THE IMPORTANCE OF INFORMATION IN SUPERIOR GRADUATING INSTITUTES WEBSITES, IN THE MATRIX CURRICULUM AND PROFESSIONAL PROFILE OF SYSTEMS ANALYSIS AND DEVELOPMENT COURSES

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José Carlos Mariano do Carmo

2018-04-01

Full Text Available Introduction: the existing information in the technological graduation course official web pages need to be clear and objective, in order to ease up the access to programmatic contents, workload, integration and other necessary knowledge so that the students have discernment in their formation choice. Objective: to analyze the curriculum matrix and professional profile in the superior courses in Systems Analysis and Development in the Metropolitan Region of Florianópolis - Santa Catarina, considering the microregion of Grande Florianópolis, composed by nine counties: Florianópolis, São José, Palhoça, Biguaçu, Santo Amaro da Imperatriz, Governador Celso Ramos, Antônio Carlos, Águas Mornas and São Pedro de Alcântara. Methodology: we have performed a qualitative research on the pointed issue, relating it to the current legislation and some of the proposed theories. The research documentally based as it focused on the topics mentioned by the Superior Graduation Institutions in their virtual course environment. It was also used semistructured interviews by phone contact and even visiting when necessary, including searches in the Education Ministry web site to base the study, the curriculum matrix comparison and the course professional profile. Results: results show that the analyzed courses are focused in the job market demands in the studied region, regarding the desktop, web and mobile development solutions using programming languages. The formation professional profile also involves knowledge about logical reasoning, abstract math and learning of a second language. Conclusions: to show to interested students in joining the Systems Analysis and Development course, about the importance of the disciplines approached, utilized technologies, professional profiles and the main educational characteristics offered by the institutions. It is thus intended to contribute that these information are used for the purpose of qualification for the job

Superior intellectual ability in schizophrenia: neuropsychological characteristics.

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MacCabe, James H; Brébion, Gildas; Reichenberg, Abraham; Ganguly, Taposhri; McKenna, Peter J; Murray, Robin M; David, Anthony S

2012-03-01

It has been suggested that neurocognitive impairment is a core deficit in schizophrenia. However, it appears that some patients with schizophrenia have intelligence quotients (IQs) in the superior range. In this study, we sought out schizophrenia patients with an estimated premorbid Intelligence Quotient (IQ) of at least 115 and studied their neuropsychological profile. Thirty-four patients meeting diagnostic criteria for schizophrenia or schizoaffective disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV), with mean estimated premorbid IQ of 120, were recruited and divided into two subgroups, according to whether or not their IQ had declined by at least 10 points from their premorbid estimate. Their performance on an extensive neuropsychological battery was compared with that of 19 IQ-matched healthy controls and a group of 16 "typical" schizophrenia patients with estimated premorbid IQ Schizophrenia patients whose estimated premorbid and current IQ both lay in the superior range were statistically indistinguishable from IQ-matched healthy controls on all neurocognitive tests. However, their profile of relative performance in subtests was similar to that of typical schizophrenia patients. Patients with superior premorbid IQ and evidence of intellectual deterioration had intermediate scores. Our results confirm the existence of patients meeting DSM-IV diagnostic criteria for schizophrenia who have markedly superior premorbid intellectual level and appear to be free of gross neuropsychological deficits. We discuss the implications of these findings for the primacy of cognitive deficits in schizophrenia.

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.

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

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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.

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...

77 FR 48856 - Safety Zone; Superior Bay, Duluth, MN

Science.gov (United States)

2012-08-15

... environmental risk to health or risk to safety that may disproportionately affect children. 10. Indian Tribal... the Bayfront Festival Park. The Captain of the Port Duluth has determined that the swim leg of the... 1.05-1(f), the Captain of the Port Duluth is establishing a temporary safety zone to protect...

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)

Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment.

Science.gov (United States)

DeJesus, Edwin; Haas, Bernard; Segal-Maurer, Sorana; Ramgopal, Moti N; Mills, Anthony; Margot, Nicolas; Liu, Ya-Pei; Makadzange, Tariro; McCallister, Scott

2018-04-01

We previously demonstrated superior efficacy and safety advantages in HIV-infected, virologically suppressed adults switched to a regimen containing tenofovir alafenamide (TAF) as compared with those remaining on a tenofovir disoproxil fumarate (TDF) regimen through week 48. We now report long-term data through week 96. In this randomized, active-controlled, multicenter, open-label, noninferiority trial (ClinicalTrials.gov No. NCT01815736), we randomized virologically suppressed (HIV-1 RNA TAF group or to continue one of four TDF-containing regimens (TDF group) for 96 weeks. We evaluated efficacy (HIV-1 RNA TAF n = 959, TDF n = 477). At week 96, TAF was superior to TDF in virologic efficacy, with 93% on TAF and 89% on TDF having HIV-1 RNA TAF versus TDF continued through week 96 (p TAF group versus TDF through week 96 (p TAF group as compared with one case in the TDF group. Switching to EVG/COBI/FTC/TAF (E/C/F/TAF) was associated with statistically significant efficacy and safety advantages over remaining on a standard-of-care TDF-based regimen.

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

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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.

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

2013-12-01

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

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

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Moataz Alhaj

2016-01-01

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

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

Science.gov (United States)

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

2017-07-01

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

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

International Nuclear Information System (INIS)

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

2005-01-01

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

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

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Gotmi Sharwan

2016-09-01

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

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

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Meyer B

2015-02-01

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

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...

Superior versus inferior Ahmed glaucoma valve implantation.

Science.gov (United States)

Pakravan, Mohammad; Yazdani, Shahin; Shahabi, Camelia; Yaseri, Mehdi

2009-02-01

To compare the efficacy and safety of Ahmed glaucoma valve (AGV) (New World Medical Inc., Rancho Cucamonga, CA) implantation in the superior versus inferior quadrants. Prospective parallel cohort study. A total of 106 eyes of 106 patients with refractory glaucoma. Consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included intraocular pressure (IOP) and rate of complications. Other outcome measures included best corrected visual acuity (BCVA), number of glaucoma medications, and success rate (defined as at least 30% IOP reduction and 5glaucoma surgery, phthisis bulbi, or loss of light perception. Of a total of 106 eyes, 58 and 48 eyes underwent AGV implantation in the superior and inferior quadrants, respectively. Baseline characteristics were comparable in the study groups, except for preoperative IOP, which was higher in the superior group (P = 0.01). Patients were followed for a mean period of 10.6+/-8.49 months and 10.58+/-6.75 months in the superior and inferior groups, respectively (P = 0.477). BCVA was comparable between the groups at all postoperative visits (P>0.122). After 1 year, statistically significant but comparable IOP reduction from baseline (Pglaucoma medications was comparable after 1 year (1.3+/-1.2 vs. 1.9+/-0.8 for superior and inferior implants, respectively, P = 0.256). Success rates were also similar at 1 year: 27 eyes (81.8%) versus 20 eyes (95.2%) for superior and inferior implants, respectively (P = 0.227). However, the overall rate of complications, such as implant exposure necessitating removal, cosmetically unappealing appearance, and endophthalmitis, was higher in the inferior group: 12 eyes (25%) versus 3 eyes (5.2%) for superior and inferior groups, respectively, (P = 0.004). Superior and inferior AGV implants have similar intermediate efficacy in terms of IOP reduction, decrease in number of glaucoma medications, and preservation of vision. However

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...

Neurocognitive decrements are present in intellectually superior schizophrenia

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Anja eVaskinn

2014-05-01

Full Text Available Data suggests that individuals with schizophrenia (SZ and superior intelligence can present without specific neurocognitive deficits. However, neurocognitive decrements, defined as worse cognition than expected, have been reported in practically all schizophrenia cases. This study investigated if neurocognitive decrements are present in intellectually superior SZ by comparing the neuropsychological profile of SZ cases with IQ-matched healthy controls (HC across intellectual level. Participants with SZ and HCs were stratified into three IQ-groups; intellectually low (IQ 80-95; SZ n = 65 & HC n = 13, intellectually normal (IQ = 100-115; SZ n = 111 & HC n = 115 and intellectually superior (IQ > 120; SZ n = 20 & HC n = 50. A repeated measures multivariate analysis of co-variance compared performance on eight selected neuropsychological tests across IQ-strata and diagnostic group. Differences in clinical characteristics and social functioning in SZ across IQ-strata were investigated with multivariate and univariate analyses of variance. Intellectually superior SZ participants scored within normal limits, but had neurocognitive decrements compared to superior HCs. Decrements were of the same magnitude as in the low and normal IQ-strata. Levels of functional impairments and clinical characteristics in participants with SZ did not differ significantly across IQ-strata. Results indicate that neurocognitive decrements are present in intellectually superior SZ to the same extent as in intellectually low and intellectually normal SZ, supporting the notion that SZ is a neurocognitive disorder. Similar levels of social functional deficits and clinical symptoms suggest similar disease processes in SZ across intellectual level.

Sedimentation rates and depositional processes in Lake Superior from 210Pb geochronology

International Nuclear Information System (INIS)

Evans, J.E.; Johnson, T.C.; Alexander, E.C. Jr.; Lively, R.S.; Eisenreich, S.J.

1981-01-01

Sedimentation rates range from 0.01 to 0.32 cm/yr in 17 sediment box cores from Lake Superior, as determined by 210 Pb geochronology. Shoreline erosion and resuspension of nearshore sediments causes moderate to high (0.05-0.11 cm/yr) sedimentation rates in the western arm of Lake Superior. Sedimentation rates are very high (> 0.15 cm/yr) in marginal bays adjoining Lake Superior; and moderate to very high (0.07-0.19 cm/yr) in open lake regions adjacent to marginal bays. Resuspension of nearshore and shoal top sediments in southern and southeastern Lake Superior by storms is responsible for depositional anomalies in 210 Pb profiles corresponding to 1905, 1916-1918, and 1940 storms. Sedimentation rates are very low (0.01-0.03 cm/yr) in the central basins due to isolation from sediment sources. These data indicate that sedimentation rates and processes vary significantly in different regions of Lake Superior. The sedimentation rates provided by this study, in conjunction with previously-reported sedimentation rates, yield a better understanding of the Lake Superior depositional environment

Facile synthesis of carbon dots with superior sensing ability

Science.gov (United States)

Jin, Lin; Li, Jingguo; Liu, Liyun; Wang, Zhenling; Zhang, Xingcai

2018-04-01

Carbon dots (CDs) have various applications in biomedical and environmental field, such as bio-imaging, bio-sensing and heavy metal detection. In this study, a novel class of CDs were synthesized using a one-step hydrothermal method. The fabricated CDs displayed stable photoluminescence, good water solubility, and photo stability. Moreover, the functional groups (carboxylic acid moieties and hydroxyls) on the surface of the obtained CDs enable it with superior sensing ability (e.g., very low detectable concentration for Pb2+: 5 nmol/L). With superior detection sensitivity, excellent fluorescent properties and facile fabrication method, the as-obtained CDs can find practical applications as cost-effective and sensitive chemo-sensors in water and food safety field.

Double elevator weakening for unilateral congenital superior oblique palsy with ipsilateral superior rectus contracture and lax superior oblique tendon.

Science.gov (United States)

Khan, Arif O

2012-06-01

In unilateral congenital superior oblique palsy, a large hypertropia is sometimes associated with ipsilateral contracture of the superior rectus muscle and apparent overaction of the contralateral superior oblique. Ipsilateral double elevator weakening is one surgical approach; however, this procedure could compromise supraduction. We report a series of three consecutive patients who underwent ipsilateral superior rectus and inferior oblique recessions for unilateral superior oblique palsy. Intraoperatively, all three patients were found to have a lax ipsilateral superior oblique tendon. Postoperatively, all three patients had satisfactory correction of the hypertropia and abnormal head position with minimal supraduction defect. This procedure seems to be an acceptable initial surgical option for treating congenital superior oblique muscle palsy with ipsilateral contracture of the superior rectus muscle, even when the ipsilateral superior oblique tendon is lax. Copyright © 2012 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

[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.

Inherent/passive safety for fusion

International Nuclear Information System (INIS)

Piet, S.J.

1986-06-01

The concept of inherent or passive passive safety for fusion energy is explored, defined, and partially quantified. Four levels of safety assurance are defined, which range from true inherent safety to passive safety to protection via active engineered safeguard systems. Fusion has the clear potential for achieving inherent or passive safety, which should be an objective of fusion research and design. Proper material choice might lead to both inherent safety and high mass power density, improving both safety and economics. When inherent safety is accomplished, fusion will be well on the way to achieving its ultimate potential and to be truly different and superior

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

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.

The clinical application of the implantation of retrievable filters in superior vena cava

International Nuclear Information System (INIS)

Tian Yulong; Zhang Xitong; Hong Duo

2011-01-01

Objective: To investigate the safety of the placement of Tulip retrievable filter in superior vena cava and to discuss the prevention of pulmonary embolism (PE). Methods: Implantation of Tulip retrievable filter in superior vena cava was performed in ten patients (6 males and 4 females, aged 42-60 years) with acute or subacute deep venous thrombosis in upper extremity or cephalo-cervical region. After the placement of filter, the local via-catheter thrombolysis was conducted. The clinical results, such as the improvement of venous obstructed symptoms at upper extremity or cephalo-cervical region, were recorded. The filter's shape and location were checked. The possible occurrence of pulmonary embolism was observed. Results: The filter was successfully implanted in supper vena cava in all patients, and the deep venous thrombosis at upper extremity and cephalo-cervical region responded well to the local via-catheter thrombolysis. The filters showed no displacement or tilting. The swelling at upper extremity and cephalo-cervical region was markedly faded away. No symptomatic pulmonary embolism occurred. the filter was successfully retrieved via the femoral vein in four patients. Conclusion: Tulip filter can be safety implanted in superior vena cava and can be smoothly retrieved. The occurrence of pulmonary embolism can be effectively prevented if corresponding local via-catheter thrombolysis is carried out. (authors)

Superior coexistence: systematicALLY regulatING land subsidence BASED on set pair theory

Directory of Open Access Journals (Sweden)

Y. Chen

2015-11-01

Full Text Available Anthropogenic land subsidence is an environmental side effect of exploring and using natural resources in the process of economic development. The key points of the system for controlling land subsidence include cooperation and superior coexistence while the economy develops, exploring and using natural resources, and geological environmental safety. Using the theory and method of set pair analysis (SPA, this article anatomises the factors, effects, and transformation of land subsidence. Based on the principle of superior coexistence, this paper promotes a technical approach to the system for controlling land subsidence, in order to improve the prevention and control of geological hazards.

Perfil de tradutores-intérpretes de Libras (TILS que atuam no ensino superior no Brasil Profile of brazilian sign language translators/interpreters (BSLIS working in higher education

Directory of Open Access Journals (Sweden)

Cristina Broglia Feitosa de Lacerda

2011-12-01

Full Text Available Este trabalho traz resultados de uma investigação mais ampla junto a tradutores intérpretes de Língua Brasileira de Sinais (TILS que atuam no Ensino Superior (ES. Destaca o perfil de profissionais que hoje exercem este trabalho na academia, mostrando um pouco as diversas realidades de diferentes regiões em que atuam, faixa etária, formação, como começaram ou se tornaram TILS, como iniciaram seus trabalhos nas Instituições de Ensino Superior (IES, dentre outras. Nesse contexto, destacam-se principalmente aspectos de suas formações e práticas. A investigação se baseou em entrevistas e os resultados variam bastante, demonstrando que há diferentes perfis e especificidades nos processos de escolha para atuarem nesta profissão como intérpretes. Pensando no atual contexto universitário brasileiro e na atual política educacional que defende a inclusão da pessoa com deficiência frequentando cursos superiores, e neste caso, estudantes surdos, cabe destacar que esta inclusão demanda a presença de um profissional para mediar as relações de comunicação entre surdos e ouvintes, favorecendo sua construção de conhecimento no espaço educacional. Entre os profissionais que atuam na efetivação de práticas de educação inclusiva encontram-se os TILS, o que é previsto pelo Decreto 5.626, responsável pela acessibilidade linguística dos alunos surdos que frequentam parte da Educação Básica e Ensino Superior, interpretando do Português para a LIBRAS e vice-versa. Conhecer melhor os caminhos e o perfil dos TILS e a sua atuação no ES, pode contribuir para a reflexão acerca das necessidades de formação deste profissional para atuar no processo de inclusão bilíngue de estudantes surdos em nível superior.This article presents results from a broader study with LIBRAS - Brazilian Sign Language translators/interpreters (BSLIs that work in Higher Education (HE. The study highlights the profile of professionals who work in

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.

Ensuring the safety of future PCIVs : paper 09-0316.

Science.gov (United States)

2009-06-01

NHTSA, in partnership with Federal agencies, industry, and academia, will support research on safety-centered design and performance modeling and validation to enable and foster superior, integrated safety performance of future light-weight Plastics ...

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

Science.gov (United States)

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

2017-01-01

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

Persistent left superior vena cava with absent right superior vena cava: image findings

International Nuclear Information System (INIS)

Araujo Junior, Cyrillo Rodrigues de; Carvalho, Tarcisio Nunes; Fraguas Filho, Sergio Roberto; Costa, Marlos Augusto Bitencourt; Jacob, Beatriz Mahmud; Machado, Marcio Martins; Teixeira, Kim-Ir-Sen Santos; Ximenes, Carlos Alberto

2003-01-01

Persistent left superior vena cava absent right superior vena cava is a rare anomaly, with less than 150 cases reported in the literature. Congenitally persistent left superior vena cava is the most common variant of systemic venous return to the heart, resulting embryologically from failure of the left anterior cardinal vein to become obliterated. Its incidence varies from 0.3% in patients with otherwise normal heart to 4.3% in patients with congenital heart disease. In the majority of the patients, a right superior vena cava is present as well, but rarely the right anterior cardinal vein degenerates resulting in the absence of the normal right superior vena cava. The blood from the right side is carried by the persistent left superior vena cava to the right atrium through the coronary sinus. We report the case of a patient with a persistent left superior vena cava and absence of right superior vena cava identified by chance during a chest radiograph and computed tomography examination for investigation of chronic pulmonary obstructive disease. The patient had no congenital heart disease and the blood from the right side was drained by the persistent left superior vena cava into the right atrium through the coronary sinus. (author)

Inherent/passive safety in fusion power plants

International Nuclear Information System (INIS)

Piet, S.J.; Crocker, J.G.

1986-01-01

The concept of inherent or passive safety for fusion energy is explored, defined, and partially quantified. Four levels of safety assurance are defined, which range from true inherent safety to passive safety to protection via active engineered safeguard systems. Fusion has the clear potential for achieving inherent or passive safety, which should be an objective of fusion research and design. Proper material choice might lead to both inherent/passive safety and high mass power density, improving both safety and economics. When inherent or passive safety is accomplished, fusion will be well on the way to achieving its ultimate potential and to be a truly superior energy source for the future

Occupational safety in the petroleum industry

Energy Technology Data Exchange (ETDEWEB)

Elsner, W

1987-03-01

The original technique-oriented accident prevention today has grown to a comprehensive occupational workers protection system. Modern occupational safety requires latest strategies. Side by side with technical and organizational measures we see duties for all superiors directed to plant related occupational safety. These new principles of leadership on the basis of occupational safety policies from top management require equivalent tactics to cause change in behaviour of the employees. Such a not only formulated but also accepted safety strategy is extremely clear by its positive results in the petroleum industry.

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

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.

Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

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Raghavendra Charan P Makam

Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

Veia cava superior esquerda anômala com ausência de veia cava superior direita: achados de imagem Persistent left superior vena cava with absent right superior vena cava: image findings

Directory of Open Access Journals (Sweden)

Cyrillo Rodrigues de Araújo Júnior

2003-10-01

Full Text Available A persistência da veia cava superior esquerda com ausência da veia cava superior direita é uma anomalia rara, com menos de 150 casos descritos na literatura. A não-obliteração e regressão da veia cardinal anterior esquerda durante o desenvolvimento embriológico promove uma variação sistêmica de retorno venoso ao coração, com persistência da veia cava superior esquerda. Sua incidência varia de 0,3% em pacientes sem alterações cardíacas congênitas concomitantes a 4,3% naqueles com cardiopatias. Na maioria das vezes coexiste a veia cava superior direita, porém se houver regressão e degeneração da veia cardinal anterior direita, implicará a sua ausência e a drenagem venosa para o coração será feita pela veia cava superior esquerda ao átrio direito, através do seio coronariano. Mostramos um caso de um paciente submetido a radiografia de tórax e tomografia computadorizada para avaliação de doença pulmonar obstrutiva crônica, tendo como achado a persistência da veia cava superior esquerda com ausência da direita, sem qualquer cardiopatia associada e com a drenagem cardíaca sendo feita, através do seio coronariano, para o átrio direito.Persistent left superior vena cava with absent right superior vena cava is a rare anomaly, with less than 150 cases reported in the literature. Congenitally persistent left superior vena cava is the most common variant of systemic venous return to the heart, resulting embryologically from failure of the left anterior cardinal vein to become obliterated. Its incidence varies from 0.3% in patients with otherwise normal heart to 4.3% in patients with congenital heart disease. In the majority of the patients, a right superior vena cava is present as well, but rarely the right anterior cardinal vein degenerates resulting in the absence of the normal right superior vena cava. The blood from the right side is carried by the persistent left superior vena cava to the right atrium through the

Pictorial Superiority Effect

Science.gov (United States)

Nelson, Douglas L.; And Others

1976-01-01

Pictures generally show superior recognition relative to their verbal labels. This experiment was designed to link this pictorial superiority effect to sensory or meaning codes associated with the two types of symbols. (Editor)

Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

DEFF Research Database (Denmark)

Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

2010-01-01

BACKGROUND: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery...... disease who were receiving routine clinical care with no direct follow-up. METHODS: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five...... Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial...

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

Directory of Open Access Journals (Sweden)

Madureira AR

2016-08-01

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

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

NARCIS (Netherlands)

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

2009-01-01

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

Magnetic resonance imaging evaluation of meniscoid superior labrum: normal variant or superior labral tear

Directory of Open Access Journals (Sweden)

Marcelo Novelino Simão

Full Text Available Abstract Objective: The objective of this study was to determine the incidence of a "meniscoid" superior labrum. Materials and Methods: This was a retrospective analysis of 582 magnetic resonance imaging examinations of shoulders. Of those 582 examinations, 110 were excluded, for a variety of reasons, and the final analysis therefore included 472 cases. Consensus readings were performed by three musculoskeletal radiologists using specific criteria to diagnose meniscoid labra. Results: A meniscoid superior labrum was identified in 48 (10.2% of the 472 cases evaluated. Arthroscopic proof was available in 21 cases (43.8%. In 10 (47.6% of those 21 cases, the operative report did not include the mention a superior labral tear, thus suggesting the presence of a meniscoid labrum. In only one of those cases were there specific comments about a mobile superior labrum (i.e., meniscoid labrum. In the remaining 11 (52.4%, surgical correlation demonstrated superior labral tears. Conclusion: A meniscoid superior labrum is not an infrequent finding. Depending upon assumptions and the requirement of surgical proof, the prevalence of a meniscoid superior labrum in this study was between 2.1% (surgically proven and 4.8% (projected. However, superior labral tears are just as common and are often confused with meniscoid labra.

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

Science.gov (United States)

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

2017-05-01

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

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

International Nuclear Information System (INIS)

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

2015-01-01

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

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

Directory of Open Access Journals (Sweden)

Stef Robijn

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

Refactoring Real-Time Java Profiles

DEFF Research Database (Denmark)

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

2011-01-01

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

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].

Nuclear power and safety

International Nuclear Information System (INIS)

Chidambaram, R.

1992-01-01

Some aspects of safety of nuclear power with special reference to Indian nuclear power programme are discussed. India must develop technology to protect herself from the adverse economic impact arising out of the restrictive regime which is being created through globalization of safety and environmental issues. Though the studies done and experience gained so far have shown that the PHWR system adopted by India has a number of superior safety features, research work is needed in the field of operation and maintenance of reactors and also in the field of reactor life extension through delaying of ageing effects. Public relations work must be pursued to convince the public at large of the safety of nuclear power programme. The new reactor designs in the second stage of evolution are based on either further improvement of existing well-proven designs or adoptions of more innovative ideas based on physical principles to ensure a higher level of safety. The development of Indian nuclear power programme is characterised by a balanced approach in the matter of assuring safety. Safety enforcement is not just looked upon as a pure administrative matter, but experts with independent minds are also involved in safety related matters. (M.G.B.)

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.

Preparing a Safety Analysis Report using the building block approach

International Nuclear Information System (INIS)

Herrington, C.C.

1990-01-01

The credibility of the applicant in a licensing proceeding is severely impacted by the quality of the license application, particularly the Safety Analysis Report. To ensure the highest possible credibility, the building block approach was devised to support the development of a quality Safety Analysis Report. The approach incorporates a comprehensive planning scheme that logically ties together all levels of the investigation and provides the direction necessary to prepare a superior Safety Analysis Report

Tratamento da síndrome da veia cava superior Treatment of superior vena cava syndrome

Directory of Open Access Journals (Sweden)

Luís Marcelo Inaco Cirino

2005-12-01

Full Text Available A veia cava superior é formada pela união das duas veias inominadas, direita e esquerda, e localiza-se no mediastino médio, à direita da artéria aorta e anteriormente à traquéia. A síndrome da veia cava superior representa um conjunto de sinais (dilatação das veias do pescoço, pletora facial, edema de membros superiores, cianose e sintomas (cefaléia, dispnéia, tosse, edema de membro superior, ortopnéia e disfagia decorrentes da obstrução do fluxo sanguíneo através da veia cava superior em direção ao átrio direito. A obstrução pode ser causada por compressão extrínseca, invasão tumoral, trombose ou por dificuldade do retorno venoso ao coração secundária a doenças intra-atriais ou intraluminais. Aproximadamente 73% a 97% dos casos de síndrome da veia cava superior ocorrem durante a evolução de processos malignos intratorácicos. A maioria dos pacientes com a síndrome secundária a neoplasias malignas é tratada sem necessidade de cirurgia, através de radioterapia ou quimioterapia, ou através da colocação de stents endoluminais. Quando a síndrome é de etiologia benigna, o tratamento é feito através de medidas clínicas (anticoagulação, elevação da cabeça, etc. ou, em casos refratários, através de angioplastia, colocação de stents endoluminais e cirurgia.The superior vena cava is formed by the union of the right and left brachiocephalic veins. It is located in the middle mediastinum, to the right of the aorta and anterior to the trachea. Superior vena cava syndrome consists of a group of signs (dilation of the veins in the neck, facial swelling, edema of the upper limbs, and cyanosis and symptoms (headache, dyspnea, cough, orthopnea and dysphagia caused by the obstruction of blood flow through the superior vena cava to the right atrium. This obstruction can be caused by extrinsic compression, tumor invasion or thrombosis. Such obstruction may also occur as a result of insufficient venous return

Kompetisi Stasiun Televisi Swasta Nasional Berdasarkan Superiority Direction dan Superiority Magnitude

Directory of Open Access Journals (Sweden)

Anastasia Winanti Riesardhy

2013-11-01

Full Text Available Abstract: Uses and gratification theory is employed particularly as the teoritical frame of the research to examine the extent to which ten national television stations compete to satisfy Indonesian audiences. In particular, two main concepts of that theory namely audiences “gratification sought and gratifications obtained, are broken down and counted based on superiority direction and superiority magnitude. In general, the findings show that those televisions have satisfied their audiences, although in terms of gratifications to dispersal motives, they haven’t satisfied as much as it was expected. Significant competition occurs between TRANSTV and TRANS7, RCTI and SCTV, and TVONE and METROTV. TVONE become the most satisfiyng television station. Abstrak: Teori Uses & Gratification menjadi dasar penelitian ini untuk mengukur bagaimana kompetisi yang terjadi di antara sepuluh stasiun televisi yang bersiaran secara nasional di Indonesia. Aplikasi dari teori tersebut dimunculkan dalam konsep kepuasan yang diharapkan dan kepuasan yang diperoleh ketika menonton acara televisi dan didasarkan pada penghitungan superiority direction dan superiority magnitude. Sepuluh stasiun televisi yang diteliti telah dapat memuaskan audiensnya, meskipun untuk kepuasan atas motif pengalihan masih belum dapat melampaui kepuasan yang diharapkan. Kompetisi yang signifikan terjadi antara TRANSTV dengan TRANS7, RCTI dengan SCTV serta TVONE dengan METROTV. TVONE menjadi stasiun televisi yang menduduki peringkat pertama dalam memberikan kepuasan tertinggi kepada audiens.

Review of key Belotero Balance safety and efficacy trials.

Science.gov (United States)

Lorenc, Z Paul; Fagien, Steven; Flynn, Timothy C; Waldorf, Heidi A

2013-10-01

Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

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

Directory of Open Access Journals (Sweden)

Emanuele Montomoli

2018-03-01

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

Information Superiority through Data Warehousing

National Research Council Canada - National Science Library

Warner, Neil

2001-01-01

.... A precursor to a knowledge edge is Information Superiority. Within most current Command Support Systems minimal integration and fusion of data is undertaken to provide the basis of information superiority...

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...

Visual sensitivity of deepwater fishes in Lake Superior.

Directory of Open Access Journals (Sweden)

Kelly A Harrington

Full Text Available The predator-prey interactions in the offshore food web of Lake Superior have been well documented, but the sensory systems mediating these interactions remain unknown. The deepwater sculpin, (Myoxocephalus thompsoni, siscowet (Salvelinus namaycush siscowet, and kiyi (Coregonus kiyi inhabit low light level environments. To investigate the potential role of vision in predator-prey interactions, electroretinography was used to determine visual sensitivity for each species. Spectral sensitivity curves revealed peak sensitivity at 525 nm for each species which closely corresponds to the prevalent downwelling light spectrum at depth. To determine if sufficient light was available to mediate predator-prey interactions, visual sensitivity was correlated with the intensity of downwelling light in Lake Superior to construct visual depth profiles for each species. Sufficient daytime irradiance exists for visual interactions to approximately 325 m for siscowet and kiyi and 355 m for the deepwater sculpin during summer months. Under full moon conditions, sufficient irradiance exists to elicit ERG response to light available at approximately 30 m for the siscowet and kiyi and 45 m for the deepwater sculpin. Visual interactions are therefore possible at the depths and times when these organisms overlap in the water column indicating that vision may play a far greater role at depth in deep freshwater lakes than had been previously documented.

Gender stereotypes and superior conformity of the self in a sample of cyclists.

Science.gov (United States)

Félonneau, Marie-Line; Causse, Elsa; Constant, Aymery; Contrand, Benjamin; Messiah, Antoine; Lagarde, Emmanuel

2013-01-01

In the field of driving, people tend to think they are more competent and more cautious than others. This is the superior conformity of the self (SCS). Our main hypothesis was that, among cyclists, women would show a higher SCS on cautiousness, though men would show a higher SCS concerning competence. 1799 cyclists provided a self-assessment of their own cautiousness and of other people's cautiousness. The same procedure was used for competence. Consistent with the hypothesis, the SCS was gender-specific: it was more prominent for women concerning cautiousness and more prominent for men concerning competence. These results could explain why people tend to ignore the safety campaigns. They also indicate the importance of adapting messages concerning safety measures to gender. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

Burlington Northern Taconite Transshipment Facility, Duluth-Superior Harbor, Superior Wisconsin. Environmental Assessment Report.

