski, P.; Iwanejko, I.; Mierzejewska, A.

2001-01-01

Depth resolved analyses of several types of microparticles are presented. Particles for secondary ion mass spectrometry (SIMS) depth profile analysis were collected in the working environment of glass plant, steelworks and welding station using eight-stage cascade impactor with particle size range of 0.3 μm to 15 μm. Ion beam sputtering and sample rotation technique allowed to describe morphology i.e. the elemental structure of collected sub-micrometer particles. Also model particles Iriodin 221 (Merck) were depth profiled. The core-shell structure is found for all types of investigated particles. Steelworks particles consist mainly of iron and manganese cores. At the shells of these microparticles: lead, chlorine and fluorine are found. The particles collected in the glass-works consist mainly of lead-zirconium glass cores covered by carbon and copper. Stainless-steel welding particles compose of iron, manganese and chromium cores covered by a shell rich in carbon, chlorine and fluorine. Sample rotation technique applied in SIMS appears to be an effective tool for environmental microparticle morphology studies

National Machine Guarding Program: Part 2. Safety management in small metal fabrication enterprises.

Science.gov (United States)

Parker, David L; Yamin, Samuel C; Brosseau, Lisa M; Xi, Min; Gordon, Robert; Most, Ivan G; Stanley, Rodney

2015-11-01

Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33-question safety management audit. Audits were completed during an interview with the business owner or manager. Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P < 0.0001). Critical safety management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc.

LGBTQ Women, Appearance Negotiations, and Workplace Dress Codes.

Science.gov (United States)

Reddy-Best, Kelly L

2018-01-01

The purpose of this study was to explore LGBTQ women's experiences with unwritten or formal dress codes at work. I asked: What are LGBTQ women's experiences in the workplace with appearance management, and what are LGBTQ women's experiences navigating the written and unwritten dress codes in the workplace? To answer the research question, interviews were conducted with 24 self-identifying LGBTQ women. Six key themes emerged from the data. Themes included (1) expressed sexual identity in appearance, (2) unwritten dress codes in work environments did not always allow for expression of sexual identity in appearance, (3) motivations for pressure or desire to conceal expression of sexual identity in appearance at work, (4) negotiations of revealing or concealing sexual identity in appearance in the workplace impacted levels of comfort and confidence, (5) verbal and nonverbal negative experiences related to appearance at work, and (6) received compliments about appearance at work.

39 CFR 953.7 - Default; Appearances.

Science.gov (United States)

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Default; Appearances. 953.7 Section 953.7 Postal... § 953.7 Default; Appearances. If a timely reply to the appeal is not filed, the presiding officer shall... Inspector or his or her designee is in default. Whenever the General Counsel or the Chief Postal Inspector...

Rapid descriptive sensory methods – Comparison of Free Multiple Sorting, Partial Napping, Napping, Flash Profiling and conventional profiling

DEFF Research Database (Denmark)

Dehlholm, Christian; Brockhoff, Per B.; Meinert, Lene

2012-01-01

is a modal restriction of Napping to specific sensory modalities, directing sensation and still allowing a holistic approach to products. The new methods are compared to Flash Profiling, Napping and conventional descriptive sensory profiling. Evaluations are performed by several panels of expert assessors......Two new rapid descriptive sensory evaluation methods are introduced to the field of food sensory evaluation. The first method, free multiple sorting, allows subjects to perform ad libitum free sortings, until they feel that no more relevant dissimilarities among products remain. The second method...... are applied for the graphical validation and comparisons. This allows similar comparisons and is applicable to single-block evaluation designs such as Napping. The partial Napping allows repetitions on multiple sensory modalities, e.g. appearance, taste and mouthfeel, and shows the average...

Strengthening the culture of safety and performance in nuclear installations

International Nuclear Information System (INIS)

Briant, V.S.; Germann, R.P.

1997-01-01

In mid-1995, the International Atomic Energy Agency (IAEA) in Vienna brought together a group of safety culture experts from around the world to explore and summarize those practices they viewed as important in establishing sound safety cultures in nuclear installations. This paper will summarize key findings of the Vienna team and also expand those ideas based on related work in which the authors are engaged. The paper includes a definition of safety culture, a description of three stages of safety culture, and five key practices essential to establishing and maintaining a sound safety culture. Additionally, the authors contradicts the conventional view of safety and production as trade-offs, supporting the Vienna team's conclusion that the principles, attitudes, and practices which bring about sustained levels of high performance are the same as those which enhance safety. Based on input from colleagues in several countries, this appears to hold true across geographical and ethnic boundaries. The authors also discuss how this information can be put to practical use to obtain an objective, measurable, and repeated assessment of the current state of the safety culture within a company, plant or work unit. With that information, leaders are then in the position to act on any of the several parameters which affect both safety and performance effectiveness. (author)

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.

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.

Investing in the ideal: does objectified body consciousness mediate the association between appearance contingent self-worth and appearance self-esteem in women?

Science.gov (United States)

Noser, Amy; Zeigler-Hill, Virgil

2014-03-01

Appearance contingent self-worth has been shown to be associated with low appearance self-esteem but little is known about the role that objectified body consciousness may play in this relationship. The purpose of the present study with 465 female undergraduates was to examine whether objectified body consciousness mediates the association between appearance contingent self-worth and low levels of appearance self-esteem. This was accomplished using a multiple mediation model to examine whether components of objectified body consciousness (i.e., body surveillance, body shame, and control beliefs) play unique roles in the connection between appearance contingent self-worth and appearance self-esteem. Results showed that body surveillance and body shame were significant mediators of the connection between appearance contingent self-worth and low levels of appearance self-esteem. Discussion focuses on the implications of these results for the ways in which appearance contingent self-worth may promote heightened body consciousness and possibly contribute to low levels of appearance self-esteem. Copyright © 2013 Elsevier Ltd. All rights reserved.

Study on application of safety checklist in preventive maintenance activities

International Nuclear Information System (INIS)

Shi Jin; Chen Song; Liu Jingquan

2013-01-01

The paper describes the principles and the characteristics of safety checklist as a risk evaluation method. Examples of application of safety checklists to preventive maintenance activities such as criteria comparison and checkup items in place in nuclear power plants are illustrated in details with issues appeared in the checklist establishment. Checklist has a good application in the RCM analysis or in the actual preventive maintenance program for Chashma Nuclear Power Plant indicated by concrete instances. In the light of safety checklist which is used to sustain preventive maintenance as a simple and applicable risk analysis approach, we can get deep knowledge of risks of nuclear power plant to perfect preventive maintenance activities. (authors)

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.

How many employees receive safety training during their first year of a new job?

Science.gov (United States)

Smith, Peter M; Mustard, Cameron A

2007-01-01

Objective To describe the provision of safety training to Canadian employees, specifically those in their first year of employment with a new employer. Design Three repeated national Canadian cross‐sectional surveys. Subjects 59 159 respondents from Statistics Canada's Workplace and Employee Surveys (1999, 2001 and 2003), 5671 who were in their first year of employment. Main outcome Receiving occupational health and safety training, orientation training or office or non‐office equipment training in either a classroom or on‐the‐job in the previous 12 months. Results Only 12% of women and 16% of men reported receiving safety training in the previous 12 months. Employees in their first 12 months of employment were more likely to receive safety training than employees with >5 years of job tenure. However, still only one in five new employees had received any safety training while with their current employer. In a fully adjusted regression model, employees who had access to family and support programs, women in medium‐sized workplaces and in manufacturing, and men in large workplaces and in part‐time employment all had an increased probability of receiving safety training. No increased likelihood of safety training was found in younger workers or those in jobs with higher physical demands, both of which are associated with increased injury risk. Conclusions From our results, it would appear that only one in five Canadian employees in their first year of a new job received safety training. Further, the provision of safety training does not appear to be more prevalent among workers or in occupations with increased risk of injuries. PMID:17296687

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

Introduction of Autonomous Vehicles: Roundabouts Design and Safety Performance Evaluation

Directory of Open Access Journals (Sweden)

Aleksandra Deluka Tibljaš

2018-04-01

Full Text Available Driving experiences provided by the introduction of new vehicle technologies are directly impacting the criteria for road network design. New criteria should be taken into consideration by designers, researchers and car owners in order to assure traffic safety in changed conditions that will appear with, for example, introduction of Autonomous Vehicles (AVs in everyday traffic. In this paper, roundabout safety level is analysed on the originally developed microsimulation model in circumstances where different numbers of AVs vehicles are mixed with Conventional Vehicles (CVs. Field data about speed and traffic volumes from existing roundabouts in Croatia were used for development of the model. The simulations done with the Surrogate Safety Assessment Model (SSAM give some relevant highlights on how the introduction of AVs could change both operational and safety parameters at roundabouts. To further explore the effects on safety of roundabouts with the introduction of different shares of AVs, hypothetical safety treatments could be tested to explore whether their effects may change, leading to the estimation of a new set of Crash Modification Factors.

The Role of Fear Appeals in Improving Driver Safety: A Review of the Effectiveness of Fear-Arousing (Threat) Appeals in Road Safety Advertising

Science.gov (United States)

Lewis, I.; Watson, B.; Tay, R.; White, K. M.

2007-01-01

This paper reviews theoretical and empirical evidence relating to the effectiveness of fear (threat) appeals in improving driver safety. The results of the review highlight the mixed and inconsistent findings that have been reported in the literature. While fear arousal appears important for attracting attention, its contribution to behaviour…

Should intranasal corticosteroids be used for the treatment of ocular symptoms of allergic rhinoconjunctivitis? A review of their efficacy and safety profile.

Science.gov (United States)

Lightman, Sue; Scadding, Glenis K

2012-01-01

Allergic rhinoconjunctivitis (ARC) presents as nasal symptoms, eye watering and additional signs of ocular allergy (e.g. itchy/burning eyes). Intranasal corticosteroids (INSs) are the most effective treatment for the nasal symptoms of seasonal allergic rhinitis (SAR; based on 4 meta-analyses) and are considered first-line therapy when nasal congestion forms a substantial component of the patient's rhinitis symptoms. Clinical trial evidence shows that INSs also provide some relief from ocular symptoms of SAR and seasonal ARC in adults. INSs probably alleviate eye watering, the main ocular symptom of SAR, by relieving nasal congestion. Other ocular symptoms also improve with INSs. The mechanism for this effect is unknown, but might relate to naso-ocular reflex reduction. There are limited data on ocular safety with INSs. However, the literature supports the use of INSs over several months as there appears to be no considerable increase in the risk of ocular hypertension or glaucoma. Copyright © 2012 S. Karger AG, Basel.

Reprint of "Persuasive appeals in road safety communication campaigns: Theoretical frameworks and practical implications from the analysis of a decade of road safety campaign materials".

Science.gov (United States)

Guttman, Nurit

2016-12-01

Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

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.

One-Stage Treatment for Adult Patients With Crouzonoid Appearance by Orthognathic and Face Contouring Surgery.