Science.gov (United States)

1975-03-01

the Federal Government declared the Duluth- Superior area to be economically depressed . The reason given was the "consistant and chronic unemployment...include dogwood, sumac, arrowwood, blueberry, highbush cranberry , elderberry, wild grape, buttonbrush, snowberry and partridgeberry. Aquatic and...water for the proposed greenbelt areas and as dust sup- pression spray. 10.003 The depressed economy of the Duluth-Superior area would benefit by the

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

Superior oblique luxation and trochlear luxation as new concepts in superior oblique muscle weakening surgery

NARCIS (Netherlands)

Mombaerts, I.; Koornneef, L.; Everhard-Halm, Y. S.; Hughes, D. S.; Maillette de Buy Wenniger-Prick, L. J.

1995-01-01

We used superior oblique luxation and trochlear luxation as new surgical procedures to treat acquired Brown's syndrome and superior oblique muscle overaction. We studied nine patients (11 eyes) who underwent trochlear surgery between 1988 and 1993. Four patients had acquired Brown's syndrome and

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

Alternate superior Julia sets

International Nuclear Information System (INIS)

Yadav, Anju; Rani, Mamta

2015-01-01

Alternate Julia sets have been studied in Picard iterative procedures. The purpose of this paper is to study the quadratic and cubic maps using superior iterates to obtain Julia sets with different alternate structures. Analytically, graphically and computationally it has been shown that alternate superior Julia sets can be connected, disconnected and totally disconnected, and also fattier than the corresponding alternate Julia sets. A few examples have been studied by applying different type of alternate structures

Advice 14-2014 of the Scientific Committee of the Belgian Food Safety Agency and the Superior Health Council Nr. 9160 on food safety

OpenAIRE

Federal Agency for the Safety of the Food Chain

2014-01-01

In the search for alternative dietary protein sources, insects appear to offer great potential. Currently there are no specific regulations neither in Belgium, nor in Europe, on the breeding and marketing of insects destined for human consumption. The trade of a number of insect species destined for human consumption is however tolerated in Belgium. In this context, the Scientific Committee and the Superior Health Council are asked to give advice on the potential risk...

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

Analysing supercritical water reactor's (SCWR's) special safety systems using probabilistic tools

International Nuclear Information System (INIS)

Ituen, I.; Novog, D.R.

2011-01-01

The next generation of reactors, termed Generation IV, has very attractive features -- its superior safety characteristics, high thermal efficiency, and fuel cycle sustainability. A key element of the Generation IV designs is the improvement in safety, which in turn requires improvements in safety system performance and reliability, as well as a reduction in initiating event frequencies. This study compares the response of the systems important to safety in the CANDU-Supercritical Water Reactor to those of the generic CANDU under a main steamline break accident and loss of forced circulation events -- to quantify the improvements in safety for the pre-conceptual CANDU SCWR design. Probabilistic safety analysis is the tool used in this study to test the behavior of the pre- conceptual design during these events. (author)

Safety of bisphosphonates

DEFF Research Database (Denmark)

Pazianas, Michael; Abrahamsen, Bo

2011-01-01

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

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.

Environmental, health, and safety by design

International Nuclear Information System (INIS)

Soklow, R.G.

1999-01-01

Solar Turbines Incorporated created a self-directed work team, the Safety and Environmental Awareness (SEA) Team that initiated a company wide effort to raise employee awareness to promote integrating responsible environmental, health, and safety practices into product design, manufacturing, and services. Environmental, health, and safety issues influence how all businesses operate around the world. Companies choose to operate in an environmentally responsible manner because it not only benefits employees and the communities where they live, it also benefits the business when superior performance results in a competitive advantage. Solar surveyed gas turbines users to identify their top environmental and safety concerns and issues. The authors asked about various environmental and safety aspects of their equipment. Results from the survey has helped engineering and design focus efforts so that future products and product improvements assist customers in meeting their regulatory obligations and social responsibilities. Air pollution has historically been one of the most important environmental issues facing customers, because pollutant emissions greatly influence equipment choices and operation flexibility. There are other environmental, health and safety issues: sustainable fire suppression choices, start systems, hazardous materials use and ability to recycle materials, package accessibility, noise and product take back issues

A cost and safety superiority of fusion-fission hybrid reactor in China nuclear energy development

International Nuclear Information System (INIS)

Pereslavtszev, P.E.; Luan Guishi; Xia Chengang

1994-08-01

Considering economy and safety, an optimization model of nuclear energy developing scenarios of China was set up. An objective function to optimize was determined. Three prospective developing scenarios of China nuclear energy system including hybrid reactor were calculated and discussed. In the system which has no fissile material exchange with other system, a smooth developing model has a smooth distribution of inventory of Pu, thus the potential danger of whole nuclear energy system will be decreased. This scheme will improve investment effectiveness. Result shows that the optimization is necessary and the significant profit in cost and safety can be obtained. (5 tabs., 8 figs., 12 refs.)

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

Superior Hiking Trail

Data.gov (United States)

Minnesota Department of Natural Resources — Superior Hiking Trail main trail, spurs, and camp spurs for completed trail throughout Cook, Lake, St. Louis and Carlton counties. These data were collected with...

Therapeutic superiority and safety of combined hydroxyurea with recombinant human erythropoietin over hydroxyurea in young β-thalassemia intermedia patients.

Science.gov (United States)

Elalfy, Mohsen S; Adly, Amira A M; Ismail, Eman A; Elhenawy, Yasmine I; Elghamry, Islam R

2013-12-01

To assess the efficacy and safety of combined hydroxyurea (HU) and recombinant human erythropoietin (rHuEPO) in β-thalassemia intermedia (TI) patients compared with single HU therapy. An interventional prospective randomized study registered in the ClinicalTrials.gov (NCT01624038) was performed on 80 TI patients (≤ 18 yr) divided into group A (40 patients received combined HU and rHuEPO) and group B (40 patients received single HU therapy). Baseline serum EPO levels were measured, and both groups were followed up for a mean period of 1 yr with regular assessment of transfusion requirements, blood pressure, ferritin, liver and renal functions, hemoglobin, and HbF. Quality of life (QoL) was assessed at the start and end of the study. Transfusion frequency and index were significantly decreased, while QoL was increased in group A compared with group B where 85% of patients showed improvement on combined therapy compared with 50% of patients on HU. Hemoglobin and HbF were significantly increased in both TI groups; however, this was more evident in group A than in group B. Also, 37.5% of patients in group A became transfusion-independent compared with 15% in group B. EPO levels were negatively related to increments of hemoglobin and HbF. Splenectomized patients and those with initial HbF% >40% had the best response to combined therapy. No serious adverse events necessitating discontinuation of therapy in both groups. HU was effective in management of TI; however, combination with rHuEPO gave a superior therapeutic effect resulting in the best clinical and hematological responses without adverse events. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study.

Science.gov (United States)

Pepin, Stephanie; Szymanski, Henryk; Rochín Kobashi, Ilya Angélica; Villagomez Martinez, Sandra; González Zamora, José Francisco; Brzostek, Jerzy; Huang, Li-Min; Chiu, Cheng-Hsun; Chen, Po-Yen; Ahonen, Anitta; Forstén, Aino; Seppä, Ilkka; Quiroz, René Farfán; Korhonen, Tiina; Rivas, Enrique; Monfredo, Celine; Hutagalung, Yanee; Menezes, Josemund; Vesikari, Timo

2016-12-01

A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomized, double-blind, active-controlled, multi-center study to examine the immunogenicity and safety of IIV4 in children 3-8 y of age (EudraCT no. 2011-005374-33). Participants were randomized 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received 2 doses of vaccine 28 d apart; all others received a single dose. 1242 children were included. For all 4 strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 d after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3-8 y who received one dose or 2 doses 28 d apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.

Gene Expression Profiling of Early Stage Non-Small Cell Lung Cancer

NARCIS (Netherlands)

J. Hou (Jun)

2010-01-01

textabstractNSCLC is a highly heterogeneous malignancy with a poor prognosis. Treatment for NSCLC is currently based on a combination of pathological staging and histological classification. Recently, gene expression-based NSCLC profiling is proven a superior approach to stratify cancer cases with

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

Science.gov (United States)

2004-09-01

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

Safety and Efficacy of Low-dose Nanoparticle Albumin-bound Paclitaxel for HER2-negative Metastatic Breast Cancer.

Science.gov (United States)

Takashima, Tsutomu; Kawajiri, Hidemi; Nishimori, Takeo; Tei, Seika; Nishimura, Shigehiko; Yamagata, Shigehito; Tokunaga, Shinya; Mizuyama, Yoko; Sunami, Takeshi; Tezuka, Kenji; Ikeda, Katsumi; Ogawa, Yoshinari; Kashiwagi, Shinichiro; Noda, Satoru; Onoda, Naoyoshi; Ishikawa, Tetsuro; Kudoh, Shinzoh; Takada, Minoru; Hirakawa, Kosei; Ohira, Masaichi

2018-01-01

Nab-paclitaxel (nab-PTX) is an albumin-bound paclitaxel formulation. Although nab-PTX has shown superior efficacy compared to conventional paclitaxel (PTX) in metastatic breast cancer (MBC), chemotherapy-induced peripheral neuropathy (CIPN) was more frequently observed in nab-PTX. In this study, we aimed to estimate the feasibility of the nab-PTX 175 mg/m 2 /3weeks regimen. Patients having metastatic or inoperable HER2-negative breast cancer received 175 mg/m 2 of nab-PTX every three weeks. The primary endpoint was safety and the secondary endpoints were response and survival. Seventeen patients were enrolled with a median age of 64 years. Ten patients had estrogen receptor positive disease and seven had triple-negative disease. CIPN was observed in seven patients (41%) however, grade 3 CIPN was only seen in one patient (6%). Objective response rate was 41% and progression-free survival was 23 weeks. Nab-PTX 175 mg/m 2 /3wks regimen has a good safety profile and less frequent CIPN. This regimen can contribute to the strategy of MBC treatment. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

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

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

Directory of Open Access Journals (Sweden)

Jianxi Wang

2017-01-01

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

Radiation Safety for Sustainable Development

International Nuclear Information System (INIS)

2015-10-01

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

Occurrence and sources of polychlorinated dibenzo-p-dioxins, dibenzofurans and dioxin-like polychlorinated biphenyls in surficial sediments of Lakes Superior and Huron

International Nuclear Information System (INIS)

Shen Li; Gewurtz, Sarah B.; Reiner, Eric J.; MacPherson, Karen A.; Kolic, Terry M.; Khurana, Vin; Helm, Paul A.; Howell, E. Todd; Burniston, Debbie A.; Brindle, Ian D.; Marvin, Chris H.

2009-01-01

Concentrations and congener profile patterns of 2378-substituted PCDD/Fs and DLPCBs in offshore, nearshore and tributary sediments of Lakes Superior and Huron are reported, and spatial trends and source contributions assessed. PCDD/F concentrations ranged from 5 to 18 000 pg/g dw (Lake Superior) and 3 to 6100 pg/g dw (Lake Huron); DLPCBs ranged from 9 to 11 000 pg/g dw (Lake Superior) and 9 to 27 000 pg/g dw (Lake Huron). Our analysis indicated atmospheric deposition is a primary source to depositional areas of both lakes; however, greater PCDD/F and DLPCB concentrations were observed at several nearshore and tributary sites, and were attributed to corresponding land use in the watershed. Statistical analysis and pattern comparison suggested that industrial inputs mainly associated with wood treatment plants, pulp and paper mills, mining operations, and chlorine-based chemical manufacturing also contributed to contamination by PCDD/Fs and DLPCBs in certain nearshore and offshore areas of Lakes Superior and Huron. - Lake-wide 2378-PCDD/F and DLPCB concentrations, spatial trends, and congener patterns are first reported in Lakes Superior and Huron sediments

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.

Absent right superior caval vein in situs solitus

DEFF Research Database (Denmark)

Lytzen, Rebekka; Sundberg, Karin; Vejlstrup, Niels

2015-01-01

Introduction In up to 0.07% of the general population, the right anterior cardinal vein obliterates and the left remains open, creating an absent right superior caval vein and a persistent left superior caval vein. Absent right superior caval vein is associated with additional congenital heart...... disease in about half the patients. We wished to study the consequences of absent right superior caval vein as an incidental finding on prenatal ultrasonic malformation screening. Material and methods This is a retrospective case series study of all foetuses diagnosed with absent right superior caval vein...... no postnatal complications. All children were found to have healthy hearts at follow-up. CONCLUSIONS: In all cases, the findings proved to be a benign condition with no clinical manifestations or complications. Although isolated absent right superior caval vein does not seem to affect the outcome, associated...

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 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.

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates.

Science.gov (United States)

Minervini, Gianmaria; McCarson, Barbara J; Reisinger, Keith S; Martin, Jason C; Stek, Jon E; Atkins, Barbara M; Nadig, Karin B; Liska, Vladimir; Schödel, Florian P; Bhuyan, Prakash K

2012-02-14

A manufacturing process using a modified adjuvant was developed to optimize the consistency and immunogenicity for recombinant hepatitis B vaccine (control: RECOMBIVAX-HB™). This modified process hepatitis B vaccine (mpHBV), which was previously shown to have an acceptable safety and immunogenicity profile in young adults, has now been studied in newborn infants. Healthy 1-10-day-old neonates (N=566) received 3 intramuscular doses (5μg hepatitis B surface antigen [HBsAg] per dose) of either mpHBV or control at Day 1, and Months 1 and 6. Serum antibody to HBsAg (anti-HBs) was assayed at Month 7 (1 month Postdose 3). Anti-HBs geometric mean titers (GMTs) and seroprotection rates (SPRs) (% of subjects with an anti-HBs titer ≥10mIU/mL) were compared at Month 7. After each dose, injection-site adverse experiences (AEs) and axillary temperatures were recorded for 5 days; systemic AEs were recorded for Days 1-14. Month 7 SPR was 97.9% for the mpHBV group and 98.9% for the control. The GMT was 843.7mIU/mL for the mpHBV group and 670.1mIU/mL for the control. The GMT ratio (mpHBV/control) was 1.26 (95% confidence interval [CI]: 0.94, 1.69), meeting the prespecified non-inferiority criteria. The percentages of subjects reporting any AE, injection-site AEs, or systemic AEs were similar across the 2 vaccination groups. There were no serious AEs. The safety profile of mpHBV was comparable to that of the control vaccine. The geometric mean antibody titer for mpHBV was higher than control vaccine in this infant population, but the difference did not meet the predefined statistical criterion for superiority. Copyright © 2012 Elsevier Ltd. All rights reserved.

Electrophysiological and Histological Evaluation of Acute Efficacy and Safety of Balloon Occlusive Ablation at Superior Vena Cava-Right Atrial Junction

Directory of Open Access Journals (Sweden)

Kazushi Tanaka, MD

2007-01-01

Full Text Available We evaluated efficacy and safety of occlusive radiofrequency catheter ablation (o-RFA using our thermal balloon catheter (TBC at superior vena cava (SVC-right atrial (RA junction (SVCJ compared to that of RFA with a standard-tip catheter. Methods: To electrically isolate (SVCI SVC from RA in 10 pigs (group 1, the initial o-RFA at a balloon surface temperature of 53.9 ± 3.0°C for 3–5 min (13.56 MHz was achieved at the SVCJ completely obstructed with an inflated balloon. If unsuccessful, subsequent o-RFA was repeated in a ࣘ5°C increments until reaching either SVCI or sinus arrest. Before and after each o-RFA, stimulation protocol from the RA was performed. Additionally, in 5 different pigs (group 2, RFA at 55°C (ࣘ50 W for 1 min with a 4 mm-tip catheter was achieved at multiple sites along the SVCJ. Finally, the neighboring tissues of the SVCJ were histologically investigated. Results: In group 1, successful SVCI could be easily accomplished at the final temperature of 57.2 ± 2.4°C; however, in 3 pigs, a new atrial tachycardia was induced after o-RFA at <55°C and in 2 pigs sinus arrest occurred during o-RFA at 60°C. Histologically, transmural and circumferential contraction band necrosis was mainly confirmed around the SVCJ without damage to collateral tissue. In group 2, coagulation necrosis occupied almost all the ablative lesions, leading to severe degeneration of collateral tissue. Conclusion: O-RFA at the SVCJ may be more feasible and safer than RFA.

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)

Superior mesenteric artery syndrome causing growth retardation

Directory of Open Access Journals (Sweden)

Halil İbrahim Taşcı

2013-03-01

Full Text Available Superior mesenteric artery syndrome is a rare and lifethreateningclinical condition caused by the compressionof the third portion of the duodenum between the aortaand the superior mesenteric artery’s proximal part. Thiscompression may lead to chronic intermittent, acute totalor partial obstruction. Sudden weight-loss and the relateddecrease in the fat tissue are considered to be the etiologicalreason of acute stenosis. Weight-loss accompaniedby nausea, vomiting, anorexia, epigastric pain, andbloating are the leading complaints. Barium radiographs,computerized tomography, conventional angiography,tomographic and magnetic resonance angiography areused in the diagnosis. There are medical and surgical approachesto treatment. We hereby present the case ofa patient with superior mesenteric artery syndrome withdelayed diagnosis.Key words: superior mesenteric artery syndrome, nausea-vomiting, anorexia

Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

Science.gov (United States)

Chittaro, Luca; Buttussi, Fabio

2015-04-01

Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

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

75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...

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.

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...

Further results on binary convolutional codes with an optimum distance profile

DEFF Research Database (Denmark)

Johannesson, Rolf; Paaske, Erik

1978-01-01

Fixed binary convolutional codes are considered which are simultaneously optimal or near-optimal according to three criteria: namely, distance profiled, free distanced_{ infty}, and minimum number of weightd_{infty}paths. It is shown how the optimum distance profile criterion can be used to limit...... codes. As a counterpart to quick-look-in (QLI) codes which are not "transparent," we introduce rateR = 1/2easy-look-in-transparent (ELIT) codes with a feedforward inverse(1 + D,D). In general, ELIT codes haved_{infty}superior to that of QLI codes....

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.

Superiority in value and the repugnant conclusion

DEFF Research Database (Denmark)

Jensen, Karsten Klint

2007-01-01

superiority does not amount to a radical value difference at all. I then spell out the consequences of these results for different interpretations of Griffin's suggestion regarding population ethics. None of them comes out very successful, but perhaps they nevertheless retain some interest.......James Griffin has considered a weak form of superiority in value a possible remedy to the Repugnant Conclusion. In this paper, I demonstrate that, in a context where value is additive, this weaker form collapses into a stronger form of superiority. And in a context where value is non-additive, weak...

164 original article profile of institutional infrastructure

African Journals Online (AJOL)

Dr Oboro VO

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

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

Science.gov (United States)

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

2014-05-01

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

Superior Hiking Trail Facilities

Data.gov (United States)

Minnesota Department of Natural Resources — Superior Hiking Trail main trail, spurs, and camp spurs for completed trail throughout Cook, Lake, St. Louis and Carlton counties. These data were collected with...

Patterns for Safety-Critical Java Memory Usage

DEFF Research Database (Denmark)

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

2012-01-01

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

Country nuclear power profiles. 2000 ed

International Nuclear Information System (INIS)

2001-03-01

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

Skull fracture with effacement of the superior sagittal sinus following drone impact: a case report.

Science.gov (United States)

Chung, Lawrance K; Cheung, Yuri; Lagman, Carlito; Au Yong, Nicholas; McBride, Duncan Q; Yang, Isaac

2017-09-01

The popularity of unmanned aerial vehicles, or drones, raises safety concerns as they become increasingly common for commercial, personal, and recreational use. Collisions between drones and people may result in serious injuries. A 13-year-old male presented with a comminuted depressed skull fracture causing effacement of the superior sagittal sinus secondary to a racing drone impact. The patient experienced a brief loss of consciousness and reported lower extremity numbness and weakness after the accident. Imaging studies revealed bone fragments crossing the superior sagittal sinus with a short, focal segment of blood flow interruption. Neurosurgical intervention was deferred given the patient's improving neurological deficits, and the patient was treated conservatively. He was discharged home in stable condition. Drones may represent a hazard when operated inappropriately due to their capacity to fly at high speeds and altitudes. Impacts from drones can carry enough force to cause skull fractures and significant head injuries. The rising popularity of drones likely translates to an increased incidence of drone-related injuries. Thus, clinicians should be aware of this growing trend.

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.

The CT appearance of the superior intercostal veins

International Nuclear Information System (INIS)

Lund, G.

1982-01-01

The CT appearance of the superior intercostal veins is described. The veins are more frequently seen on the right side. The right superior intercostal vein should not be misinterpreted as a paraspinal mass when it is large or bulges into the contour of the right lung. A case of stenosis of the left brachiocephalic vein is shown, where the left superior intercostal vein serves as a collateral. (orig.)

Nitrogen-system safety study: Portsmouth Gaseous Diffusion Plant

International Nuclear Information System (INIS)

1982-07-01

The Department of Energy has primary responsibility for the safety of operations at DOE-owned nuclear facilities. The guidelines for the analysis of credible accidents are outlined in DOE Order 5481.1. DOE has requested that existing plant facilities and operations be reviewed for potential safety problems not covered by standard industrial safety procedures. This review is being conducted by investigating individual facilities and documenting the results in Safety Study Reports which will be compiled to form the Existing Plant Final Safety Analysis Report which is scheduled for completion in September, 1984. This Safety Study documents the review of the Plant Nitrogen System facilities and operations and consists of Section 4.0, Facility and Process Description, and Section 5.0, Accident Analysis, of the Final Safety Analysis Report format. The existing nitrogen system consists of a Superior Air Products Company Type D Nitrogen Plant, nitrogen storage facilities, vaporization facilities and a distribution system. The system is designed to generate and distribute nitrogen gas used in the cascade for seal feed, buffer systems, and for servicing equipment when exceptionally low dew points are required. Gaseous nitrogen is also distributed to various process auxiliary buildings. The average usage is approximately 130,000 standard cubic feet per day

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

Characterization and improvement of the nuclear safety culture through self-assessment

International Nuclear Information System (INIS)

Levin, H.A.; McGehee, R.B.; Cottle, W.T.

1996-01-01

Organizational culture has a powerful influence on overall corporate performance. The ability to sustain superior results in ensuring the public's health and safety is predicated on an organization's deeply embedded values and behavioral norms and how these affect the ability to change and seek continuous improvement. The nuclear industry is developing increased recognition of the relationship of culture to nuclear safety performance as a critical element of corporate strategy. This paper describes a self-assessment methodology designed to characterize and improve the nuclear safety culture, including processes for addressing employee concerns. This methodology has been successfully applied on more than 30 occasions in the last several years, resulting in measurable improvements in safety performance and quality and employee motivation, productivity, and morale. Benefits and lessons learned are also presented

75 FR 28542 - Superior Resource Advisory Committee

Science.gov (United States)

2010-05-21

... Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to orient the new Superior Resource Advisory Committee members on their roles... following business will be conducted: Overview of the roles and responsibilities of the Superior Resource...

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.

Comparison of corneal safety and intraocular pressure-lowering effect of tafluprost ophthalmic solution with other prostaglandin ophthalmic solutions.

Science.gov (United States)

Kumagami, Takeshi; Wakiyama, Harumi; Kusano, Mao; Kajiyama, Ayano; Miura, Yoko; Uematsu, Masafumi; Yoneda, Ai; Kurihara, Junko; Suzuma, Kiyoshi; Kitaoka, Takashi

2014-05-01

The benzalkonium chloride (BAK) content of tafluprost ophthalmic solution (Tapros(®): tafluprost) has been reduced to balance corneal safety and preservative effectiveness (old formulation: 0.01%; new formulation: 0.001%). However, no reports have been published on its clinical effect. Therefore, we conducted a clinical research study to compare the safety of BAK-reduced tafluprost on the ocular surface with other prostaglandin ophthalmic solutions. This clinical study included 28 glaucoma patients (28 eyes) with a treatment history of latanoprost ophthalmic solution (Xalatan(®)) or travoprost ophthalmic solution (Travatan Z(®)), who presented with corneal epithelial disorders. The subjects were switched to BAK-reduced tafluprost, and its effect on the ocular surface was examined after 1 and 2 months of treatment [using fluorescein staining score, hyperemia, tear film breakup time, and intraocular pressure (IOP) lowering]. In all analyzed subjects (N=27), the fluorescein staining score was significantly improved after switching to BAK-reduced tafluprost (P<0.0001). Conversely, the IOP-lowering effect was not notably changed. The subjects switched from latanoprost (n=10) showed significant improvement in fluorescein staining score (P<0.05) as well as in IOP lowering (P<0.01). The subjects switched from travoprost (n=17) also showed significant improvement in fluorescein staining score (P<0.001), but without a significant change in IOP lowering. Tafluprost with reduced BAK has potential as a superior antiglaucoma drug, not only for its IOP-lowering effect, but also for its good corneal safety profile.

The Safety and Efficacy of Adjustable Postoperative Position after Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment

OpenAIRE

Lin, Zhong; Sun, Jin Tao; Wu, Rong Han; Moonasar, Nived; Zhou, Ye Hui

2017-01-01

Purpose. To report the safety and efficacy of adjustable postoperative position for rhegmatogenous retinal detachment (RRD). Methods. Retrospective review of 536 consecutive RRD eyes that underwent vitrectomy surgery for retina repair from year 2008 to 2014. The retinal breaks were divided into superior, lateral (nasal, temporal, and macular), and inferior locations, according to the clock of breaks. Patients with superior and lateral break location were allowed to have facedown position or l...

Superiority of Bessel function over Zernicke polynomial as base ...

Indian Academy of Sciences (India)

Abstract. Here we describe the superiority of Bessel function as base function for radial expan- sion over Zernicke polynomial in the tomographic reconstruction technique. The causes for the superiority have been described in detail. The superiority has been shown both with simulated data for Kadomtsev's model for ...

Bathymetry of Lake Superior

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — Bathymetry of Lake Superior has been compiled as a component of a NOAA project to rescue Great Lakes lake floor geological and geophysical data and make it more...

The impact of cardinal rules on employee safety behaviour at power stations in Mpumalanga / Chauke, T.L.

OpenAIRE

Chauke, Tinyiko Lourence

2011-01-01

Occupational risk management can be a catalyst in generating superior returns for all stakeholders on a sustainable basis. A number of companies in South Africa have implemented Cardinal Rules of Safety adopted from international companies to ensure the safety of their employees. The purpose of this study was to measure the impact of the cardinal rules on employee safety behaviour implemented at power stations in Mpumalanga. The empirical study was done by using a questionnaire as measurin...

Specific Regional and Age-Related Small Noncoding RNA Expression Patterns Within Superior Temporal Gyrus of Typical Human Brains Are Less Distinct in Autism Brains.

Science.gov (United States)

Stamova, Boryana; Ander, Bradley P; Barger, Nicole; Sharp, Frank R; Schumann, Cynthia M

2015-12-01

Small noncoding RNAs play a critical role in regulating messenger RNA throughout brain development and when altered could have profound effects leading to disorders such as autism spectrum disorders (ASD). We assessed small noncoding RNAs, including microRNA and small nucleolar RNA, in superior temporal sulcus association cortex and primary auditory cortex in typical and ASD brains from early childhood to adulthood. Typical small noncoding RNA expression profiles were less distinct in ASD, both between regions and changes with age. Typical micro-RNA coexpression associations were absent in ASD brains. miR-132, miR-103, and miR-320 micro-RNAs were dysregulated in ASD and have previously been associated with autism spectrum disorders. These diminished region- and age-related micro-RNA expression profiles are in line with previously reported findings of attenuated messenger RNA and long noncoding RNA in ASD brain. This study demonstrates alterations in superior temporal sulcus in ASD, a region implicated in social impairment, and is the first to demonstrate molecular alterations in the primary auditory cortex. © The Author(s) 2015.

Superior Administrative Court of Mannheim. Judgement of March 30, 1982 (Wyhl)

International Nuclear Information System (INIS)

Anon.

1983-01-01

This publication deals with the decision of March 30, 1982 of the Superior Administrative Court of Mannheim, dismissing the action for annulment of the first part-construction permit for Wyhl nuclear power plant. The publication discusses that part of the Court's statements dealing with the term nuclear installation within the purview of the Atomic Energy Act, section 7, sub-section (1). According to the statement, the term ''nuclear installation for the fission of nuclear fuel'' includes not only that part of an installation where fission takes place but also those components including the surrounding buildings which serve the nuclear purpose of the installation and which thus are subject to the same standards and regulations relating to safety engineering and air pollution control. This definition includes switchgear buildings, reactor auxiliary equipment buildings, the engine house, and cooling water systems including cooling towers. (CB) [de

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)

Prosopomorphic vessels from Moesia Superior

Directory of Open Access Journals (Sweden)

Nikolić Snežana

2008-01-01

Full Text Available The prosopomorphic vessels from Moesia Superior had the form of beakers varying in outline but similar in size. They were wheel-thrown, mould-made or manufactured by using a combination of wheel-throwing and mould-made appliqués. Given that face vessels are considerably scarcer than other kinds of pottery, more than fifty finds from Moesia Superior make an enviable collection. In this and other provinces face vessels have been recovered from military camps, civilian settlements and necropolises, which suggests that they served more than one purpose. It is generally accepted that the faces-masks gave a protective role to the vessels, be it to protect the deceased or the family, their house and possessions. More than forty of all known finds from Moesia Superior come from Viminacium, a half of that number from necropolises. Although tangible evidence is lacking, there must have been several local workshops producing face vessels. The number and technological characteristics of the discovered vessels suggest that one of the workshops is likely to have been at Viminacium, an important pottery-making centre in the second and third centuries.

The Development of the Picture-Superiority Effect

Science.gov (United States)

Whitehouse, Andrew J. O.; Maybery, Murray T.; Durkin, Kevin

2006-01-01

When pictures and words are presented serially in an explicit memory task, recall of the pictures is superior. While this effect is well established in the adult population, little is known of the development of this picture-superiority effect in typical development. This task was administered to 80 participants from middle childhood to…

Genome-wide DNA methylation profiling in the superior temporal gyrus reveals epigenetic signatures associated with Alzheimer's disease.

Science.gov (United States)

Watson, Corey T; Roussos, Panos; Garg, Paras; Ho, Daniel J; Azam, Nidha; Katsel, Pavel L; Haroutunian, Vahram; Sharp, Andrew J

2016-01-19

Alzheimer's disease affects ~13% of people in the United States 65 years and older, making it the most common neurodegenerative disorder. Recent work has identified roles for environmental, genetic, and epigenetic factors in Alzheimer's disease risk. We performed a genome-wide screen of DNA methylation using the Illumina Infinium HumanMethylation450 platform on bulk tissue samples from the superior temporal gyrus of patients with Alzheimer's disease and non-demented controls. We paired a sliding window approach with multivariate linear regression to characterize Alzheimer's disease-associated differentially methylated regions (DMRs). We identified 479 DMRs exhibiting a strong bias for hypermethylated changes, a subset of which were independently associated with aging. DMR intervals overlapped 475 RefSeq genes enriched for gene ontology categories with relevant roles in neuron function and development, as well as cellular metabolism, and included genes reported in Alzheimer's disease genome-wide and epigenome-wide association studies. DMRs were enriched for brain-specific histone signatures and for binding motifs of transcription factors with roles in the brain and Alzheimer's disease pathology. Notably, hypermethylated DMRs preferentially overlapped poised promoter regions, marked by H3K27me3 and H3K4me3, previously shown to co-localize with aging-associated hypermethylation. Finally, the integration of DMR-associated single nucleotide polymorphisms with Alzheimer's disease genome-wide association study risk loci and brain expression quantitative trait loci highlights multiple potential DMRs of interest for further functional analysis. We have characterized changes in DNA methylation in the superior temporal gyrus of patients with Alzheimer's disease, highlighting novel loci that facilitate better characterization of pathways and mechanisms underlying Alzheimer's disease pathogenesis, and improve our understanding of epigenetic signatures that may contribute to the

Superior semicircular canal dehiscence in relation to the superior petrosal sinus: a potential cause of pulsatile tinnitus

International Nuclear Information System (INIS)

Liu, Z.; Bi, W.; Li, J.; Li, Q.; Dong, C.; Zhao, P.; Lv, H.; Wang, Z.

2015-01-01

Aim: To examine the association between superior semicircular canal dehiscence (SSCD) and pulsatile tinnitus (PT). Materials and methods: Two SSCD groups included 408 unilateral persistent PT patients, and 511 controls undergoing head and neck dual-phase contrast-enhanced computed tomography (DP-CECT) for reasons other than PT. The prevalence of type I (no the superior petrosal sinus running through the dehiscence) and type II (superior semicircular canal dehiscence in relation to the superior petrosal sinus) SSCD was analysed using chi-square test. Results: SSCD was identified in 5.1% (21/408) of PT ears, significantly different from 2% (8/408) of non-PT ears and 0.7% (7/1022) of controls. There was no significant difference in SSCD prevalence between non-PT ears in the PT group and controls. In the PT group, 15/21 ears were type II SSCD; 6/21 ears were type I. Fifteen combined non-PT and control ears with SSCD included two type II and 13 type I SSCD. The prevalence of type II SSCD in PT ears was significantly higher than that of non-PT ears in both groups, and the prevalence of type I SSCD in PT ears was similar to that of non-PT ears in both groups. Conclusion: Compared with type I SSCD, there may be a causal relationship between type II SSCD and PT. -- Highlights: •The prevalence of type II SSCD in PT ears was significantly higher than that in non-PT ears in both the PT group and controls. •The prevalence of type I SSCD was similar among the PT ears and non-PT ears. •The superior petrosal sinus running through the dehiscence may be essential for SSCD to induce PT. •Venous phase CT images with bone window settings is the modality method to differentiate type II from type I SSCD

Safety issues and updates under MR environments

Energy Technology Data Exchange (ETDEWEB)

Kim, Soo Jung; Kim, Kyung Ah, E-mail: bellenina@daum.net

2017-04-15

Highlights: • Unexpected biological effects can occur within stronger magnetic fields. • MR safety for MR conditional items is not guaranteed beyond the tested conditions. • Updated knowledge about MR-related safety is important for a safe MR environment. - Abstract: Magnetic resonance (MR) imaging is a useful imaging tool with superior soft tissue contrast for diagnostic evaluation. The MR environments poses unique risks to patients and employees differently from ionizing radiation exposure originated from computed tomography and plain x-ray films. The technology associated with MR system has evolved continuously since its introduction in the late 1970s. MR systems have advanced with static magnetic fields, faster and stronger gradient magnetic fields and more powerful radiofrequency transmission coils. Higher field strengths of MR offers greater signal to noise capability and better spatial resolution, resulting in better visualization of anatomic detail, with a reduction in scan time. With the rapid evolution of technology associated with MR, we encounter new MR-related circumstances and unexpected dangerous conditions. A comprehensive update of our knowledge about MR safety is necessary to prevent MR-related accidents and to ensure safety for patients and staff associated with MR. This review presents an overview about MR-related safety issues and updates.

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.

Agenesia de cava superior associada a bloqueio atrioventricular de 3º grau Agenesis of the right superior vena cava associated with total heart block

Directory of Open Access Journals (Sweden)

Gustavo J. Ventura Couto

2008-03-01

Full Text Available A persistência de veia cava superior esquerda com ausência da veia cava superior é uma anomalia rara, principalmente quando associada a bloqueio atrioventricular de 3º grau. Relatamos o caso de uma paciente, na qual durante implante de marca-passo definitivo, para a correção de bloqueio atrioventricular total, foi detectada presença de veia cava superior esquerda com suspeição de ausência de veia cava superior, o que levou ao emprego de técnica diferenciada para fixação do eletrodo ventricular. Para confirmação da provável agenesia, foram realizados diversos exames complementares de imagem, demonstrando-se a dificuldade no diagnóstico da síndrome aqui descrita.The superior left vena cava with the absent superior vena cava is a rare abnormality, especially when associated with total heart block. We report a case of a patient in which the presence of superior left vena cava and the absence of the superior vena cava was detected during the implantation of a pacemaker for the correction of a total heart block, which led us to use a different technique for the fixation of the ventricular electrode. To confirm the supposed absence, several image exams were made showing the difficulty on the diagnosis of the described syndrome.

Writing superiority in cued recall

Directory of Open Access Journals (Sweden)

Carina eFueller

2013-10-01

Full Text Available In list learning paradigms with free recall, written recall has been found to be less susceptible to intrusions of related concepts than spoken recall when the list items had been visually presented. This effect has been ascribed to the use of stored orthographic representations from the study phase during written recall (Kellogg, 2001. In other memory retrieval paradigms, either better recall for modality-congruent items or an input-independent writing superiority effect have been found (Grabowski, 2005. In a series of four experiments using a paired associate (PA learning paradigm we tested (a whether output modality effects on verbal recall can be replicated in a paradigm that does not involve the rejection of semantically related intrusion words, (b whether a possible superiority for written recall was due to a slower response onset for writing as compared to speaking in immediate recall, and (c whether the performance in PA word recall was correlated with performance in an additional episodic memory task. We found better written recall in the first half of the recall phase, irrespective of the modality in which the material was presented upon encoding. An explanation based on longer response latencies for writing and hence more time for retrieval could be ruled out by showing that the effect persisted in delayed response versions of the task. Although there was some evidence that stored additional episodic information may contribute to the successful retrieval of associate words, this evidence was only found in the immediate response experiments and hence is most likely independent from the observed output modality effect. In sum, our results from a PA learning paradigm suggest that superior performance for written versus spoken recall cannot be (solely explained in terms of additional access to stored orthographic representations from the encoding phase. Our findings rather suggest a general writing-superiority effect at the time of memory

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.

Superior facet syndrome

International Nuclear Information System (INIS)

Kubo, Yoshichika; Igarashi, Seishi; Koyama, Tsunemaro

1985-01-01

Sciatica caused by root entrapment in the lateral recess was named superior facet syndrome by Epstein in 1972. Few reports on this subject based on large numbers of cases have been documented to date. Of the patients with sciatica, 32 patients were diagnosed to have root entrapment at the lateral recess L 5 or/and S 1 lumbar spine. Out of 32 patients, 20 patients were operated on and the lateral entrapment was recognized in all of surgical cases. Neuroradiological findings, especially of metrizamide CT (met. CT), were documented in detail. Thirty two patients were classified in three types according to radiological findings. They were congenital or developmental, degenerative, and combined type, respectively, Fourteen cases belonged to the congenital type, 13 to the degenerative and 5 to the combined type. Each group had the mean ages of 23.4, 53.8, and 36.8 years old, respectively. Of 32 cases the entrapment occured in 47 L 5 roots and 11 S 1 roots. There was no remarkable laterality. In operation the unroofing of the lateral recess were done and the sciatica subsided postoperatively in all of surgical cases. Met. CT revealed extreme medial protrusion of the superior articular joint in 18 of 24 cases(75%) and none filling of the root in the lateral recess in 21 of 24 cases (87.5%). In the degenerative type, met. CT showed some degenerative changes that were hypertrophy or deformity of the articular joints and spur formation of the vertebral body. In contrast to met. CT, metrizamide myelography revealed only slight changes, which were poor filling of the root before it turned out the pedicle of lateral compression of the root. In plain films or lumbar spine articular joints at Lsub(4/5) were formed in coronal plane in 69% of cases of the L 5 root entrapment. Met. CT using ReView technique was of great diagnostic value in superior facet syndrome. (author)

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.

Motor mechanisms of vertical fusion in individuals with superior oblique paresis.

Science.gov (United States)

Mudgil, Ananth V; Walker, Mark; Steffen, Heimo; Guyton, David L; Zee, David S

2002-06-01

We wanted to determine the mechanisms of motor vertical fusion in patients with superior oblique paresis and to correlate these mechanisms with surgical outcomes. Ten patients with superior oblique paresis underwent 3-axis, bilateral, scleral search coil eye movement recordings. Eye movements associated with fusion were analyzed. Six patients had decompensated congenital superior oblique paresis and 4 had acquired superior oblique paresis. All patients with acquired superior oblique paresis relied predominantly on the vertical rectus muscles for motor fusion. Patients with congenital superior oblique paresis were less uniform in their mechanisms for motor fusion: 2 patients used predominantly the oblique muscles, 2 patients used predominantly the vertical recti, and 2 patients used predominantly the superior oblique in the hyperdeviated eye and the superior rectus in the hypodeviated eye. The last 2 patients developed the largest changes in torsional eye alignment relative to changes in vertical eye alignment and were the only patients to develop symptomatic surgical overcorrections. There are 3 different mechanisms for vertical fusion in individuals with superior oblique paresis, with the predominant mechanism being the vertical recti. A subset of patients with superior oblique paresis uses predominantly the superior oblique muscle in the hyperdeviated paretic eye and the superior rectus muscle in the fellow eye for fusion. This results in intorsion of both eyes, causing a large change in torsional alignment. The consequent cyclodisparity, in addition to the existing vertical deviation, may make fusion difficult. The differing patterns of vertical fusional vergence may have implications for surgical treatment.

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

Marketing at Superior: Theory meets application in the field

International Nuclear Information System (INIS)

Jeffrey, S.

1992-01-01

The field marketing practices of Superior Propane in rural Ontario are illustrated. In the Smithville area, Superior's customer base consists of agricultural, industrial, commercial, and residential customers, plus a large market for auto propane. A 6,900 ft 2 showroom presents a representative selection of the wide range of appliances using propane. Superior's Smithville branch is one of the top five in Canada, in terms of volume. To expand business beyond its traditional branch structures, Superior has an Independent Partners Program which is aimed at all phases of business including independent sales agents, conversions, propane fuel stops, appliance installations, and building contractors. In Keswick, located in the summer resort region on the south shore of Lake Simcoe, Superior's base load is 40% commercial and 20% each agricultural, residential, and automotive. A new 4,100 ft 2 showroom was recently constructed with separate display units for each appliance. The new building has brought increases in auto propane and appliance sales. The different branches of Superior Propane are able to tailor their marketing programs according to local needs by choosing the appropriate programs from those available at head office. 5 figs

Long term safety, efficacy, and patient acceptability of hyaluronic acid injection in patients with painful osteoarthritis of the knee

Science.gov (United States)

McArthur, Benjamin A; Dy, Christopher J; Fabricant, Peter D; Valle, Alejandro Gonzalez Della

2012-01-01

The increasing prevalence of painful knee osteoarthritis has created an additional demand for pharmacologic management to prevent or delay surgical management. Viscosupplementation, via intraarticular injection of hyaluronic acid (HA), aims to restore the favorable milieu present in the nonarthritic joint. The safety profile of intraarticular HA injections for painful knee osteoarthritis is well established, with the most common adverse effect being a self-limited reaction at the injection site. Although acceptance of the early literature has been limited by publication bias and poor study quality, more recent and rigorous meta-analysis suggests that intraarticular HA injection is superior to placebo injection for pain relief and matches, if not surpasses, the effect size of other nonoperative treatments, such as nonsteroidal anti-inflammatory medication. Intraarticular HA injection is effective in providing temporary pain relief in patients with painful knee osteoarthritis. Future investigations should focus on optimizing the composition and administration of HA agents to provide prolonged relief of painful osteoarthritis in the knee and other joints. PMID:23271899

Gene expression signature is shared by patients with Alzheimer's disease and schizophrenia at the superior temporal gyrus.

Science.gov (United States)

Horesh, Y; Katsel, P; Haroutunian, V; Domany, E

2011-03-01

Alzheimer's disease and Schizophrenia are two common diseases of the brain with significant differences in neuropathology, etiology and symptoms. This dissimilarity in the two diseases makes a comparison of the two ideal for detecting molecular substrates that are common to brain disorders in general. In this study, we compared gene expression profiles across multiple brain areas, taken postmortem from patients with well-characterized Alzheimer's disease and Schizophrenia, and from cognitively normal control group with no neuro- or psychopathology. Although the totality of gene expression changes in the two diseases is dissimilar, a subset of genes appears to play a role in both diseases in specific brain regions. We find at Brodmann area 22, the superior temporal gyrus, a statistically significant number of genes with apparently disregulated expression in both diseases. Furthermore, we found genes that differentiate the two diseases from the control across multiple brain regions, and note that these genes were usually down-regulated. Brodmann area 8, part of the superior frontal cortex, is relatively abundant with them. We show overwhelming statistical evidence for Alzheimer's and Schizophrenia sharing a specific molecular background at the superior temporal gyrus. We suggest that impairment of the regulation of autophagy pathway is shared, in BA 22, by the two diseases. © 2010 The Author(s). European Journal of Neurology © 2010 EFNS.

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.

Global metabolic profiling procedures for urine using UPLC-MS.

Science.gov (United States)

Want, Elizabeth J; Wilson, Ian D; Gika, Helen; Theodoridis, Georgios; Plumb, Robert S; Shockcor, John; Holmes, Elaine; Nicholson, Jeremy K

2010-06-01

The production of 'global' metabolite profiles involves measuring low molecular-weight metabolites (sample preparation, stability/storage and the selection of chromatographic conditions that balance metabolome coverage, chromatographic resolution and throughput. We discuss quality control and metabolite identification, as well as provide details of multivariate data analysis approaches for analyzing such MS data. Using this protocol, the analysis of a sample set in 96-well plate format, would take ca. 30 h, including 1 h for system setup, 1-2 h for sample preparation, 24 h for UPLC-MS analysis and 1-2 h for initial data processing. The use of UPLC-MS for metabolic profiling in this way is not faster than the conventional HPLC-based methods but, because of improved chromatographic performance, provides superior metabolome coverage.

Acute Superior Mesenteric Venous Thrombosis: Transcatheter Thrombolysis and Aspiration Thrombectomy Therapy by Combined Route of Superior Mesenteric Vein and Artery in Eight Patients

International Nuclear Information System (INIS)

Yang, Shuofei; Liu, Baochen; Ding, Weiwei; He, Changsheng; Wu, Xingjiang; Li, Jieshou

2015-01-01

PurposeTo assess the feasibility, effectiveness, and safety of catheter-directed thrombolysis and aspiration thrombectomy therapy by combined route of superior mesenteric vein and artery (SMV+SMA) for acute superior mesenteric venous thrombosis (ASMVT).MethodsThis retrospective study reviewed eight ASMVT patients with transcatheter direct thrombolysis and aspiration thrombectomy therapy via SMV and indirect thrombolysis via SMA during a period of 14 months. The demographics, etiology, risk factors, therapeutic effect, complications, mortality, and follow-up of the study population were assessed. Anatomic and imaging classification of location and extent of thrombus at diagnosis and degree of thrombus lysis were described.ResultsTechnical success was achieved with substantial improvement in symptoms and thrombus resolution after thrombolytic therapy in all patients. The local urokinase infusion by SMA and SMV was performed for 5–7 (6.13 ± 0.83) and 7–15 (12 ± 2.51) days. Anticoagulation was performed catheter-directed and then orally throughout hospitalization and after discharge. Four patients required delayed localized bowel resection after thrombolytic therapy with no death. Thrombolytic therapy was not interrupted despite minor bleeding at the puncture site in two patients and sepsis in another two postoperatively. Nearly complete removal of thrombus was demonstrated by contrast-enhanced CT scan and portography before discharge. Patients were discharged in 10–27 (19.25 ± 4.89) days after admission. No recurrence developed during the follow-up of 10–13 (12.13 ± 0.99) months.ConclusionsCatheter-directed thrombolytic and aspiration therapy via SMV+SMA is beneficial for ASMVT in avoiding patient death, efficient resolving thrombus, rapid improving symptoms, reversing extensive intestinal ischemia, averting bowel resection, or localizing infarcted bowel segment and preventing short bowel syndrome

Acute Superior Mesenteric Venous Thrombosis: Transcatheter Thrombolysis and Aspiration Thrombectomy Therapy by Combined Route of Superior Mesenteric Vein and Artery in Eight Patients

Energy Technology Data Exchange (ETDEWEB)

Yang, Shuofei, E-mail: yangshuofei@gmail.com; Liu, Baochen, E-mail: 306446264@qq.com; Ding, Weiwei, E-mail: dingwei-nju@hotmail.com; He, Changsheng, E-mail: hechsh@163.com; Wu, Xingjiang, E-mail: wuxingjiang@sohu.com; Li, Jieshou, E-mail: lijieshou2013@sohu.com [Research Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University (China)

2015-02-15

PurposeTo assess the feasibility, effectiveness, and safety of catheter-directed thrombolysis and aspiration thrombectomy therapy by combined route of superior mesenteric vein and artery (SMV+SMA) for acute superior mesenteric venous thrombosis (ASMVT).MethodsThis retrospective study reviewed eight ASMVT patients with transcatheter direct thrombolysis and aspiration thrombectomy therapy via SMV and indirect thrombolysis via SMA during a period of 14 months. The demographics, etiology, risk factors, therapeutic effect, complications, mortality, and follow-up of the study population were assessed. Anatomic and imaging classification of location and extent of thrombus at diagnosis and degree of thrombus lysis were described.ResultsTechnical success was achieved with substantial improvement in symptoms and thrombus resolution after thrombolytic therapy in all patients. The local urokinase infusion by SMA and SMV was performed for 5–7 (6.13 ± 0.83) and 7–15 (12 ± 2.51) days. Anticoagulation was performed catheter-directed and then orally throughout hospitalization and after discharge. Four patients required delayed localized bowel resection after thrombolytic therapy with no death. Thrombolytic therapy was not interrupted despite minor bleeding at the puncture site in two patients and sepsis in another two postoperatively. Nearly complete removal of thrombus was demonstrated by contrast-enhanced CT scan and portography before discharge. Patients were discharged in 10–27 (19.25 ± 4.89) days after admission. No recurrence developed during the follow-up of 10–13 (12.13 ± 0.99) months.ConclusionsCatheter-directed thrombolytic and aspiration therapy via SMV+SMA is beneficial for ASMVT in avoiding patient death, efficient resolving thrombus, rapid improving symptoms, reversing extensive intestinal ischemia, averting bowel resection, or localizing infarcted bowel segment and preventing short bowel syndrome.

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

Why do employees follow their superiors' instructions? Identification of the reasons to comply with superiors' will in a group of Polish employees.

Science.gov (United States)

Wójcik, Aleksandra; Merecz-Kot, Dorota; Andysz, Aleksandra

2015-01-01

Managers influence the way organization works as well as the functioning of subordinates - in the context of their work life but non-professional functioning as well e.g., attitude towards work-life balance or taking care of health. We focused on the superior-subordinate relation, referring to social power bases theory by Raven. We identified the reasons why subordinates decide to follow their superiors' orders and determined specific styles of compliance with superiors' will. Understanding why employees listen to their superiors may be valuable in the context of supporting healthy organizational climate and atmosphere of co-operation or communicating values - for example, as regards taking care of own health. We discussed the results referring to the issue of influencing employees in the context of their health behavior. The research involved 100 Polish employees, aged 28 years old on average, who filled in the Interpersonal Power Inventory by Raven et al. for subordinates in a Polish adaptation by Zaleski. The questionnaire includes 11 subscales referring to power bases. Based on the cluster analysis results, we recognized people who complied because of: all kinds of power bases (typical for 46% of the respondents); the respect for superiors' professionalism (34%); and formal/objective reasons (20%). Employees differ in terms of their styles of compliance. Their motives to comply with superiors' instructions constitute compilations of power bases. The superiors' awareness of the reasons why their employees decide to follow orders is necessary for successful management. It may motivate employees to work but also to take care of their own health. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

Establishment of safety goal and its quantification based on risk assessment

International Nuclear Information System (INIS)

Miyano, Hiroshi; Muramatsu, Ken

2017-01-01

We must clarify the safety objectives sought by society in securing the safety of nuclear reactors and nuclear power plants. For that purpose, it is useful to utilize risk assessment. Quantitative methods including probabilistic risk assessment (PRA) are superior in terms of scientific rationality and quantitative performance compared with conventional deterministic methods, and able to indicate an objective numerical value of safety level. Consequently, quantitative methods can enhance the transparency, consistency, compliance, predictability, and explanatory power of regulatory decisions toward business operators and citizens. Business operators can explain the validity of their own safety assurance activities to regulators and citizens. The goal to be secured becomes clear by incorporating the safety goal into the specific performance goal required for the nuclear power plant from the viewpoint of deep safeguard, and it becomes easy to evaluate the effectiveness of the safety measures. It helps us greatly in judging and selecting the appropriateness of safety measures. It should be noted: the fact that the result of implementing the PRA satisfies the safety goal is not a sufficient condition in the sense of guaranteeing complete safety but a necessary condition. The nuclear power field is a region with large uncertainty, and research/efforts for accuracy improvement and evaluation validity will be required continuously. (A.O.)

Aging and the Picture Superiority Effect in Recall.

Science.gov (United States)

Winograd, Eugene; And Others

1982-01-01

Compared verbal and visual encoding using the picture superiority effect. One experiment found an interaction between age and type of material. In other experiments, the picture superiority effect was found in both age groups with no interaction. Performing a semantic-orienting task had no effect on recall. (Author/RC)

Fatal pericardial tamponade after superior vena cava stenting.

NARCIS (Netherlands)

Ploegmakers, M.J.M.; Rutten, M.J.C.M.

2009-01-01

We discuss a fatal complication of percutaneous superior vena cava (SVC) self-expandable stent placement in a patient with superior vena cava syndrome (SVCS). The SVCS was caused by a malignant mediastinal mass with total occlusion of the SVC. Twenty-four hours after the procedure, the patient died

Physiologic profile of professional cricketers.

Science.gov (United States)

Johnstone, James A; Ford, Paul A

2010-11-01

This study aims to provide a physiologic profile of professional cricketers and note positional differences at the start of the 2007/08 competitive season. Fifteen participants (9 bowlers, 6 batsmen) aged 25.0 ± 5.0 years (mean ± SD) took part in this study. Participants (bowlers and batsmen) completed a series of field-based fitness assessments: body composition (sum of 7 skinfolds, 72.5 ± 16.5 and 65.5 ± 19.3 mm, respectively), flexibility (sit and reach 8.1 ± 10.3 and 6.0 ± 6.2 cm, respectively), predicted maximal oxygen uptake (multistage shuttle run, 54.1 ± 2.8 and 56.1 ± 4.5 ml-1·kg-1·min-1, respectively), upper- (medicine ball throw, 7.7 ± 0.6 and 7.0 ± 0.1 m, respectively) and lower-body strength (countermovement jump, 45.7 ± 5.8 and 43.9 ± 4.1 cm, respectively), speed (sprint 17.7 m, 2.76 ± 0.6 and 2.77 ± 0.1 s, respectively), and explosive power (repeated jump, 31.0 ± 2.0 and 34.1 ± 4.8 cm, respectively). The data provided the physical fitness profile for each player, which, compared with normative data, identified that this cohort of professional cricketers had some superior fitness parameters compared with the general population, and where applicable, were comparable with other professional athletes. In addition, after effect size calculations, the results showed that some physical fitness differences existed between playing positions. Cricket professionals possess a superior level of physical fitness and strength, and conditioning coaches should seek to progress these physical parameters and further identify position-specific physical requirements to progress the modern game.

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 ...

Perturbation resilience and superiorization of iterative algorithms

International Nuclear Information System (INIS)

Censor, Y; Davidi, R; Herman, G T

2010-01-01

Iterative algorithms aimed at solving some problems are discussed. For certain problems, such as finding a common point in the intersection of a finite number of convex sets, there often exist iterative algorithms that impose very little demand on computer resources. For other problems, such as finding that point in the intersection at which the value of a given function is optimal, algorithms tend to need more computer memory and longer execution time. A methodology is presented whose aim is to produce automatically for an iterative algorithm of the first kind a 'superiorized version' of it that retains its computational efficiency but nevertheless goes a long way toward solving an optimization problem. This is possible to do if the original algorithm is 'perturbation resilient', which is shown to be the case for various projection algorithms for solving the consistent convex feasibility problem. The superiorized versions of such algorithms use perturbations that steer the process in the direction of a superior feasible point, which is not necessarily optimal, with respect to the given function. After presenting these intuitive ideas in a precise mathematical form, they are illustrated in image reconstruction from projections for two different projection algorithms superiorized for the function whose value is the total variation of the image

Drug safety evaluation of defibrotide.

Science.gov (United States)

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

2013-01-01

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

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

Science.gov (United States)

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

2016-01-01

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

PECULIARITIES OF CONSTRUCTION PROFILES OF SECURITY SYSTEMS OF INFORMATION SYSTEMS

Directory of Open Access Journals (Sweden)

Olga V. Lukinova

2015-01-01

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

Perfiles docentes para el espacio europeo de educación superior (EEES en el ámbito universitario español. [Profiles of University Professors in Spain for the European Higher Education Area (EHEA].

Directory of Open Access Journals (Sweden)

Rodríguez-Gómez, Gregorio

2009-04-01

Full Text Available This paper presents the findings of a research study of professors’ profiles for the European Higher Education Area (EHEA conducted in five spanish universities. Through the application of qualitative methods of inquiry, the perceptions of several groups of university professors over the principal teaching qualifications necessary for the coordination of higher education throughout the European Union have been obtained. Data analysis indicates a significant discrepancy between actual Spanish professors and those required by EHEA. It has also made possible the detailed description of teaching competency profiles that professors believe to be fundamental for the new functions demanded of them in the present changing social and educational situation. En este trabajo se presentan los resultados de una investigación llevada a cabo en cinco universidades españolas sobre los perfiles docentes que demanda el EEES. Utilizando procedimientos de corte cualitativo se han obtenido en dos momentos consecutivos las percepciones de grupos de profesores sobre las principales competencias docentes necesarias para la armonización de la educación superior en la UE. El análisis de los datos indica, por una parte, la discrepancia entre los tipos de profesores actualmente existentes y los percibidos como necesarios; por otra, ha posibilitado la descripción pormenorizada de los perfiles de competencias docentes que el profesorado percibe como fundamentales para el ejercicio de las nuevas funciones que se le demandan en estos momentos.

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

Globalització i internacionalització en l'ensenyament superior

OpenAIRE

de Wit, J.W.M (Hans)

2011-01-01

La internacionalització és un fenomen cada cop més important i generalitzat en l'ensenyament superior en els àmbits institucional, nacional i internacional. La globalització de les nostres economies i societats ha tingut un impacte en l'ensenyament superior dels últims vint-i-cinc anys, i el mateix ensenyament superior s'ha convertit en un actor en l'economia de coneixement global, en la recerca i en altres àrees que impliquen aspectes com la c...

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

Superior Mesenteric Artery Syndrome: An Infrequent Complication of Scoliosis Surgery

Directory of Open Access Journals (Sweden)

Metin Keskin

2014-01-01

Full Text Available Superior mesenteric artery syndrome is a rare condition that causes a proximal small intestinal obstruction due to contraction of the angle between the superior mesenteric artery and the aorta. Scoliosis surgery is one of the 15 reasons for superior mesenteric artery syndrome, which can present with acute or chronic manifestations. Although conservative treatment is usually possible, surgical treatment is required in certain cases that cannot be treated using conservative methods. In this paper, we describe a patient who developed superior mesenteric artery syndrome after scoliosis surgery and was treated with duodenojejunostomy due to failure and complications of conservative treatment.

Superior dislocation hip with anterior column acetabular fracture ...

African Journals Online (AJOL)

Superior variety of anterior dislocation of the hip is a rare injury. Its occurrence with acetabular fractures has been documented infrequently. We report a case of superior dislocation of the hip with anterior column acetabular fracture. Open reduction of the hip and internal fixation of the fracture was carried out using a twin ...

Superior mesenteric artery syndrome: case report | Jani | East ...

African Journals Online (AJOL)

Superior Mesenteric Artery Syndrome (SMAS) is caused by trapping of the third part of the duodenum between Superior Mesenteric Artery (SMA) and aorta as result of narrowing of the angle between the two vessels due to acute loss of mesenteric fat which is secondary to rapid weight loss. A fifteen year old caucasian ...

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.

Identification of Novel Alleles Conferring Superior Production of Rose Flavor Phenylethyl Acetate Using Polygenic Analysis in Yeast

Directory of Open Access Journals (Sweden)

Bruna Trindade de Carvalho

2017-11-01

Full Text Available Flavor compound metabolism is one of the last areas in metabolism where multiple genes encoding biosynthetic enzymes are still unknown. A major challenge is the involvement of side activities of enzymes having their main function in other areas of metabolism. We have applied pooled-segregant whole-genome sequence analysis to identify novel Saccharomyces cerevisiae genes affecting production of phenylethyl acetate (2-PEAc. This is a desirable flavor compound of major importance in alcoholic beverages imparting rose- and honey-like aromas, with production of high 2-PEAc levels considered a superior trait. Four quantitative trait loci (QTLs responsible for high 2-PEAc production were identified, with two loci each showing linkage to the genomes of the BTC.1D and ER18 parents. The first two loci were investigated further. The causative genes were identified by reciprocal allele swapping into both parents using clustered regularly interspaced short palindromic repeat (CRISPR/Cas9. The superior allele of the first major causative gene, FAS2, was dominant and contained two unique single nucleotide polymorphisms (SNPs responsible for high 2-PEAc production that were not present in other sequenced yeast strains. FAS2 encodes the alpha subunit of the fatty acid synthetase complex. Surprisingly, the second causative gene was a mutant allele of TOR1, a gene involved in nitrogen regulation. Exchange of both superior alleles in the ER18 parent strain increased 2-PEAc production 70%, nearly to the same level as in the best superior segregant. Our results show that polygenic analysis combined with CRISPR/Cas9-mediated allele exchange is a powerful tool for identification of genes encoding missing metabolic enzymes and for development of industrial yeast strains generating novel flavor profiles in alcoholic beverages.

[Neuromolecular mechanism of the superiority illusion].

Science.gov (United States)

Yamada, Makiko

2014-01-01

The majority of individuals evaluate themselves as above average. This is a cognitive bias called "the superiority illusion". This illusory self-evaluation helps us to have hopes for the future, and has been central to the process of human evolution. Possessing this illusion is also important for mental health, as depressed people appear to have a more realistic perception of themselves, dubbed "depressive realism". Our recent study revealed the spontaneous brain activity and central dopaminergic neurotransmission that generate this illusion, using resting-state fMRI and PET. A functional connectivity between the frontal cortex and striatum, regulated by inhibitory dopaminergic neurotransmission, determines individual levels of the superiority illusion. We further revealed that blocking the dopamine transporter, which enhanced the level of dopamine, increased the degree of the superiority illusion. These findings suggest that dopamine acts on striatal dopamine receptors to suppress fronto-striatal functional connectivity, leading to disinhibited, heuristic, approaches to positive self-evaluation. These findings help us to understand how this key aspect of the human mind is biologically determined, and will suggest treatments for depressive symptoms by targeting specific molecules and neural circuits.

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.

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)

Biomechanical Effects of Acromioplasty on Superior Capsule Reconstruction for Irreparable Supraspinatus Tendon Tears.