Science.gov (United States)

Kim, Byung Jun; Bae, Hahn Sol; Lee, Yoonho

2017-07-01

Crouzon syndrome is a rare genetic disorder with autosomal-dominant inheritance that shows a triad of hallmark characteristics: craniosynostosis, exophthalmos, and midface retrusion. General treatment protocol for patients with Crouzon syndrome has already been established, but there is no standard treatment strategy for adult patients with Crouzonoid appearance. The authors present clinical patients of 1-stage orthognathic and face contouring surgery to achieve functional and aesthetic improvement.One-stage surgery was performed in adult patients with Crouzonoid appearance without a history of facial surgery. Orthognathic 2-jaw surgery was first performed to treat class III malocclusion. Face contouring surgery was conducted next to improve the aesthetic appearance using midface augmentation with onlay rib bone graft, advancement genioplasty, augmentation rhinoplasty, and ancillary procedures such as neck lift, fat graft, or fillers.Five patients (2 men, 3 women) were enrolled in this study. The mean age at the time of surgery was 19.0 years. No specific surgery-related complications such as infection, nerve injury, or recurred malocclusion were observed during the 3.5 years of follow-up. Normal class I occlusion was reached in all patients. The frontonasal angle, nasolabial angle, and labiomental angle improved from 125.1° to 135.1° (P > 0.05), 60.9° to 86.3° (P = 0.018), and 146.3° to 125.0° (P = 0.018), respectively. The Global Aesthetic Improvement Scale score was 4.75 and 5.00 in frontal and profile views, respectively.One-stage orthognathic and face contouring surgery may be an effective surgical option with good postoperative functional and aesthetic improvement in adult patients with Crouzonoid appearance.

Masculinity, consumerism, and appearance: a look at men's hair.

Science.gov (United States)

Ricciardelli, Rosemary

2011-05-01

Historically, being concerned about appearance was stereotypically associated with women. Now masculinities too have become embedded in appearance norms. Consequently men too are increasingly concerned about their appearance. Via interviews with 14 Canadian men, the role of hair in self-identification and both satisfaction and dissatisfaction with appearance is examined. Emergent themes suggest that masculinity and appearance are increasingly intertwined, and consumer culture cultivates a climate that encourages men to view their appearance as something worthy of investment. Findings suggest that men are concerned about their appearance-specifically their hair-and that there is a relationship between masculinity, appearance, and self-identification. Findings are discussed within theories of masculinity and consumerism.

Subcutaneous granuloma annulare: radiologic appearance

International Nuclear Information System (INIS)

Kransdorf, M.J.; Murphey, M.D.; Temple, H.T.

1998-01-01

Objective. Granuloma annulare is an uncommon benign inflammatory dermatosis characterized by the formation of dermal papules with a tendency to form rings. There are several clinically distinct forms. The subcutaneous form is the most frequently encountered by radiologists, with the lesion presenting as a superficial mass. There are only a few scattered reports of the imaging appearance of this entity in the literature. We report the radiologic appearance of five cases of subcutaneous granuloma annulare. Design and patients. The radiologic images of five patients (three male, two female) with subcutaneous granuloma annulare were retrospectively studied. Mean patient age was 6.4 years (range, 2-13 years). The lesions occurred in the lower leg (two), foot, forearm, and hand. MR images were available for all lesions, gadolinium-enhanced imaging in three cases, radiographs in four, and bone scintigraphy in one. Results. Radiographs showed unmineralized nodular masses localized to the subcutaneous adipose tissue. The size range, in greatest dimension on imaging studies, was 1-4 cm. MR images show a mass with relatively decreased signal intensity on all pulse sequences, with variable but generally relatively well defined margins. There was extensive diffuse enhancement following gadolinium administration. Conclusion. The radiologic appearance of subcutaneous granuloma annulare is characteristic, typically demonstrating a nodular soft-tissue mass involving the subcutaneous adipose tissue. MR images show a mass with relatively decreased signal intensity on all pulse sequences and variable but generally well defined margins. There is extensive diffuse enhancement following gadolinium administration. Radiographs show a soft-tissue mass or soft-tissue swelling without evidence of bone involvement or mineralization. This radiologic appearance in a young individual is highly suggestive of subcutaneous granuloma annulare. (orig.)

Canister Storage Building (CSB) Technical Safety Requirements

International Nuclear Information System (INIS)

KRAHN, D.E.

2000-01-01

The purpose of this section is to explain the meaning of logical connectors with specific examples. Logical connectors are used in Technical Safety Requirements (TSRs) to discriminate between, and yet connect, discrete Conditions, Required Actions, Completion Times, Surveillances, and Frequencies. The only logical connectors that appear in TSRs are AND and OR. The physical arrangement of these connectors constitutes logical conventions with specific meanings

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...

2013 Bike safety campaign: outcome and feedback

CERN Multimedia

HSE Unit

2013-01-01

From 3 to 17 June, the HSE Unit, in collaboration with the Reception and Access Control Service, led a campaign targeting CERN cyclists.   Photo: Laëtitia Wohlgemuth. In exchange for vouchers distributed by the security guards, 195 persons received a helmet and a reflective vest as well as documents on safety issues (ex: how to adjust one’s safety helmet properly; how to avoid blind spots; what is the required equipment for bikes and bike users, etc.). These persons also took part in a survey that contained questions on their cycling habits and level of knowledge on bike safety issues. It appeared that, for instance, 43% of the participants were aware that wearing a reflective vest is mandatory whenever visibility is poor (in France). 95% gave particular attention to the need to protect their heads (by assuming that wearing a helmet is either “mandatory” or “highly recommended”). The HSE Unit provided the participants with further i...

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.

Adolescent perceptions of cigarette appearance.

Science.gov (United States)

Ford, Allison; Moodie, Crawford; MacKintosh, Anne M; Hastings, Gerard

2014-06-01

To reduce the possibility of cigarette appearance misleading consumers about harm caused by the product, the European Commission's draft Tobacco Products Directive proposed banning cigarettes implied a more pleasant and palatable smoke for young smokers. A long brown cigarette was viewed as particularly unattractive and communicated a stronger and more harmful product. This exploratory study provides some support that standardising cigarette appearance could reduce the appeal of cigarettes in adolescents and reduce the opportunity for stick design to mislead young smokers in terms of harm. © The Author 2013. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Seismic safety in nuclear-waste disposal

International Nuclear Information System (INIS)

Carpenter, D.W.; Towse, D.

1979-01-01

Seismic safety is one of the factors that must be considered in the disposal of nuclear waste in deep geologic media. This report reviews the data on damage to underground equipment and structures from earthquakes, the record of associated motions, and the conventional methods of seismic safety-analysis and engineering. Safety considerations may be divided into two classes: those during the operational life of a disposal facility, and those pertinent to the post-decommissioning life of the facility. Operational hazards may be mitigated by conventional construction practices and site selection criteria. Events that would materially affect the long-term integrity of a decommissioned facility appear to be highly unlikely and can be substantially avoided by conservative site selection and facility design. These events include substantial fault movement within the disposal facility and severe ground shaking in an earthquake epicentral region. Techniques need to be developed to address the question of long-term earthquake probability in relatively aseismic regions, and for discriminating between active and extinct faults in regions where earthquake activity does not result in surface ruptures

Seismic safety in nuclear-waste disposal

Energy Technology Data Exchange (ETDEWEB)

Carpenter, D.W.; Towse, D.

1979-04-26

Seismic safety is one of the factors that must be considered in the disposal of nuclear waste in deep geologic media. This report reviews the data on damage to underground equipment and structures from earthquakes, the record of associated motions, and the conventional methods of seismic safety-analysis and engineering. Safety considerations may be divided into two classes: those during the operational life of a disposal facility, and those pertinent to the post-decommissioning life of the facility. Operational hazards may be mitigated by conventional construction practices and site selection criteria. Events that would materially affect the long-term integrity of a decommissioned facility appear to be highly unlikely and can be substantially avoided by conservative site selection and facility design. These events include substantial fault movement within the disposal facility and severe ground shaking in an earthquake epicentral region. Techniques need to be developed to address the question of long-term earthquake probability in relatively aseismic regions, and for discriminating between active and extinct faults in regions where earthquake activity does not result in surface ruptures.

Preparation of the initial safety case

International Nuclear Information System (INIS)

Hensley, G.

1987-01-01

In British Nuclear Fuels plc (BNFL), the design of nuclear chemical plants for construction and subsequent operation at Sellafield Works is carried out by the Engineering Division of the Spent Fuel Management Services Group based at Risley, Warrington. Plant construction cannot take place, nor plant commissioning, until it has been demonstrated in the initial (design) safety case that the chosen design will allow the plant to be operated in an adequately safe manner, corresponding to an extremely low level of risk. The safety documentation procedure is described. A Preliminary Design Safety Appraisal is made of the initial design proposal to give an early indication of the order of risk that might prevail. The risk from each hazard is compared with an allocated risk target which makes up a proportion of the total plant risk which is quantified in BNFL's risk criteria. Where the risk appears unacceptable, appropriate modifications are made to the design. Prior to commissioning, a comprehensive, detailed risk assessment is carried out. The methodology of probabilistic risk assessment is described and examples given of how different hazards are assessed. (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.

Designing visual appearance using a structured surface

DEFF Research Database (Denmark)

Johansen, Villads Egede; Thamdrup, Lasse Højlund; Smitrup, Christian

2015-01-01

followed by numerical and experimental verification. The approach comprises verifying all design and fabrication steps required to produce a desired appearance. We expect that the procedure in the future will yield structurally colored surfaces with appealing prescribed visual appearances.......We present an approach for designing nanostructured surfaces with prescribed visual appearances, starting at design analysis and ending with a fabricated sample. The method is applied to a silicon wafer structured using deep ultraviolet lithography and dry etching and includes preliminary design...

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

Angiographic appearances of rare renal tumours

International Nuclear Information System (INIS)

Schmidt, M.; Taenzer, V.

1980-01-01

Oncocytomas, called oxyphil proximal tubular adenomas in the Anglo Saxon literature, and benign hypernephromas are non-malignant, usually symptomless, rare tumours belonging to the renal adenomas. Oncocytomas have angiographic appearances sufficiently uniform to permit a tentative diagnosis. Histologically benign hypernephromas do not possess characteristic angiographic appearances and, in the presence of tumour in the renal vein or necrotic avascular areas, must be regarded as potentially malignant. (orig.) [de

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.

Full Tokamak discharge simulation and kinetic plasma profile control for ITER

International Nuclear Information System (INIS)

Hee Kim, S.