Science.gov (United States)

Mihata, Teruhisa; McGarry, Michelle H; Kahn, Timothy; Goldberg, Iliya; Neo, Masashi; Lee, Thay Q

2016-01-01

Acromioplasty is increasingly being performed for both reparable and irreparable rotator cuff tears. However, acromioplasty may destroy the coracoacromial arch, including the coracoacromial ligament, consequently causing a deterioration in superior stability even after superior capsule reconstruction. The purpose of this study was to investigate the effects of acromioplasty on shoulder biomechanics after superior capsule reconstruction for irreparable supraspinatus tendon tears. The hypothesis was that acromioplasty with superior capsule reconstruction would decrease the area of subacromial impingement without increasing superior translation and subacromial contact pressure. Controlled laboratory study. Seven fresh-frozen cadaveric shoulders were evaluated using a custom shoulder testing system. Glenohumeral superior translation, the location of the humeral head relative to the glenoid, and subacromial contact pressure and area were compared among 4 conditions: (1) intact shoulder, (2) irreparable supraspinatus tendon tear, (3) superior capsule reconstruction without acromioplasty, and (4) superior capsule reconstruction with acromioplasty. Superior capsule reconstruction was performed using the fascia lata. Compared with the intact shoulder, the creation of an irreparable supraspinatus tear significantly shifted the humeral head superiorly in the balanced muscle loading condition (without superior force applied) (0° of abduction: 2.8-mm superior shift [P = .0005]; 30° of abduction: 1.9-mm superior shift [P = .003]) and increased both superior translation (0° of abduction: 239% of intact [P = .04]; 30° of abduction: 199% of intact [P = .02]) and subacromial peak contact pressure (0° of abduction: 308% of intact [P = .0002]; 30° of abduction: 252% of intact [P = .001]) by applying superior force. Superior capsule reconstruction without acromioplasty significantly decreased superior translation (0° of abduction: 86% of intact [P = .02]; 30° of abduction: 75

Securing the future through occupational safety. A managerial task; Zukunftssicherung durch Arbeitssicherheit. Eine Managementaufgabe

Energy Technology Data Exchange (ETDEWEB)

Gaertner, Dieter [RWE Power AG, Bergheim (Germany). Opencast Mines Div.; Groener, Harald [RWE Power AG, Essen (Germany). Arbeitssicherheit; Obermeyer, Bjoern [RWE Power AG, Koeln (Germany). PHS-B Operativer Arbeitsschutz

2010-05-15

The significance of occupational safety has increased over recent years so that this topic is now an integral task of management. To be able to meet the tighter requirements, occupational safety has to be dealt with in the same way as other topics. Therefore, RWE Power has introduced an occupational health and safety management system (AMS) whose organizational and operational structures are described in the following. The consistent implementation of occupational safety requires issue- and target group-related programmes of emphasis to be carried out in addition to the AMS. Two of these occupational safety programmes of RWE Power, which have contributed to a successful reduction in accident numbers, are presented along with the steps involved. Further examples from several plants and mines show how occupational safety has been further developed. In a company, occupational safety can only be successful if the managerial tasks are accepted and if superiors, occupational safety officers, industrial physicians, works council members, and partners ''pull together'' and if all employees are actively involved. (orig.)

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

Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

Science.gov (United States)

Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

2016-04-01

With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

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.

Novel anammox bacteria and nitrogen loss from Lake Superior

DEFF Research Database (Denmark)

Crowe, Sean A.; Treusch, Alexander H.; Forth, Michael

2017-01-01

and diversity of anammox bacteria in the world's largest freshwater lake - Lake Superior. We found that anammox performed by previously undiscovered bacteria is an important contributor to sediment N2 production. We observed striking differences in the anammox bacterial populations found at different locations...... within Lake Superior and those described from other locations. Our data thus reveal that novel anammox bacteria underpin N-loss from Lake Superior, and if more broadly distributed across inland waters would play an important role in continental N-cycling and mitigation of fixed nitrogen transfer from...

Oral ketamine/midazolam is superior to intramuscular meperidine, promethazine, and chlorpromazine for pediatric cardiac catheterization.

Science.gov (United States)

Auden, S M; Sobczyk, W L; Solinger, R E; Goldsmith, L J

2000-02-01

An IM combination of meperidine, promethazine, and chlorpromazine (DPT) has been given as sedation for pediatric procedures for more than 40 years. We compared this IM combination to oral (PO) ketamine/midazolam in children having cardiac catheterization. A total of 51 children, ages 9 mo to 10 yr, were enrolled and randomized in this double-blinded study. All children received an IM injection at time zero and PO fluid 15 minutes later. We observed acceptance of medication, onset of sedation and sleep, and sedative efficacy. The cardiorespiratory changes were evaluated. Sedation was supplemented with IV propofol as required. Recovery time, parental satisfaction, and patient amnesia were assessed. Ketamine/midazolam given PO was better tolerated (P < 0.0005), had more rapid onset (P < 0.001), and provided superior sedation (P < 0.005). Respiratory rate decreased after IM DPT only. Heart rate and shortening fraction were stable. Oxygen saturation and mean blood pressure decreased minimally in both groups. Supplemental propofol was more frequently required (P < or = 0.02) and in larger doses (P < 0.05) after IM DPT. Parental satisfaction ratings were higher (P < 0.005) and amnesia was more reliably obtained (P = 0.007) with PO ketamine/midazolam. Two patients needed airway support after the PO medication, as did two other patients when PO ketamine/midazolam was supplemented with IV propofol. Although PO ketamine/midazolam provided superior sedation and amnesia compared to IM DPT, this regimen may require the supervision of an anesthesiologist for safe use. Oral medication can be superior to IM injections for sedating children with congenital heart disease; however, the safety of all medications remains an issue.

The picture superiority effect in associative recognition.

Science.gov (United States)

Hockley, William E

2008-10-01

The picture superiority effect has been well documented in tests of item recognition and recall. The present study shows that the picture superiority effect extends to associative recognition. In three experiments, students studied lists consisting of random pairs of concrete words and pairs of line drawings; then they discriminated between intact (old) and rearranged (new) pairs of words and pictures at test. The discrimination advantage for pictures over words was seen in a greater hit rate for intact picture pairs, but there was no difference in the false alarm rates for the two types of stimuli. That is, there was no mirror effect. The same pattern of results was found when the test pairs consisted of the verbal labels of the pictures shown at study (Experiment 4), indicating that the hit rate advantage for picture pairs represents an encoding benefit. The results have implications for theories of the picture superiority effect and models of associative recognition.

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

Cell-specific prediction and application of drug-induced gene expression profiles.

Science.gov (United States)

Hodos, Rachel; Zhang, Ping; Lee, Hao-Chih; Duan, Qiaonan; Wang, Zichen; Clark, Neil R; Ma'ayan, Avi; Wang, Fei; Kidd, Brian; Hu, Jianying; Sontag, David; Dudley, Joel

2018-01-01

Gene expression profiling of in vitro drug perturbations is useful for many biomedical discovery applications including drug repurposing and elucidation of drug mechanisms. However, limited data availability across cell types has hindered our capacity to leverage or explore the cell-specificity of these perturbations. While recent efforts have generated a large number of drug perturbation profiles across a variety of human cell types, many gaps remain in this combinatorial drug-cell space. Hence, we asked whether it is possible to fill these gaps by predicting cell-specific drug perturbation profiles using available expression data from related conditions--i.e. from other drugs and cell types. We developed a computational framework that first arranges existing profiles into a three-dimensional array (or tensor) indexed by drugs, genes, and cell types, and then uses either local (nearest-neighbors) or global (tensor completion) information to predict unmeasured profiles. We evaluate prediction accuracy using a variety of metrics, and find that the two methods have complementary performance, each superior in different regions in the drug-cell space. Predictions achieve correlations of 0.68 with true values, and maintain accurate differentially expressed genes (AUC 0.81). Finally, we demonstrate that the predicted profiles add value for making downstream associations with drug targets and therapeutic classes.

PROFIL AROMA DAN MUTU SENSORI CITARASA PASTA KAKAO UNGGULAN DARI BEBERAPA DAERAH DI INDONESIA [Aroma and Flavor Sensory Profiles of Superior Cocoa Liquors from Different Regions in Indonesia

Directory of Open Access Journals (Sweden)

Intan Kusumaningrum*

2014-06-01

Full Text Available The objective of this research was to compare the aroma profiles and flavor sensory qualities of three cocoa liquors obtained from different regions in Indonesia, namely East Java, South Sulawesi and Bali. The Ghanaian cocoa liquor was used as the reference. The aroma of cocoa liquors was extracted by using a Solid Phase Microextraction (SPME, followed by detection with Gas Chromatography-Mass Spectrometry/Olfactometry (GC-MS/O with the Nassal Impact Frequency (NIF method. A total of 28 aroma active compounds in the cocoa liquors were identified, where in 21, 19, 22 and 18 compounds were detected in East Java, Bali, South Sulawesi and Ghana liquors, respectively. The profiles of these three liquors were not only different from one another but were also different from the reference. East Java liquor had a specific aroma of strong chocolate, enriched with creamy, caramel and coffee bean aroma, whileBali liquor was dominated by creamy, caramel and sweet, and South Sulawesi liquor was specified by its sweet green aroma. The aroma sensory characteristic was evaluated by descriptive test, presenting the aroma of nutty, acid, caramel, earthy and chocolate, while the taste sensory attributes included astringency, bitterness and acidity. The sensory profile analysis was carried out by applying a Quantitative Descriptive Analysis (QDA method. Accompired with preference and ranking tests were also conducted. Among the three cocoa liquors, the sensory profile of South Sulawesi was the most similar to that of Ghanaian cocoa liquor. However, the cocoa liquor from Bali and East Java cocoa were more preferred comparing to the liquor from South Sulawesi.

Fatty Acid Profile and Physicochemical Properties of Landolphia ...

African Journals Online (AJOL)

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

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

International Nuclear Information System (INIS)

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

2014-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2014-10-01

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

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

Science.gov (United States)

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

2017-07-01

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

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

Science.gov (United States)

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

2017-03-01

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

Right superior vena cava draining into the left atrium

Energy Technology Data Exchange (ETDEWEB)

Calcagni, Giulio; Sidi, Daniel; Bonnet, Damien [University Rene Descartes-Paris 5, Department of Paediatric Cardiology, Hopital Necker-Enfants Malades, Paris (France); Batisse, Alain [Institut de Puericulture et de Perinatalogie, Paris (France); Vouhe, Pascal [University Rene Descartes-Paris 5, Department of Paediatric Cardiac Surgery, Hopital Necker-Enfants Malades, Paris (France); Ou, Phalla [University Rene Descartes-Paris 5, Department of Paediatric Cardiology, Hopital Necker-Enfants Malades, Paris (France); University Rene Descartes-Paris 5, Department of Pediatric Radiology, Hopital Necker-Enfants Malades, Paris (France)

2008-08-15

The right superior vena cava draining into the left atrium is a rare malformation causing cyanosis and clubbing in patients in whom no other signs of congenital heart defect are present. Diagnosis may be difficult as cyanosis may be mild and the anomaly is not always easily detectable by echocardiography. For this reason we report a 13-month-old male in whom we confirmed the clinical and echocardiographic suspicion of anomalous drainage of the right superior vena cava using multidetector CT. This allowed successful surgical reconnection of the right superior vena cava to the right atrium. (orig.)

Right superior vena cava draining into the left atrium

International Nuclear Information System (INIS)

Calcagni, Giulio; Sidi, Daniel; Bonnet, Damien; Batisse, Alain; Vouhe, Pascal; Ou, Phalla

2008-01-01

The right superior vena cava draining into the left atrium is a rare malformation causing cyanosis and clubbing in patients in whom no other signs of congenital heart defect are present. Diagnosis may be difficult as cyanosis may be mild and the anomaly is not always easily detectable by echocardiography. For this reason we report a 13-month-old male in whom we confirmed the clinical and echocardiographic suspicion of anomalous drainage of the right superior vena cava using multidetector CT. This allowed successful surgical reconnection of the right superior vena cava to the right atrium. (orig.)

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. �

Eutrophication monitoring for Lake Superior's Chequamegon ...

Science.gov (United States)

A priority for the Lake Superior CSMI was to identify susceptible nearshore eutrophication areas. We developed an integrated sampling design to collect baseline data for Lake Superior’s Chequamegon Bay to understand how nearshore physical processes and tributary loading relate to observed chlorophyll concentrations. Sampling included ship-based water samples combined with vertical CTD casts, continuous in situ towing and data collected from an autonomous underwater glider. Sampling was conducted during June, July and September. The glider collected regional data as part of three extended missions in Lake Superior over the same periods. During the study, two significant storm events impacted the western end of Lake Superior; the first occurred during July 11-12, with 8-10 inches of rain in 24hrs, and the second on July 21 with winds in excess of 161 km/h. Using GIS software, we organized these diverse temporal data sets along a continuous time line with temporally coincident Modis Satellite data to visualize surface sediment plumes in relation to water quality measurements. Preliminary results suggest that both events impacted regional water quality, and that nearshore physical forces (upwelling and currents) influenced the spatial variability. Results comparing in situ measures with remotely sensed images will be discussed. not applicable

La educación superior como eje del desarrollo

Directory of Open Access Journals (Sweden)

Benjamín Afanador Vargas

2003-11-01

Full Text Available Este documento analiza cómo ha sido la interacción entre la política educativa y las estrategiasde desarrollo en Colombia, a lo largo del siglo XX. Se presenta una revisión del estadoactual de la educación en Colombia, tanto a nivel de educación básica y media, como de laeducación superior. Para ello se toman tres criterios básicos que son la cobertura, la calidady la equidad en el acceso a la educación. Para el caso de la educación superior, se comparala oferta de cupos con la demanda existente, se clasifican los distintos segmentos en que sedivide la educación superior y se hace una breve reseña sobre el recurso humano con que secuenta en la educación superior colombiana. Así mismo, se expone una conceptualización delos retos que enfrenta la educación superior, sobretodo para lograr una cohesión de la sociedad,evitando que algunos de sus integrantes sean excluidos y permitiendo que todos losestamentos de la sociedad puedan compartir los mismos ideales y los consideren asequibles.Finalmente, se presentan unas conclusiones que se derivan del estudio y se proponen algunasrecomendaciones de política .

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

An empirical investigation of the work environment on board industrial- and cruise ships and the associations with safety

OpenAIRE

Heidenstrøm, Øyvind Teige

2011-01-01

The overall aim of this study was to examine the work environment and the associations with safety, and see the relations with occupational accidents and undesired events on board industrial and cruise ships. 215 seafarers participated in this quantitative survey study, with a response rate of 35%. When conducting the hierarchical block regression analysis separately on superiors/officers and subordinates/ratings, the work environment emerged as a predictor for safety status (compliance, atti...

Self and Superior Assessment.

Science.gov (United States)

1986-06-01

model of the self-evaluation process as it differs from the evaluation process used by superiors. Symbolic Interactionism One view of self assessment is...supplied by the symbolic interactionists (Cooley, 1902; Head, 1934), who state that self perceptions are generated largely from individuals...disagreements remained even immediately after an appraisal interview in which a great deal of feedback was given. Research on the symbolic interactionist

14 CFR 385.7 - Exercise of authority by superiors.

Science.gov (United States)

2010-01-01

... PROCEEDINGS) ORGANIZATION STAFF ASSIGNMENTS AND REVIEW OF ACTION UNDER ASSIGNMENTS General Provisions § 385.7 Exercise of authority by superiors. Any assignment of authority to a staff member other than the Chief... be made, severally, to each such staff member's respective superiors. In accordance with the...

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

Superior Canal Dehiscence Syndrome: Lessons from the First 20 Years

Directory of Open Access Journals (Sweden)

Bryan K. Ward

2017-04-01

Full Text Available Superior semicircular canal dehiscence syndrome was first reported by Lloyd Minor and colleagues in 1998. Patients with a dehiscence in the bone overlying the superior semicircular canal experience symptoms of pressure or sound-induced vertigo, bone conduction hyperacusis, and pulsatile tinnitus. The initial series of patients were diagnosed based on common symptoms, a physical examination finding of eye movements in the plane of the superior semicircular canal when ear canal pressure or loud tones were applied to the ear, and high-resolution computed tomography imaging demonstrating a dehiscence in the bone over the superior semicircular canal. Research productivity directed at understanding better methods for diagnosing and treating this condition has substantially increased over the last two decades. We now have a sound understanding of the pathophysiology of third mobile window syndromes, higher resolution imaging protocols, and several sensitive and specific diagnostic tests. Furthermore, we have a treatment (surgical occlusion of the superior semicircular canal that has demonstrated efficacy. This review will highlight some of the fundamental insights gained in SCDS, propose diagnostic criteria, and discuss future research directions.

Aneurysm of the superior mesenteric artery

Energy Technology Data Exchange (ETDEWEB)

Gebauer, A

1984-11-01

This is a report about 4 patients with aneurysms of the superior mesenteric artery of arteriosclerotic, mycotic and probably congenital etiology together with a review of the literature as to the etiology, diagnostic possibilities and therapy. Arteriography is the method of choice even though a diagnosis may be possible by sonography or CT in special cases. Even though an aneurysm of the superior mesenteric artery is rare, it has to be considered in the differential diagnosis of persisting abdominal problems of unknown origin. This is especially true for patients with a predisposing history such as previous or existing endocarditis, sepsis, arteriosclerosis and hypertension. Because of the possibility of rupture followed by life threating bleeding an adequate diagnostic step such as arteriography has to be considered finally.

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.

Science.gov (United States)

Wang, Long; Chandrasekaran, Vijayalakshmi; Domachowske, Joseph B; Li, Ping; Innis, Bruce L; Jain, Varsha K

2016-06-01

Viruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection. We compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6-35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314). Seroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%-86.6%), 72.0% (95% CI, 63.9%-79.2%), 86.0% (95% CI, 79.2%-91.2%), and 66.4% (95% CI, 58.1%-74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%-5.99%) and SCR difference of 54.02% (95% CI, 43.88%-62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination. Quadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6-35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group. © The Author 2015. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society.

Superior mesenteric artery compression syndrome - case report

Directory of Open Access Journals (Sweden)

Paulo Rocha França Neto

2011-12-01

Full Text Available Superior mesenteric artery syndrome is an entity generally caused by the loss of the intervening mesenteric fat pad, resulting in compression of the third portion of the duodenum by the superior mesenteric artery. This article reports the case of a patient with irremovable metastatic adenocarcinoma in the sigmoid colon, that evolved with intense vomiting. Intestinal transit was carried out, which showed important gastric dilation extended until the third portion of the duodenum, compatible with superior mesenteric artery syndrome. Considering the patient's nutritional condition, the medical team opted for the conservative treatment. Four months after the surgery and conservative measures, the patient did not present vomiting after eating, maintaining previous weight. Superior mesenteric artery syndrome is uncommon and can have unspecific symptoms. Thus, high suspicion is required for the appropriate clinical adjustment. A barium examination is required to make the diagnosis. The treatment can initially require gastric decompression and hydration, besides reversal of weight loss through adequate nutrition. Surgery should be adopted only in case of clinical treatment failure.A síndrome da artéria mesentérica superior é uma entidade clínica causada geralmente pela perda do tecido adiposo mesentérico, resultando na compressão da terceira porção do duodeno pela artéria mesentérica superior. Esse artigo relata o caso clínico de uma paciente portadora de adenocarcinoma de cólon sigmoide metastático irressecável, que evoluiu com vômitos incoercíveis. Realizou-se, então, trânsito intestinal que evidenciou dilatação gástrica importante, que se prolongava até a terceira porção duodenal, quadro radiológico compatível com pinçamento da artéria mesentérica superior. Diante da condição nutricional da paciente, foi optado por iniciar medidas conservadoras (porções alimentares pequenas e mais frequentes, além de dec

Air Power's First Among Equals: Why Air Superiority Still Matters

National Research Council Canada - National Science Library

Slawson, Andrew T

2008-01-01

.... History is replete with examples of successful or failed air superiority campaigns. This paper details air superiority's role in both the Battle of Britain, and the 1967 Six Day War's Operation MOKED...

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)

[Out of hospital emergencies towards a safety culture].

Science.gov (United States)

Cano-del Pozo, M I; Obón-Azuara, B; Valderrama-Rodríguez, M; Revilla-López, C; Brosed-Yuste, C; Fajardo-Trasobares, E; Garcés-Baquero, P; Mateo-Clavería, J; Molina-Estrada, I; Perona-Flores, N; Salcedo-de Dios, S; Tomé-Rey, A

2014-01-01

The aim of this study is to measure the degree of safety culture (CS) among healthcare professional workers of an out-of-hospital Emergency Medical Service. Most patient safety studies have been conducted in relation to the hospital rather than pre-hospital Emergency Medical Services. The objective is to analyze the dimensions with lower scores in order to plan futures strategies. A descriptive study using the AHRQ (Agency for Healthcare Research and Quality) questionnaire. The questionnaire was delivered to all healthcare professionals workers of 061 Advanced Life Support Units of Aragón, during the month of August 2013. The response rate was 55%. Main strengths detected: an adequate number of staff (96%), good working conditions (89%), tasks supported from immediate superior (77%), teamwork climate (74%), and non-punitive environment to report adverse events (68%). Areas for improvement: insufficient training in patient safety (53%) and lack of feedback of incidents reported (50%). The opportunities for improvement identified focus on the training of professionals in order to ensure safer care, while extending the safety culture. Also, the implementation of a system of notification and registration of adverse events in the service is deemed necessary. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

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

Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial.

Science.gov (United States)

Park, Dae Hyun; Chung, Jin Kwon; Seo, Du Ri; Lee, Sung Jin

2016-03-01

To compare the efficacies and safety profiles of 3% diquafosol and 0.1% sodium hyaluronate in patients with dry eye after cataract surgery. Randomized controlled trial. setting: Soonchunhyang University Hospital, Seoul, South Korea. In all, 130 eyes of 86 dry eye patients who had undergone cataract surgery between January 2014 and January 2015 were enrolled and randomly divided into a diquafosol group and a sodium hyaluronate group. The diquafosol group used diquafosol 6 times a day and the hyaluronate group used sodium hyaluronate 6 times a day after cataract surgery. Evaluations of efficacy were conducted based on an Ocular Surface Disease Index questionnaire, tear breakup time (TBUT), Schirmer I test, corneal fluorescein and conjunctival lissamine green staining scores, serial measurement of ocular higher-order aberrations (HOAs), corneal HOAs, and uncorrected distance visual acuity test. Safety evaluations were based on anterior chamber inflammation and discontinuation of the eye drops. Objective signs and subjective symptoms were aggravated at 1 week postoperatively and began to recover significantly 4 weeks after surgery. The diquafosol group showed significantly superior TBUT (P < .001), corneal fluorescein (P = .045), and conjunctival staining (P = .001) compared to the sodium hyaluronate group throughout the study period. TBUT (P < .001) and the change in HOAs (P = .018) recovered significantly more quickly in the diquafosol group. The safety evaluations showed no intergroup differences. Eye drops of 3% diquafosol may be an effective and safe treatment for the management of cataract surgery-induced dry eye aggravation in patients with preexisting dry eye. Copyright © 2016 Elsevier Inc. All rights reserved.

Aging and the picture superiority effect in recall.

Science.gov (United States)

Winograd, E; Smith, A D; Simon, E W

1982-01-01

One recurrent theme in the literature on aging and memory is that the decline of memory for nonverbal information is steeper than for verbal information. This research compares verbal and visual encoding using the picture superiority effect, the finding that pictures are remembered better than words. In the first experiment, an interaction was found between age and type of material; younger subjects recalled more pictures than words while older subjects did not. However, the overall effect was small and two further experiments were conducted. In both of these experiments, the picture superiority effect was found in both age groups with no interaction. In addition, performing a semantic orienting task had no effect on recall. The finding of a picture superiority effect in older subjects indicates that nonverbal codes can be effectively used by subjects in all age groups to facilitate memory performance.

Contributions to the Definition of the Managerial Profiles

Directory of Open Access Journals (Sweden)

Dan Constantinescu

2008-01-01

Full Text Available Considering that the superior manager variety is a result of the different levels of “accommodation” of the characteristics met in the dedicated literature, in the beginning we have summed up the opinions of the subjects of a statistical research in some managerial profiles, closer to the real life. The same procedure was applied in middle management, making some adjustments regarding the main characteristics. The last part of the study is dedicated to define the best performing managerial teams (tandems, reported to the role of the two representatives of the organizational structures in accomplishing the general objectives of each company.

High Burnup Fuel Performance and Safety Research

Energy Technology Data Exchange (ETDEWEB)

Bang, Je Keun; Lee, Chan Bok; Kim, Dae Ho (and others)

2007-03-15

The worldwide trend of nuclear fuel development is to develop a high burnup and high performance nuclear fuel with high economies and safety. Because the fuel performance evaluation code, INFRA, has a patent, and the superiority for prediction of fuel performance was proven through the IAEA CRP FUMEX-II program, the INFRA code can be utilized with commercial purpose in the industry. The INFRA code was provided and utilized usefully in the universities and relevant institutes domesticallly and it has been used as a reference code in the industry for the development of the intrinsic fuel rod design code.

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 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.

Multi-dimensional database design and implementation of dam safety monitoring system

Directory of Open Access Journals (Sweden)

Zhao Erfeng

2008-09-01

Full Text Available To improve the effectiveness of dam safety monitoring database systems, the development process of a multi-dimensional conceptual data model was analyzed and a logic design was achieved in multi-dimensional database mode. The optimal data model was confirmed by identifying data objects, defining relations and reviewing entities. The conversion of relations among entities to external keys and entities and physical attributes to tables and fields was interpreted completely. On this basis, a multi-dimensional database that reflects the management and analysis of a dam safety monitoring system on monitoring data information has been established, for which factual tables and dimensional tables have been designed. Finally, based on service design and user interface design, the dam safety monitoring system has been developed with Delphi as the development tool. This development project shows that the multi-dimensional database can simplify the development process and minimize hidden dangers in the database structure design. It is superior to other dam safety monitoring system development models and can provide a new research direction for system developers.

Noise management to achieve superiority in quantum information systems.

Science.gov (United States)

Nemoto, Kae; Devitt, Simon; Munro, William J

2017-08-06

Quantum information systems are expected to exhibit superiority compared with their classical counterparts. This superiority arises from the quantum coherences present in these quantum systems, which are obviously absent in classical ones. To exploit such quantum coherences, it is essential to control the phase information in the quantum state. The phase is analogue in nature, rather than binary. This makes quantum information technology fundamentally different from our classical digital information technology. In this paper, we analyse error sources and illustrate how these errors must be managed for the system to achieve the required fidelity and a quantum superiority.This article is part of the themed issue 'Quantum technology for the 21st century'. © 2017 The Author(s).

Noise management to achieve superiority in quantum information systems

Science.gov (United States)

Nemoto, Kae; Devitt, Simon; Munro, William J.

2017-06-01

Quantum information systems are expected to exhibit superiority compared with their classical counterparts. This superiority arises from the quantum coherences present in these quantum systems, which are obviously absent in classical ones. To exploit such quantum coherences, it is essential to control the phase information in the quantum state. The phase is analogue in nature, rather than binary. This makes quantum information technology fundamentally different from our classical digital information technology. In this paper, we analyse error sources and illustrate how these errors must be managed for the system to achieve the required fidelity and a quantum superiority. This article is part of the themed issue 'Quantum technology for the 21st century'.

Aneurysm of the superior mesenteric artery

International Nuclear Information System (INIS)

Gebauer, A.

1984-01-01

This is a report about 4 patients with aneurysms of the superior mesenteric artery of arteriosclerotic, mycotic and probably congenital etiology together with a review of the literature as to the etiology, diagnostic possibilities and therapy. Arteriography is the method of choice even though a diagnosis may be possible by sonography or CT in special cases. Even though an aneurysm of the superior mesenteric artery is rare, it has to be considered in the differential diagnosis of persisting abdominal problems of unknown origin. This is especially true for patients with a predisposing history such as previous or existing endocarditis, sepsis, arteriosclerosis and hypertension. Because of the possibility of rupture followed by life threating bleeding an adequate diagnostic step such as arteriography has to be considered finally. (orig.) [de

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.

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

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.

Enlarged right superior temporal gyrus in children and adolescents with autism.

Science.gov (United States)

Jou, Roger J; Minshew, Nancy J; Keshavan, Matcheri S; Vitale, Matthew P; Hardan, Antonio Y

2010-11-11

The superior temporal gyrus has been implicated in language processing and social perception. Therefore, anatomical abnormalities of this structure may underlie some of the deficits observed in autism, a severe neurodevelopmental disorder characterized by impairments in social interaction and communication. In this study, volumes of the left and right superior temporal gyri were measured using magnetic resonance imaging obtained from 18 boys with high-functioning autism (mean age=13.5±3.4years; full-scale IQ=103.6±13.4) and 19 healthy controls (mean age=13.7±3.0years; full-scale IQ=103.9±10.5), group-matched on age, gender, and handedness. When compared to the control group, right superior temporal gyral volumes was significantly increased in the autism group after controlling for age and total brain volume. There was no significant difference in the volume of the left superior temporal gyrus. Post-hoc analysis revealed a significant increase of the right posterior superior temporal gyral volume in the autism group, before and after controlling for age and total brain volume. Examination of the symmetry index for the superior temporal gyral volumes did not yield statistically significant between-group differences. Findings from this preliminary investigation suggest the existence of volumetric alterations in the right superior temporal gyrus in children and adolescents with autism, providing support for a neuroanatomical basis of the social perceptual deficits characterizing this severe neurodevelopmental disorder. Copyright © 2010 Elsevier B.V. All rights reserved.

Superior refining performance beyond 2000 -- Breaking traditional paradigms

International Nuclear Information System (INIS)

Tassel, B. van

1995-01-01

Over the last 5 years, refining companies have not performed well financially, generating returns below the cost of capital. Environmental regulations have caused the industry to invest significant amounts of capital, and while new regulations will cause the shutdown of between 500 thousand and 1.2 million barrels per day of capacity, the industry structure will remain poor and financial returns for the average player will likely be volatile, cyclical, and below the cost of capital. Based on this industry outlook, refining companies seeking superior performance will have to break the traditional paradigms and adopt world-class practices used in other industries. Changes required to significantly improve financial returns will include shifts in business strategy to accommodate growth, and development of nontraditional services, as well as initiates to dramatically reshape cost structure and improve profitability. Making the changes to become a superior performer in the refining business will require a clear vision and strong leadership at multiple levels in the organization. The transformation will also require changes in company culture and incentive plans that encourage managers to act as owners. In addition, superior performers will push accountability for results to low levels in the organization. Given the herd mentality of the oil industry, superior performers must take decisive, preemptive action to generate a substantial, competitive advantage

Superior refining performance beyond 2000 -- Breaking traditional paradigms

Energy Technology Data Exchange (ETDEWEB)

Tassel, B. van [McKinsey and Co., Inc., Houston, TX (United States)

1995-09-01

Over the last 5 years, refining companies have not performed well financially, generating returns below the cost of capital. Environmental regulations have caused the industry to invest significant amounts of capital, and while new regulations will cause the shutdown of between 500 thousand and 1.2 million barrels per day of capacity, the industry structure will remain poor and financial returns for the average player will likely be volatile, cyclical, and below the cost of capital. Based on this industry outlook, refining companies seeking superior performance will have to break the traditional paradigms and adopt world-class practices used in other industries. Changes required to significantly improve financial returns will include shifts in business strategy to accommodate growth, and development of nontraditional services, as well as initiates to dramatically reshape cost structure and improve profitability. Making the changes to become a superior performer in the refining business will require a clear vision and strong leadership at multiple levels in the organization. The transformation will also require changes in company culture and incentive plans that encourage managers to act as owners. In addition, superior performers will push accountability for results to low levels in the organization. Given the herd mentality of the oil industry, superior performers must take decisive, preemptive action to generate a substantial, competitive advantage.

Persistencia de la vena cava superior izquierda: Diagnóstico e importancia prenatal Persistency of the left superior caval vein: Diagnosis and its prenatal importance

Directory of Open Access Journals (Sweden)

Juan F Jaramillo

2010-04-01

Full Text Available Durante un ultrasonido obstétrico de rutina se deben realizar ciertos planos del corazón en los cuales no es complejo identificar un grupo de anomalías como la persistencia de la vena cava superior izquierda. Cuando se identifica una vena cava superior izquierda aislada, sin otras anomalías del corazón fetal, no existe ninguna repercusión perinatal. Su importancia radica en que un grupo considerable de estos casos se acompaña de cardiopatías congénitas y anomalías anatómicas y cromosómicas. En este artículo se describen nueve casos de vena cava superior izquierda persistente, al igual que las anomalías del corazón asociadas, como también las alteraciones extracardiacas encontradas.Certain heart fetal planes must be realized during a routine obstetric ultrasound in order to identify a group of anomalies such as the persistency of the left superior caval vein. When an isolated left superior venal vein is identified without any other anomaly of the fetal heart, it does not have any perinatal repercussion. Its importance lies in the fact that a considerable number of these cases are associated with a high incidence of congenital heart diseases and anatomic and chromosomal abnormalities. This article reports nine cases of persistency of the left superior caval vein as well as the associated heart abnormalities and the extra-cardiac alterations found.

Whole-body profile scanner for in vivo quantitative activity measurement

International Nuclear Information System (INIS)

Bergmann, H.

1978-01-01

A whole-body profile scanner has been developed by fitting parallel slit collimators to a shadow shield whole-body counter. Sensitivity, uniformity and resolution measurements were performed using a number of different counting conditions. It is shown that improved accuracy of activity measurements is obtained by using a wide window counting technique for low and medium energy gamma emitters (99m Tc, 131 I), whereas a photopeak window should be used for high energy gamma emitters (47 Ca). Due to the finite spatial resolution of the system a systematic error in evaluating regional activities from the counting rate profile occurs which is characterized by a spatial spillover factor. The spatial spillover factor is measured and is subsequently used to calculate the error on basis of a simple model. It is shown that only small errors are caused by spatial spillover when the length of a region is at least three times the full width half maximum of the point spread function. Applying the above mentioned simple rules it is concluded that profile scanning is a sensitive and accurate technique for activity measurements in vivo. Two examples of clinical applications (measurement of bone accretion rates of calcium and Tc-pyrophosphate, regional radioiodine retention in patients with thyroid carcinoma) and a review of the papers on profile scanning demonstrate the types of investigations in which profile scanning is superior to alternative techniques. (author)

5 CFR 531.212 - Superior qualifications and special needs pay-setting authority.

Science.gov (United States)

2010-01-01

... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Superior qualifications and special needs... Appointment Or Position Changes § 531.212 Superior qualifications and special needs pay-setting authority. (a) Agency authority. (1) An agency may use the superior qualifications and special needs pay-setting...

On the Analytical Superiority of 1D NMR for Fingerprinting the Higher Order Structure of Protein Therapeutics Compared to Multidimensional NMR Methods.

Science.gov (United States)

Poppe, Leszek; Jordan, John B; Rogers, Gary; Schnier, Paul D

2015-06-02

An important aspect in the analytical characterization of protein therapeutics is the comprehensive characterization of higher order structure (HOS). Nuclear magnetic resonance (NMR) is arguably the most sensitive method for fingerprinting HOS of a protein in solution. Traditionally, (1)H-(15)N or (1)H-(13)C correlation spectra are used as a "structural fingerprint" of HOS. Here, we demonstrate that protein fingerprint by line shape enhancement (PROFILE), a 1D (1)H NMR spectroscopy fingerprinting approach, is superior to traditional two-dimensional methods using monoclonal antibody samples and a heavily glycosylated protein therapeutic (Epoetin Alfa). PROFILE generates a high resolution structural fingerprint of a therapeutic protein in a fraction of the time required for a 2D NMR experiment. The cross-correlation analysis of PROFILE spectra allows one to distinguish contributions from HOS vs protein heterogeneity, which is difficult to accomplish by 2D NMR. We demonstrate that the major analytical limitation of two-dimensional methods is poor selectivity, which renders these approaches problematic for the purpose of fingerprinting large biological macromolecules.

Anatomical relation between S1 sacroiliac screws' entrance points and superior gluteal artery.

Science.gov (United States)

Zhao, Yong; You, Libo; Lian, Wei; Zou, Dexin; Dong, Shengjie; Sun, Tao; Zhang, Shudong; Wang, Dan; Li, Jingning; Li, Wenliang; Zhao, Yuchi

2018-01-18

To conduct radiologic anatomical study on the relation between S1 sacroiliac screws' entry points and the route of the pelvic outer superior gluteal artery branches with the aim to provide the anatomical basis and technical reference for the avoidance of damage to the superior gluteal artery during the horizontal sacroiliac screw placement. Superior gluteal artery CTA (CT angiography) vascular imaging of 74 healthy adults (37 women and 37 men) was done with 128-slice spiral CT (computed tomography). The CT attendant-measuring software was used to portray the "safe bony entrance area" (hereinafter referred to as "Safe Area") of the S1 segment in the standard lateral pelvic view of three-dimensional reconstruction. The anatomical relation between S1 sacroiliac screws' Safe Area and the pelvic outer superior gluteal artery branches was observed and recorded. The number of cases in which artery branches intersected the Safe Area was counted. The cases in which superior gluteal artery branches disjointed from the Safe Area were identified, and the shortest distance between the Safe Area and the superior gluteal artery branch closest to the Safe Area was measured. Three cases out of the 74 sample cases were excluded from this study as they were found to have no bony space for horizontal screw placement in S1 segment. Among the remaining 71 sample cases, there are 32 cases (45.1%) where the deep superior branch of superior gluteal artery passes through the Safe Area of S1 entrance point. There was no distinguishing feature and rule on how the deep superior branches and the Safe Area overlapped. In the 39 cases in which superior gluteal artery branches disjointed from the Safe Area, the deep superior branches of superior gluteal artery were the branches closest to the Safe Area and the part of the branch closest to the Safe Area was located in front of the widest part of the Safe Area. The shortest distance between the deep superior branch and the Safe Area is 0.86�

Comprendiendo la Desigualdad en Educación Superior de Guanajuato en 1997 Comprendiendo la Desigualdad en Educación Superior de Guanajuato en 1997

Directory of Open Access Journals (Sweden)

Humberto Rodríguez Partida

2012-02-01

Full Text Available Social inequalities regarding access, permanence, and success in educational processes have their origin in personal, family, social, and economic factors. The profile of students seeking entry into institutions of higher education was studied in order to identify which personal factors, such as gender, educational path, socioeconomic background and locality, have an influence on access to higher education programs at the Universidad de Guanajuato in the academic year 1997-1998. Results show several differences: Family income is higher for accepted applicants than for non-accepted ones; more male than female applicants were accepted; more residents from the industrial corridor were accepted than from other localities; and there was more intergenerational social mobility of children in reference to mothers than fathers. Uncovering the origin of educational inequities and knowing the relations between socioeconomic features of prospective students will permit the understanding, prevention, and management of educational inequalities in our society. Las desigualdades relacionadas con el acceso, la permanencia y el éxito en la educación se originan por factores personales, familiares, sociales y económicos. Se estudió el perfil de aspirantes a educación superior, con objeto de identificar qué factores influyen para ingresar o no a este nivel; se analizaron aspectos como género, trayectoria educativa, nivel socioeconómico y localidad de origen. Participaron 3,098 aspirantes a 24 programas académicos de la Universidad de Guanajuato del ciclo escolar 1997-1998. Los resultados muestran que: El ingreso familiar es superior para los aspirantes aceptados que para los no aceptados; fueron aceptados más varones que mujeres; se aceptaron más residentes del corredor industrial que de otras localidades; hubo más movilidad social intergeneracional con respecto a las madres que a los padres. Entender el origen de las inequidades educativas y conocer la

Vena cava superior syndrome associated with sarcoidosis

International Nuclear Information System (INIS)

Wurm, K.; Walz, M.; Reidemeister, J.C.; Donhuijsen, K.

1988-01-01

We report the first observation of clinical manifestations of vena cava superior syndrome (VCSS) associated with sarcoidosis. Twenty-four years after the first signs of the disease had been noted, mediastinal lymphomas penetrating the wall of the vena cava superior caused complete obstruction. It is most unusual for the vessel wall to be destroyed in this way, which explains why VCSS is often missed in sarcoidosis. The obstructed vessel was resected and successfully replaced by a Gore-Tex prosthesis. The importance of VCSS for the differential diagnosis is pointed out. Two further peculiarities are the simultaneous occurrence of elevated intraocular pressure and VCSS, and the familial incidence. (orig.) [de

Designing Pareto-superior demand-response rate options

International Nuclear Information System (INIS)

Horowitz, I.; Woo, C.K.

2006-01-01

We explore three voluntary service options-real-time pricing, time-of-use pricing, and curtailable/interruptible service-that a local distribution company might offer its customers in order to encourage them to alter their electricity usage in response to changes in the electricity-spot-market price. These options are simple and practical, and make minimal information demands. We show that each of the options is Pareto-superior ex ante, in that it benefits both the participants and the company offering it, while not affecting the non-participants. The options are shown to be Pareto-superior ex post as well, except under certain exceptional circumstances. (author)

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial

Science.gov (United States)

Wang, Long; Chandrasekaran, Vijayalakshmi; Domachowske, Joseph B.; Li, Ping; Innis, Bruce L.; Jain, Varsha K.

2016-01-01

Background Viruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection. Methods We compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6–35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314). Results Seroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%–86.6%), 72.0% (95% CI, 63.9%–79.2%), 86.0% (95% CI, 79.2%–91.2%), and 66.4% (95% CI, 58.1%–74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%–5.99%) and SCR difference of 54.02% (95% CI, 43.88%–62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination. Conclusions Quadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6–35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group. PMID:26407273

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

Temporal Bone Fracture Causing Superior Semicircular Canal Dehiscence

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Kevin A. Peng

2014-01-01

Full Text Available Importance. Superior semicircular canal dehiscence (SCD is a third window lesion of the inner ear causing symptoms of vertigo, autophony, tinnitus, and hearing loss. A “two-hit” hypothesis has traditionally been proposed, whereby thinly developed bone overlying the superior canal is disrupted by a sudden change in intracranial pressure. Although the symptoms of SCD may be precipitated by head injury, no previous reports have described a temporal bone fracture directly causing SCD. Observations. Two patients sustained temporal bone fractures after closed head trauma, and developed unilateral otologic symptoms consistent with SCD. In each instance, computed tomography imaging revealed fractures extending through the bony roof of the superior semicircular canal. Conclusions and Relevance. Temporal bone fractures, which are largely treated nonoperatively, have not previously been reported to cause SCD. As it is a potentially treatable entity, SCD resulting from temporal bone fracture must be recognized as a possibility and diagnosed promptly if present.

Spatial vision is superior in musicians when memory plays a role.

Science.gov (United States)

Weiss, Atalia H; Biron, Tali; Lieder, Itay; Granot, Roni Y; Ahissar, Merav

2014-08-21

Musicians' perceptual advantage in the acoustic domain is well established. Recent studies show that musicians' verbal working memory is also superior. Additionally, some studies report that musicians' visuospatial skills are enhanced although others failed to find this enhancement. We now examined whether musicians' spatial vision is superior, and if so, whether this superiority reflects refined visual skills or a general superiority of working memory. We examined spatial frequency discrimination among musicians and nonmusician university students using two presentation conditions: simultaneous (spatial forced choice) and sequential (temporal forced choice). Musicians' performance was similar to that of nonmusicians in the simultaneous condition. However, their performance in the sequential condition was superior, suggesting an advantage only when stimuli need to be retained, i.e., working memory. Moreover, the two groups showed a different pattern of correlations: Musicians' visual thresholds were correlated, and neither was correlated with their verbal memory. By contrast, among nonmusicians, the visual thresholds were not correlated, but sequential thresholds were correlated with verbal memory scores, suggesting that a general working memory component limits their performance in this condition. We propose that musicians' superiority in spatial frequency discrimination reflects an advantage in a domain-general aspect of working memory rather than a general enhancement in spatial-visual skills. © 2014 ARVO.

Ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock: Case report

Directory of Open Access Journals (Sweden)

Kerem Seref Corbacioglu

2016-03-01

Full Text Available Pseudoaneurysm of the superior gluteal artery (SGA is very rare and the most common causes are blunt or penetrating pelvic traumas. Although pseudoaneurysm can be asymptomatic at the time of initial trauma, it can be symptomatic weeks, months, even years after initial trauma. We present a case of a ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock twenty days after a bomb injury in the Syria civil war. In addition, we review the anatomy of the SGA, clinical presentation and pitfalls of pseudoaneurysm, and imaging and treatment options. Keywords: Pseudoaneurysm, Superior gluteal artery, Pitfall, Angiography

Preliminary safety evaluation of the Gas Turbine-Modular Helium Reactor (GT-MHR)

International Nuclear Information System (INIS)

Dunn, T.D.; Lommers, L.J.; Tangirala, V.E.

1994-04-01

A qualitative comparison between the safety characteristics of the Gas Turbine-Modular Helium Reactor (GT-MHR) and those of the steam cycle shows that the two designs achieve equivalent levels of overall safety performance. This comparison is obtained by applying the scaling laws to detailed steam-cycle computations as well as the conclusions obtained from preliminary GT-MHR model simulations. The gas turbine design is predicted to be superior for some event categories, while the steam cycle design is better for others. From a safety perspective, the GT-MHR has a modest advantage for pressurized conduction cooldown events. Recent computational simulations of 102 column, 550 MW(t) GT-MHR during a depressurized conduction cooldown show that peak fuel temperatures are within the limits. The GT-MHR has a significantly lower risk due to water ingress events under operating conditions. Two additional scenarios, namely loss of load event and turbine deblading event that are specific to the GT-MHR design are discussed. Preliminary evaluation of the GT-MHR's safety characteristics indicate that the GT-MHR can be expected to satisfy or exceed its safety requirements

Superior vena cava obstruction caused by radiation induced venous fibrosis

NARCIS (Netherlands)

Van Putten, JWG; Schlosser, NJJ; Vujaskovic, Z; Van der Leest, AHD; Groen, HJM

Superior vena cava syndrome is most often caused by lung carcinoma. Two cases are described in whom venous obstruction in the superior mediastinum was caused by local vascular fibrosis due to radiotherapy five and seven years earlier. The development of radiation injury to greater vessels is

Total variation superiorized conjugate gradient method for image reconstruction

Science.gov (United States)

Zibetti, Marcelo V. W.; Lin, Chuan; Herman, Gabor T.

2018-03-01

The conjugate gradient (CG) method is commonly used for the relatively-rapid solution of least squares problems. In image reconstruction, the problem can be ill-posed and also contaminated by noise; due to this, approaches such as regularization should be utilized. Total variation (TV) is a useful regularization penalty, frequently utilized in image reconstruction for generating images with sharp edges. When a non-quadratic norm is selected for regularization, as is the case for TV, then it is no longer possible to use CG. Non-linear CG is an alternative, but it does not share the efficiency that CG shows with least squares and methods such as fast iterative shrinkage-thresholding algorithms (FISTA) are preferred for problems with TV norm. A different approach to including prior information is superiorization. In this paper it is shown that the conjugate gradient method can be superiorized. Five different CG variants are proposed, including preconditioned CG. The CG methods superiorized by the total variation norm are presented and their performance in image reconstruction is demonstrated. It is illustrated that some of the proposed variants of the superiorized CG method can produce reconstructions of superior quality to those produced by FISTA and in less computational time, due to the speed of the original CG for least squares problems. In the Appendix we examine the behavior of one of the superiorized CG methods (we call it S-CG); one of its input parameters is a positive number ɛ. It is proved that, for any given ɛ that is greater than the half-squared-residual for the least squares solution, S-CG terminates in a finite number of steps with an output for which the half-squared-residual is less than or equal to ɛ. Importantly, it is also the case that the output will have a lower value of TV than what would be provided by unsuperiorized CG for the same value ɛ of the half-squared residual.

The Penokean orogeny in the Lake Superior region

Science.gov (United States)

Schulz, K.J.; Cannon, W.F.

2007-01-01

The Penokean orogeny began at about 1880 Ma when an oceanic arc, now the Pembine-Wausau terrane, collided with the southern margin of the Archean Superior craton marking the end of a period of south-directed subduction. The docking of the buoyant craton to the arc resulted in a subduction jump to the south and development of back-arc extension both in the initial arc and adjacent craton margin to the north. A belt of volcanogenic massive sulfide deposits formed in the extending back-arc rift within the arc. Synchronous extension and subsidence of the Superior craton resulted in a broad shallow sea characterized by volcanic grabens (Menominee Group in northern Michigan). The classic Lake Superior banded iron-formations, including those in the Marquette, Gogebic, Mesabi and Gunflint Iron Ranges, formed in that sea. The newly established subduction zone caused continued arc volcanism until about 1850 Ma when a fragment of Archean crust, now the basement of the Marshfield terrane, arrived at the subduction zone. The convergence of Archean blocks of the Superior and Marshfield cratons resulted in the major contractional phase of the Penokean orogeny. Rocks of the Pembine-Wausau arc were thrust northward onto the Superior craton causing subsidence of a foreland basin in which sedimentation began at about 1850 Ma in the south (Baraga Group rocks) and 1835 Ma in the north (Rove and Virginia Formations). A thick succession of arc-derived turbidites constitutes most of the foreland basin-fill along with lesser volcanic rocks. In the southern fold and thrust belt tectonic thickening resulted in high-grade metamorphism of the sediments by 1830 Ma. At this same time, a suite of post-tectonic plutons intruded the deformed sedimentary sequence and accreted arc terranes marking the end of the Penokean orogeny. The Penokean orogen was strongly overprinted by younger tectonic and thermal events, some of which were previously ascribed to the Penokean. Principal among these was a

The safety basis of the integral fast reactor program

International Nuclear Information System (INIS)

Pedersen, D.R.; Seidel, B.R.

1990-01-01

The Integral Fast Reactor (IFR) and metallic fuel have emerged as the US Department of Energy reference reactor concept and fuel system for the development of an advanced liquid-metal reactor. This article addresses the basic elements of the IFR reactor concept and focuses on the safety advances achieved by the IFR Program in the areas of (1) fuel performance, (2) superior local faults tolerance, (3) transient fuel performance, (4) fuel-failure mechanisms, (5) performance in anticipated transients without scram, (6) core-melt mitigation, and (7) actinide recycle

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 ...

File list: His.Neu.05.AllAg.Superior_Cervical_Ganglion [Chip-atlas[Archive

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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

Waldenstrom macroglobulinemia involving the superior rectus muscle

Directory of Open Access Journals (Sweden)

J.B. Hellman

2018-06-01

Full Text Available Purpose: We present the first reported case of Waldenstrom macroglobulinemia in the right superior rectus causing diplopia. Observations: A 72-year-old man with a 6-month history of untreated asymptomatic Waldenstrom macroglobulinemia presented with 2 years of diagonal binocular diplopia that was previously thought to be due to ocular myasthenia gravis. Examination showed mild right proptosis and right hypotropia, and MRI revealed a focal lesion of the right superior rectus muscle. Orbital biopsy was performed, and histopathology showed lymphoplasmacytic infiltration among the skeletal muscle fibers of the rectus muscle. Immunostaining confirmed a B-cell preponderance, along with more extensive staining for IgM than IgG, and in situ hybridization confirmed lambda restriction. These findings corresponded with those of his previous bone marrow biopsy, confirming Waldenstrom macroglobulinemia as the etiology for the extraocular muscle mass. Conclusions and Importance: Lymphoma of an extraocular muscle is a rare manifestation of orbital lymphoma, and the tumors are usually mucosa-associated lymphoid tissue (MALT lymphomas (i.e. extranodal marginal zone lymphomas. There are 4 previous reports of lymphoplasmacytic lymphoma of an extraocular muscle; however this is the first reported case of such a lesion in a patient with concurrent Waldenstrom macroglobulinemia at the time of diagnosis. Keywords: Waldenstrom's macroglobulinemia, Lymphoma, Superior rectus, Diplopia

Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation.

Science.gov (United States)

Nyong, Jonathan; Amit, Guy; Adler, Alma J; Owolabi, Onikepe O; Perel, Pablo; Prieto-Merino, David; Lambiase, Pier; Casas, Juan Pablo; Morillo, Carlos A

2016-11-22

The optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited. To determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions. We included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up. Two review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables. We included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non

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.

Computed tomography imaging for superior semicircular canal dehiscence syndrome

International Nuclear Information System (INIS)

Dobeli, Karen

2006-01-01

Superior semicircular canal dehiscence is a newly described syndrome of sound and/or pressure induced vertigo. Computed tomography (CT) imaging plays an important role in confirmation of a defect in the bone overlying the canal. A high resolution CT technique utilising 0.5 mm or thinner slices and multi-planar reconstructions parallel to the superior semicircular canal is required. Placement of a histogram over a suspected defect can assist CT diagnosis

Superior Administrative Court Baden-Wuerttemberg. Judgement of March 30, 1982 (Wyhl)

International Nuclear Information System (INIS)

Anon.

1983-01-01

Presentation and discussion of the leading statements of the decision delivered by the Mannheim Superior Administrative Court on March 30, 1982 concerning the Wyhl nuclear power plant, unit 1. With this decision, covering 548 pages, the Superior Administrative Court changed the decision of the Freiburg Administrative Court of the year 1977 and finally dismissed the action for annulment of the construction licence. The Superior Administrative Court acted upon the appeal brought in by the Land and the plant operator, Kernkraftwerksgesellschaft. (CB) [de

Efficacy and safety of adalimumab in ankylosing spondylitis

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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

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

File list: Oth.Neu.10.AllAg.Superior_Cervical_Ganglion [Chip-atlas[Archive

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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)

THE HUMAN SUBJECTIVITY BETWEEN THE SUPERIOR AND INFERIOR TYPES A SUBJETIVIDADE HUMANA ENTRE OS TIPOS SUPERIORES E INFERIORES

Directory of Open Access Journals (Sweden)

Vagner Silva

2011-12-01

Full Text Available This article attempts to solve the following contradiction of Nietzsche's thought: man has a subjective drive constitution, these drives, however, are individuals, and its being (the being of the drives, is constituted for more power fight (the will to power. Nietzsche's superior man (educated and cultivated man is that one, in which there is harmony in the drives, who can give greater freedom to its most terrible drives, without, however, loses the control over them. That is the contradiction: if man has to control the drives, they are not harmonics. There is incompatibility between harmony and control. In other words, the superior man is indeed the man of culture and cultivated man of Nietzsche? If the answer to this question is yes, then, in this man, reigns the drives harmony. If, on the other hand, the answer is no, then, for this man does not become a barbarian destroyer, dangerous to himself and to others it is necessary that a drive dominates the others. However it is not possible to escape the contradiction: either there is harmony in human drive or control.Este artigo busca resolver a seguinte contradição do pensamento de Nietzsche: o homem possui uma constituição subjetiva pulsional, estas pulsões, porém, são individuais, e o seu ser, o das pulsões, constitui-se da luta por mais poder (vontade de poder. O homem superior de Nietzsche (homem culto e cultivado é aquele no qual há harmonia nas pulsões, aquele que pode dar mais liberdade às suas mais terríveis pulsões, sem, no entanto, perder o controle sobre elas. Eis a contradição: se o homem superior exerce controle sobre as pulsões então elas não são harmônicas. Há, aqui, a incompatibilidade entre harmonia e controle. Em outros termos: o homem superior é de fato o homem culto e cultivado de Nietzsche? Se a resposta para esta pergunta for sim, então neste homem reina a harmonia pulsional. Se, por outro lado, a resposta for não, então, para que este homem n

Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial.

Science.gov (United States)

Leung, Ting Fan; Liu, Anthony Pak-Yin; Lim, Fong Seng; Thollot, Franck; Oh, Helen May Lin; Lee, Bee Wah; Rombo, Lars; Tan, Ngiap Chuan; Rouzier, Roman; De Simoni, Stéphanie; Suryakiran, Pemmaraju; Hezareh, Marjan; Thomas, Florence; Folschweiller, Nicolas; Struyf, Frank

2018-01-02

This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of two doses (2D) of the HPV-16/18 AS04-adjuvanted vaccine (2D of AS04-HPV-16/18) vs. two or three doses of the 4vHPV vaccine [2D or 3D of 4vHPV] in 1075 healthy girls aged 9-14 years. Girls were randomized (1:1:1) to receive 2D of AS04-HPV-16/18 at months (M) 0, 6 (N = 359), 2D of 4vHPV at M0, 6 (N = 358) or 3D of 4vHPV at M0, 2, 6 (N = 358). 351, 339 and 346 girls, respectively, returned for the concluding visit at M36. Superiority was demonstrated at M7 and M12; comparison of the immune response to both vaccine antigens was made between 2D of AS04-HPV-16/18 and 2D or 3D of 4vHPV at subsequent time points in the according-to-protocol immunogenicity cohort (ATP-I; N = 958 at M36) and the total vaccinated cohort (TVC: N = 1036 at M36). HPV-16/18-specific T-cell- and B-cell-mediated immune responses and safety were also investigated. At M36, anti-HPV-16/18 ELISA responses in the 2D AS04-HPV-16/18 group remained superior to those of the 2D and 3D 4vHPV groups. In the M36 TVC, geometric mean titers were 2.78-fold (HPV-16) and 6.84-fold (HPV-18) higher for 2D of AS04-HPV-16/18 vs. 2D of 4vHPV and 2.3-fold (HPV-16) and 4.14-fold (HPV-18) higher vs. 3D of 4vHPV. Results were confirmed by vaccine pseudovirion-based neutralisation assay. Numbers of circulating CD4 + T cells and B cells appeared similar across groups. Safety was in line with the known safety profiles of both vaccines. In conclusion, superior HPV-16/18 antibody responses were elicited by 2D of the AS04-HPV-16/18 compared with 2D or 3D of the 4vHPV vaccine in girls aged 9-14 years. NCT0146235. Copyright © 2017. Published by Elsevier Ltd.

Williams syndrome-specific neuroanatomical profile and its associations with behavioral features.

Science.gov (United States)

Fan, Chun Chieh; Brown, Timothy T; Bartsch, Hauke; Kuperman, Joshua M; Hagler, Donald J; Schork, Andrew; Searcy, Yvonne; Bellugi, Ursula; Halgren, Eric; Dale, Anders M

2017-01-01

Williams Syndrome (WS) is a rare genetic disorder with unique behavioral features. Yet the rareness of WS has limited the number and type of studies that can be conducted in which inferences are made about how neuroanatomical abnormalities mediate behaviors. In this study, we extracted a WS-specific neuroanatomical profile from structural magnetic resonance imaging (MRI) measurements and tested its association with behavioral features of WS. Using a WS adult cohort (22 WS, 16 healthy controls), we modeled a sparse representation of a WS-specific neuroanatomical profile. The predictive performances are robust within the training cohort (10-fold cross-validation, AUC = 1.0) and accurately identify all WS individuals in an independent child WS cohort (seven WS, 59 children with diverse developmental status, AUC = 1.0). The WS-specific neuroanatomical profile includes measurements in the orbitofrontal cortex, superior parietal cortex, Sylvian fissures, and basal ganglia, and variability within these areas related to the underlying size of hemizygous deletion in patients with partial deletions. The profile intensity mediated the overall cognitive impairment as well as personality features related to hypersociability. Our results imply that the unique behaviors in WS were mediated through the constellation of abnormalities in cortical-subcortical circuitry consistent in child WS and adult WS. The robustness of the derived WS-specific neuroanatomical profile also demonstrates the potential utility of our approach in both clinical and research applications.

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

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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.

Aliskiren: a clinical profile

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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.

Carbon dioxide insufflation is superior to air insufflation during endoscopic retrograde cholangiopancreatography: A randomized trial

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Santosh Darisetty

2016-01-01

Full Text Available Background: Carbon dioxide (CO 2 insufflation has been shown to be superior to air insufflation in colonoscopy, and double balloon enteroscopy. However, the value of CO 2 insufflation in endoscopic retrograde cholangiopancreatography (ERCP is not established. This study aims to assess the efficacy and safety of CO 2 insufflation during ERCP. Materials and Methods: Consecutive patients referred for ERCP at a single center were randomized to either air or CO 2 insufflation during ERCP. The primary objectives were a post-ERCP abdominal pain (measured by 10 cm visual analog scale [VAS] 30 and 90 min, and 3 h and 24 h after ERCP. Secondary objectives included end-tidal CO 2 (ETCO 2 values and procedural complications. Results: We randomized 298 patients; 149 into air group and 149 into CO 2 group. The VAS score for pain was higher in the air group compared to the CO 2 group at 30 min, with a median of 1 (interquartile range 1-0 versus median of 1 (interquartile range 1-0; P = 0.031 and 90 min after the procedure with a median of 0 (interquartile range 1-0 versus median of 0 (interquartile range 0-0; P = 0.006. There were no serious adverse events, and the ETCO 2 was within normal limits in both groups. Conclusions: CO 2 insufflation is superior to air insufflation during ERCP with regard to patient pain and discomfort and warrants wide adoption. Clinical Trials.gov registration number NCT 01321203.

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.

Age-related audiovisual interactions in the superior colliculus of the rat.

Science.gov (United States)

Costa, M; Piché, M; Lepore, F; Guillemot, J-P

2016-04-21

It is well established that multisensory integration is a functional characteristic of the superior colliculus that disambiguates external stimuli and therefore reduces the reaction times toward simple audiovisual targets in space. However, in a condition where a complex audiovisual stimulus is used, such as the optical flow in the presence of modulated audio signals, little is known about the processing of the multisensory integration in the superior colliculus. Furthermore, since visual and auditory deficits constitute hallmark signs during aging, we sought to gain some insight on whether audiovisual processes in the superior colliculus are altered with age. Extracellular single-unit recordings were conducted in the superior colliculus of anesthetized Sprague-Dawley adult (10-12 months) and aged (21-22 months) rats. Looming circular concentric sinusoidal (CCS) gratings were presented alone and in the presence of sinusoidally amplitude modulated white noise. In both groups of rats, two different audiovisual response interactions were encountered in the spatial domain: superadditive, and suppressive. In contrast, additive audiovisual interactions were found only in adult rats. Hence, superior colliculus audiovisual interactions were more numerous in adult rats (38%) than in aged rats (8%). These results suggest that intersensory interactions in the superior colliculus play an essential role in space processing toward audiovisual moving objects during self-motion. Moreover, aging has a deleterious effect on complex audiovisual interactions. Copyright © 2016 IBRO. Published by Elsevier Ltd. All rights reserved.

A new Nitinol stent for use in superior vena cava syndrome

DEFF Research Database (Denmark)

Andersen, Poul Erik; Midtgaard, Annette; Brenøe, Anne-Sofie

2015-01-01

AIM: The aim of the study was to assess the early clinical experience with the Zilver Vena stent in treating patients with malignant superior vena cava syndrome. METHODS: Demographic, procedural, and follow-up data of 12 patients (seven women; mean age 69 years) treated for superior vena cava...... syndrome with in all 21 Zilver Vena stents between March 2012 and October 2013 were retrospectively reviewed. All cavographies and contrast enhanced CT related to the treatment and during follow-up were evaluated and the patients had clinical follow-up until dead. They were all in terminal state...... at the time of stent deployment. RESULTS: All patients had superior vena cava obstruction and clinical superior vena cava syndrome caused by malignant expansive mediastinal disease (eight patients non-small cell lung cancer and four small cell lung cancer). The technical success with deployment of the stents...

Proteomic Profiling of Cranial (Superior) Cervical Ganglia Reveals Beta-Amyloid and Ubiquitin Proteasome System Perturbations in an Equine Multiple System Neuropathy.