2009-10-01

transitions were not fully achievable due to a vertical displacement event (VDE) caused by a strong inward plasma movement. In the part dedicated to full tokamak discharge simulations, firstly, we have introduced the combined DINA-CH/CRONOS tokamak discharge simulator. DINA-CH self-consistently calculates the non-linear evolution of the free-boundary plasma equilibrium with the plasma current diffusion, in response to both controlled poloidal field (PF) coil currents and inductively driven currents in the surrounding conducting system. CRONOS provides the evolution of the plasma profiles by self-consistently solving heat and particle transport with source profiles. Secondly, we have successfully simulated ITER operation scenario 2 as a demonstration of the capabilities of the combined simulator, as well as being a design study in itself. The fusion power ratio to the total auxiliary power Q was about 10 with the application of 53 MW of auxiliary heating and current drive (H and CD) power. We have investigated several specific issues related to the tokamak operation, such as the vertical instability, PF coil current limits and poloidal flux consumption during the current ramp-up. Lower hybrid (LH) applied from the initial phase of the plasma current ramp-up increased the safety margins in operating the superconducting PF coils both by reducing resistive ohmic flux consumption and by providing non-inductively driven plasma current. Lastly, we have studied ITER hybrid mode operation, focusing on the operational capability of obtaining a stationary flat safety factor (q) profile at the start of at-top (SOF) phase and sustaining it as long as possible by combining various non-inductively driven current sources. Application of a near on-axis electron cyclotron current drive (ECCD) appears to be effective compared to the far off-axis lower hybrid current drive (LHCD), at least on short time scales. In the active plasma profile control part, we have developed a robust control

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

Safety sign designs for children by considering effect of the colors preferences: A case study

Science.gov (United States)

Iftadi, Irwan; Nugraha, Dian Cahya; Jauhari, Wakhid Ahmad

2018-02-01

Color has become a major consideration in ergonomics. Color conveys a message and it is an important element in safety signs. The importance of colors usage in safety sign designs makes the colors research into one of the things that must be done before designing them. So far, research in the related field only focused on the adult's perspective without involving children's perspective in designing the safety signs. This paper aims to find out how children's perception towards colors affects the safety sign designs. This study consist of eight sections which are literature study, direct observation, determining referents and other parameters, determining research respondents, making the booklet, assessing the colors preferences, determining the design's parameter value and creating the safety sign designs. Limitation of the research are the objects are the students with the age of 10 - 11 years old in Grade IV and then the research is conducted in the school day and hours that apply to the school. Chi square test and odds ratio are employed to assess the colors preferences. Twelve safety sign designs are proposed by considering the children's colors perception. The designs are grouped into three types of sign which are Mandatory Action Sign, Warning Sign and Prohibition Sign. Six colors are used to draw the safety signs i.e. red, orange, yellow, green, blue and black. On the basis of the study, it is concluded that the colors that often appears in safety signs is green with the percentage of 75% and that rarely appears is red with the percentage of 8.33%.

Alcohol brand appearances in US popular music.

Science.gov (United States)

Primack, Brian A; Nuzzo, Erin; Rice, Kristen R; Sargent, James D

2012-03-01

The average US adolescent is exposed to 34 references to alcohol in popular music daily. Although brand recognition is an independent, potent risk factor for alcohol outcomes among adolescents, alcohol brand appearances in popular music have not been assessed systematically. We aimed to determine the prevalence of and contextual elements associated with alcohol brand appearances in US popular music. Qualitative content analysis. We used Billboard Magazine to identify songs to which US adolescents were most exposed in 2005-07. For each of the 793 songs, two trained coders analyzed independently the lyrics of each song for references to alcohol and alcohol brand appearances. Subsequent in-depth assessments utilized Atlas.ti to determine contextual factors associated with each of the alcohol brand appearances. Our final code book contained 27 relevant codes representing six categories: alcohol types, consequences, emotional states, activities, status and objects. Average inter-rater reliability was high (κ = 0.80), and all differences were easily adjudicated. Of the 793 songs in our sample, 169 (21.3%) referred explicitly to alcohol, and of those, 41 (24.3%) contained an alcohol brand appearance. Consequences associated with alcohol were more often positive than negative (41.5% versus 17.1%, P brand appearances were associated commonly with wealth (63.4%), sex (58.5%), luxury objects (51.2%), partying (48.8%), other drugs (43.9%) and vehicles (39.0%). One in five songs sampled from US popular music had explicit references to alcohol, and one-quarter of these mentioned a specific alcohol brand. These alcohol brand appearances are associated commonly with a luxury life-style characterized by wealth, sex, partying and other drugs. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Imaging appearances of cholesterol pneumonia

International Nuclear Information System (INIS)

Miao Yanwei; Zhang Jingwen; Wu Jianlin; Zhou Yong; Li Mingwu; Lei Zhen; Shi Lifu

2006-01-01

Objection: To analyze the imaging appearances of cholesterol pneumonia. Methods We retrospectively analyzed the X-ray and CT findings of 3 patients with cholesterol pneumonia confirmed pathologically and reviewed correlative literature. Results: Lesions similar to mass were found in X-ray and CT imaging of three cases. Two of them appeared cavity with fluid-level and one showed multiple ring enhancement after CT contrast. The course of disease was very. long and it had no respond to antibiotic therapy. Amounts of foam cells rich in cholesterol crystal were detected in pathological examination. Conclusions: Cholesterol pneumonia is a rare chronic pulmonary idiopathic disease, and the radiological findings can do some help to its diagnosis. (authors)

Strengthening the culture of safety and performance in nuclear installations

Energy Technology Data Exchange (ETDEWEB)

Briant, V S [GPU Nuclear, Parsippany (United States); Germann, R P [Aberdeen Center for Team Learning, Matawan (United States)

1997-07-01

In mid-1995, the International Atomic Energy Agency (IAEA) in Vienna brought together a group of safety culture experts from around the world to explore and summarize those practices they viewed as important in establishing sound safety cultures in nuclear installations. This paper will summarize key findings of the Vienna team and also expand those ideas based on related work in which the authors are engaged. The paper includes a definition of safety culture, a description of three stages of safety culture, and five key practices essential to establishing and maintaining a sound safety culture. Additionally, the authors contradicts the conventional view of safety and production as trade-offs, supporting the Vienna team`s conclusion that the principles, attitudes, and practices which bring about sustained levels of high performance are the same as those which enhance safety. Based on input from colleagues in several countries, this appears to hold true across geographical and ethnic boundaries. The authors also discuss how this information can be put to practical use to obtain an objective, measurable, and repeated assessment of the current state of the safety culture within a company, plant or work unit. With that information, leaders are then in the position to act on any of the several parameters which affect both safety and performance effectiveness. (author) 9 refs., 5 tabs.

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 biological pump: Profiles of plankton production and consumption in the upper ocean

Science.gov (United States)

Longhurst, Alan R.; Glen Harrison, W.

The ‘biological pump’ mediates flux of carbon to the interior of the ocean by interctions between the components of the vertically-structured pelagic ecosystem of the photic zone. Chlorophyll profiles are not a simple indicator of autotrophic biomass or production, because of non-linearities in the physiology of cells and preferential vertical distribution of taxa. Profiles of numbers or biomass of heterotrophs do not correspond with profiles of consumption, because of depth-selection (taxa, seasons) for reasons unconnected with feeding. Depths of highest plant biomass, chlorophyll and growth rate coincide when these depths are shallow, but become progressively separated in profiles where they are deeper - so that highest growth rate lies progressively shallower than the chloropyll maximum. It is still uncertain how plant biomass is distributed in deep profiles. Depths of greatest heterotroph biomass (mesozooplankton) are usually close to depths of fastest plant growth rate, and thus lie shallower than the chlorophyll maximum in profiles where this itself is deep. This correlation is functional, and relates to the role of heterotrophs in excreting metabolic wastes (especially ammonia), which may fuel a significant component of integrated algal production, especially in the oligotrophic ocean. Some, but not all faecal material from mesozooplankton of the photic zone appears in vertical flux below the pycnocine, depending on the size of the source organisms, and the degree of vertical mixing above the pycnocline. Diel, but probably not seasonal, vertical migration is significant in the vertical flux of dissolved nitrogen. Regional generalisations of the vertical relations of the main components of the ‘biological pump’ now appear within reach, and an approach is suggested.

Material appearance modeling a data-coherent approach

CERN Document Server

Dong, Yue; Guo, Baining

2013-01-01

A principal aim of computer graphics is to generate images that look as real as photographs. Realistic computer graphics imagery has however proven to be quite challenging to produce, since the appearance of materials arises from complicated physical processes that are difficult to analytically model and simulate, and image-based modeling of real material samples is often impractical due to the high-dimensional space of appearance data that needs to be acquired.This book presents a general framework based on the inherent coherency in the appearance data of materials to make image-based appeara

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.

Cultural safety as an ethic of care: a praxiological process.

Science.gov (United States)

McEldowney, Rose; Connor, Margaret J

2011-10-01

New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.

AREVA General Inspectorate 2010 Annual Report. Status of safety in nuclear facilities

International Nuclear Information System (INIS)

2010-01-01

After messages by different managers, this report proposes a description of the context for nuclear safety: group's policy in matters of nuclear safety and radiation protection, regulatory changes (in France, with respect to information, changes in administrative organization, overhaul of general technical regulations, international context). It describes the organizational changes which occurred within the company. It reports actions regarding transparency, briefly describes actions and principles aimed at improving safety, indicates and comments noteworthy nuclear events, discusses their assessment from a HOF (human and organizational factors) perspective, comments lessons learned from inspections, comments data regarding radiation protection and actions aimed at improving radiation protection. It discusses environmental impact issues. It addresses the different processes and factors which transversely appear in nuclear safety: safety management, human and organizational factors, safety in design, project management, and emergency management. Several specific risks are discussed: criticality control, nuclear materials safeguards, fire, spill prevention, transportation, radioactive waste, shutdown and dismantling, service operations, mining, and environmental liabilities. Document in French and in English

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.

Solid Biomass Climate Change Interventions Examined in a Context of Inherent Safety, Media Shifting and Emerging Risks

DEFF Research Database (Denmark)

Hedlund, Frank Huess; Astad, John

2014-01-01

benefits over safety concerns seems to run deep and not confined to the realm of only solid biomass. Danish environmental ambitions are very high and the costs to society of introducing solid biomass fuels are breathtaking. In this setting, the general failure to address safety risk s appears particularly...

Aviation and healthcare: a comparative review with implications for patient safety.

Science.gov (United States)

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Basal View Reference Photographs for Nasolabial Appearance Rating in Unilateral Cleft Lip and Palate.

Science.gov (United States)

Rubin, Marcie S; Lowe, Kristen M; Clouston, Sean; Shetye, Pradip R; Warren, Stephen M; Grayson, Barry H

2015-07-01

The Asher-McDade system is a 5-point ordinal scale frequently used to rate the components of nasolabial appearance, including nasal form and nasal symmetry, in unilateral cleft lip and palate. Although reference photographs illustrating this scale have been identified for the frontal and right profile view, no reference photographs exist for the basal view. The aim of this study was to identify reference photographs for nasal form and nasal symmetry from the basal view to illustrate this scale and facilitate its use. Four raters assessed nasolabial appearance (form and symmetry) on basal view photographs of 50 children (average age 8 years) with a repaired cleft lip. Intraclass correlation coefficients show fair to moderate inter-rater reliability. Cronbach α indicated strong agreement between raters (0.77 nasal form; 0.78 nasal symmetry; 0.80 overall), along with low duplicate measurement error and strong internal consistency between the measures. The photographs with the highest agreement among raters were selected to illustrate each point on the 5-point scale for nasal form and for nasal symmetry, resulting in the selection of 10 reference photographs. The basal view reference photograph set developed from this study may complement existing reference photograph sets for other views and facilitate rating tasks.