Science.gov (United States)

McGorum, Bruce C; Pirie, R Scott; Eaton, Samantha L; Keen, John A; Cumyn, Elizabeth M; Arnott, Danielle M; Chen, Wenzhang; Lamont, Douglas J; Graham, Laura C; Llavero Hurtado, Maica; Pemberton, Alan; Wishart, Thomas M

2015-11-01

Equine grass sickness (EGS) is an acute, predominantly fatal, multiple system neuropathy of grazing horses with reported incidence rates of ∼2%. An apparently identical disease occurs in multiple species, including but not limited to cats, dogs, and rabbits. Although the precise etiology remains unclear, ultrastructural findings have suggested that the primary lesion lies in the glycoprotein biosynthetic pathway of specific neuronal populations. The goal of this study was therefore to identify the molecular processes underpinning neurodegeneration in EGS. Here, we use a bottom-up approach beginning with the application of modern proteomic tools to the analysis of cranial (superior) cervical ganglion (CCG, a consistently affected tissue) from EGS-affected patients and appropriate control cases postmortem. In what appears to be the proteomic application of modern proteomic tools to equine neuronal tissues and/or to an inherent neurodegenerative disease of large animals (not a model of human disease), we identified 2,311 proteins in CCG extracts, with 320 proteins increased and 186 decreased by greater than 20% relative to controls. Further examination of selected proteomic candidates by quantitative fluorescent Western blotting (QFWB) and subcellular expression profiling by immunohistochemistry highlighted a previously unreported dysregulation in proteins commonly associated with protein misfolding/aggregation responses seen in a myriad of human neurodegenerative conditions, including but not limited to amyloid precursor protein (APP), microtubule associated protein (Tau), and multiple components of the ubiquitin proteasome system (UPS). Differentially expressed proteins eligible for in silico pathway analysis clustered predominantly into the following biofunctions: (1) diseases and disorders, including; neurological disease and skeletal and muscular disorders and (2) molecular and cellular functions, including cellular assembly and organization, cell

Histological evaluation of levator palpebralis superior muscle in patients with congenital blepharoptosis

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Sevda Söker

2011-03-01

Full Text Available The aim of this study was to examine levator palpebralis superior muscle histologically in patients with congenital blepharoptosis and to investigate the relationship between these findings and age, sex and degree of blefaroptosis in this patient group.Materials and methods: Levator muscle of 13 patients with congenital ptosis, who had applied to Dicle University Medical Faculty Ophthalmology Clinic and had undergone levator palpebralis superior muscle resection between january 2009-january 2010, has been examined histopathologically in Histology and Embriology Deparment. During preoperative period, ptosis amount, levator function (LF, tear functions, Bell’s phenomenon and jaw-winking phenomenon were evaluated. All patients underwent resection of levator palpebralis superior muscle. Received postoperative levator muscle was examined by light microscopy.Results: The average age of 9 (69.2% male and 4 (30.8% female cases were 10.61 ± 4.77 (4- 19 years. In histological examination, the quality and quantity of the levator muscle fibrils have been assessed. There was no relationship detected between histological features of levator palpebralis superior muscle and patient’s age and gender (p>0.05. Patients with weak levator palpebralis superior muscle were detected to have fatty degeneration histologically. The higher the levator palpebralis superior muscle function revealed decreased fatty degeneration and increased skeletal muscle fibrils.Conclusion: More ultrastructural studies in larger populations are needed to support the relationship between structure and function of levator palpebralis superior muscle in patients with congenital blepharoptosis.

Safety leadership at construction sites: the importance of rule-oriented and participative leadership.

Science.gov (United States)

Grill, Martin; Pousette, Anders; Nielsen, Kent; Grytnes, Regine; Törner, Marianne

2017-07-01

Objectives The construction industry accounted for >20% of all fatal occupational accidents in Europe in 2014. Leadership is an essential antecedent to occupational safety. The aim of the present study was to assess the influence of transformational, active transactional, rule-oriented, participative, and laissez-faire leadership on safety climate, safety behavior, and accidents in the Swedish and Danish construction industry. Sweden and Denmark are similar countries but have a large difference in occupational accidents rates. Methods A questionnaire study was conducted among a random sample of construction workers in both countries: 811 construction workers from 85 sites responded, resulting in site and individual response rates of 73% and 64%, respectively. Results The results indicated that transformational, active transactional, rule-oriented and participative leadership predict positive safety outcomes, and laissez-faire leadership predict negative safety outcomes. For example, rule-oriented leadership predicts a superior safety climate (β=0.40, Pleadership on workers' safety behavior was moderated by the level of participative leadership (β=0.10, Pleadership behaviors on safety outcomes were largely similar in Sweden and Denmark. Rule-oriented and participative leadership were more common in the Swedish than Danish construction industry, which may partly explain the difference in occupational accident rates. Conclusions Applying less laissez-faire leadership and more transformational, active transactional, participative and rule-oriented leadership appears to be an effective way for construction site managers to improve occupational safety in the industry.

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.

Use of Foodomics for Control of Food Processing and Assessing of Food Safety.

Science.gov (United States)

Josić, D; Peršurić, Ž; Rešetar, D; Martinović, T; Saftić, L; Kraljević Pavelić, S

Food chain, food safety, and food-processing sectors face new challenges due to globalization of food chain and changes in the modern consumer preferences. In addition, gradually increasing microbial resistance, changes in climate, and human errors in food handling remain a pending barrier for the efficient global food safety management. Consequently, a need for development, validation, and implementation of rapid, sensitive, and accurate methods for assessment of food safety often termed as foodomics methods is required. Even though, the growing role of these high-throughput foodomic methods based on genomic, transcriptomic, proteomic, and metabolomic techniques has yet to be completely acknowledged by the regulatory agencies and bodies. The sensitivity and accuracy of these methods are superior to previously used standard analytical procedures and new methods are suitable to address a number of novel requirements posed by the food production sector and global food market. © 2017 Elsevier Inc. All rights reserved.

Observational Pharmacoepidemiology in the Drug Safety and Effectiveness Evaluation

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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.

Isolated abscess in superior rectus muscle in a child

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Sushank Ashok Bhalerao

2015-01-01

Full Text Available Pyomyositis is a primary bacterial infection of striated muscles nearly always caused by Staphylococcus aureus. Development of the intramuscular abscess involving the extra-ocular muscles (EOMs remains an extremely rare process. We herein present a case of isolated EOM pyomyositis involving superior rectus muscle in a 2-year male child who was referred with complaints of swelling in left eye (LE and inability to open LE since last 1-month. Orbital computed tomography (CT scan showed a well-defined, hypo-dense, peripheral rim-enhancing lesion in relation to left superior rectus muscle suggestive of left superior rectus abscess. The abscess was drained through skin approach. We concluded that pyomyositis of EOM should be considered in any patient presenting with acute onset of orbital inflammation and characteristic CT or magnetic resonance imaging features. Management consists of incision and drainage coupled with antibiotic therapy.

Slice sensitivity profiles and pixel noise of multi-slice CT in comparison with single-slice CT

International Nuclear Information System (INIS)

Schorn, C.; Obenauer, S.; Funke, M.; Hermann, K.P.; Kopka, L.; Grabbe, E.

1999-01-01

Purpose: Presentation and evaluation of slice sensitivity profile and pixel noise of multi-slice CT in comparison to single-slice CT. Methods: Slice sensitivity profiles and pixel noise of a multi-slice CT equiped with a 2D matrix detector array and of a single-slice CT were evaluated in phantom studies. Results: For the single-slice CT the width of the slice sensitivity profiles increased with increasing pitch. In spite of a much higher table speed the slice sensitivity profiles of multi-slice CT were narrower and did not increase with higher pitch. Noise in single-slice CT was independent of pitch. For multi-slice CT noise increased with higher pitch and for the higher pitch decreased slightly with higher detector row collimation. Conclusions: Multi-slice CT provides superior z-resolution and higher volume coverage speed. These qualities fulfill one of the prerequisites for improvement of 3D postprocessing. (orig.) [de

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

Random Subspace Aggregation for Cancer Prediction with Gene Expression Profiles

Directory of Open Access Journals (Sweden)

Liying Yang

2016-01-01

Full Text Available Background. Precisely predicting cancer is crucial for cancer treatment. Gene expression profiles make it possible to analyze patterns between genes and cancers on the genome-wide scale. Gene expression data analysis, however, is confronted with enormous challenges for its characteristics, such as high dimensionality, small sample size, and low Signal-to-Noise Ratio. Results. This paper proposes a method, termed RS_SVM, to predict gene expression profiles via aggregating SVM trained on random subspaces. After choosing gene features through statistical analysis, RS_SVM randomly selects feature subsets to yield random subspaces and training SVM classifiers accordingly and then aggregates SVM classifiers to capture the advantage of ensemble learning. Experiments on eight real gene expression datasets are performed to validate the RS_SVM method. Experimental results show that RS_SVM achieved better classification accuracy and generalization performance in contrast with single SVM, K-nearest neighbor, decision tree, Bagging, AdaBoost, and the state-of-the-art methods. Experiments also explored the effect of subspace size on prediction performance. Conclusions. The proposed RS_SVM method yielded superior performance in analyzing gene expression profiles, which demonstrates that RS_SVM provides a good channel for such biological data.

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.

Os cursos superiores de tecnologia no contexto de expansão da educação superior no Brasil: a retomada da ênfase na educação profissional

Directory of Open Access Journals (Sweden)

Juliana Favretto

2013-06-01

Full Text Available O artigo analisa a expansão e o comportamento da oferta dos cursos superiores de tecnologia no âmbito da educação superior brasileira. Resgata a origem da educação profissional, das legislações e ações públicas que constituíram o processo de desenvolvimento da educação superior tecnológica no Brasil. Apresenta evidências da estrutura da oferta de cursos superiores de tecnologia, em nível de categoria acadêmica, administrativa e distribuição regional, no período de 2000 a 2010, um recorte de dados secundários extraídos do banco de dados do Inep/MEC. Os dados revelam que houve uma expansão substancial dos cursos superiores de tecnologia no período analisado, quando comparados aos demais cursos de graduação, com maior ênfase no setor privado e no âmbito acadêmico das universidades.

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)

The perceptions of patient safety culture: A difference between physicians and nurses in Taiwan.

Science.gov (United States)

Huang, Chih-Hsuan; Wu, Hsin-Hung; Lee, Yii-Ching

2018-04-01

In order to pursue a better patient safety culture and provide a superior medical service for patients, this study aims to respectively investigate the perceptions of patient safety from the viewpoints of physicians and nurses in Taiwan. Little knowledge has clearly identified the difference of perceptions between physicians and nurses in patient safety culture. Understanding physicians and nurses' attitudes toward patient safety is a critical issue for healthcare organizations to improve medical quality. Confirmatory factor analysis (CFA) is used to verify the structure of data (e.g. reliability and validity), and Pearson's correlation analysis is conducted to demonstrate the relationships among seven patient safety culture dimensions. Research results illustrate that more teamwork is exhibited among team members, the more safety of a patient is committed. Perceptions of management and emotional exhaustion are important components that contribute to a better patient safety. More importantly, working conditions and stress recognition are found to be negatively related from the perceptions of nurses. Compared to physicians, nurses reported higher stress and challenges which result from multi-task working conditions in the hospital. This study focused on the contribution of a better patient safety culture from different viewpoints of physicians and nurses for healthcare organizations in Taiwan. A different attitudes toward patient safety is found between physicians and nurses. The results enable the hospital management to realize and design appropriate implications for hospital staffs to establish a better patient safety culture. Copyright © 2017. Published by Elsevier Inc.

COSEE Superior Creates Passion for Science

Science.gov (United States)

COSEE was a transformative educational experience that has changed the way I teach. In July, I participated in the COSEE Lake Superior Shipboard and Shoreline Science program. I spent a week on the US EPA’s R/V Lake Guardian with 14 other teachers and a crew of sailors and scient...

Superior sagittal sinus thrombosis: a rare complication of nephrotic syndrome.

Directory of Open Access Journals (Sweden)

Tullu M

1999-10-01

Full Text Available A two and half year-old-male child, known case of steroid responsive nephrotic syndrome presented with fever and vomiting of acute onset. He was diagnosed to have superior sagittal sinus thrombosis on a contrast computerised tomographic scan of brain. Recovery was complete without anticoagulant therapy. Superior sagittal sinus thrombosis is an extremely rare complication of nephrotic syndrome.

Partial anomalous pulmonary venous connection to the superior vena cava.

Science.gov (United States)

Aramendi, José I; Rey, Estibaliz; Hamzeh, Gadah; Crespo, Alejandro; Luis, Maite; Voces, Roberto

2011-04-01

We describe the surgical technique of reimplantation of the right superior pulmonary vein into the left atrium in 2 patients with partial anomalous pulmonary venous connection to the superior vena cava without atrial septal defect. A right axillary minithoracotomy is done through the fourth intercostal space. The pulmonary vein is detached from its origin in the superior vena cava. This is sutured with 6-0 reabsorbable polydioxanone suture (Ethicon, Somerville, NJ). A lateral clamp is applied to the left atrium, and the pulmonary vein is reimplanted. The patient is extubated in the operating room. Neither cardiopulmonary bypass nor blood transfusion was required. It is simple, safe, and reproducible. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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 ...

Upper midbrain profile sign and cingulate sulcus sign. MRI findings on sagittal images in idiopathic normal-pressure hydrocephalus, Alzheimer's disease, and progressive supranuclear palsy

International Nuclear Information System (INIS)

Adachi, Michito; Ohshima, Fumi; Kawanami, Toru; Kato, Takeo

2006-01-01

On magnetic resonance imaging (MRI) sagittal sections, we sometimes encounter abnormal aspects of the superior profile of the midbrain and the cingulate sulcus in patients with dementia. In this preliminary study, we refer to these findings as the ''upper midbrain profile sign'' and the cingulate sulcus sign.'' We prospectively evaluated the usefulness of these signs for the diagnosis of idiopathic normal-pressure hydrocephalus (iNPH), Alzheimer's disease (AD) and progressive supranuclear palsy (PSP). We evaluated the upper midbrain profile sign and the cingulate sulcus sign on MRI sagittal images obtained from 21 people with headaches but no neurological deficit (controls), 10 iNPH patients, 11 AD patients, and 5 PSP patients. The upper midbrain profile sign indicated a concave shape to the superior profile of the midbrain on mid-sagittal images, and the cingulate sulcus sign indicated a narrow, tight aspect of the posterior part of the cingulate sulcus on paramedian-sagittal images. These signs were never seen in any images from the controls. The upper midbrain profile sign was seen in 7 of 10 patients with iNPH, 5 of 11 with AD, and 3 of 5 with PSP. The cingulate sulcus sign was seen in all 10 patients with iNPH but was never seen in any patient with AD or PSP. The upper midbrain profile sign could support a diagnosis of PSP but cannot discriminate among iNPH, AD, and PSP. In contrast, the cingulate sulcus sign has a very high sensitivity for iNPH and should facilitate the distinction of iNPH from other dementias. In the clinical setting, it is momentous to evaluate these signs easily by one simple MRI sequence. (author)

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.

Food suppliers' perceptions and practical implementation of food safety regulations in Taiwan

Directory of Open Access Journals (Sweden)

Wen-Hwa Ko

2015-12-01

Full Text Available The relationships between the perceptions and practical implementation of food safety regulations by food suppliers in Taiwan were evaluated. A questionnaire survey was used to identify individuals who were full-time employees of the food supply industry with at least 3 months of experience. Dimensions of perceptions of food safety regulations were classified using the constructs of attitude of employees and corporate concern attitude for food safety regulation. The behavior dimension was classified into employee behavior and corporate practice. Food suppliers with training in food safety were significantly better than those without training with respect to the constructs of perception dimension of employee attitude, and the constructs of employee behavior and corporate practice associated with the behavior dimension. Older employees were superior in perception and practice. Employee attitude, employee behavior, and corporate practice were significantly correlated with each other. Satisfaction with governmental management was not significantly related to corporate practice. The corporate implementation of food safety regulations by suppliers was affected by employees' attitudes and behaviors. Furthermore, employees' attitudes and behaviors explain 35.3% of corporate practice. Employee behavior mediates employees' attitudes and corporate practices. The results of this study may serve as a reference for governmental supervision and provide training guidelines for workers in the food supply industry.

(Mis)placed central venous catheter in the left superior intercostal vein

International Nuclear Information System (INIS)

Padovan, Ranka Stern; Paar, Maja Hrabak; Aurer, Igor

2010-01-01

Chest X-ray is routinely performed to check the position of the central venous catheter (CVC) inserted through the internal jugular or subclavian vein, while the further evaluation of CVC malfunction is usually performed by contrast venography. In patients with superior vena cava obstruction, the tip of the catheter is often seen in collateral mediastinal venous pathways, rather than in the superior vena cava. In such cases detailed knowledge of thoracic vessel anatomy is necessary to identify the exact location of the catheter. We report a case of 32-year-old female patient with relapsing mediastinal lymphoma and previous superior vena cava obstruction with collateral azygos-hemiazygos venous pathways. The patient had CVC inserted through the left subclavian vein and its position was detected by CT to be in the dilated left superior intercostal vein and accessory hemiazygos vein. Considering that dilated accessory hemiazygos vein can tolerate infusion, the CVC was left in place and the patient had no complaints related to CVC (mal)position. Furthermore, we present anatomical and radiological observations on the azygos-hemiazygos venous system with the special emphasis on the left superior intercostal vein. Non-contrast CT scans can be a valuable imaging tool in the detection of the CVC position, especially in patients with renal insufficiency and contrast media hypersensitivity

The pygmy whitefish, Coregonus coulteri, in Lake Superior

Science.gov (United States)

Eschmeyer, Paul H.; Bailey, Reeve M.

1955-01-01

Bottom trawling by the U. S. Fish and Wildlife Service motor vessel Cisco in Lake Superior in 1952–1953 revealed a large population of a tiny whitefish, Coregonus (Prosopium) coulteri, which has been reported previously only from northwestern North America. The hiatus in range, from Lake Superior to the Columbia River basin, is the greatest known for a North American freshwater fish. Although minor structural differences characterize the disjunct populations of the pygmy whitefish, these are not deemed worthy of nomenclatorial recognition. Comparisons with related species indicate that the pygmy whitefish is distinctive in the small size, large scales, few vertebrae, few pyloric caeca, and in other characters.

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...

Global aphasia without hemiparesis: language profiles and lesion distribution

Science.gov (United States)

Hanlon, R.; Lux, W.; Dromerick, A.

1999-01-01

OBJECTIVES—Global aphasia without hemiparesis (GAWH) is an uncommon stroke syndrome involving receptive and expressive language impairment, without the hemiparesis typically manifested by patients with global aphasia after large left perisylvian lesions. A few cases of GAWH have been reported with conflicting conclusions regarding pathogenesis, lesion localisation, and recovery. The current study was conducted to attempt to clarify these issues.
METHODS—Ten cases of GAWH were prospectively studied with language profiles and lesion analysis; five patients had multiple lesions, four patients had a single lesion, and one had a subarachnoid haemorrhage. Eight patients met criteria for cardioembolic ischaemic stroke.
RESULTS—Cluster analysis based on acute language profiles disclosed three subtypes of patients with GAWH; these clusters persisted on follow up language assessment. Each cluster evolved into a different aphasia subtype: persistent GAWH, Wernicke's aphasia, or transcortical motor aphasia (TCM). Composite lesion analysis showed that persistent GAWH was related to lesioning of the left superior temporal gyrus. Patients with acute GAWH who evolved into TCM type aphasia had common lesioning of the left inferior frontal gyrus and adjacent subcortical white matter. Patients with acute GAWH who evolved into Wernicke's type aphasia were characterised by lesioning of the left precentral and postcentral gyri. Recovery of language was poor in all but one patient.
CONCLUSIONS—Although patients with acute GAWH are similar on neurological examination, they are heterogeneous with respect to early aphasia profile, language recovery, and lesion profile.

 PMID:10084536

Papaya Development Model As A Competitive Local Superior Commodity

Directory of Open Access Journals (Sweden)

Reny Sukmawani

2014-12-01

Full Text Available The aim of this research is to study the comparative advantage and papaya competitive and to design its development model by using the approach of local base agriculture development. This research uses survey method. The resulting research shows that papaya is a base commodity that has comparative advantage and competitive. The development papaya in the district of Sukabumi is quite good bases on eight superior creations. But in order to be the main sector in economic development and has a competition, the development of papaya must concern to its influence factors. In supporting papaya development as a competitive local superior commodity, it needs to be done some efforts are as follows: (1 increase a skillful worker; (2 improve business management; (3 increase papaya productivity by using technology and study papaya planted technology in specific local superior commodity; (4 develop the involvement of the business relation; (5 provide market information and information technology network; and (6 improve infrastructures.

Hacia una educación superior inclusiva en Colombia

Directory of Open Access Journals (Sweden)

Sandra Lucia Arizabaleta Dominguez

2016-12-01

Full Text Available En este artículo se analizan concepciones teórico-conceptuales básicas que subyacen a la educación superior inclusiva, en el marco de los Lineamientos de la Política de Educación Superior Inclusiva del Ministerio de Educación Nacional de Colombia (men. Además, se plantean los desafíos que deben asumir las instituciones de educación superior (ies en la identificación de barreras de aprendizaje de su población estudiantil y la promoción de estrategias que garanticen la accesibilidad, permanencia, pertinencia académica y la graduación. Esta situación lleva a las ies a reflexionar y repensarse a partir de los procesos de autoevaluación institucional para crear estrategias participativas que promuevan la gestión inclusiva en un sistema educativo equitativo, pertinente y de calidad

INFORMATION ASSURANCE - INTELLIGENCE - INFORMATION SUPERIORITY RELATIONSHIP WITHIN NATO OPERATIONS

Directory of Open Access Journals (Sweden)

Gheorghe BOARU, Ioan-Mihai ILIEŞ

2011-01-01

Full Text Available There is a tight relationship between information assurance, the intelligence cycle and information superiority within NATO operations. The intelligence cycle has a discrete architecture and provides on-time and relevant intelligence products to the joint force commanders and to other authorized users in a specifi c joint area of operations. The intelligence cycle must follow the evolution of the operation. A permanent intelligence estimate will be performed during the military decision making process and operations execution. Information superiority is one of the most powerful intelligence cycle achievements. and decisively infuences the success of NATO joint operations. Information superiority must be preserved and enhanced through information assurance. Information assurance is an information operation that must be planned by the military in charge of operation security or by non-military experts, executed by all personnel during the entire intelligence cycle life time and employed during the planning and execution of NATO joint operations.

Impact of mismatched and misaligned laser light sheet profiles on PIV performance

Science.gov (United States)

Grayson, K.; de Silva, C. M.; Hutchins, N.; Marusic, I.

2018-01-01

The effect of mismatched or misaligned laser light sheet profiles on the quality of particle image velocimetry (PIV) results is considered in this study. Light sheet profiles with differing widths, shapes, or alignment can reduce the correlation between PIV images and increase experimental errors. Systematic PIV simulations isolate these behaviours to assess the sensitivity and implications of light sheet mismatch on measurements. The simulations in this work use flow fields from a turbulent boundary layer; however, the behaviours and impacts of laser profile mismatch are highly relevant to any fluid flow or PIV application. Experimental measurements from a turbulent boundary layer facility are incorporated, as well as additional simulations matched to experimental image characteristics, to validate the synthetic image analysis. Experimental laser profiles are captured using a modular laser profiling camera, designed to quantify the distribution of laser light sheet intensities and inform any corrective adjustments to an experimental configuration. Results suggest that an offset of just 1.35 standard deviations in the Gaussian light sheet intensity distributions can cause a 40% reduction in the average correlation coefficient and a 45% increase in spurious vectors. Errors in measured flow statistics are also amplified when two successive laser profiles are no longer well matched in alignment or intensity distribution. Consequently, an awareness of how laser light sheet overlap influences PIV results can guide faster setup of an experiment, as well as achieve superior experimental measurements.

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.

Residual symptoms after surgery for unilateral congenital superior oblique palsy.

Science.gov (United States)

Caca, Ihsan; Sahin, Alparslan; Cingu, Abdullah; Ari, Seyhmus; Akbas, Umut

2012-01-01

To establish the surgical results and residual symptoms in 48 cases with unilateral congenital superior oblique muscle palsy that had surgical intervention to the vertical muscles alone. Myectomy and concomitant disinsertion of the inferior oblique (IO) muscle was performed in 38 cases and myectomy and concomitant IO disinsertion and recession of the superior rectus muscle in the ipsilateral eye was performed in 10 cases. The preoperative and postoperative vertical deviation values and surgical results were compared. Of the patients who had myectomy and concomitant IO disinsertion, 74% achieved an "excellent" result, 21% a "good" result, and 5% a "poor" result postoperatively. The difference in deviation between preoperative and postoperative values was statistically significant (P < .001). Of the patients who had myectomy and concomitant inferior oblique disinsertion and ipsilateral superior rectus recession, 50% achieved an "excellent" result, 20% a "good" result, and 30% a "poor" result postoperatively. The difference in deviation between preoperative and postoperative values was statistically significant (P < .001). Both procedures are effective and successful in patients with superior oblique muscle palsy, but a secondary surgery may be required. Copyright 2012, SLACK Incorporated.

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…

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.

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On the same wavelength: predictable language enhances speaker-listener brain-to-brain synchrony in posterior superior temporal gyrus.

Science.gov (United States)

Dikker, Suzanne; Silbert, Lauren J; Hasson, Uri; Zevin, Jason D

2014-04-30

Recent research has shown that the degree to which speakers and listeners exhibit similar brain activity patterns during human linguistic interaction is correlated with communicative success. Here, we used an intersubject correlation approach in fMRI to test the hypothesis that a listener's ability to predict a speaker's utterance increases such neural coupling between speakers and listeners. Nine subjects listened to recordings of a speaker describing visual scenes that varied in the degree to which they permitted specific linguistic predictions. In line with our hypothesis, the temporal profile of listeners' brain activity was significantly more synchronous with the speaker's brain activity for highly predictive contexts in left posterior superior temporal gyrus (pSTG), an area previously associated with predictive auditory language processing. In this region, predictability differentially affected the temporal profiles of brain responses in the speaker and listeners respectively, in turn affecting correlated activity between the two: whereas pSTG activation increased with predictability in the speaker, listeners' pSTG activity instead decreased for more predictable sentences. Listeners additionally showed stronger BOLD responses for predictive images before sentence onset, suggesting that highly predictable contexts lead comprehenders to preactivate predicted words.

Metagenome and Metatranscriptome Analyses Using Protein Family Profiles.

Directory of Open Access Journals (Sweden)

Cuncong Zhong

2016-07-01

Full Text Available Analyses of metagenome data (MG and metatranscriptome data (MT are often challenged by a paucity of complete reference genome sequences and the uneven/low sequencing depth of the constituent organisms in the microbial community, which respectively limit the power of reference-based alignment and de novo sequence assembly. These limitations make accurate protein family classification and abundance estimation challenging, which in turn hamper downstream analyses such as abundance profiling of metabolic pathways, identification of differentially encoded/expressed genes, and de novo reconstruction of complete gene and protein sequences from the protein family of interest. The profile hidden Markov model (HMM framework enables the construction of very useful probabilistic models for protein families that allow for accurate modeling of position specific matches, insertions, and deletions. We present a novel homology detection algorithm that integrates banded Viterbi algorithm for profile HMM parsing with an iterative simultaneous alignment and assembly computational framework. The algorithm searches a given profile HMM of a protein family against a database of fragmentary MG/MT sequencing data and simultaneously assembles complete or near-complete gene and protein sequences of the protein family. The resulting program, HMM-GRASPx, demonstrates superior performance in aligning and assembling homologs when benchmarked on both simulated marine MG and real human saliva MG datasets. On real supragingival plaque and stool MG datasets that were generated from healthy individuals, HMM-GRASPx accurately estimates the abundances of the antimicrobial resistance (AMR gene families and enables accurate characterization of the resistome profiles of these microbial communities. For real human oral microbiome MT datasets, using the HMM-GRASPx estimated transcript abundances significantly improves detection of differentially expressed (DE genes. Finally, HMM

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

File list: InP.Neu.50.AllAg.Superior_Cervical_Ganglion [Chip-atlas[Archive

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QUAL DEMOCRATIZAÇÃO DO ENSINO SUPERIOR?

Directory of Open Access Journals (Sweden)

François Dubet

Full Text Available Esse artigo, resultante de uma conferência, discute traços do processo de democratização do ensino superior. Procura distinguir analiticamente várias dimensões da democratização, baseadas, por sua vez, em concepções diferentes da justiça: igualdade de oportunidades, meritocracia, utilidades e equidade dos procedimentos. Cada sociedade constrói modelos de democratização desse ensino. A massificação do ensino superior desempenhou papel democrático objetivo, favorável aos grupos sociais antes excluídos. Mas massificação não equivale à democratização. Todas as categorias sociais não se beneficiam da mesma forma da massificação. A democratização do acesso ao ensino superior não depende apenas das famílias. Depende também da estrutura geral do sistema educativo. A meritocracia acadêmica constrói uma hierarquia de competências que é também social, com forte impacto reprodutivo. As desigualdades de utilidade das diferentes formações têm impacto sobre o conjunto das desigualdades sociais. Os sistemas educativos implementam distintos procedimentos de seleção, de concessão de gratuidades, bolsas e auxílios, que podem ser considerados como mais ou menos equitativos segundo as normas de justiça que mobilizam.

Training Programs on Radiological Safety for users of Ionizing Radiations in Peru

International Nuclear Information System (INIS)

Medina Gironzini, E.

2003-01-01

In Peru, people who work with ionizing radiations must have an authorization (Individual License) as established in the Radiological Safety Regulations, which are the mandatory rules. The Technical Office of the National Authority (OTAN), which is the technical organ of the Peruvian Institute of Nuclear Energy (IPEN) in charge of controlling radiations within the country , grants the authorization after the candidate demonstrates that he/she knows the specific use of the technique using radiations, as well a s the aspects related to safety and radiological protection. Since it was created in 1972, the Superior Center of Nuclear Studies (VSEN) from IPEN has carried out different training courses so that people can work safety with ionizing radiations in medicine, industry and investigation. The analysis of the radiological safety programs carried out by CSEN during the last 30 years, which allowed the training of more than 2200 people in the country and, at the same time, made possible the securing of the respective Individual License, is presented in this work. The courses, nuclear medicine, radiotherapy, industrial radiography, nuclear gauges gamma irradiator, etc...) and are part of the continuous education program of CSEN. (Author)

Ecocardiografia transesofágica e diagnóstico intraoperatório de veia cava superior esquerda persistente Ecocardiografía transesofágica y diagnóstico intraoperatorio de vena cava superior izquierda persistente Transesophageal echocardiography and intraoperative diagnosis of persistent left superior vena cava

Directory of Open Access Journals (Sweden)

Alexander Alves da Silva

2009-12-01

Full Text Available JUSTIFICATIVA E OBJETIVOS: A persistência da veia cava superior esquerda ocorre isoladamente em 0,5% da população normal, porém nos pacientes com cardiopatia congênita chega a estar presente em 3% a 10% dos casos. O objetivo deste relato foi apresentar um caso de diagnóstico intraoperatório com o auxílio da ecocardiografia transesofágica e ressaltar a importância da sua utilização rotineira em intervenções cirúrgicas para correção de cardiopatia congênita. RELATO DO CASO: Paciente do sexo masculino, 16 anos, ASA II, com diagnóstico prévio de comunicação interatrial (CIA tipo seio venoso superior com drenagem anômala parcial de veias pulmonares em programação para correção cirúrgica da cardiopatia. Após indução da anestesia geral foi realizado ecocardiograma transesofágico (ETE. O exame inicial mostrou dilatação das câmaras cardíacas direitas, CIA tipo seio venoso superior de 17 milímetros, drenagem anômala da veia pulmonar superior direita desembocando na veia cava superior (VCS direita e dilatação do seio coronário, o que aventou a possibilidade da persistência da veia cava superior esquerda. Para a confirmação da suspeita foram injetados no acesso venoso do braço esquerdo 10 mL de solução fisiológica a 0,9% (faz o papel de "contraste" no exame ecocardiográfico e imediatamente após foram visualizadas as microbolhas passando pelo seio coronário, teste positivo para o diagnóstico de VCS superior esquerda persistente. CONCLUSÕES: A ecocardiografia transesofágica rotineira no intraoperatório de pacientes com cardiopatia congênita tem fundamental importância como método auxiliar não só ao cirurgião, muitas vezes influenciando diretamente na técnica cirúrgica empregada, como também para o anestesiologista, que pode extrair do exame uma série de informações úteis no manuseio hemodinâmico do paciente.JUSTIFICATIVA Y OBJETIVOS: La persistencia de la vena cava superior izquierda ocurre

[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.