Food Place Profiling and the Conformity Paradox

DEFF Research Database (Denmark)

Therkelsen, Anette; Gyimóthy, Szilvia

that these destinations appear to conjure up quite generic food place brands where the promotional discourses are conceived as fairly similar thereby giving little substance to local food. The paper concludes with a discussion of alternative promotional discourses aiming at enhancing local food identity.......Drawing on earlier research on local food, terroir, authenticity, food narratives and conformity in branding efforts, we study the place branding strategies of four Danish coastal destinations, each focusing on profiling themselves as food places for tourists. Based on analyses of online food......-related promotional material along the food tourism value chain, overlapping food discourses characterised by terroir typicality and historical references are identified. Differences in food discourses also appear which are critical in view of achieving a distinct food place brand. Moreover, it is argued...

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

Science.gov (United States)

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

22 CFR 41.102 - Personal appearance of applicant.

Science.gov (United States)

2010-04-01

... interview. (d) Cases in which personal appearance may not be waived. A consular officer or the Deputy... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Personal appearance of applicant. 41.102... IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Nonimmigrant Visa § 41.102 Personal appearance of...

Safety and Efficacy of D-Tagatose in Glycemic Control in Subjects with Type 2 Diabetes

OpenAIRE

Ensor, Mark; Banfield, Amy B.; Smith, Rebecca R.; Williams, Jarrod; Lodder, Robert A.

2014-01-01

The primary objectives of this study were to evaluate the treatment effect of D-tagatose on glycemic control, determined by a statistically significant decrease in hemoglobin A1c (HbA1c), and safety profile of D-tagatose compared to placebo. The secondary objectives were to evaluate the treatment effects on fasting blood glucose, insulin, lipid profiles, changes in BMI, and the proportion of subjects achieving HbA1c targets of

Realistic Material Appearance Modelling

Czech Academy of Sciences Publication Activity Database

Haindl, Michal; Filip, Jiří; Hatka, Martin

2010-01-01

Roč. 2010, č. 81 (2010), s. 13-14 ISSN 0926-4981 R&D Projects: GA ČR GA102/08/0593 Institutional research plan: CEZ:AV0Z10750506 Keywords : bidirectional texture function * texture modelling Subject RIV: BD - Theory of Information http:// library .utia.cas.cz/separaty/2010/RO/haindl-realistic material appearance modelling.pdf

Tuberculous peritonitis: CT appearance

International Nuclear Information System (INIS)

Hanson, R.D.; Hunter, T.B.

1985-01-01

Rare, sporadic cases of tuberculous peritonitis do occur in the United States and other advanced countries. Because there are few descriptions of the CT appearance of the peritoneal forms of tuberculous (TB), this report illustrates a case of tuberculous peritonitis with prominent CT findings and discusses the differentiation of this entity from other, more common diseases

Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

Science.gov (United States)

Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

2016-12-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Development of quantitative goals for inherent safety feature design and licensing

International Nuclear Information System (INIS)

Kastenberg, W.E.; Apostolakis, G.; Dhir, V.K.; Okrent, D.

1987-01-01

There is now considerable interest in the development of advanced fast reactors whose major focus is inherent safety. The achievement of inherent safety can be viewed from several aspects. In the Integral Fast Reactor Concept the approach is to utilize the intrinsic characteristics of pool-type liquid metal fast breeder reactors (LMFBRs) and the properties of metal fuels to integrate a high degree of inherent safety into the design. The PRISM and SAFR concepts focus on other inherent safety features. The reactors discussed above represent a radical departure from existing LWR designs as well as previous LMFBR designs (e.g., CRBRP) which are based, for the most part, on the General Design Criteria found in 10CFR50 Appendix. In view of these parallel developments (advanced reactors exploiting inherent safety and the use of quantitative goals to augment licensing), there appears to be a need to perform research on the development of methods for designing, assessing, and licensing inherent safety features in advanced reactors. The objectives of such research are outlined

Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

Science.gov (United States)

Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

2016-01-01

Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

Color and appearance metrology facility

Data.gov (United States)

Federal Laboratory Consortium — The NIST Physical Measurement Laboratory has established the color and appearance metrology facility to support calibration services for 0°/45° colored samples, 20°,...

Immunogenicity and safety of yellow fever vaccine among 115 HIV-infected patients after a preventive immunisation campaign in Mali.

Science.gov (United States)

Sidibe, Mariam; Yactayo, Sergio; Kalle, Abdoulaye; Sall, Amadou A; Sow, Samba; Ndoutabe, Modjirom; Perea, William; Avokey, Fenella; Lewis, Rosamund F; Veit, Olivia

2012-07-01

The immune response to yellow fever (YF) vaccine and its safety among HIV-infected individuals living in YF endemic areas is not well understood. Following a national YF preventive immunisation campaign in Mali in April 2008, we assessed the immunogenicity and safety of 17D yellow fever vaccine (17DV) among HIV-infected patients in two HIV treatment centres in Bamako, Mali, by testing for neutralising antibodies and identifying serious adverse events following immunisation (AEFI). A YF neutralisation titre (NT) of 1:≥20 was considered to be adequate and protective. A serious AEFI included hospitalisation, any life-threatening condition, or death, occurring within 30 days following 17DV administration. Of 115 HIV-infected patients who reported having received 17DV, 110 (96%) were on combination antiretroviral therapy and 83 patients were tested for neutralising antibodies. Around the time of vaccination, median CD4 cell count was 389 cells/mm(3) (IQR 227-511cells/mm(3)); HIV-RNA was undetectable in 24 of 46 patients tested. Seventy-six (92%) of 83 participants had adequate immune titres 9 months after the immunisation campaign. Previous vaccination or flavivirus exposure could contribute to this finding. No serious AEFI was found in the 115 participants. In this small series, YF vaccine appeared to be immunogenic with a favourable safety profile in HIV-infected patients on antiretroviral therapy. Higher CD4 cell counts and suppressed HIV-RNA were associated with the presence of an adequate immune titre and higher NTs. Copyright © 2012 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

Memory and disgust: Effects of appearance-congruent and appearance-incongruent information on source memory for food.

Science.gov (United States)

Mieth, Laura; Bell, Raoul; Buchner, Axel

2016-01-01

The present study was stimulated by previous findings showing that people preferentially remember person descriptions that violate appearance-based first impressions. Given that until now all studies used faces as stimuli, these findings can be explained by referring to a content-specific module for social information processing that facilitates social orientation within groups via stereotyping and counter-stereotyping. The present study tests whether the same results can be obtained with fitness-relevant stimuli from another domain--pictures of disgusting-looking or tasty-looking food, paired with tasty and disgusting descriptions. A multinomial model was used to disentangle item memory, guessing and source memory. There was an old-new recognition advantage for disgusting-looking food. People had a strong tendency towards guessing that disgusting-looking food had been previously associated with a disgusting description. Source memory was enhanced for descriptions that disconfirmed these negative, appearance-based impressions. These findings parallel the results from the social domain. Heuristic processing of stimuli based on visual appearance may be complemented by intensified processing of incongruent information that invalidates these first impressions.

Low-profile stent system for treatment of atherosclerotic renal artery stenosis : The GREAT trial

NARCIS (Netherlands)

Sapoval, Marc; Zahringer, Markus; Pattynama, Peter; Rabbia, Claudio; Vignali, Claudio; Maleux, Geert; Boyer, Louis; Szczerbo-Trojanowska, Malgorzata; Jaschke, Werner; Hafsahl, Geir; Downes, Mark; Beregi, Jean Paul; Veeger, Nic; Talen, Aly

PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly

Diagnostic development for current density profile control at KSTAR

Energy Technology Data Exchange (ETDEWEB)

Ko, J., E-mail: jinseok@nfri.re.kr [National Fusion Research Institute, Daejeon 34133 (Korea, Republic of); University of Science and Technology, Daejeon 34113 (Korea, Republic of); Chung, J. [National Fusion Research Institute, Daejeon 34133 (Korea, Republic of); Messmer, M.C.C. [Department of Applied Physics, Eindhoven University of Technology, Eindhoven (Netherlands)

2016-11-01

Highlights: • The motional Stark effect (MSE) diagnostic installed at KSTAR. • Engineering challenges and solutions on the design and fabrication of the front optics housing and filter modules. • Characterization of the bandpass filters and the responses to polarized light. - Abstract: The current density profile diagnostics are critical for the control of the steady-state burning plasma operations. A multi-channel motional Stark effect (MSE) diagnostic system has been implemented for the measurements of the internal magnetic field structures that constrain the magnetic equilibrium reconstruction to accurately produce the tokamak safety factor and current density profiles for the Korea Superconducting Tokamak Advanced Research (KSTAR). This work presents the design and fabrication of the front optics and the filter modules and the calibration activities for the MSE diagnostic at KSTAR.

Burnout in Health Professionals According to Their Self-Esteem, Social Support and Empathy Profile

OpenAIRE

María del Mar Molero Jurado; María del Carmen Pérez-Fuentes; José Jesús Gázquez Linares; José Jesús Gázquez Linares; Ana Belén Barragán Martín

2018-01-01

Introduction: Professionals in the healthcare field are in situations that could be a source of stress and sometimes develop burnout syndrome. Self-esteem, social support, and empathy are variables which intervene and influence the appearance of this syndrome.Objective: Identify healthcare professional profiles based on self-esteem, empathy and perceived social support, and analyze the extent to which these profiles show differences in developing burnout.Method: The sample was made up of 719 ...

The Sensitivity Analysis of Axial Pressure Tube Creep Profile for Dryout Power in PHWR

Energy Technology Data Exchange (ETDEWEB)

Ryu, Euiseung; Kim, Youngae [KHNP CRI, Daejeon (Korea, Republic of)

2016-10-15

The Stern Laboratory performed the CHF tests with only one axial pressure tube creep profile per 3.3%, 5.1% peak crept channel and made CHF correlation including creep factor from the CHF test results. Wolsong nuclear power plants also have utilized the same CHF correlation derived by CNL. Pressure tube diameter creep rate is function of fast neutron, coolant temperature, and coolant pressure in a channel. It means that various axial pressure tube creep profiles exist in PHWR due to the history of operating conditions. Usually, CHF correlation is used during ROP(Regional Overpower Protection) Trip Setpoint Analysis or Safety Analysis in PHWR. The sensitivity analysis for CHF effects using various creep profiles is needed. This paper summarizes the comparison results of dryout power between CHF test creep profile and estimated creep profiles of Wolsong units. The effect of axial pressure tube creep profile for dryout power in fuel channel is evaluated by using Stern Lab. CHF test creep profile and 380 channel creep profiles of Wolsong. The dryout powers at 3.3% and 5.1% test conditions are slightly smaller when using 380 Wolsong channels creep profiles. These also show that the simulated dryout powers maintain consistency regardless of flow conditions.

National Space Agencies vs. Commercial Space: Towards Improved Space Safety

Science.gov (United States)

Pelton, J.

2013-09-01

assume that thiscondition will not change. This seems particularly true for high profile, multi-billion dollar programs.The second part of the paper focuses on new commercial space programs that appear to be undertaken in a less restrictive manner; i.e. outside the constraints of politically-driven national space policies. Here the drivers—even within international consortia—seem to be on reliable performance and commercial return. Since sustained accident-free performance is critical to commercial programs very existence and profitability, the inherent role of safety in commercial space industry would seem clear. The question of prime interest for this paper is whether or not it might be possible for smaller and more focused commercial space entities, free from the constraints of space agency organizational and political constraints, to be more "risk adverse" and thus be more nimble in designing "safe" vehicles? If so how can this "safety first" corporate philosophy and management practice be detected and even objectively measured? Could, in the future, risk reduction at the level of design, quality verification, etc., be objectively measured?

Patient safety in undergraduate radiography curricula: A European perspective

International Nuclear Information System (INIS)

England, A.; Azevedo, K.B.; Bezzina, P.; Henner, A.; McNulty, J.P.

2016-01-01

Purpose: To establish an understanding of patient safety within radiography education across Europe by surveying higher education institutions registered as affiliate members of the European Federation of Radiographer Societies (EFRS). Method: An online survey was developed to ascertain data on: programme type, patient safety definitions, relevant safety topics, specific areas taught, teaching and assessment methods, levels of teaching and curriculum drivers. Responses were identifiable in terms of educational institution and country. All 54 affiliated educational institutions were invited to participate. Descriptive and thematic analyses are reported. Results: A response rate of 61.1% (n = 33) was achieved from educational institutions representing 19 countries. Patient safety topics appear to be extremely well covered across curricula, however, topics including radiation protection and optimisation were not reported as being taught at an ‘advanced level’ by five and twelve respondents, respectively. Respondents identified the clinical department as the location of most patient safety-related teaching. Conclusions: Patient safety topics are deeply embedded within radiography curricula across Europe. Variations exist in terms of individual safety topics including, teaching and assessment methods, and the depth in which subjects are taught. Results from this study provide a baseline for assessing developments in curricula and can also serve as a benchmark for comparisons. - Highlights: • First European report on patient safety (PS). • PS deeply embedded within training curricula. • Terms and definitions largely consistent. • Some variety in the delivery and assessment methods. • Report provides baseline and opportunities for comparisons.

[Safety and efficacy of ketamine for pain relief].

Science.gov (United States)

Niesters, Marieke; Dahan, Albert; van Kleef, Maarten

2016-01-01

Intravenous ketamine treatment is frequently used for the management of chronic pain, especially in those patients who do not benefit from other therapies. In this commentary we discuss the efficacy of ketamine for relief of chronic pain and ketamine's safety profile. A review of the literature indicates that only a few studies show that intravenous ketamine has analgesic effects that persist beyond the infusion period, an effect that occurs in about two-thirds of patients. Ketamine has multiple safety issues, ranging from psychotomimetic and schizotypal symptoms, sympathetic stimulation, tachycardia and hypertension, and damage to the liver and the urogenital tract. Damage to the urogenital tract seems to be restricted to individuals who chronically abuse ketamine. We indicate the need for large randomized trials in which ketamine is compared with an 'active' placebo.

Utilization of the MCNP-3A code for criticality safety analysis

International Nuclear Information System (INIS)

Maragni, M.G.; Moreira, J.M.L.

1996-01-01

In the last decade, Brazil started to operate facilities for processing and storing uranium in different forms. The necessity of criticality safety analysis appeared in the design phase of the uranium pilot process plants and also in the licensing of transportation and storage of fissile materials. The 2-MW research reactor and the Angra I power plant also required criticality safety assessments because their spent-fuel storage was approaching full-capacity utilization. The criticality safety analysis in Brazil has been based on KENO IV code calculations, which present some difficulties for correct geometry representation. The MCNP-3A code is not reported to be used frequently for criticality safety analysis in Brazil, but its good geometry representation makes it a possible tool for treating problems of complex geometry. A set of benchmark tests was performed to verify its applicability for criticality safety analysis in Brazil. This paper presents several benchmark tests aimed at selecting a set of options available in the MCNP-3A code that would be adequate for criticality safety analysis. The MCNP-3A code is also compared with the KENO-IV code regarding its performance for criticality safety analysis

Measuring the safety culture in a hospital setting: a concept whose time has come?

Science.gov (United States)

Robb, Gillian; Seddon, Mary

2010-05-14

Getting the right 'patient safety culture' is thought to be an important component in improving patient safety in hospitals, however there is a lack of clarity in how best to measure and improve it, and whether such improvement actually translates to better patient outcomes. This paper reflects on the Counties Manukau District Health Board (CMDHB) experience with a patient safety survey and attempts to answer questions other organisations may ask when deciding whether to invest in such survey. A literature search was undertaken to identify valid and reliable patient safety culture survey tools. These were reviewed with respect to how best to interpret and use the results. If hospitals decide to undertake a patient safety culture survey, the recommended survey tools are the Safety Attitudes Questionnaire (SAQ) and the Hospital Survey on Patient Safety (HSOPS). Both have been widely used and have sound and comprehensive psychometrics. Only the SAQ has established links with patient safety outcomes such as reduced healthcare associated infections. Surveys can provide some insights into the patient safety culture within an organisation, but the opportunity costs of undertaking a survey should be carefully considered. Much of their value lies in raising the profile of patient safety and promoting conversations; making patient safety 'the way we do business around here'.

Tissue concentration-time profile of selenium after sodium selenite administration to rats

Energy Technology Data Exchange (ETDEWEB)

Kaneko, Megumi; Natsuhori, Masahiro; Ito, Nobuhiko [Department of Veterinary Radiology and Radiation Biology, Kitasato University School of Veterinary Medicine, Towada, Aomori (Japan); Sera, Koichiro [Cyclotron Research Center, Iwate Medical University, Takizuka, Iwate (Japan); Futatsugawa, Shoji [Nishina Memorial Cyclotron Center (NMCC), Takizuka, Iwate (Japan)

1999-07-01

Selenium (Se) concentration-time profiles in plasma and organs including liver, kidney, heart, lung, spleen and brain of rats (Jcl Wister, 9 wks old, n=32) were investigated after a single intravenous (iv) / oral (po) administration of sodium selenite (dose is equivalent to 2 mg/kg b.w. of Se). The Se concentration was determined by PIXE analysis. Among the investigated biological samples, Se concentration was the highest in the kidney or liver, followed by the heart, lung or spleen, then plasma, and the brain. Se concentrations in these organs were 0.5 to 5 times of plasma Se. The distribution profiles of Se in the organs were dependent on the route of administration. Furthermore, their profiles appeared almost parallel to the plasma Se-concentration in a logarithmic scale. Compared to the Se concentration-time profiles in plasma and organs by the route of administration, po group showed about 1/4-1/2 of the Se concentration in iv group except for kidney. Kidney kept relatively higher concentration of Se, which was similar in the both groups. This may explain our recently published data that urinary excretion was similar in the both groups. The relative oral bioavailability of plasma and each organ was calculated by the ratio of area under the concentration-time curve after oral administration (AUCpo) to AUCiv. Each organ appeared to have their own bioavailability (i.e., liver 39%, kidney 97%, heart 37%, lung 18%, spleen 10%, and brain 72%), where plasma was 46%. These results highly suggested that different Se distribution in organs by the different route of administration was due to the different metabolic profile. (author)

Tissue concentration-time profile of selenium after sodium selenite administration to rats

International Nuclear Information System (INIS)

Kaneko, Megumi; Natsuhori, Masahiro; Ito, Nobuhiko; Sera, Koichiro; Futatsugawa, Shoji

1999-01-01

Selenium (Se) concentration-time profiles in plasma and organs including liver, kidney, heart, lung, spleen and brain of rats (Jcl Wister, 9 wks old, n=32) were investigated after a single intravenous (iv) / oral (po) administration of sodium selenite (dose is equivalent to 2 mg/kg b.w. of Se). The Se concentration was determined by PIXE analysis. Among the investigated biological samples, Se concentration was the highest in the kidney or liver, followed by the heart, lung or spleen, then plasma, and the brain. Se concentrations in these organs were 0.5 to 5 times of plasma Se. The distribution profiles of Se in the organs were dependent on the route of administration. Furthermore, their profiles appeared almost parallel to the plasma Se-concentration in a logarithmic scale. Compared to the Se concentration-time profiles in plasma and organs by the route of administration, po group showed about 1/4-1/2 of the Se concentration in iv group except for kidney. Kidney kept relatively higher concentration of Se, which was similar in the both groups. This may explain our recently published data that urinary excretion was similar in the both groups. The relative oral bioavailability of plasma and each organ was calculated by the ratio of area under the concentration-time curve after oral administration (AUCpo) to AUCiv. Each organ appeared to have their own bioavailability (i.e., liver 39%, kidney 97%, heart 37%, lung 18%, spleen 10%, and brain 72%), where plasma was 46%. These results highly suggested that different Se distribution in organs by the different route of administration was due to the different metabolic profile. (author)

MR appearance of central neurocytoma

International Nuclear Information System (INIS)

Chang, K.H.; Han, M.H.; Kim, D.G.; Chi, J.G.; Suh, D.C.; Kim, S.J.; Cha, S.H.; Han, M.C.

1993-01-01

To provide a detailed description of the MR appearances of central neurocytoma, MR images of 13 patients with central neurocytoma were retrospectively reviewed and compared with CT examinations. The histology was confirmed by ultrastructural and immunohistochemical studies. In 12 patients the tumors were histologically benign and located in the anterior part of the lateral ventricle, 6 of which extended to the 3rd ventricle. There was one case of a histologically malignant variant involving the thalamus and lateral ventricle. The tumors were primarily solid, but contained cysts (85%, 11/13), calcifications (69%, 9/13), and signal void from tumor vessels (62%, 8/13), frequently producing heterogeneous signal intensity on both T1- and T2-weighted images. Most of the solid portion appeared isointense or slightly hyperintense relative to the cerebral cortex on all MR pulse sequences. Calcifications were iso- or hypointense on MR, making them difficult to characterize with MR alone. Intratumoral hemorrhage was seen in 2 patients on MR but not on CT. Contrast enhancement was variable in degree and pattern. Coronal and sagittal MR images were valuable in evaluating the tumor extent and origin site, and in planning the surgical approach. It is concluded that MR imaging appears to be more useful than CT in the overall evaluation of central neurocytoma, even though calcification is better characterized with CT. (orig.)

Color categories and color appearance

Science.gov (United States)

Webster, Michael A.; Kay, Paul

2011-01-01

We examined categorical effects in color appearance in two tasks, which in part differed in the extent to which color naming was explicitly required for the response. In one, we measured the effects of color differences on perceptual grouping for hues that spanned the blue–green boundary, to test whether chromatic differences across the boundary were perceptually exaggerated. This task did not require overt judgments of the perceived colors, and the tendency to group showed only a weak and inconsistent categorical bias. In a second case, we analyzed results from two prior studies of hue scaling of chromatic stimuli (De Valois, De Valois, Switkes, & Mahon, 1997; Malkoc, Kay, & Webster, 2005), to test whether color appearance changed more rapidly around the blue–green boundary. In this task observers directly judge the perceived color of the stimuli and these judgments tended to show much stronger categorical effects. The differences between these tasks could arise either because different signals mediate color grouping and color appearance, or because linguistic categories might differentially intrude on the response to color and/or on the perception of color. Our results suggest that the interaction between language and color processing may be highly dependent on the specific task and cognitive demands and strategies of the observer, and also highlight pronounced individual differences in the tendency to exhibit categorical responses. PMID:22176751

Safety Assessment in the AREVA Group: Operating Experience from a Self-Assessment Tool

International Nuclear Information System (INIS)

Coye de Brunélis, T.; Mignot, E.; Sidaner, J.-F.