Effect of bilateral superior oblique split lengthening on torsion

Directory of Open Access Journals (Sweden)

Jitendra Jethani

2015-01-01

Full Text Available Introduction: Superior oblique split lengthening (SOSL is done for weakening of superior oblique. It corrects the superior oblique overaction (SOOA and A pattern. Its effect on the torsion of the eye is not known. We present our data on the effect of this particular procedure on torsion. Materials and Methods: We did a study of 16 patients (32 eyes who underwent bilateral SOSL and compared the disc foveal angle (DFA preoperatively and postoperatively. The split lengthening was done from 4 mm to 7 mm depending upon the overaction of superior oblique. Results: The mean age was 15.3 ± 8.4 years. Mean preoperative DFA in the right eye (RE was −3.9° and in the left eye (LE was −2.9°. Mean postoperative DFA in RE was 0.2° and in LE was 0.9°. The mean change in the DFA for RE was 4.1° ± 1.3° and for LE was 3.8° ± 1.2°. All the patients were aligned horizontally within 6 prism diopter and no pattern and no diplopia postoperatively. The A pattern was corrected in all the patient postsurgery. For each mm of surgery, an improvement of 0.8° was seen in the DFA. Conclusion: We report the effect of SOSL on torsion. The SOSL reduces intorsion postsurgery and is, therefore, a valuable procedure in SOOA where both pattern and in torsion needs to be corrected.

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)

Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease

DEFF Research Database (Denmark)

Pedersen, Lene Rørholm; Olsen, Rasmus Huan; Anholm, Christian

2016-01-01

disease (CAD). METHODS: Seventy non-diabetic participants with CAD, BMI 28-40 kg/m(2), age 45-75 years were randomized to 12 weeks' aerobic interval training (AIT) at 85-90% of peak heart rate three times/week or a low energy diet (LED, 800-1000 kcal/day) for 8-10 weeks followed by 2-4 weeks' weight...... maintenance diet. Lipid profile atherogenicity was described using lipoprotein particle size and density profiling. Low-grade inflammation was evaluated by tumor necrosis factor alpha (TNFα), C-reactive protein, interleukin 6 and soluble urokinase plasminogen activator receptor. RESULTS: Twenty-six (74%) AIT...

Selective amygdalohippocampectomy via trans-superior temporal gyrus keyhole approach.

Science.gov (United States)

Mathon, Bertrand; Clemenceau, Stéphane

2016-04-01

Hippocampal sclerosis is the most common cause of drug-resistant epilepsy amenable for surgical treatment and seizure control. The rationale of the selective amygdalohippocampectomy is to spare cerebral tissue not included in the seizure generator. Describe the selective amygdalohippocampectomy through the trans-superior temporal gyrus keyhole approach. Selective amygdalohippocampectomy for temporal lobe epilepsy is performed when the data (semiology, neuroimaging, electroencephalography) point to the mesial temporal structures. The trans-superior temporal gyrus keyhole approach is a minimally invasive and safe technique that allows disconnection of the temporal stem and resection of temporomesial structures.

Frequency of the superior rectus muscle overaction/contracture syndrome in unilateral fourth nerve palsy.

Science.gov (United States)

Molinari, Andrea; Ugrin, Maria Cristina

2009-12-01

Superior oblique palsy is accompanied in most cases by overaction of the muscle's ipsilateral antagonist, the inferior oblique muscle. Overaction and contracture of the ipsilateral superior rectus muscle in patients with unilateral fourth (trochlear) nerve palsy is seldom discussed in the literature. The purpose of this study is to evaluate the frequency of superior rectus muscle overaction/contracture syndrome in patients with unilateral trochlear nerve palsy. The records of 198 patients with unilateral trochlear nerve palsy examined by the authors between July 1987 and July 2008 were reviewed retrospectively. All patients underwent complete eye examination with measurement of the deviation in the 9 positions of gaze and with the head tilted to both sides in all cooperative patients. Selection criteria for superior rectus muscle overaction/contracture syndrome in these patients were as follows: vertical deviation of 15(Delta) or larger in primary position, equal or larger hypertropia with the ipsilateral forced tilt test than with the eyes looking straight ahead, more than 5(Delta) hypertropia of the affected eye in horizontal gaze to the same side, hypertropia in all upgazes, and overaction of the contralateral superior oblique muscle. Of 198 patients, 33 (16.6%) met the selection criteria for superior rectus muscle overaction/contracture syndrome. Superior rectus muscle overaction/contracture syndrome frequently occurs in unilateral superior oblique palsy.

An Investigation of Health and Safety Measures in a Hydroelectric Power Plant.

Science.gov (United States)

Acakpovi, Amevi; Dzamikumah, Lucky

2016-12-01

Occupational risk management is known as a catalyst in generating superior returns for all stakeholders on a sustainable basis. A number of companies in Ghana implemented health and safety measures adopted from international companies to ensure the safety of their employees. However, there exist great threats to employees' safety in these companies. The purpose of this paper is to investigate the level of compliance of Occupational Health and Safety management systems and standards set by international and local legislation in power producing companies in Ghana. The methodology is conducted by administering questionnaires and in-depth interviews as measuring instruments. A random sampling technique was applied to 60 respondents; only 50 respondents returned their responses. The questionnaire was developed from a literature review and contained questions and items relevant to the initial research problem. A factor analysis was also carried out to investigate the influence of some variables on safety in general. Results showed that the significant factors that influence the safety of employees at the hydroelectric power plant stations are: lack of training and supervision, non-observance of safe work procedures, lack of management commitment, and lack of periodical check on machine operations. The study pointed out the safety loopholes and therefore helped improve the health and safety measures of employees in the selected company by providing effective recommendations. The implementation of the proposed recommendations in this paper, would lead to the prevention of work-related injuries and illnesses of employees as well as property damage and incidents in hydroelectric power plants. The recommendations may equally be considered as benchmark for the Safety and Health Management System with international standards.

Tullio phenomenon in superior semicircular canal dehiscence syndrome.

Science.gov (United States)

Basura, Gregory J; Cronin, Scott J; Heidenreich, Katherine D

2014-03-18

Tullio phenomenon refers to eye movements induced by sound.(1) This unusual examination finding may be seen in superior semicircular canal dehiscence (SSCD) syndrome.(2) This disorder is due to absent bone over the superior semicircular canal (figure). Patients complain of dizziness triggered by loud sound, aural fullness, autophony, and pulsatile tinnitus. When Tullio phenomenon exists in SSCD syndrome, the patient develops a mixed vertical-torsional nystagmus in which the slow phase rotates up and away from the affected ear (video on the Neurology® Web site at Neurology.org). This pattern of nystagmus aligns in the plane of the dehiscent semicircular canal and is due to excitation of its afferent nerves.

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...

Programa de Formação Interdisciplinar Superior: um novo caminho para a educação superior

Directory of Open Access Journals (Sweden)

Cibele Y. Andrade

Full Text Available Apresenta o Programa de Formação Interdisciplinar Superior (ProFIS, curso de nível superior implantado na Universidade Estadual de Campinas (Unicamp em 2011. Primeiramente, são citados os objetivos e as diretrizes que nortearam a criação do curso - aumento do ingresso de alunos de escolas públicas na universidade e a adoção de um programa de formação geral - e, em seguida, descritos, em linhas gerais, o novo curso, seu currículo e o processo de transferência dos alunos concluintes do ProFIS para os cursos de graduação da Unicamp. Conclui apresentando uma análise sobre o critério de seleção adotado, bem como alguns dados estatísticos que revelam que os propósitos de inclusão social foram plenamente alcançados pela primeira turma matriculada no programa.

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,...

German safety engineering in comparison to the Chernobyl reactor; Deutsche Sicherheitstechnik im Vergleich zum Tschernobyl-Reaktor

Energy Technology Data Exchange (ETDEWEB)

NONE

2014-04-15

In Germany the Russian RBMK would not have been licensed, since the safety standards in Germany were superior to those in the former USSR. The most significant differences - the containment, the control rod system, the void coefficient and the emergency cooling system are shortly summarized. The consequences for the population are cumulative environmental radiation exposure are reported using the official data of IAEA, WHO and UNDP.

Anthropogenic climate change has altered primary productivity in Lake Superior.

Science.gov (United States)

O'Beirne, M D; Werne, J P; Hecky, R E; Johnson, T C; Katsev, S; Reavie, E D

2017-06-09

Anthropogenic climate change has the potential to alter many facets of Earth's freshwater resources, especially lacustrine ecosystems. The effects of anthropogenic changes in Lake Superior, which is Earth's largest freshwater lake by area, are not well documented (spatially or temporally) and predicted future states in response to climate change vary. Here we show that Lake Superior experienced a slow, steady increase in production throughout the Holocene using (paleo)productivity proxies in lacustrine sediments to reconstruct past changes in primary production. Furthermore, data from the last century indicate a rapid increase in primary production, which we attribute to increasing surface water temperatures and longer seasonal stratification related to longer ice-free periods in Lake Superior due to anthropogenic climate warming. These observations demonstrate that anthropogenic effects have become a prominent influence on one of Earth's largest, most pristine lacustrine ecosystems.

Reproduction of superior sagittal sinus animal model by bypass transplantation of biomaterial graft

Directory of Open Access Journals (Sweden)

Qing-yong LUO

2011-03-01

Full Text Available Objective To establish the beagles model of superior sagittal sinus bypass graft,and explore the feasibility of reconstruction of superior sagittal sinus with biomaterials using this model.Methods Eight adult male beagles(weight: 12.5-22.0kg were involved in the present study.The superior sagittal sinus was exposed and blocked via bone window,and then anastomosed side-to-end to the biomaterial graft under the dedicated microscope of neurosurgery surgery,expectant treatment such as anti-inflammatory was given for the animals.The digital subtraction venography(DSV and color Doppler flow imaging(CDFI of superior sagittal sinus were performed in 1,2,4 and 8 weeks after the operation.Eight weeks after the operation,all the animals were sacrificed and the material graft was examined histologically.Results The DSV and CDFI of superior sagittal sinus showed that the stomas of 2 beagles were with slight stenosis and high flow velocity,of 1 beagle with small leakage and low flow velocity,while of other 5 beagles were normal.The histological examination showed endothelial cells were growing on the graft and superior sagittal sinus,and crawling toward the lumen of graft 8 weeks after the operation.Conclusion The beagles model of superior sagittal sinus bypass graft was established successfully.The short-term effect of the model was satisfactory,while further work should be performed to determine the long-term effects.

Information Superiority: Outsourcing an Air Force Core Competency?

National Research Council Canada - National Science Library

McTerman, Hugh

1997-01-01

.... This thesis explores the perceived relationship between the core competency requirements for information superiority and the tasks defined for the Air Force communication, computer, and information career field...

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.

Superiority illusion arises from resting-state brain networks modulated by dopamine.

Science.gov (United States)

Yamada, Makiko; Uddin, Lucina Q; Takahashi, Hidehiko; Kimura, Yasuyuki; Takahata, Keisuke; Kousa, Ririko; Ikoma, Yoko; Eguchi, Yoko; Takano, Harumasa; Ito, Hiroshi; Higuchi, Makoto; Suhara, Tetsuya

2013-03-12

The majority of individuals evaluate themselves as superior to average. This is a cognitive bias known as the "superiority illusion." This illusion helps us to have hope for the future and is deep-rooted in the process of human evolution. In this study, we examined the default states of neural and molecular systems that generate this illusion, using resting-state functional MRI and PET. Resting-state functional connectivity between the frontal cortex and striatum regulated by inhibitory dopaminergic neurotransmission determines individual levels of the superiority illusion. Our findings help elucidate how this key aspect of the human mind is biologically determined, and identify potential molecular and neural targets for treatment for depressive realism.

Mycotic aneurysm of the superior mesenteric artery after septic embolism; Entwicklung eines mykotischen Aneurysmas der A. mesenterica superior nach septischer Embolie

Energy Technology Data Exchange (ETDEWEB)

Schmidt, F.; Dinkel, H.P. [Institut fuer Diagnostische Radiologie, Inselspital, Universitaetsklinik Bern (Switzerland)

2002-07-01

Mycotic aneurysms of the aorta and the visceral arteries are life-threatening diseases, due to potential rupture and organ or limb ischemia. They occur in endocarditis, immunodeficiency, bacteremia and fungemia, and have a poor prognosis.We report on a case of a 54-year-old male patient suffering from abdominal angina after mitral valve replacement for septic mycotic endocarditis. In presence of a mycotic-embolic occlusion of the left popliteal artery and multiple septic organ infarctions a mycotic aneurysm of the superior mesenteric artery was found in abdominal spiral-CT.Based on sequential spiral-CT examinations, this case demonstrates the development of a septic aneurysm of the superior mesenteric artery. (orig.) [German] Mykotische Aneurysmen der Aorta und ihrer Aeste stellen wegen Rupturgefahr und moeglicher Minderperfusion von Organen und Extremitaeten eine lebensgefaehrliche Erkrankung mit unguenstiger Prognose dar. Beguenstigende Faktoren sind geschwaechte Immunabwehr, Endokarditis, Bakteriaemie und Fungaemie.Wir berichten ueber einen 54-jaehrigen Patienten, der nach einem Mitralklappenersatz bei mykotischer Endokarditis zunehmende abdominelle Beschwerden im Sinne einer Angina abdominalis entwickelte. Die abdominelle Spiralcomputertomographie zeigte ein mykotisches Aneurysma der A. mesenterica superior. Daneben bestanden ein mykotischer Verschluss der linken A. poplitea und multiple septische Organinfarkte.Der Fall demonstriert anhand sequentieller Computertomographien eindrucksvoll die Entwicklung eines septischen Viszeralarterienaneurysmas. (orig.)

Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study.

Science.gov (United States)

Ballard, C; Sauter, M; Scheltens, P; He, Y; Barkhof, F; van Straaten, E C W; van der Flier, W M; Hsu, C; Wu, S; Lane, R

2008-09-01

The aim was to evaluate the efficacy, safety and tolerability of rivastigmine capsules in patients diagnosed with probable vascular dementia (VaD). VantagE (Vascular Dementia trial studying Exelon) was a 24-week, multicentre, double-blind study. VaD patients aged 50-85 years were randomized to rivastigmine capsules (3-12 mg/day) or placebo. Efficacy assessments included global and cognitive performances, activities of daily living and neuropsychiatric symptoms. Adverse events were recorded. Additional exploratory analyses determined whether heterogeneity in pathologies and symptoms extended to differential treatment effects. NCT00099216. 710 patients were randomized. Rivastigmine demonstrated superiority over placebo on three measures of cognitive performance (Vascular Dementia Assessment Scale, Alzheimer's Disease Assessment Scale cognitive subscale, Mini-Mental State Examination; all p or =75 years old), assumed more likely to also have Alzheimer's disease (AD) pathology, demonstrated significant cognitive responses to rivastigmine and a safety profile similar to that seen in AD patients. Younger patients, assumed less likely to have concomitant AD pathology, showed no efficacy response and were associated with slight elevations of blood pressure, cerebrovascular accidents and mortality. Rivastigmine-placebo differences in patients with, versus those without, medial temporal atrophy (also suggestive of concomitant AD) showed a numerical difference similar to that seen between the older versus younger patients, but did not attain statistical significance. Consistent with trials evaluating other cholinesterase inhibitors, rivastigmine did not provide consistent efficacy in probable VaD. The efficacy apparent on cognitive outcomes was derived from effects in older patients likely to have concomitant Alzheimer pathology. This is supportive of an existing argument that the putative cholinergic deficit in VaD reflects the presence of concomitant Alzheimer pathology.

Mechanism of the superior mechanical strength of nanometer-sized metal single crystals revealed

KAUST Repository

Afify, N. D.

2013-10-01

Clear understanding of the superior mechanical strength of nanometer-sized metal single crystals is required to derive advanced mechanical components retaining such superiority. Although high quality studies have been reported on nano-crystalline metals, the superiority of small single crystals has neither been fundamentally explained nor quantified to this date. Here we present a molecular dynamics study of aluminum single crystals in the size range from 4.1 nm to 40.5 nm. We show that the ultimate mechanical strength deteriorates exponentially as the single crystal size increases. The small crystals superiority is explained by their ability to continuously form vacancies and to recover them. © 2013 Published by Elsevier B.V.

Mammographic varicosities indicative of a superior mediastinal ...

African Journals Online (AJOL)

In addition, an abnormal calibre of the superficial veins can reflect not only underrying breast pathology, but a collateral venous return resulting from an upper mediastinal obstruction. A case mammographically demonstrating mammary varicosities resulting from a superior mediastinal syndrome is described. S. Afr. Med.

Síndrome de Deiscência de Canal Semicircular Superior Superior Canal Dehiscence Syndrome

Directory of Open Access Journals (Sweden)

Suzane da Cunha Ferreira

2006-06-01

Full Text Available A Síndrome de Deiscência de Canal Semicircular Superior (SDCSS, primeiramente descrita em 1998 por Minor et al., caracteriza-se por vertigem associada à presença de nistagmo, relacionados à exposição a estímulos sonoros intensos ou a modificações de pressão dentro da orelha média ou intracraniana. Disacusia, em sua maioria de padrão condutivo à audiometria tonal, também pode estar presente. Nesta revisão da literatura objetivou-se abordar a SDCSS, com seus principais sinais e sintomas, achados diagnósticos e tratamento, assim como enfatizar a importância de sua inclusão dentre as causas de vertigem, visto tratar-se de acometimento ainda pouco conhecido até mesmo entre especialistas. O diagnóstico correto, além de possibilitar seu tratamento, impede que abordagens diagnósticas e terapêuticas inapropriadas sejam realizadas.The Superior Canal Dehiscence Syndrome (SCDS was first reported by Minor at. Al. (1998, and has been characterized by vertigo and vertical-torsional eye movements related to loud sounds or stimuli that change middle ear or intracranial pressure. Hearing loss, for the most part with conductive patterns on audiometry, may be present in this syndrome. We performed a literature survey in order to to present symptoms, signs, diagnostic and therapeutic approaches to the SCDS, also aiming at stressing the great importance of including this syndrome among the tractable cause of vertigo. We should emphasize that this is a recent issue, still unknown by some specialists. The Correct SCDS diagnosis, besides enabling patient treatment, precludes misdiagnosis and inadequate therapeutic approaches.

[Analysis of the safety culture in a Cardiology Unit managed by processes].

Science.gov (United States)

Raso-Raso, Rafael; Uris-Selles, Joaquín; Nolasco-Bonmatí, Andreu; Grau-Jornet, Guillermo; Revert-Gandia, Rosa; Jiménez-Carreño, Rebeca; Sánchez-Soriano, Ruth M; Chamorro-Fernández, Carlos I; Marco-Francés, Elvira; Albero-Martínez, José V

2017-04-04

Safety culture is one of the requirements for preventing the occurrence of adverse effects. However, this has not been studied in the field of cardiology. The aim of this study is to evaluate the safety culture in a cardiology unit that has implemented and certified an integrated quality and risk management system for patient safety. A cross-sectional observational study was conducted in 2 consecutive years, with all staff completing the Spanish version of the questionnaire, "Hospital Survey on Patient Safety Culture" of the "Agency for Healthcare Research and Quality", with 42 items grouped into 12 dimensions. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. The overall assessment out of a possible 5, was 4.5 in 2014 and 4.7 in 2015. Seven dimensions were identified as strengths. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions compared to national data, and in 8 of them compared to American data. The safety culture in a Cardiology Unit with an integrated quality and risk management patient safety system is high, and higher than nationally in all its dimensions and in most of them compared to the United States. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

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.

Magnetic resonance imaging in congenital superior oblique palsy

International Nuclear Information System (INIS)

Sato, Miho; Kondo, Nagako; Awaya, Shinobu; Nomura, Hideki; Yagasaki, Teiji.

1996-01-01

MRI examinations were carried out on the defined congenital superior oblique palsy in order to distinguish the congenital and acquired palsies. Subjects were 19 patients diagnosed as congenital and their MRI images of 3 or 5 mm-thick coronary slice were taken. The volume of the oblique muscle was calculated from the images and a comparison was made between the diseased and healthy normal sides. The oblique muscle volume at the diseased side was found reduced in most of congenital superior oblique palsy patients. The reduction was observed even at childhood and was thus considered to be a malformation. Further, it is conceivable that the palsy could be caused by the abnormality in the central nervous system as well as by the present anatomical abnormality. (K.H.)

Safety Profile of Meswak Root Extract on Liver, Kidney, Sexual Hormones and Hematological Parameters of Rats

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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.

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.

Status of the shortjaw cisco (Coregonus zenithicus) in Lake Superior

Science.gov (United States)

Hoff, Michael H.; Todd, Thomas N.

2004-01-01

The shortjaw cisco (Coregonus zenithicus) was historically found in Lakes Huron, Michigan, and Superior, but has been extirpated in Lakes Huron and Michigan apparently as the result of commercial overharvest. During 1999-2001, we conducted an assessment of shortjaw cisco abundance in five areas, spanning the U.S. waters of Lake Superior, and compared our results with the abundance measured at those areas in 1921-1922. The shortjaw cisco was found at four of the five areas sampled, but abundances were so low that they were not significantly different from zero. In the four areas where shortjaw ciscoes were found, abundance declined significantly by 99% from the 1920s to the present. To increase populations of this once economically and ecologically important species in Lake Superior, an interagency rehabilitation effort is needed. Population monitoring is recommended to assess population trends and to evaluate success of rehabilitation efforts.

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

Food suppliers' perceptions and practical implementation of food safety regulations in Taiwan.

Science.gov (United States)

Ko, Wen-Hwa

2015-12-01

The relationships between the perceptions and practical implementation of food safety regulations by food suppliers in Taiwan were evaluated. A questionnaire survey was used to identify individuals who were full-time employees of the food supply industry with at least 3 months of experience. Dimensions of perceptions of food safety regulations were classified using the constructs of attitude of employees and corporate concern attitude for food safety regulation. The behavior dimension was classified into employee behavior and corporate practice. Food suppliers with training in food safety were significantly better than those without training with respect to the constructs of perception dimension of employee attitude, and the constructs of employee behavior and corporate practice associated with the behavior dimension. Older employees were superior in perception and practice. Employee attitude, employee behavior, and corporate practice were significantly correlated with each other. Satisfaction with governmental management was not significantly related to corporate practice. The corporate implementation of food safety regulations by suppliers was affected by employees' attitudes and behaviors. Furthermore, employees' attitudes and behaviors explain 35.3% of corporate practice. Employee behavior mediates employees' attitudes and corporate practices. The results of this study may serve as a reference for governmental supervision and provide training guidelines for workers in the food supply industry. Copyright © 2015. Published by Elsevier B.V.

Acute Bilateral Superior Branch Vestibular Neuropathy

Directory of Open Access Journals (Sweden)

Dario A. Yacovino

2018-05-01

Full Text Available The rapid onset of a bilateral vestibular hypofunction (BVH is often attributed to vestibular ototoxicity. However, without any prior exposure to ototoxins, the idiopathic form of BVH is most common. Although sequential bilateral vestibular neuritis (VN is described as a cause of BVH, clinical evidence for simultaneous and acute onset bilateral VN is unknown. We describe a patient with an acute onset of severe gait ataxia and oscillopsia with features compatible with acute BVH putatively due to a bilateral VN, which we serially evaluated with clinical and laboratory vestibular function testing over the course of 1 year. Initially, bilateral superior and horizontal semicircular canals and bilateral utricles were impaired, consistent with damage to both superior branches of each vestibular nerve. Hearing was spared. Only modest results were obtained following 6 months of vestibular rehabilitation. At a 1-year follow-up, only the utricular function of one side recovered. This case is the first evidence supporting an acute presentation of bilateral VN as a cause for BVH, which would not have been observed without critical assessment of each of the 10 vestibular end organs.

DEMANDA E POLÍTICAS PÚBLICAS PARA O ENSINO SUPERIOR NOS BRICS

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Simon Schwartzman

Full Text Available Este artigo analisa a expansão do ensino superior nos países chamados BRICS. A aspiração crescente pelo ensino superior obriga os governos a gerir os custos de funcionamento desse sistema. As respostas de cada país variam com sua história, cultura e regime político. Todos eles enfrentam problemas semelhantes, como escassez de recursos e o poder político de atores do sistema de ensino superior e fora dele. Cinco dilemas se apresentam aos países: 1 expansão, igualdade de acesso e diversificação das matrículas, taxas de participação, o número e os tipos de instituições; 2 limitações financeiras; 3 regulação do ensino superior privado; 4 como fazer com que as instituições de ensino superior prestem mais contas a seus alunos, funcionários e à sociedade como um todo; e 5 qualidade e relevância social da aprendizagem e pesquisa em instituições de ensino superior. Utilizando dados e evidências das pesquisas mais recentes, o artigo mostra respostas comuns, com algumas exceções em cada caso: diversificação institucional; políticas de ação afirmativa; crescimento das matrículas nas ciências sociais, humanidades, profissões sociais e Educação; pouco sucesso nas políticas de internacionalização.

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...

Widening of mediastinum with persistent left superior Vena cava - CT diagnosis

International Nuclear Information System (INIS)

Neuwirth, J.; Kolar, J.

1992-01-01

Described in this paper are radiographic findings recorded from a case of persistent left superior vena cava which grew manifest by widening of the left contour of the upper mediastinal region. Contrast-enhanced computed tomography (CT) was undertaken to clear up suspicion of mediastinal tumour and revealed double superior vena cava. The diagnosis was then confirmed by digital subtraction venography. (orig.) [de

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.

Evaluation of the Superior Gluteal Nerve During Proximal Femoral Nailing

Directory of Open Access Journals (Sweden)

Mehmet Sonmez

2017-05-01

Full Text Available Aim: The superior gluteal nerve may be compromised during hip surgery. We retrospectively evaluated the patients who underwent proximal femoral nailing for unstable trochanteric fractures in order to investigate the presence of superior gluteal nerve injury and its clinical findings. Material and Method: Twenty five patients (14 women, 11 men were included in the study who had femoral nailing between January 2004 and March 2010 at Hamidiye Sisli Etfal Training and Research Hospital Department of Orthopaedics. Two different types of nails which have similar designs and surgical techniques were used for fracture fixation. Patients who had a history of cerebrovascular disease, electromyography findings of polyneuropathy, or degenerative vertebral disease were excluded from the study. Patients were evaluated clinically and radiologically. Findings related to acute denervation in the gluteus medius muscle and motor unit action potential changes were accepted as signs of superior gluteal nerve injury. Results: Eight patients were using support during walking and three of these patients had positive Trendelenburg sign, but only one patient had acute denervation signs of the superior gluteal nerve. Discussion: Based on the present study the incidence of iatrogenic nerve injury is a rare complication of proximal femoral nailing. Elderly patients, regardless of whether they have nerve injury, may limp and need to use a walking support.

Superior pre-attentive auditory processing in musicians.

Science.gov (United States)

Koelsch, S; Schröger, E; Tervaniemi, M

1999-04-26

The present study focuses on influences of long-term experience on auditory processing, providing the first evidence for pre-attentively superior auditory processing in musicians. This was revealed by the brain's automatic change-detection response, which is reflected electrically as the mismatch negativity (MMN) and generated by the operation of sensoric (echoic) memory, the earliest cognitive memory system. Major chords and single tones were presented to both professional violinists and non-musicians under ignore and attend conditions. Slightly impure chords, presented among perfect major chords elicited a distinct MMN in professional musicians, but not in non-musicians. This demonstrates that compared to non-musicians, musicians are superior in pre-attentively extracting more information out of musically relevant stimuli. Since effects of long-term experience on pre-attentive auditory processing have so far been reported for language-specific phonemes only, results indicate that sensory memory mechanisms can be modulated by training on a more general level.

Laparoscopic management of superior mesentric artery syndrome: A case report and review of literature

Directory of Open Access Journals (Sweden)

Makam Ramesh

2008-01-01

Full Text Available Superior mesentric artery syndrome is a rare cause of high small bowel obstruction, caused by compression of the transverse part of the duodenum in between the superior mesentric artery and aorta. Patients present with chronic abdominal pain, vomiting and weight loss. We report a case of superior mesenteric artery syndrome, managed laparoscopically with laparoscopic duodenojejunostomy.

A Inclusão de Pessoas com Necessidades Especiais no Ensino Superior

Directory of Open Access Journals (Sweden)

Ronaldo Queiroz de OLIVEIRA

Full Text Available RESUMO: trata-se de uma revisão integrativa que objetivou analisar a produção científica sobre a educação inclusiva no ensino superior. Os dados foram coletados nas bases de dados Lilacs, Scielo, Cochrane, Medline e PubMed, entre os anos 2005 e 2014, utilizando-se os descritores controlados Special Education, Education Higher, Mainstreaming Education e Disabled Personse e os descritores não controlados Educação Especial, Educação Superior, Inclusão Educacional e Pessoas com Deficiência; Educación Superior, Propensíon Educación, Personas com Discapacidad. A amostra constituiu em 16 artigos. As publicações sobre a educação inclusiva no ensino superior têm sido tênues, demonstrando que ainda há muito a avançar nesse assunto. Conclui-se que o tema educação inclusiva é mais estudado em relação às crianças; as atenções dos estudiosos em relação a pessoas adultas com necessidades especiais envolvem mais a assistência em saúde e não a educação inclusiva no ensino superior.

Accommodation and convergence palsy caused by lesions in the bilateral rostral superior colliculus.

Science.gov (United States)

Ohtsuka, Kenji; Maeda, Sachie; Oguri, Naomi

2002-03-01

To report a patient who developed accommodation and convergence palsy caused by lesions in the bilateral rostral superior colliculus. Observational case report. A 30-year-old right-handed man experienced sudden onset of diplopia and blurred vision at near vision. The patient showed accommodation and convergence palsy. Magnetic resonance imaging revealed lesions located in the bilateral rostral superior colliculus. These findings suggest that the rostral superior colliculus is involved in the control of accommodation and vergence eye movements.

Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin

DEFF Research Database (Denmark)

Sperl, Jan; Horvath, Gabor; Halota, Waldemar

2016-01-01

daily (n=129) or sofosbuvir (400mg once daily) plus PR (n=128). Primary efficacy objective was sustained virologic response 12weeks after the end of therapy (SVR12, HCV RNA tier 1 safety event. RESULTS: The majority...... the lower bound of the 1-sided 1-sample exact test was greater than -10% and greater than zero, both non-inferiority and superiority of EBR/GZR vs. SOF/PR were established. The frequency of tier 1 safety events was lower among patients receiving EBR/GZR than SOF/PR (0.8% vs. 27.8%, between group difference...... pegylated interferon/ribavirin (SOF/PR) in patients with HCV infection. METHODS: This was a randomized, open-label, phase III trial. Two hundred fifty-seven patients with HCV genotype (GT)1 or 4 infection and baseline viral load >10,000IU/ml were randomized to receive 12weeks of EBR/GZR 50mg/100mg once...