2016-01-01

The expression “safety culture” first appeared following analysis of the Chernobyl accident in 1986. It was first defined in INSAG-4 (International Nuclear Safety Advisory Group safety series) in 1991. Other events have occurred in nuclear facilities and during transportation since Chernobyl: Tokai Mura in 1999, Roissy Transport in 2002, Davis Besse in 2002, Thorp in 2005. These events show that the initial approach was too simplistic. Based on this observation, the definition of safety culture was supplemented by including concepts of cultural value (associated with the country and the company) and human and organizational factors, and was integrated in that form with the emergence and implementation of integrated management systems (IMS). Today, the concept of nuclear safety culture covers a wide set of factors such as safety, quality, corporate culture, defined processes and policies, organizations and related resources. Any assessment of people’s safety culture, particularly people directly involved in facility operations, is thus part of a comprehensive policy and contributes to a de facto demonstration of the priority which management assigns to safety.

National machine guarding program: Part 2. Safety management in small metal fabrication enterprises

Science.gov (United States)

Yamin, Samuel C.; Brosseau, Lisa M.; Xi, Min; Gordon, Robert; Most, Ivan G.; Stanley, Rodney

2015-01-01

Background Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. Methods The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33‐question safety management audit. Audits were completed during an interview with the business owner or manager. Results Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. Am. J. Ind. Med. 58:1184–1193, 2015. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc. PMID:26345591

Food appearances in children's television programmes in Iceland.

Science.gov (United States)

Olafsdottir, Steingerdur; Berg, Christina

2017-11-01

Exposure to advertisements cannot fully explain the associations between young children's dietary intake and the time they spend in front of the television. It is therefore of importance to study television content other than advertisements in this aspect. The present study aimed to examine the nature and extent of verbal and visual appearances of foods and beverages in children's television programmes on Icelandic public service television. A total of 27 h of children's programmes (domestic and internationally produced) were watched. All verbal and visual appearances of foods and beverages were coded, as well as the context in which the foods/beverages were discussed or appeared. Children's programmes on Icelandic public service television. Two food groups were of special interest for their importance from a public health perspective: high-calorie and low-nutrient (HCLN) foods and fruits and vegetables (F&V). The χ 2 test and logistic regression were performed to analyse if the occurrence of the two groups was associated with the context where foods/beverages appeared. Of the 125 different programmes, a food or beverage appeared in 86 %. Of the total food appearances (n 599), HCLN foods accounted for 26 % and F&V for 23 %. HCLN foods were presented as desirable by appearing more frequently with child characters (Pfood and eating is presented in children's programmes, as young childhood is a critical period for founding healthy habits for later life.

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. 

Selecting fillers on emotional appearance improves lineup identification accuracy.

Science.gov (United States)

Flowe, Heather D; Klatt, Thimna; Colloff, Melissa F

2014-12-01

Mock witnesses sometimes report using criminal stereotypes to identify a face from a lineup, a tendency known as criminal face bias. Faces are perceived as criminal-looking if they appear angry. We tested whether matching the emotional appearance of the fillers to an angry suspect can reduce criminal face bias. In Study 1, mock witnesses (n = 226) viewed lineups in which the suspect had an angry, happy, or neutral expression, and we varied whether the fillers matched the expression. An additional group of participants (n = 59) rated the faces on criminal and emotional appearance. As predicted, mock witnesses tended to identify suspects who appeared angrier and more criminal-looking than the fillers. This tendency was reduced when the lineup fillers matched the emotional appearance of the suspect. Study 2 extended the results, testing whether the emotional appearance of the suspect and fillers affects recognition memory. Participants (n = 1,983) studied faces and took a lineup test in which the emotional appearance of the target and fillers was varied between subjects. Discrimination accuracy was enhanced when the fillers matched an angry target's emotional appearance. We conclude that lineup member emotional appearance plays a critical role in the psychology of lineup identification. The fillers should match an angry suspect's emotional appearance to improve lineup identification accuracy. PsycINFO Database Record (c) 2014 APA, all rights reserved.

The Impact of Appearance Management Training, Work Status, and Plans after High School on Opinions Regarding Appearance at Work and School

Science.gov (United States)

Freeburg, Beth Winfrey; Arnett, Sally E.

2010-01-01

The purpose of this study was to measure the effect of appearance management training, work status, and plans after high school on students' opinions about appearance at school and at work. A nonprobability sample of 132 high school juniors and seniors in a consumer education class were administered the Appearance Management Survey before and…

Sensory profile of eleven peach cultivars

Directory of Open Access Journals (Sweden)

Francine Lorena Cuquel

2012-03-01

Full Text Available The goal of this study was to evaluate the sensory profile of eleven peach cultivars grown in an experimental orchard located in the city of Lapa (PR, Brazil in two seasons. The peach cultivars analyzed were Aurora I, Chimarrita, Chiripá, Coral, Eldorado, Granada, Leonense, Maciel, Marli, Premier, and Vanguarda. The sensory analysis was performed by previously trained panelists; 20 of them in the first season and 10 in the second season. The sensory evaluation was performed using Quantitative Descriptive Analysis, in which the following attributes were measured: appearance, aroma, flesh color, flesh firmness, flavor, and juiciness. The results showed preference for sweet, soft, and juicy fruits. Chimarrita, Chiripá, and Coral fruits showed better sensorial performance than the other peach cultivars. It was also verified that the analysis of the attributes aroma, flesh firmness, and flavor is enough for performing the sensory profile of peach fruits for in natura consumption.

Assessing the relationship between patient safety culture and EHR strategy.

Science.gov (United States)

Ford, Eric W; Silvera, Geoffrey A; Kazley, Abby S; Diana, Mark L; Huerta, Timothy R

2016-07-11

Purpose - The purpose of this paper is to explore the relationship between hospitals' electronic health record (EHR) adoption characteristics and their patient safety cultures. The "Meaningful Use" (MU) program is designed to increase hospitals' adoption of EHR, which will lead to better care quality, reduce medical errors, avoid unnecessary cost, and promote a patient safety culture. To reduce medical errors, hospital leaders have been encouraged to promote safety cultures common to high-reliability organizations. Expecting a positive relationship between EHR adoption and improved patient safety cultures appears sound in theory, but it has yet to be empirically demonstrated. Design/methodology/approach - Providers' perceptions of patient safety culture and counts of patient safety incidents are explored in relationship to hospital EHR adoption patterns. Multi-level modeling is employed to data drawn from the Agency for Healthcare Research and Quality's surveys on patient safety culture (level 1) and the American Hospital Association's survey and healthcare information technology supplement (level 2). Findings - The findings suggest that the early adoption of EHR capabilities hold a negative association to the number of patient safety events reported. However, this relationship was not present in providers' perceptions of overall patient safety cultures. These mixed results suggest that the understanding of the EHR-patient safety culture relationship needs further research. Originality/value - Relating EHR MU and providers' care quality attitudes is an important leading indicator for improved patient safety cultures. For healthcare facility managers and providers, the ability to effectively quantify the impact of new technologies on efforts to change organizational cultures is important for pinpointing clinical areas for process improvements.

Modernization of Physical Appearance and Solution Color Tests Using Quantitative Tristimulus Colorimetry: Advantages, Harmonization, and Validation Strategies.

Science.gov (United States)

Pack, Brian W; Montgomery, Laura L; Hetrick, Evan M

2015-10-01

Color measurements, including physical appearance, are important yet often misunderstood and underappreciated aspects of a control strategy for drug substances and drug products. From a patient safety perspective, color can be an important control point for detecting contamination, impurities, and degradation products, with human visual acuity often more sensitive for colored impurities than instrumental techniques such as HPLC. Physical appearance tests and solution color tests can also serve an important role in ensuring that appropriate steps are taken such that clinical trials do not become unblinded when the active material is compared with another product or a placebo. Despite the importance of color tests, compendial visual tests are not harmonized across the major pharmacopoeias, which results in ambiguous specifications of little value, difficult communication of true sample color, and significant extra work required for global registration. Some pharmacopoeias have not yet recognized or adopted technical advances in the instrumental measurement of color and appearance, whereas others begin to acknowledge the advantage of instrumental colorimetry, yet leave implementation of the technology ambiguous. This commentary will highlight the above-mentioned inconsistencies, provide an avenue toward harmonization and modernization, and outline a scientifically sound approach for implementing quantitative technologies for improved measurement, communication, and control of color and appearance for both solutions and solids. Importantly, this manuscript, for the first time, outlines a color method validation approach that is consistent with the International Conference on Harmonization's guidance on the topic of method validation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Reflectance, illumination, and appearance in color constancy.

Science.gov (United States)

McCann, John J; Parraman, Carinna; Rizzi, Alessandro

2014-01-01

We studied color constancy using a pair of identical 3-D Color Mondrian displays. We viewed one 3-D Mondrian in nearly uniform illumination, and the other in directional, nonuniform illumination. We used the three dimensional structures to modulate the light falling on the painted surfaces. The 3-D structures in the displays were a matching set of wooden blocks. Across Mondrian displays, each corresponding facet had the same paint on its surface. We used only 6 chromatic, and 5 achromatic paints applied to 104 block facets. The 3-D blocks add shadows and multiple reflections not found in flat Mondrians. Both 3-D Mondrians were viewed simultaneously, side-by-side. We used two techniques to measure correlation of appearance with surface reflectance. First, observers made magnitude estimates of changes in the appearances of identical reflectances. Second, an author painted a watercolor of the 3-D Mondrians. The watercolor's reflectances quantified the changes in appearances. While constancy generalizations about illumination and reflectance hold for flat Mondrians, they do not for 3-D Mondrians. A constant paint does not exhibit perfect color constancy, but rather shows significant shifts in lightness, hue and chroma in response to the structure in the nonuniform illumination. Color appearance depends on the spatial information in both the illumination and the reflectances of objects. The spatial information of the quanta catch from the array of retinal receptors generates sensations that have variable correlation with surface reflectance. Models of appearance in humans need to calculate the departures from perfect constancy measured here. This article provides a dataset of measurements of color appearances for computational models of sensation.

Reflectance, illumination, and appearance in color constancy

Directory of Open Access Journals (Sweden)

John J. McCann

2014-01-01

Full Text Available We studied color constancy using a pair of identical 3-D Color Mondrian displays. We viewed one 3-D Mondrian in nearly uniform illumination, and the other in directional, nonuniform illumination. We used the three dimensional structures to modulate the light falling on the painted surfaces. The 3-D structures in the displays were a matching set of wooden blocks. Across Mondrian displays, each corresponding facet had the same paint on its surface. We used only 6 chromatic, and 5 achromatic paints applied to 104 block facets. The 3-D blocks add shadows and multiple reflections not found in flat Mondrians. Both 3-D Mondrians were viewed simultaneously, side-by-side. We used two techniques to measure correlation of appearance with surface reflectance. First, observers made magnitude estimates of changes in the appearances of identical reflectances. Second, an author painted a watercolor of the 3-D Mondrians. The watercolor’s reflectances quantified the changes in appearances. While constancy generalizations about illumination and reflectance hold for flat Mondrians, they do not for 3-D Mondrians. A constant paint does not exhibit perfect color constancy, but rather shows significant shifts in lightness, hue and chroma in response to the structure in the nonuniform illumination. Color appearance depends on the spatial information in both the illumination and the reflectances of objects. The spatial information of the quanta catch from the array of retinal receptors generates sensations that have variable correlation with surface reflectance. Models of appearance in humans need to calculate the departures from perfect constancy measured here. This article provides a dataset of measurements of color appearances for computational models of sensation.

Optical measurement of the free carrier profile in ion implanted silicon

International Nuclear Information System (INIS)

Geffroy, Y.; Bennaceur, R.; Sebenne, C.; Balkanski, M.

1974-01-01

The infrared reflective power spectrum measured for Si inhomogeneously doped samples, near plasma resonance can be reproduced by a computer program from a given profile of free carrier concentration. A comparison between theoretical and experimental plots allows the appropriate selection of a series of parameters defining the depth distribution of free carriers. The method appears well suited for investigating the upper part of the concentration profiles of strongly doped films (implantation doses above 10 14 cm -2 for 100keV energies). The sensitivity obtained grows with the dose up to 15-20% in the 10 16 cm -2 range [fr

Reinvention, renewal or repetition? the great western railway and occupational safety on Britain’s railways, c.1900-c.1920

OpenAIRE

Esbester, Mike

2005-01-01

In 1913, the Great Western Railway introduced an occupational safety education campaign that appeared to be a radical break with all previous methods of promoting safety in the British industrial workplace. In this paper, I assess the extent to which this “new” campaign reinvented occupational safety education in Britain. I argue that the Great Western combined new techniques of communicating safety messages with the relatively traditional content of those messages. Rather than a simple repet...

Radiological appearances of degenerative uterine leiomyomas

International Nuclear Information System (INIS)

Tzvetankov, K.; Hadjidekov, G.; Plachkov, I.; Yankova, M.

2013-01-01

Uterine fibroids, also known as leiomyomas, are the most common uterine neoplasms. Although benign, they can be associated with significant morbidity and are the commonest indication for hysterectomy. They are often discovered incidentally when performing imaging for other reasons. Usually first identified with US, they can be further characterized with MRI. They are usually easily recognizable, but degenerate fibroids can have unusual appearances. Knowledge of the different appearances of fibroids on imaging is important as it enables prompt diagnosis and thereby guides treatment. (authors)

Metabolic Profiling of Alpine and Ecuadorian Lichens

Directory of Open Access Journals (Sweden)

Verena K. Mittermeier

2015-10-01

Full Text Available Non-targeted 1H-NMR methods were used to determine metabolite profiles from crude extracts of Alpine and Ecuadorian lichens collected from their natural habitats. In control experiments, the robustness of metabolite detection and quantification was estimated using replicate measurements of Stereocaulon alpinum extracts. The deviations in the overall metabolite fingerprints were low when analyzing S. alpinum collections from different locations or during different annual and seasonal periods. In contrast, metabolite profiles observed from extracts of different Alpine and Ecuadorian lichens clearly revealed genus- and species-specific profiles. The discriminating functions determining cluster formation in principle component analysis (PCA were due to differences in the amounts of genus-specific compounds such as sticticin from the Sticta species, but also in the amounts of ubiquitous metabolites, such as sugar alcohols or trehalose. However, varying concentrations of these metabolites from the same lichen species e.g., due to different environmental conditions appeared of minor relevance for the overall cluster formation in PCA. The metabolic clusters matched phylogenetic analyses using nuclear ribosomal DNA (nrDNA internal transcribed spacer (ITS sequences of lichen mycobionts, as exemplified for the genus Sticta. It can be concluded that NMR-based non-targeted metabolic profiling is a useful tool in the chemo-taxonomy of lichens. The same approach could also facilitate the discovery of novel lichen metabolites on a rapid and systematical basis.

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

Science.gov (United States)

Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

2017-08-01

Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

Compliance With Recommended Food Safety Practices in Television Cooking Shows.

Science.gov (United States)

Cohen, Nancy L; Olson, Rita Brennan

Examine compliance with recommended food safety practices in television cooking shows. Using a tool based on the Massachusetts Food Establishment Inspection Report, raters examined 39 episodes from 10 television cooking shows. Chefs demonstrated conformance with good retail practices for proper use and storage of utensils in 78% of episodes; preventing contamination (62%), and fingernail care (82%). However, 50% to 88% of episodes were found to be out of compliance with other personal hygiene practices, proper use of gloves and barriers (85% to 100%), and maintaining proper time and temperature controls (93%). Over 90% failed to conform to recommendations regarding preventing contamination through wiping cloths and washing produce. In only 13% of episodes were food safety practices mentioned. There appears to be little attention to food safety during most cooking shows. Celebrity and competing chefs have the opportunity to model and teach good food safety practices for millions of viewers. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study

International Nuclear Information System (INIS)

Adleman, Jenna; Gillan, Caitlin; Caissie, Amanda; Davis, Carol-Anne; Liszewski, Brian; McNiven, Andrea; Giuliani, Meredith

2017-01-01

Purpose: To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. Methods and Materials: A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through web conference discussion and reranked in Round 2. Results: An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. Conclusions: This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study

Energy Technology Data Exchange (ETDEWEB)

Adleman, Jenna [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Gillan, Caitlin [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Caissie, Amanda [Department of Radiation Oncology, Dalhousie University, Halifax, Nova Scotia (Canada); Saint John Regional Hospital, Saint John, New Brunswick (Canada); Davis, Carol-Anne [Department of Radiation Oncology, Dalhousie University, Halifax, Nova Scotia (Canada); Nova Scotia Cancer Centre, Halifax, Nova Scotia (Canada); Liszewski, Brian [Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario (Canada); McNiven, Andrea [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Giuliani, Meredith, E-mail: Meredith.Giuliani@rmp.uhn.ca [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada)

2017-06-01

Purpose: To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. Methods and Materials: A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through web conference discussion and reranked in Round 2. Results: An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. Conclusions: This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs.

Safety-related topics from the Nuclear Power Options Viability Study

International Nuclear Information System (INIS)

Trauger, D.B.; White, J.D.

1986-01-01

The Nuclear Power Options Viability Study (NPOVS) evaluated innovative reactor concepts, and this article reviews NPOVS findings, with emphasis on safety and licensing. The reactors studied were of light-water, liquid-metal, and helium-cooled concepts, and most were of modular design. Prelicensed standard plants offer an important step toward regulatory stability and early licensing approvals with public participation before major expenditures. Advanced reactors with passive safety features offer the possibility of performance-based regulation. The concepts studied appear to be potentially viable, but more complete designs will be required before economic evaluations can be definitive

On the physical mechanism at the origin of multiple double layers appearance in plasma

International Nuclear Information System (INIS)

Dimitriu, D.G.; Gurlui, S.; Aflori, M.; Ivan, L.M.

2005-01-01

Double layers (DLs) in plasma are nonlinear potential structures consisting of two adjacent layers of positive and negative space charge, respectively. Between these layers a potential jump exists, creating an electric field. A common way to obtain a DL structure is to positively bias an electrode immersed in asymptotic stable plasma. In this way, a complex space charge structure (CSCS) in form of a positive 'nucleus' surrounded by a nearly spherical DL is obtained. Under certain experimental conditions (gas nature and pressure, plasma density, electron temperature) a more complex structure in form of two or more subsequent DLs was observed, which was called multiple double layers (MDL). It appears as several bright and concentric plasma shells attached to the electrode. The successive DLs are located at the abrupt changes of luminosity between two adjacent plasma shells. Probe measurements emphasized that the axial profile of the plasma potential has a stair steps shape, with potential jumps close to the ionization potential of the used gas. Experimental results clarify the essential role of excitation and ionization electron-neutral collisions for the generation and dynamics of MDL structures. However, if the electrode is large, the MDL structure appears non-concentrically, as a network of plasma spheres, near each other, almost equally distributed on the electrode surface. Each of the plasma spots is a CSCS as described above. Here, we will present experimental result on concentric and non-concentric MDL, which prove that the same physical mechanism is at the origin of their appearance in plasma. In this mechanism the electron-neutral impact excitations and ionizations play the key role. A simultaneously generation of both types of MDL was recorded. The dynamics of the MDL structures was analyzed by using the modern methods provided by the nonlinear dynamics. In this way, a scenario of transition to chaos by torus breakdown was emphasized, related with the

Profile of drowning victims in a coastal community.

Science.gov (United States)

Nichter, M A; Everett, P B

1989-02-01

Accidental drowning accounts for 15% of all accidental deaths in Pinellas County, Florida, and this study was conducted to better understand the epidemiologic profile of the victim. The medical examiner's records of 230 drownings in Pinellas County from January 1, 1983, through December 31, 1987, were reviewed for demographic and epidemiologic data. Bodies of salt water were the most common drowning site (47%), followed by swimming pools (22%), lakes (11%), baths (7%), and canals (6%). The drowning incidence for males was more than three times that for females. Drowning was endemic among boys less than five years of age (30/100,000/year). Fifty-nine percent of young adult victims had detectable postmortem blood alcohol levels. Drowning rates were highest among children less than five years and adults more than 80 years. Epidemiologic profiles of populations at risk and contributing factors are described and public safety measures are suggested.

Holes in the US nuclear safety net

International Nuclear Information System (INIS)

Utroska, D.

1987-01-01

Contrary to popular perception, the NRC has neither the authority nor the resources to comprehensively regulate the authority nor the resources to comprehensively regulate the nuclear power industry: it cannot check and monitor every nuclear plant in detail to assure reasonable reactor safety. This is widely understood within the power industry. After the Three Mile Island accident, the nuclear industry formed a group called the Institute of Nuclear Power Operations (INPO), based in Atlanta, Georgia. Its self-proclaimed mandate is to pick up the safety initiative where NRC regulations and reviews leave off; to make sure that each nuclear plant in the United States goes beyond compliance with minimum regulations and achieves excellence in safe and efficient performance. INPO's 1986 budget was $44 million, paid to the institute by electricity ratepayers via the nuclear utilities. Among other things, the money funds INPO's development of nuclear plant operating criteria and pays for plant inspections to determine if the standards are being met. INPO has deliberately maintained a low profile. INPO does not become involved in public or media activities on behalf of the industry or in the role of promoting the nuclear power option, the organization's formal institutional plan declares. A key aspect of INPO's public noninvolvement is keeping to itself and its members the results of its nuclear plant safety evaluations. Although consumers fund INPO activities and have a stake in nuclear plant safety, the press and the public are denied access to INPO safety investigation reports. 8 references

Musculoskeletal infections: ultrasound appearances

Energy Technology Data Exchange (ETDEWEB)

Chau, C.L.F. [Department of Radiology, North District Hospital, NTEC, Fanling, NT, Hong Kong (China)]. E-mail: c8681@yahoo.com; Griffith, J.F. [Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, NTEC, Shatin, NT, Hong Kong (China)

2005-02-01

Musculoskeletal infections are commonly encountered in clinical practice. This review will discuss the ultrasound appearances of a variety of musculoskeletal infections such as cellulitis, infective tenosynovitis, pyomyositis, soft-tissue abscesses, septic arthritis, acute and chronic osteomyelitis, and post-operative infection. The peculiar sonographic features of less common musculoskeletal infections, such as necrotizing fasciitis, and rice body formation in atypical mycobacterial tenosynovitis, and bursitis will also be presented.