Safety concerns in composite manufacturing and machining

Science.gov (United States)

Asmatulu, Eylem; Alonayni, Abdullah; Alamir, Mohammed

2018-03-01

Because of the superior properties, composites have been used in many industrial applications, including aerospace, wind turbines, ships, cars, fishing rods, storage tanks, swimming pool panels, and baseball bats. Each application may require different combinations of reinforcements and matrices, which make the manufacturing safety even more challenging while working on these substances. In this study, safety issues in composite manufacturing and machining were investigated in detail, and latest developments were provided for workers. The materials most frequently used in composite manufacturing, such as matrix (polyester, vinylester, phenolic, epoxies, methyl ethyl ketone peroxide, benzoil peroxide, hardeners, and solvents), and reinforcement materials (carbon, glass and Kevlar fibers, honeycomb and foams) can be highly toxic to human body. These materials can also be very toxic to the environment when dumped out uncontrollably, creating major future health and environmental concerns. Throughout the manufacturing process, workers inhale vapors of the liquid matrix, hardeners and solvents / thinners, as well as reinforcement materials (chopped fibers and particles) in airborne. Milling, cutting and machining of the composites can further increase the toxic inhalations of airborne composite particles, resulting in major rashes, irritation, skin disorders, coughing, severe eye and lung injury and other serious illnesses. The major portions of these hazardous materials can be controlled using appropriate personal protective equipment for the chemicals and materials used in composite manufacturing and machining. This study provides best possible safety practices utilized in composite manufacturing facilities for workers, engineers and other participants.

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...

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.

Mechanism of the superior mechanical strength of nanometer-sized metal single crystals revealed

KAUST Repository

Afify, N. D.; Salem, H. G.; Yavari, A.; El Sayed, Tamer S.

2013-01-01

Clear understanding of the superior mechanical strength of nanometer-sized metal single crystals is required to derive advanced mechanical components retaining such superiority. Although high quality studies have been reported on nano

Financial Control and Safety. An investigation on how financial and safety aspects are integrated in the decision making at the Swedish nuclear power plants; Ekonomistyrning och saekerhet. En utredning om hur ekonomi- och saekerhetsaspekter integreras vid beslutsfattandet vid kaernkraftverken

Energy Technology Data Exchange (ETDEWEB)

Vaernild, Ola [OV Konsult i Vaesteraas AB, Vaesteraas (Sweden)

2005-08-01

The alleged inter-relationship between economy and nuclear safety has been investigated. Through interviews and review of instructions and other documents, information on how management at Swedish nuclear power plants integrates financial control and safety management has been compiled. Owners of nuclear power plants have well founded expectations on that the plants are profitable and that the operations are rationalized in order to reduce costs. This could allegedly threaten the nuclear safety. However, it is not to be expected that there are any obvious relationships between expenditures and safety. The quality of the safety management has to be judged in terms of how well safety requirements are met irrespective of the associated costs. The owners have imposed clear financial objectives on the nuclear power plants. At the same time they have also established policies for nuclear safety. The nuclear power plants have systems for operations management, which basically comprise separate parts for operations planning and quality management. Financial control and safety management are included in the operations planning and quality management respectively. The quality management impose restrictions to be adhered to in the operations planning. This means that from a formal point of view, the safety management is superior to the operations planning. There are examples of simple as well as advanced approaches to financial management at the nuclear power plants. In all cases the methods used are reasonably well adapted to the needs. Typical for all plants is the focus on long-term aspects. Investments are for example analysed in a plant life-time perspective. With regard to safety, profitability calculations are not required to the same extent for safety related investments as for other investments. A number of factors, which tend to warrant that safety aspects are given the appropriate attention in the decision making, have been identified. Examples of such factors are

Information Superiority generated through proper application of Geoinformatics

Science.gov (United States)

Teichmann, F.

2012-04-01

Information Superiority generated through proper application of Geoinformatics Information management and especially geoscience information delivery is a very delicate task. If it is carried out successfully, geoscientific data will provide the main foundation of Information Superiority. However, improper implementation of geodata generation, assimilation, distribution or storage will not only waste valuable resources like manpower or money, but could also give rise to crucial deficiency in knowledge and might lead to potentially extremely harmful disasters or wrong decisions. Comprehensive Approach, Effect Based Operations and Network Enabled Capabilities are the current buzz terms in the security regime. However, they also apply to various interdisciplinary tasks like catastrophe relief missions, civil task operations or even in day to day business operations where geo-science data is used. Based on experience in the application of geoscience data for defence applications the following procedure or tool box for generating geodata should lead to the desired information superiority: 1. Understand and analyse the mission, the task and the environment for which the geodata is needed 2. Carry out a Information Exchange Requirement between the user or customer and the geodata provider 3. Implementation of current interoperability standards and a coherent metadata structure 4. Execute innovative data generation, data provision, data assimilation and data storage 5. Apply a cost-effective and reasonable data life cycle 6. Implement IT security by focusing of the three pillar concepts Integrity, Availability and Confidentiality of the critical data 7. Draft and execute a service level agreement or a memorandum of understanding between the involved parties 8. Execute a Continuous Improvement Cycle These ideas from the IT world should be transferred into the geoscience community and applied in a wide set of scenarios. A standardized approach of how to generate, provide

The Picture Superiority Effect and Biological Education.

Science.gov (United States)

Reid, D. J.

1984-01-01

Discusses learning behaviors where the "picture superiority effect" (PSE) seems to be most effective in biology education. Also considers research methodology and suggests a new research model which allows a more direct examination of the strategies learners use when matching up picture and text in efforts to "understand"…

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.

Three-Dimensional Printed Prosthesis for Repair of Superior Canal Dehiscence.

Science.gov (United States)

Kozin, Elliott D; Remenschneider, Aaron K; Cheng, Song; Nakajima, Hideko Heidi; Lee, Daniel J

2015-10-01

Outcomes following repair of superior canal dehiscence (SCD) are variable, and surgery carries a risk of persistent or recurrent SCD symptoms, as well as a risk of hearing loss and vestibulopathy. Poor outcomes may occur from inadequate repair of the SCD or mechanical insult to the membranous labyrinth. Repair of SCD using a customized, fixed-length prosthesis may address current operative limitations and improve surgical outcomes. We aim to 3-dimensionally print customized prostheses to resurface or occlude bony SCD defects. Dehiscences were created along the arcuate eminence of superior semicircular canals in cadaveric temporal bones. Prostheses were designed and created using computed tomography and a 3-dimensional printer. The prostheses occupied the superior semicircular canal defect, reflected in postrepair computed tomography scans. This novel approach to SCD repair could have advantages over current techniques. Refinement of prosthesis design and materials will be important if this approach is translated into clinical use. © American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.

Superior cervical gangliectomy induces non-exudative age-related macular degeneration in mice

Directory of Open Access Journals (Sweden)

Hernán H. Dieguez

2018-02-01

Full Text Available Non-exudative age-related macular degeneration, a prevalent cause of blindness, is a progressive and degenerative disease characterized by alterations in Bruch's membrane, retinal pigment epithelium, and photoreceptors exclusively localized in the macula. Although experimental murine models exist, the vast majority take a long time to develop retinal alterations and, in general, these alterations are ubiquitous, with many resulting from non-eye-specific genetic manipulations; additionally, most do not always reproduce the hallmarks of human age-related macular degeneration. Choroid vessels receive sympathetic innervation from the superior cervical ganglion, which, together with the parasympathetic system, regulates blood flow into the choroid. Choroid blood flow changes have been involved in age-related macular degeneration development and progression. At present, no experimental models take this factor into account. The aim of this work was to analyze the effect of superior cervical gangliectomy (also known as ganglionectomy on the choroid, Bruch's membrane, retinal pigment epithelium and retina. Adult male C57BL/6J mice underwent unilateral superior cervical gangliectomy and a contralateral sham procedure. Although superior cervical gangliectomy induced ubiquitous choroid and choriocapillaris changes, it induced Bruch's membrane thickening, loss of retinal pigment epithelium melanin content and retinoid isomerohydrolase, the appearance of drusen-like deposits, and retinal pigment epithelium and photoreceptor atrophy, exclusively localized in the temporal side. Moreover, superior cervical gangliectomy provoked a localized increase in retinal pigment epithelium and photoreceptor apoptosis, and a decline in photoreceptor electroretinographic function. Therefore, superior cervical gangliectomy recapitulated the main features of human non-exudative age-related macular degeneration, and could become a new experimental model of dry age

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

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.

The U.S.A. and the energy safety in East Asia

International Nuclear Information System (INIS)

Harmat, K.

2006-01-01

In the contribution under consideration the author reports on the impact of the United States of America (U.S.A.) in East Asia. The American policy in East Asia is based on two fundamental principles: providing, that no regional authority may provoke the position of the U.S.A., as well as protection of the access to regional markets for the American economy. The U.S.A. fulfill their protective function of their Asiatic partners by means of their maritime superiority with the pacific fleet. Strong-points and safety contracts with Japan and the Republic of Korea form the support of the presence of the U.S. American military. The According to energy security, the interests of the U.S.A. in East Asia are: (a) Secure supply of the national economies in East Asia; (b) Security of the maritime supply systems; (c) Stability and liberalization of the international oil markets; (d) Responsible handling of nuclear energy; (e) Environmental protection. Furthermore, the author describes the conflict potentials between the U.S.A. and the energy safety in East Asia as well as the long-term significance of the energy safety in East Asia

Subjective qualities of memories associated with the picture superiority effect in schizophrenia.

Science.gov (United States)

Huron, Caroline; Danion, Jean-Marie; Rizzo, Lydia; Killofer, Valérie; Damiens, Annabelle

2003-02-01

Patients with schizophrenia (n = 24) matched with 24 normal subjects were presented with both words and pictures. On a recognition memory task, they were asked to give remember, know, or guess responses to items that were recognized on the basis of conscious recollection, familiarity, or guessing, respectively. Compared with normal subjects, patients exhibited a lower picture superiority effect selectively related to remember responses. Unlike normal subjects, they did not exhibit any word superiority effect in relation to guess responses; this explains why the overall picture superiority effect appeared to be intact. These results emphasize the need to take into account the subjective states of awareness when analyzing memory impairments in schizophrenia.

Persistency of the left superior caval vein. Diagnosis and its prenatal importance

International Nuclear Information System (INIS)

Jaramillo, Juan F; Estrada Perea, Mercy H; Muriel, Yina Y

2010-01-01

Certain heart fetal planes must be realized during a routine obstetric ultrasound in order to identify a group of anomalies such as the persistency of the left superior caval vein. When an isolated left superior venal vein is identified without any other anomaly of the fetal heart, it does not have any perinatal repercussion. Its importance lies in the fact that a considerable number of these cases are associated with a high incidence of congenital heart diseases and anatomic and chromosomal abnormalities. This article reports nine cases of persistency of the left superior caval vein as well as the associated heart abnormalities and the extra-cardiac alterations found.

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

La macdonalización de la educación superior

Directory of Open Access Journals (Sweden)

Enrique Javier Díez Gutiérrez

2011-01-01

Full Text Available l neoliberalismo se ha convertido en el “telón de fondo” de los ajustes de la política en la educación superior a nivel mundial, que no se limitan ya al recorte en la asignación de recursos o a su privatización, sino que afectan básicamente a los núcleos centrales del ideario educativo y a las políticas pedagógicas. Los conflictos que se dirimen en la educación superior no son más que una parte de la crisis más general de la política y de la ciudadanía en el capitalismo global. Con el argumento de que la educación superior debe atender a las demandas sociales, se hace una interpretación claramente reduccionista de qué sea la sociedad, poniendo a la universidad al exclusivo servicio de las empresas y se centra la formación en preparar exclusivamente el tipo de trabajadores y trabajadoras solicitados por éstas. Las inversiones en la educación superior y los currículos deben ser pensados de acuerdo con las exigencias del mercado y como preparación al mercado de trabajo. El papel público de la educación superior como campo de entrenamiento para la democracia y para la ciudadanía democrática se ha pasado a considerar como un despilfarro del gasto público, siendo reemplazado por el punto de vista que la empresa privada tiene de la función de la enseñanza superior: un campo de entrenamiento para atender las necesidades de las empresas. La persona trabajadora “flexible” y “polivalente” constituye así la referencia del nuevo ideal pedagógico. El problema de fondo es el marco global en el que se inscribe y la filosofía que orienta esta reforma y que parece desplegar un funcionamiento mercantil de la educación en Europa. Porque esta reforma no parece tratar de poner la universidad al servicio de la sociedad para hacerla más justa, más sabia, más universal, más equitativa, más comprensiva, sino de adaptar la universidad al mercado, una parte muy concreta de la sociedad, cuyas finalidades no se orientan

A Layer-specific Corticofugal Input to the Mouse Superior Colliculus.

Science.gov (United States)

Zurita, Hector; Rock, Crystal; Perkins, Jessica; Apicella, Alfonso Junior

2017-07-05

In the auditory cortex (AC), corticofugal projections arise from each level of the auditory system and are considered to provide feedback "loops" important to modulate the flow of ascending information. It is well established that the cortex can influence the response of neurons in the superior colliculus (SC) via descending corticofugal projections. However, little is known about the relative contribution of different pyramidal neurons to these projections in the SC. We addressed this question by taking advantage of anterograde and retrograde neuronal tracing to directly examine the laminar distribution, long-range projections, and electrophysiological properties of pyramidal neurons projecting from the AC to the SC of the mouse brain. Here we show that layer 5 cortico-superior-collicular pyramidal neurons act as bandpass filters, resonating with a broad peak at ∼3 Hz, whereas layer 6 neurons act as low-pass filters. The dissimilar subthreshold properties of layer 5 and layer 6 cortico-superior-collicular pyramidal neurons can be described by differences in the hyperpolarization-activated cyclic nucleotide-gated cation h-current (Ih). Ih also reduced the summation of short trains of artificial excitatory postsynaptic potentials injected at the soma of layer 5, but not layer 6, cortico-superior-collicular pyramidal neurons, indicating a differential dampening effect of Ih on these neurons. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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).

Don't words come easy? A psychophysical exploration of word superiority

DEFF Research Database (Denmark)

Starrfelt, Randi; Petersen, Anders; Vangkilde, Signe Allerup

2013-01-01

Words are made of letters, and yet sometimes it is easier to identify a word than a single letter. This word superiority effect (WSE) has been observed when written stimuli are presented very briefly or degraded by visual noise. We compare performance with letters and words in three experiments, ...... and visual short term memory capacity. So, even if single words come easy, there is a limit to the word superiority effect....

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.

iTRAQ-based proteome profile analysis of superior and inferior Spikelets at early grain filling stage in japonica Rice.

Science.gov (United States)

You, Cuicui; Chen, Lin; He, Haibing; Wu, Liquan; Wang, Shaohua; Ding, Yanfeng; Ma, Chuanxi

2017-06-07

Large-panicle rice varieties often fail to achieve their yield potential due to poor grain filling of late-flowering inferior spikelets (IS). The physiological and molecular mechanisms of poor IS grain filling, and whether an increase in assimilate supply could regulate protein abundance and consequently improve IS grain filling for japonica rice with large panicles is still partially understood. A field experiment was performed with two spikelet removal treatments at anthesis in the large-panicle japonica rice line W1844, including removal of the top 1/3 of spikelets (T1) and removal of the top 2/3 of spikelets (T2), with no spikelet removal as a control (T0). The size, weight, setting rate, and grain filling rate of IS were significantly increased after spikelet removing. The biological functions of the differentially expressed proteins (DEPs) between superior and inferior spikelets as well as the response of IS to the removal of superior spikelets (SS) were investigated by using iTRAQ at 10 days post anthesis. A total of 159, 87, and 28 DEPs were identified from group A (T0-SS/T0-IS), group B (T0-SS/T2-IS), and group C (T2-IS/T0-IS), respectively. Among these, 104, 63, and 22 proteins were up-regulated, and 55, 24, and 6 proteins were down-regulated, respectively. Approximately half of these DEPs were involved in carbohydrate metabolism (sucrose-to-starch metabolism and energy metabolism) and protein metabolism (protein synthesis, folding, degradation, and storage). Reduced endosperm cell division and decreased activities of key enzymes associated with sucrose-starch metabolism and nitrogen metabolism are mainly attributed to the poor sink strength of IS. In addition, due to weakened photosynthesis and respiration, IS are unable to obtain a timely supply of materials and energy after fertilization, which might be resulted in the stagnation of IS development. Finally, an increased abundance of 14-3-3 protein in IS could be involved in the inhibition of starch

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.

Redes de colaboración en Educación Superior

OpenAIRE

Solano Fernández, Isabel Mª

2012-01-01

Redes de colaboración para la Educación Superior. Se analiza el modelo pedagógico constructivista social, y dentro de este el método colaborativo. Posteriormente analiza las posibilidades de las redes, redes sociales y medios sociales, para la Educación. Presentación realizada para realizar el taller "redes de colaboración en Educación Superior" en el Seminario de innovación docente Organizado por el Centro de Desarrolo Docente (CDDOC) de la Universidad Católica de Chile.

Ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock: Case report.

Science.gov (United States)

Corbacioglu, Kerem Seref; Aksel, Gokhan; Yildiz, Altan

2016-03-01

Pseudoaneurysm of the superior gluteal artery (SGA) is very rare and the most common causes are blunt or penetrating pelvic traumas. Although pseudoaneurysm can be asymptomatic at the time of initial trauma, it can be symptomatic weeks, months, even years after initial trauma. We present a case of a ruptured superior gluteal artery pseudoaneurysm with hemorrhagic shock twenty days after a bomb injury in the Syria civil war. In addition, we review the anatomy of the SGA, clinical presentation and pitfalls of pseudoaneurysm, and imaging and treatment options.

THE GENERAL CONTEXTUAL FRAME FOR PLACING SUPERIOR STUDIES GRADUATES IN THE WORK MARKET

Directory of Open Access Journals (Sweden)

FELICIA ANDRIONI

2013-12-01

Full Text Available Integration in a workplace is an interaction rapport between the individual and the environment. The process of professional integration is strongly linked to the professional aspiration, individual expectations, motivation, and work satisfaction. Placing young graduates of superior studies on the labour market is a challenge for contemporary society. Identifying a suitable work place as well as the certainty of the attained work place are very important elements for young superior studies graduates in the current context of economic crysis. The difficulties in getting a job for superior studies graduates are most frequently associated with lacks in what regards the speciality practical skills and generally, insertion in the work market is achived by getting a position in fields that are related or even different from the speciality field. In an extremely unstable social and economic context, people’s ability to quickly adapt to the requirements of the labour market is fundamental. In this respect, education and professional training have an important role, contributing to the update of knowledge, skills and qualifications of superior studies graduates or future superior studies graduates, eventually allowing them to stay active, flexible, adapted to the situations and requirements of the labour market.

LA EDUCACIÓN SUPERIOR CUBANA: LOGROS Y PERSPECTIVAS

Directory of Open Access Journals (Sweden)

Acela Cantero Zayas

2004-01-01

Full Text Available El impetuoso desarrollo de la ciencia y la técnica contemporáneo en general y muy específicamente en la realidad cubana, está dirigido a satisfacer las necesidades creciente de nuestra sociedad, lo que conlleva a un continuo perfeccionamiento de todo el sistema educativo en correspondencia con las exigencias, demandas y necesidades de nuestro pueblo. En tal sentido, para comprender los resultados que exhibe la Educación cubana y dentro de ella la Educación Superior, se precisa de toda una reflexión histórica, como soporte lógico y metodológico del hecho educativo cubano. En la actualidad, el mayor impacto de nuestra Educación Superior, desde los puntos de vista social, político, económico y en especial formativo, lo constituye, el diseño e implementación del modelo de Universalización, el cual tiene como objetivo supremo la extensión de la Universidad a los distintos municipios del país, con la finalidad de irradiar cultura y saber, que son las únicas modalidades de garantizar un hombre libre y de hecho una sociedad independiente. En el presente trabajo se muestra una panorámica de la Educación Superior en Cuba, partiendo del elemento histórico hasta la contemporaneidad y en ésta, los nuevos retos impuestos por el contexto socio-político a escala mundial.

Visual search for emotional expressions: Effect of stimulus set on anger and happiness superiority.

Science.gov (United States)

Savage, Ruth A; Becker, Stefanie I; Lipp, Ottmar V

2016-01-01

Prior reports of preferential detection of emotional expressions in visual search have yielded inconsistent results, even for face stimuli that avoid obvious expression-related perceptual confounds. The current study investigated inconsistent reports of anger and happiness superiority effects using face stimuli drawn from the same database. Experiment 1 excluded procedural differences as a potential factor, replicating a happiness superiority effect in a procedure that previously yielded an anger superiority effect. Experiments 2a and 2b confirmed that image colour or poser gender did not account for prior inconsistent findings. Experiments 3a and 3b identified stimulus set as the critical variable, revealing happiness or anger superiority effects for two partially overlapping sets of face stimuli. The current results highlight the critical role of stimulus selection for the observation of happiness or anger superiority effects in visual search even for face stimuli that avoid obvious expression related perceptual confounds and are drawn from a single database.

Superior mesenteric artery syndrome following initiation of cisplatin-containing chemotherapy: a case report

Directory of Open Access Journals (Sweden)

Ushiki Atsuhito

2012-01-01

Full Text Available Abstract Introduction Superior mesenteric artery syndrome is a rare cause of upper intestinal obstruction resulting from compression of the duodenum by the superior mesenteric artery and abdominal aorta. Case presentation We describe a case of superior mesenteric artery syndrome in a 61-year-old Japanese man with non-small cell lung cancer who had been treated with cisplatin-containing chemotherapy and had lost 7 kg in weight. The diagnosis was confirmed by the typical findings of abdominal computed tomography showing distended stomach resulting from compression of the third portion of the duodenum and reduction of an aortomesenteric distance and aortomesenteric angle. Conclusions This case highlights the importance of considering the possibility of superior mesenteric artery syndrome in patients treated with chemotherapy, especially those presenting with a low body mass index and showing weight loss during chemotherapy.

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

An MRI Study of Superior Temporal Gyrus Volume in Women With Schizotypal Personality Disorder

OpenAIRE

Dickey, Chandlee C.; McCarley, Robert William; Voglmaier, Martina M.; Niznikiewicz, Margaret A.; Seidman, Larry Joel; Demeo, Susan; Frumin, Melissa; Shenton, Martha Elizabeth

2003-01-01

Objective: An abnormal superior temporal gyrus has figured prominently in schizophrenia research, and left superior temporal gyrus volume has been shown to be smaller in male subjects with schizotypal personality disorder. This is the first structural magnetic resonance imaging study to examine a group of female subjects with schizotypal personality disorder. Method: The superior temporal gyrus was drawn on coronal images acquired from female subjects recruited from the community (schizotypal...

False memories in highly superior autobiographical memory individuals

Science.gov (United States)

Patihis, Lawrence; Frenda, Steven J.; LePort, Aurora K. R.; Petersen, Nicole; Nichols, Rebecca M.; Stark, Craig E. L.; McGaugh, James L.; Loftus, Elizabeth F.

2013-01-01

The recent identification of highly superior autobiographical memory (HSAM) raised the possibility that there may be individuals who are immune to memory distortions. We measured HSAM participants’ and age- and sex-matched controls’ susceptibility to false memories using several research paradigms. HSAM participants and controls were both susceptible to false recognition of nonpresented critical lure words in an associative word-list task. In a misinformation task, HSAM participants showed higher overall false memory compared with that of controls for details in a photographic slideshow. HSAM participants were equally as likely as controls to mistakenly report they had seen nonexistent footage of a plane crash. Finding false memories in a superior-memory group suggests that malleable reconstructive mechanisms may be fundamental to episodic remembering. Paradoxically, HSAM individuals may retrieve abundant and accurate autobiographical memories using fallible reconstructive processes. PMID:24248358

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

Superior cervical gangliectomy induces non-exudative age-related macular degeneration in mice.

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Dieguez, Hernán H; Romeo, Horacio E; González Fleitas, María F; Aranda, Marcos L; Milne, Georgia A; Rosenstein, Ruth E; Dorfman, Damián

2018-02-07

Non-exudative age-related macular degeneration, a prevalent cause of blindness, is a progressive and degenerative disease characterized by alterations in Bruch's membrane, retinal pigment epithelium, and photoreceptors exclusively localized in the macula. Although experimental murine models exist, the vast majority take a long time to develop retinal alterations and, in general, these alterations are ubiquitous, with many resulting from non-eye-specific genetic manipulations; additionally, most do not always reproduce the hallmarks of human age-related macular degeneration. Choroid vessels receive sympathetic innervation from the superior cervical ganglion, which, together with the parasympathetic system, regulates blood flow into the choroid. Choroid blood flow changes have been involved in age-related macular degeneration development and progression. At present, no experimental models take this factor into account. The aim of this work was to analyze the effect of superior cervical gangliectomy (also known as ganglionectomy) on the choroid, Bruch's membrane, retinal pigment epithelium and retina. Adult male C57BL/6J mice underwent unilateral superior cervical gangliectomy and a contralateral sham procedure. Although superior cervical gangliectomy induced ubiquitous choroid and choriocapillaris changes, it induced Bruch's membrane thickening, loss of retinal pigment epithelium melanin content and retinoid isomerohydrolase, the appearance of drusen-like deposits, and retinal pigment epithelium and photoreceptor atrophy, exclusively localized in the temporal side. Moreover, superior cervical gangliectomy provoked a localized increase in retinal pigment epithelium and photoreceptor apoptosis, and a decline in photoreceptor electroretinographic function. Therefore, superior cervical gangliectomy recapitulated the main features of human non-exudative age-related macular degeneration, and could become a new experimental model of dry age-related macular degeneration, and

Picture superiority in free recall: the effects of normal aging and primary degenerative dementia.

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Rissenberg, M; Glanzer, M

1986-01-01

A key factor in the decline of memory with age may be a breakdown of communication in the information network involved in memory and cognitive processing. A special case of this communication is assumed to underlie the picture superiority effect in recall. From this hypothesis it follows that the picture superiority effect should lessen with age. In Experiment 1, three groups of adults (young, old normal, and old memory-impaired) were tested in free recall of pictures and word lists. As predicted, the picture superiority effect declined with age. Experiment 2 replicated these findings and showed, moreover, that the picture superiority effect can be reestablished in normal old adults by instructing them to verbalize overtly during item presentation.

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.

Superior cold recycling : The score project

OpenAIRE

LESUEUR, D; POTTI, JJ; SOUTHWELL, C; WALTER, J; CRUZ, M; DELFOSSE, F; ECKMANN, B; FIEDLER, J; RACEK, I; SIMONSSON, B; PLACIN, F; SERRANO, J; RUIZ, A; KALAAJI, A; ATTANE, P

2004-01-01

In order to develop Environmentally Friendly Construction Technologies (EFCT) and as part of the 5th Framework Program of Research and Development, the European Community has decided to finance a research project on cold recycling, entitled SCORE "Superior COld REcycling based on benefits of bituminous microemulsions and foamed bitumen. A EFCT system for the rehabilitation and the maintenance of roads". This research project gathers organizations from all over Europe, from industrial partners...

Large-Scale Selection and Breeding To Generate Industrial Yeasts with Superior Aroma Production

Science.gov (United States)

Steensels, Jan; Meersman, Esther; Snoek, Tim; Saels, Veerle

2014-01-01

The concentrations and relative ratios of various aroma compounds produced by fermenting yeast cells are essential for the sensory quality of many fermented foods, including beer, bread, wine, and sake. Since the production of these aroma-active compounds varies highly among different yeast strains, careful selection of variants with optimal aromatic profiles is of crucial importance for a high-quality end product. This study evaluates the production of different aroma-active compounds in 301 different Saccharomyces cerevisiae, Saccharomyces paradoxus, and Saccharomyces pastorianus yeast strains. Our results show that the production of key aroma compounds like isoamyl acetate and ethyl acetate varies by an order of magnitude between natural yeasts, with the concentrations of some compounds showing significant positive correlation, whereas others vary independently. Targeted hybridization of some of the best aroma-producing strains yielded 46 intraspecific hybrids, of which some show a distinct heterosis (hybrid vigor) effect and produce up to 45% more isoamyl acetate than the best parental strains while retaining their overall fermentation performance. Together, our results demonstrate the potential of large-scale outbreeding to obtain superior industrial yeasts that are directly applicable for commercial use. PMID:25192996

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

The picture superiority effect in conceptual implicit memory: a conceptual distinctiveness hypothesis.

Science.gov (United States)

Hamilton, Maryellen; Geraci, Lisa

2006-01-01

According to leading theories, the picture superiority effect is driven by conceptual processing, yet this effect has been difficult to obtain using conceptual implicit memory tests. We hypothesized that the picture superiority effect results from conceptual processing of a picture's distinctive features rather than a picture's semantic features. To test this hypothesis, we used 2 conceptual implicit general knowledge tests; one cued conceptually distinctive features (e.g., "What animal has large eyes?") and the other cued semantic features (e.g., "What animal is the figurehead of Tootsie Roll?"). Results showed a picture superiority effect only on the conceptual test using distinctive cues, supporting our hypothesis that this effect is mediated by conceptual processing of a picture's distinctive features.

Generando vinculación académica en el IPN entre el nivel medio superior y superior en unidades de aprendizaje de básicas

OpenAIRE

Gil Balderrama, Sara Beatríz; Pérez Bussó, Carlos Eduardo

2016-01-01

El Instituto Politécnico Nacional (IPN) en el estado de Guanajuato presenta, como muchas instituciones educativas un enorme filtro de abandono y deserción en los primeros semestres del nivel superior. En este trabajo, presentamos una experiencia docente en el CECyT 174, una escuela del nivel medio superior del I.P.N. en la ciudad de León, Guanajuato, México. Este reporte es el trabajo desarrollado por los autores intentando que la labor académica contribuya a reducir la brecha existente entre...

USAF Warrior Studies: Air Superiority in World War 2 and Korea,

Science.gov (United States)

1983-01-01

cal aiMr. and lO\\\\ dild air s.uperiority. lit in. in the latle 1940s!? Did our- emphasis onl str~ateiC’c and nuclear air power do us harm .’ Did It...cmim l t~ ilc ItI-, t.- tha \\i,’IC t I I.t. 1 4 1, h AIR SUPERIORITY to as operational masturbation . I have always felt the B-52s were to a large

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.

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.

Superiorized algorithm for reconstruction of CT images from sparse-view and limited-angle polyenergetic data

Science.gov (United States)

Humphries, T.; Winn, J.; Faridani, A.

2017-08-01

Recent work in CT image reconstruction has seen increasing interest in the use of total variation (TV) and related penalties to regularize problems involving reconstruction from undersampled or incomplete data. Superiorization is a recently proposed heuristic which provides an automatic procedure to ‘superiorize’ an iterative image reconstruction algorithm with respect to a chosen objective function, such as TV. Under certain conditions, the superiorized algorithm is guaranteed to find a solution that is as satisfactory as any found by the original algorithm with respect to satisfying the constraints of the problem; this solution is also expected to be superior with respect to the chosen objective. Most work on superiorization has used reconstruction algorithms which assume a linear measurement model, which in the case of CT corresponds to data generated from a monoenergetic x-ray beam. Many CT systems generate x-rays from a polyenergetic spectrum, however, in which the measured data represent an integral of object attenuation over all energies in the spectrum. This inconsistency with the linear model produces the well-known beam hardening artifacts, which impair analysis of CT images. In this work we superiorize an iterative algorithm for reconstruction from polyenergetic data, using both TV and an anisotropic TV (ATV) penalty. We apply the superiorized algorithm in numerical phantom experiments modeling both sparse-view and limited-angle scenarios. In our experiments, the superiorized algorithm successfully finds solutions which are as constraints-compatible as those found by the original algorithm, with significantly reduced TV and ATV values. The superiorized algorithm thus produces images with greatly reduced sparse-view and limited angle artifacts, which are also largely free of the beam hardening artifacts that would be present if a superiorized version of a monoenergetic algorithm were used.

[Safety and efficacy of ketamine for pain relief].