Musculoskeletal infections: ultrasound appearances

International Nuclear Information System (INIS)

Chau, C.L.F.; Griffith, J.F.

2005-01-01

Musculoskeletal infections are commonly encountered in clinical practice. This review will discuss the ultrasound appearances of a variety of musculoskeletal infections such as cellulitis, infective tenosynovitis, pyomyositis, soft-tissue abscesses, septic arthritis, acute and chronic osteomyelitis, and post-operative infection. The peculiar sonographic features of less common musculoskeletal infections, such as necrotizing fasciitis, and rice body formation in atypical mycobacterial tenosynovitis, and bursitis will also be presented

Twenty-First Water Reaction Safety Information Meeting

International Nuclear Information System (INIS)

Monteleone, S.

1994-04-01

This three-volume report contains 90 papers out of the 102 that were presented at the Twenty-First Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, during the week of October 25--27, 1993. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Germany, Japan, Russia, Switzerland, Taiwan, and United Kingdom. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. Individual papers have been cataloged separately. This document, Volume 2, presents papers on severe accident research

Twenty-First Water Reactor Safety Information Meeting

International Nuclear Information System (INIS)

Monteleone, S.

1994-04-01

This three-volume report contains 90 papers out of the 102 that were presented at the Twenty-First Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, during the week of October 25-27, 1993. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Germany, Japan, Russia, Switzerland, Taiwan, and United Kingdom. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. Selected papers were indexed separately for inclusion in the Energy Science and Technology Database

Modern Aspects of Safety Assessment of Foodstuff

Directory of Open Access Journals (Sweden)

Tetiana Chorna

2018-04-01

Full Text Available Food safety is one of the decisive components of the economic security of each state and is determined by the ability of the country to control effectively the production and import of safe and high-quality food on the generally accepted principles of the world. This sphere of activity in human society has extremely important humanitarian, social, economic and political aspects. The food raw materials and food products quality and safety control is currently the most relevant analytical task. It is more important than environmental pollution, according to some data, more than 70 % of harmful pollutants in the human body gets through food, 20% of water and 10 % of the air. Technogenic pollution of the environment through soil, water and air gets directly into the food. However, food products are contaminated with natural harmful substances that appear in improper storage, in violation of technologies, food processing and processing charts. The article is devoted to the main factors analysis influencing the safety of food products and the improvement of instrumental methods for the study of quality aromatic products (for example, coffee.

Satisfaction with facial appearance and its determinants in adults with severe congenital facial disfigurement: a case-referent study.

Science.gov (United States)

Versnel, S L; Duivenvoorden, H J; Passchier, J; Mathijssen, I M J

2010-10-01

Patients with severe congenital facial disfigurement have a long track record of operations and hospital visits by the time they are 18 years old. The fact that their facial deformity is congenital may have an impact on how satisfied these patients are with their appearance. This study evaluated the level of satisfaction with facial appearance of congenital and of acquired facially disfigured adults, and explored demographic, physical and psychological determinants of this satisfaction. Differences compared with non-disfigured adults were examined. Fifty-nine adults with a rare facial cleft, 59 adults with a facial deformity traumatically acquired in adulthood, and a reference group of 201 non-disfigured adults completed standardised demographic, physical and psychological questionnaires. The congenital and acquired groups did not differ significantly in the level of satisfaction with facial appearance, but both were significantly less satisfied than the reference group. In facially disfigured adults, level of education, number of affected facial parts and facial function were determinants of the level of satisfaction. High fear of negative appearance evaluation by others (FNAE) and low self-esteem (SE) were strong psychological determinants. Although FNAE was higher in both patient groups, SE was similar in all three groups. Satisfaction with facial appearance of individuals with a congenital or acquired facial deformity is similar and will seldom reach the level of satisfaction of non-disfigured persons. A combination of surgical correction (with attention for facial profile and restoring facial functions) and psychological help (to increase SE and lower FNAE) may improve patient satisfaction. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS

Directory of Open Access Journals (Sweden)

R. V. Denisova

2012-01-01

Full Text Available The article represents the results of efficacy and safety evaluation of the human monoclonal antibodies — golimumab, according to the data of international multicenter randomized double-blind placebo-controlled trials, including patients with active stage of rheumatoid arthritis. It was shown, that golimumab was reliably more effective than placebo both when administered hypodermic and intravenous. The safety profile of golimumab is comparable to that of the other tumor necrosis factor alpha blockers. The review also contains information on the 3d phase of golimumab efficacy and safety research in patients with juvenile idiopathic arthritis.

Safety of licensed vaccines in HIV-infected persons: a systematic review protocol

Science.gov (United States)

2014-01-01

Background Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. Methods/Design We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Discussion Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be

Risk concepts in UK nuclear safety decision-making

International Nuclear Information System (INIS)

Brighton, P.W.M.

2001-01-01

This paper discusses the concept of risk as understood in the UK, with particular reference to the use of probabilistic safety assessment (PSA) in nuclear safety decision making. The way 'risk' appears in UK fundamental legislation means that the concept cannot be limited to evaluation of numerical probabilities of physical harm. Rather the focus is on doing all that is reasonably practicable to reduce risks: this entails applying relevant good practice and then seeking further safety measures until the money, time and trouble required are grossly disproportionate to the residual risk. PSA is used to inform rather than dictate such decisions. This approach is reinforced by considering how far any practical PSA can be said to measure risk. The behaviour of complex socio-technical systems such as nuclear power stations does not meet the conditions under which probability theory can be applied in an absolutely objective statistical sense. Risk is not an intrinsic real property of such systems. Rather PSA is a synthesis of data and subjective expert judgements, dependent on the extent of detailed knowledge of the plant. There are many other aspects of engineering judgement involved in safety decisions which cannot be so captured. (author)

Nodular fasciitis: MRI appearance and literature review

International Nuclear Information System (INIS)

Leung, L.Y.J.; Shu, S.J.; Chan, M.K.; Chan, C.H.S.; Chan, A.C.L.

2002-01-01

Objective: To describe the MRI features of nodular fasciitis and to review the clinical, MRI and histologic aspects of the tumor. Design and patients: Three patients with biopsy-proven nodular fasciitis were selected for a retrospective study. A literature review was also carried out. Results and conclusions: All the lesions appeared slightly hyperintense to skeletal muscle on T1-weighted images, and hyperintense on T2-weighted images with fat saturation [either frequency saturation or Short TI Inversion Recovery (STIR) sequences]. Two enhanced homogeneously after intravenous gadolinium, whereas the third showed heterogeneous enhancement with a nonenhancing area. Despite the difference in enhancing patterns, the histologic appearances of these lesions were similar. Our study shows that the MRI appearance of nodular fasciitis may not be related to the location of lesion. It is thought that the age of nodular fasciitis may reflect its gross morphology, and it is possible that the MRI and histologic appearances could correlate with the age of the lesion, but it would require a larger series to evaluate this concept. (orig.)

Progress report - list of reports from BMFT, CEA, EPRI, JSTA and USNRC reactor safety research

International Nuclear Information System (INIS)

1982-10-01

This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special problems in the field of reactor safety research. The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

Passion fruit juice with different sweeteners: sensory profile by descriptive analysis and acceptance.

Science.gov (United States)

Rocha, Izabela Furtado de Oliveira; Bolini, Helena Maria André

2015-03-01

This study evaluated the effect of different sweeteners on the sensory profile, acceptance, and drivers of preference of passion fruit juice samples sweetened with sucrose, aspartame, sucralose, stevia, cyclamate/saccharin blend 2:1, and neotame. Sensory profiling was performed by 12 trained assessors using quantitative descriptive analysis (QDA). Acceptance tests (appearance, aroma, flavor, texture and overall impression) were performed with 124 consumers of tropical fruit juice. Samples with sucrose, aspartame and sucralose showed similar sensory profile (P Passion fruit flavor affected positively and sweet aftertaste affected negatively the acceptance of the samples. Samples sweetened with aspartame, sucralose, and sucrose presented higher acceptance scores for the attributes flavor, texture, and overall impression, with no significant (P passion fruit juice.

Nuclear safety culture and nuclear safety supervision

International Nuclear Information System (INIS)

Chai Jianshe

2013-01-01

In this paper, the author reviews systematically and summarizes up the development process and stage characteristics of nuclear safety culture, analysis the connotation and characteristics of nuclear safety culture, sums up the achievements of our country's nuclear safety supervision, dissects the challenges and problems of nuclear safety supervision. This thesis focused on the relationship between nuclear safety culture and nuclear safety supervision, they are essential differences, but there is a close relationship. Nuclear safety supervision needs to introduce some concepts of nuclear safety culture, lays emphasis on humanistic care and improves its level and efficiency. Nuclear safety supervision authorities must strengthen nuclear safety culture training, conduct the development of nuclear safety culture, make sure that nuclear safety culture can play significant roles. (author)

Analysis of National Major Work Safety Accidents in China, 2003-2012.

Science.gov (United States)

Ye, Yunfeng; Zhang, Siheng; Rao, Jiaming; Wang, Haiqing; Li, Yang; Wang, Shengyong; Dong, Xiaomei

2016-01-01

This study provides a national profile of major work safety accidents in China, which cause more than 10 fatalities per accident, intended to provide scientific basis for prevention measures and strategies to reduce major work safety accidents and deaths. Data from 2003-2012 Census of major work safety accidents were collected from State Administration of Work Safety System (SAWS). Published literature and statistical yearbook were also included to implement information. We analyzed the frequency of accidents and deaths, trend, geographic distribution and injury types. Additionally, we discussed the severity and urgency of emergency rescue by types of accidents. A total of 877 major work safety accidents were reported, resulting in 16,795 deaths and 9,183 injuries. The numbers of accidents and deaths, mortality rate and incidence of major accidents have declined in recent years. The mortality rate and incidence was 0.71 and 1.20 per 10(6) populations in 2012, respectively. Transportation and mining contributed to the highest number of major accidents and deaths. Major aviation and railway accidents caused more casualties per incident, while collapse, machinery, electrical shock accidents and tailing dam accidents were the most severe situation that resulted in bigger proportion of death. Ten years' major work safety accident data indicate that the frequency of accidents and number of eaths was declined and several safety concerns persist in some segments.

The use of criteria in the regulatory safety analysis in France

International Nuclear Information System (INIS)

Queniart, D.

1988-12-01

This paper describes the framework set up in France to allow continuous technical dialogue between operators and safety organizations. The operators, who have primary responsibility for the safety of their installations, propose the measures implemented, or to be implemented, in their installations. Each of these measures is then subjected to a detailed technical examination carried out by the Institute for Nuclear Safety and Protection, without reference to any technical regulations defined a priori. This approach has resulted, particularly in the case of pressurized water reactors (PWRs), in significant progress in the field of safety. This has been achieved by progressively completing the initial approach, derived from American practice for PWR plants, by probabilistic considerations, by a specific approach to severe accidents and by constant use of experience feedback. This last method seems particularly fruitful, and there would appear to be a need also for an indepth study of containment

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

Science.gov (United States)

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

Theoretical aspects of appearing of bubbles in economy

Directory of Open Access Journals (Sweden)

Pronoza Pavlo V.

2014-01-01